Systems and methods for operating a respiratory therapy system

Abstract

A method for determining operating of a respiratory therapy system includes receiving data associated with use of the respiratory therapy system by an individual, analyzing the data to determine a value of each of one or more critical therapy pressures that are each associated with a peak of a pressure distribution curve for the one or more sleep sessions, and determining a pressure moderation curve and a pressure decay curve for use in the operation of the respiratory therapy system during a subsequent sleep session of the individual, The pressure moderation curve and the pressure decay curve are based at least in part on the value of each of the one or more critical therapy pressures for the individual.

Description

SYSTEMS AND METHODS FOR OPERATING A RESPIRATORY THERAPY SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of, and priority to, U.S. Provisional Patent Application No. 63 / 727,163 filed on December 2, 2024, and U.S. Provisional Patent Application No. 63 / 654,287 filed on May 31, 2024, each of which is hereby incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates generally to systems and methods for operating a respiratory therapy system, and more particularly, to systems and methods for determining therapy pressure increases and decreases in response to respiratory events during use of a respiratory therapy system.BACKGROUND

[0003] Many individuals suffer from sleep-related and / or respiratory disorders such as, for example, Sleep-Disordered Breathing (SDB), which can include Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), other types of apneas such as mixed apneas and hypopneas, and Respiratory Effort Related Arousal (RERA). These individuals may also suffer from other health conditions (which may be referred to as comorbidities), such as insomnia (characterized by, for example, difficult in initiating sleep, frequent or prolonged awakenings after initially falling asleep, and / or an early awakening with an inability to return to sleep), Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), rapid eye movement (REM) behavior disorder (also referred to as RBD), dream enactment behavior (DEB), hypertension, diabetes, stroke, and chest wall disorders. These individuals are often treated using a respiratory therapy system (e.g., a continuous positive airway pressure (CPAP) system), which delivers pressurized air to aid in preventing the individual’s airway from narrowing or collapsing during sleep. The respiratory therapy system can include a conduit that delivers the pressurized air from a respiratory therapy device having a flow generator (e.g., a motor), to a user interface coupled to the individual’s face. The pressure of this pressurized air can dynamically increase and decrease in response to the detection of respiratory eventsexperienced by the individual. However, different individual may require different types of increases and decreases to effectively manage the respiratory events without negatively impacting the individual’s sleep, general comfort, or compliance with their prescribed therapy. The present disclosure is directed to solving these and other problems.SUMMARY

[0004] According to some implementations of the present disclosure, a method for determining operating of a respiratory therapy system includes receiving data associated with one or more sleep sessions associated with use of the respiratory therapy system by an individual, the respiratory therapy system having provided pressurized air to the individual during the one or more sleep sessions. The method further includes analyzing the data to determine, for the individual, a value of each of one or more critical therapy pressures, each of the critical therapy pressures being associated with a peak of a pressure distribution curve for the one or more sleep sessions. The method further includes determining a pressure moderation curve and a pressure decay curve for use in the operation of the respiratory therapy system during a subsequent sleep session of the individual, the pressure moderation curve and the pressure decay curve being based at least in part on the value of each of the one or more critical therapy pressures for the individual.

[0005] According to some implementations of the present disclosure, a system for determining operation of a respiratory therapy system includes a control system and a memory. The control system includes one or more processors. The memory stores machine-readable instructions. The control system is coupled to the memory device, and is configured to execute the machine- readable instructions to implement a method. The method includes receiving data associated with one or more sleep sessions associated with use of the respiratory therapy system by an individual, the respiratory therapy system having provided pressurized air to the individual during the one or more sleep sessions. The method further includes analyzing the data to determine, for the individual, a value of each of one or more critical therapy pressures, each of the critical therapy pressures being associated with a peak of a pressure distribution curve for the one or more sleep sessions. The method further includes determining a pressure moderation curve and a pressure decay curve for use in the operation of the respiratory therapy system during a subsequent sleep session of the individual, the pressure moderation curve and thepressure decay curve being based at least in part on the value of each of the one or more critical therapy pressures for the individual.

[0006] According to some implementations of the present disclosure, a system for determining operation of a respiratory therapy system includes the respiratory therapy system, a memory device, and a control system. The respiratory therapy system is configured to supply pressurized air to an individual. The memory device stores thereon machine-readable instructions. The control system includes one or more processors that are configured to execute the machine-readable instructions to implement a method. The method includes receiving data associated with one or more sleep sessions associated with use of the respiratory therapy system by an individual, the respiratory therapy system having provided pressurized air to the individual during the one or more sleep sessions. The method further includes analyzing the data to determine, for the individual, a value of each of one or more critical therapy pressures, each of the critical therapy pressures being associated with a peak of a pressure distribution curve for the one or more sleep sessions. The method further includes determining a pressure moderation curve and a pressure decay curve for use in the operation of the respiratory therapy system during a subsequent sleep session of the individual, the pressure moderation curve and the pressure decay curve being based at least in part on the value of each of the one or more critical therapy pressures for the individual.

[0007] According to some implementations of the present disclosure, a method of operating a respiratory therapy system includes receiving data associated with one or more sleep sessions associated with use of the respiratory therapy system by an individual, the respiratory therapy system having provided pressurized air to the individual during the one or more sleep sessions. The method further includes analyzing the data to determine, for the individual, a number of critical therapy pressures, each critical therapy pressure being a pressure of air provided by the respiratory therapy system during the one or more sleep sessions at which the individual experienced less than a threshold number of respiratory events. The method further includes, in response to the number of critical therapy pressures being one or two, analyzing the data to determine, for each respective critical therapy pressure, a spread of the respective critical therapy pressure across the one or more of sleep sessions. The method further includes, based at least in part on the number of critical therapy pressures and the spread of each respective critical therapy pressure, configuring, for a subsequent sleep session of the individual, the respiratory therapy system to operate according to a first mode of operation, a second mode of operation, or a third mode of operation. The first mode of operation is associated with the individual having one critical therapy pressure. The second mode of operation is associatedwith the individual having two critical therapy pressures. The third mode of operation is associated with the individual not having one or two critical therapy pressures.

[0008] According to some implementations of the present disclosure, a system for determining operation of a respiratory therapy system includes a control system and a memory. The control system includes one or more processors. The memory stores machine-readable instructions. The control system is coupled to the memory device, and is configured to execute the machine- readable instructions to implement a method. The method includes receiving data associated with one or more sleep sessions associated with use of the respiratory therapy system by an individual, the respiratory therapy system having provided pressurized air to the individual during the one or more sleep sessions. The method further includes analyzing the data to determine, for the individual, a number of critical therapy pressures, each critical therapy pressure being a pressure of air provided by the respiratory therapy system during the one or more sleep sessions at which the individual experienced less than a threshold number of respiratory events. The method further includes, in response to the number of critical therapy pressures being one or two, analyzing the data to determine, for each respective critical therapy pressure, a spread of the respective critical therapy pressure across the one or more of sleep sessions. The method further includes, based at least in part on the number of critical therapy pressures and the spread of each respective critical therapy pressure, configuring, for a subsequent sleep session of the individual, the respiratory therapy system to operate according to a first mode of operation, a second mode of operation, or a third mode of operation. The first mode of operation is associated with the individual having one critical therapy pressure. The second mode of operation is associated with the individual having two critical therapy pressures. The third mode of operation is associated with the individual not having one or two critical therapy pressures.

[0009] According to some implementations of the present disclosure, a system for determining operation of a respiratory therapy system includes the respiratory therapy system, a memory device, and a control system. The respiratory therapy system is configured to supply pressurized air to an individual. The memory device stores thereon machine-readable instructions. The control system includes one or more processors that are configured to execute the machine-readable instructions to implement a method. The method includes receiving data associated with one or more sleep sessions associated with use of the respiratory therapy system by an individual, the respiratory therapy system having provided pressurized air to the individual during the one or more sleep sessions. The method further includes analyzing the data to determine, for the individual, a number of critical therapy pressures, each criticaltherapy pressure being a pressure of air provided by the respiratory therapy system during the one or more sleep sessions at which the individual experienced less than a threshold number of respiratory events. The method further includes, in response to the number of critical therapy pressures being one or two, analyzing the data to determine, for each respective critical therapy pressure, a spread of the respective critical therapy pressure across the one or more of sleep sessions. The method further includes, based at least in part on the number of critical therapy pressures and the spread of each respective critical therapy pressure, configuring, for a subsequent sleep session of the individual, the respiratory therapy system to operate according to a first mode of operation, a second mode of operation, or a third mode of operation. The first mode of operation is associated with the individual having one critical therapy pressure. The second mode of operation is associated with the individual having two critical therapy pressures. The third mode of operation is associated with the individual not having one or two critical therapy pressures.

[0010] The above summary is not intended to represent each embodiment or every aspect of the present invention. Additional features and benefits of the present invention are apparent from the detailed description and figures set forth below.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a functional block diagram of a system for detecting rainout in a respiratory therapy system, according to some implementations of the present disclosure;

[0012] FIG. 2 is a perspective view of the system of FIG. 1, a user of the system, and a bed partner of the user, according to some implementations of the present disclosure;

[0013] FIG. 3 illustrates an exemplary timeline for a sleep session, according to some implementations of the present disclosure;

[0014] FIG. 4 illustrates an exemplary hypnogram associated with the sleep session of FIG. 3, according to some implementations of the present disclosure;

[0015] FIG. 5 is a plot illustrating two example pressure moderation curves associated with a standard mode of operation, according to some implementations of the present disclosure;

[0016] FIG. 6A is a pressure distribution curve of recorded therapy pressures for a first individual having one critical therapy pressure, according to some implementations of the present disclosure;

[0017] FIG. 6B is a pressure distribution curve of recorded therapy pressures for a second individual having two critical therapy pressures, according to some implementations of thepresent disclosure;

[0018] FIG. 7A is a plot illustrating an example pressure moderation curve associated with a first mode of operation, according to some implementations of the present disclosure;

[0019] FIG. 7B is a plot illustrating an example pressure decay curve associated with the first mode of operation, according to some implementations of the present disclosure;

[0020] FIG. 7C is a plot illustrating an example pressure versus time curve associated with the first mode of operation, according to some implementations of the present disclosure;

[0021] FIG. 8A is a plot illustrating an example pressure moderation curve associated with a second mode of operation, according to some implementations of the present disclosure;

[0022] FIG. 8B is a plot illustrating an example pressure decay curve associated with the second mode of operation, according to some implementations of the present disclosure;

[0023] FIG. 8C is a plot illustrating an example pressure versus time curve associated with the second mode of operation, according to some implementations of the present disclosure;

[0024] FIG. 9A is a plot illustrating an example pressure moderation curve associated with a third mode of operation, according to some implementations of the present disclosure;

[0025] FIG. 9B is a plot illustrating an example pressure decay curve associated with the third mode of operation, according to some implementations of the present disclosure;

[0026] FIG. 9C is a plot illustrating an example pressure versus time curve associated with the third mode of operation, according to some implementations of the present disclosure;

[0027] FIG. 10 is a process flow diagram of a method for operating a respiratory therapy system, according to some implementations of the present disclosure;

[0028] FIG. 11 A is a pressure distribution curve of recorded therapy pressures having one peak, according to some implementations of the present disclosure;

[0029] FIG. 1 IB is a pressure distribution curve of recorded therapy pressures having two peaks, according to some implementations of the present disclosure;

[0030] FIG. 11C is a pressure distribution curve of recorded therapy pressures having three peaks, according to some implementations of the present disclosure;

[0031] FIG. 12A is a plot illustrating an example pressure moderation curve associated with a fourth mode of operation, according to some implementations of the present disclosure;

[0032] FIG. 12B is a plot illustrating an example pressure decay curve associated with the fourth mode of operation, according to some implementations of the present disclosure; and

[0033] FIG. 12C is a plot illustrating an example pressure versus time curve associated with the fourth mode of operation, according to some implementations of the present disclosure.

[0034] FIG. 13 A is a plot illustrating therapy pressure levels at the beginning of a sleep sessionwhen a ramp setting is set to On, according to some implementations of the present disclosure.

[0035] FIG. 13B is a plot illustrating therapy pressure levels at the beginning of a sleep session when a ramp setting is set to Off, according to some implementations of the present disclosure.

[0036] FIG. 13C is a plot illustrating therapy pressure levels at the beginning of a sleep session when a ramp setting is set to Auto, according to some implementations of the present disclosure.

[0037] While the present disclosure is susceptible to various modifications and alternative forms, specific implementations and embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that it is not intended to limit the present disclosure to the particular forms disclosed, but on the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.DETAILED DESCRIPTION

[0038] The present disclosure is described with reference to the attached figures, where like reference numerals are used throughout the figures to designate similar or equivalent elements. The figures are not drawn to scale, and are provided merely to illustrate the instant disclosure. Several aspects of the disclosure are described below with reference to example applications for illustration.

[0039] Many individuals suffer from sleep-related and / or respiratory disorders. Examples of sleep-related and / or respiratory disorders include Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Sleep-Disordered Breathing (SDB), Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), other types of apneas, Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and chest wall disorders.

[0040] Many individuals suffer from sleep-related and / or respiratory disorders, such as Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Sleep-Disordered Breathing (SDB) such as Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA) and other types of apneas, Respiratory Effort Related Arousal (RERA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and chest wall disorders. Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterized by events including occlusion or obstruction of the upper air passage during sleep resulting from a combination of an abnormally small upper airway and the normal loss ofmuscle tone in the region of the tongue, soft palate, and posterior oropharyngeal wall. Central Sleep Apnea (CSA) is another form of sleep disordered breathing. CSA results when the brain temporarily stops sending signals to the muscles that control breathing. Other types of apneas include hypopnea, hyperpnea, and hypercapnia. Hypopnea is generally characterized by slow or shallow breathing caused by a narrowed airway, as opposed to a blocked airway. Hyperpnea is generally characterized by an increase depth and / or rate of breathing. Hypercapnia is generally characterized by elevated or excessive carbon dioxide in the bloodstream, typically caused by inadequate respiration. A Respiratory Effort Related Arousal (RERA) event is typically characterized by an increased respiratory effort for ten seconds or longer leading to arousal from sleep and which does not fulfill the criteria for an apnea or hypopnea event. RERAs are defined as a sequence of breaths characterized by increasing respiratory effort leading to an arousal from sleep, but which does not meet criteria for an apnea or hypopnea. These events must fulfil both of the following criteria: (1) a pattern of progressively more negative esophageal pressure, terminated by a sudden change in pressure to a less negative level and an arousal, and (2) the event lasts ten seconds or longer. In some implementations, a Nasal Cannula / Pressure Transducer System is adequate and reliable in the detection of RERAs. A RERA detector may be based on a real flow signal derived from a respiratory therapy device. For example, a flow limitation measure may be determined based on a flow signal. A measure of arousal may then be derived as a function of the flow limitation measure and a measure of sudden increase in ventilation. One such method is described in WO 2008 / 138040 and U.S. Patent No. 9,358,353, assigned to ResMed Ltd., the disclosure of each of which is hereby incorporated by reference herein in their entireties.

[0041] Cheyne-Stokes Respiration (CSR) is a further form of SDB. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive de-oxygenation and re-oxygenation of the arterial blood. OHS is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness. COPD encompasses any of a group of lower airway diseases that have certain characteristics in common, such as increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. NMD encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Chest wall disorders are a group of thoracicdeformities that result in inefficient coupling between the respiratory muscles and the thoracic cage.

[0042] Many of these disorders are characterized by particular events (e.g., snoring, an apnea, a hypopnea, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof) that can occur when the individual is sleeping. A wide variety of types of data can be used to monitor the health of individuals having any of the above types of sleep-related and / or respiratory disorders (or other disorders).

[0043] The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea during a sleep session. The AHI is calculated by dividing the number of apnea and / or hypopnea events experienced by the user during the sleep session by the total number of hours of sleep in the sleep session. The event can be, for example, a pause in breathing that lasts for at least 10 seconds. An AHI that is less than 5 is considered normal. An AHI that is greater than or equal to 5, but less than 15 is considered indicative of mild sleep apnea. An AHI that is greater than or equal to 15, but less than 30 is considered indicative of moderate sleep apnea. An AHI that is greater than or equal to 30 is considered indicative of severe sleep apnea. In children, an AHI that is greater than 1 is considered abnormal. Sleep apnea can be considered “controlled” when the AHI is normal, or when the AHI is normal or mild. The AHI can also be used in combination with oxygen desaturation levels to indicate the severity of Obstructive Sleep Apnea.

[0044] Referring to FIG. 1, a system 100, according to some implementations of the present disclosure, is illustrated. The system 100 includes a control system 110, a memory device 114, an electronic interface 119, one or more sensors 130, and optionally one or more user devices 170. In some implementations, the system 100 further includes a respiratory therapy system 120 (that includes a respiratory therapy device 122), a blood pressure device 180, an activity tracker 190, or any combination thereof. The system 100 can be used to optimize the values of one or more parameters of the respiratory therapy system.

[0045] The control system 110 includes one or more processors 112 (hereinafter, processor 112). The control system 110 is generally used to control (e.g., actuate) the various components of the system 100 and / or analyze data obtained and / or generated by the components of the system 100. The processor 112 can be a general or special purpose processor or microprocessor. While one processor 112 is shown in FIG. 1, the control system 110 can include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.) that can be in a single housing, or located remotely from each other. Thecontrol system 110 (or any other control system) or a portion of the control system 110 such as the processor 112 (or any other processor(s) or portion(s) of any other control system), can be used to carry out one or more steps of any of the methods described and / or claimed herein. The control system 110 can be coupled to and / or positioned within, for example, a housing of the user device 170, and / or within a housing of one or more of the sensors 130. The control system 110 can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct). In such implementations including two or more housings containing the control system 110, such housings can be located proximately and / or remotely from each other.

[0046] The memory device 114 stores machine-readable instructions thereon that are executable by the processor 112 of the control system 110. The memory device 114 can be any suitable computer readable storage device or media, such as, for example, a random or serial access memory device, a hard drive, a solid state drive, a flash memory device, etc. While one memory device 114 is shown in FIG. 1, the system 100 can include any suitable number of memory devices 114 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). The memory device 114 can be coupled to and / or positioned within a housing of the respiratory therapy device 122 of the respiratory therapy system 120, within a housing of the user device 170, within a housing of one or more of the sensors 130, or any combination thereof. Like the control system 110, the memory device 114 can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct).

[0047] In some implementations, the memory device 114 stores a user profile associated with the user. The user profile can include, for example, demographic information associated with the user, biometric information associated with the user, medical information associated with the user, self-reported user feedback, sleep parameters associated with the user (e.g., sleep- related parameters recorded from one or more earlier sleep sessions), or any combination thereof. The demographic information can include, for example, information indicative of an age of the user, a gender of the user, a race of the user, a family medical history (such as a family history of insomnia or sleep apnea), an employment status of the user, an educational status of the user, a socioeconomic status of the user, or any combination thereof. The medical information can include, for example, information indicative of one or more medical conditions associated with the user, medication usage by the user, or both. The medical information data can further include a fall risk assessment associated with the user (e.g., a fall risk score using the Morse fall scale), a multiple sleep latency test (MSLT) result or score and / or a PittsburghSleep Quality Index (PSQI) score or value. The self-reported user feedback can include information indicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, a recent life event experienced by the user, or any combination thereof.

[0048] The electronic interface 119 is configured to receive data (e.g., physiological data and / or acoustic data) from the one or more sensors 130 such that the data can be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. The electronic interface 119 can communicate with the one or more sensors 130 using a wired connection or a wireless connection (e.g., using an RF communication protocol, a WiFi communication protocol, a Bluetooth communication protocol, an IR communication protocol, over a cellular network, over any other optical communication protocol, etc.). The electronic interface 119 can include an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof. The electronic interface 119 can also include one more processors and / or one more memory devices that are the same as, or similar to, the processor 112 and the memory device 114 described herein. In some implementations, the electronic interface 119 is coupled to or integrated in the user device 170. In some implementations, the electronic interface 119 is coupled to or integrated (e.g., in a housing) with the control system 110 and / or the memory device 114.

[0049] As noted above, in some implementations, the system 100 optionally includes a respiratory therapy system 120 (also referred to as a respiratory pressure therapy system). The respiratory therapy system 120 can include a respiratory therapy device 122 (also referred to as a respiratory pressure device), a user interface 124 (also referred to as a mask or a patient interface), a conduit 126 (also referred to as a tube or an air circuit), a display device 128, a humidification tank 129, a receptacle 182, or any combination thereof. In some implementations, the control system 110, the memory device 114, the display device 128, one or more of the sensors 130, the humidification tank 129, and the receptacle 182 are part of the respiratory therapy device 122. Respiratory pressure therapy refers to the application of a supply of air to an entrance to a user’s airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the user’s breathing cycle (e.g., in contrast to negative pressure therapies such as the tank ventilator or cuirass). The respiratory therapy system 120 is generally used to treat individuals suffering from one or more sleep-related respiratory disorders (e.g., obstructive sleep apnea, central sleep apnea, or mixed sleep apnea),other respiratory disorders such as COPD, or other disorders leading to respiratory insufficiency, that may manifest either during sleep or wakefulness.

[0050] The respiratory therapy device 122 is generally used to generate pressurized air that is delivered to a user (e.g., using one or more motors (such as a blower motor) that drive one or more compressors). In some implementations, the respiratory therapy device 122 generates continuous constant air pressure that is delivered to the user. In some implementations, the respiratory therapy device 122 generates two or more predetermined pressures (e.g., a first predetermined air pressure and a second predetermined air pressure). In some implementations, the respiratory therapy device 122 is configured to generate a variety of different air pressures within a predetermined range. For example, the respiratory therapy device 122 can deliver at least about 6 cm H2O, at least about 10 cm H2O, at least about 20 cm H2O, between about 6 cm H2O and about 10 cm H2O, between about 7 cm H2O and about 12 cm H2O, etc. These pressure values could also be referred to using SI units, where 1 cm H2O (the pressure exerted by a column of water 1 cm in height at a temperature of 4°C) is equal to about 98.0665 pascals.

[0051] The respiratory therapy device 122 can also deliver pressurized air at a predetermined flow rate between, for example, about -20 L / min and about 150 L / min, while maintaining a positive pressure (relative to the ambient pressure). In some implementations, the control system 110, the memory device 114, the electronic interface 119, or any combination thereof can be coupled to and / or positioned within a housing of the respiratory therapy device 122.

[0052] The user interface 124 engages a portion of the user’s face and delivers pressurized air from the respiratory therapy device 122 to the user’s airway to aid in preventing the airway from narrowing and / or collapsing during sleep. This may also increase the user’ s oxygen intake during sleep. Depending upon the therapy to be applied, the user interface 124 may form a seal, for example, with a region or portion of the user’s face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, for example, at a positive pressure of about 10 cm H2O relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the user interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmFhO.

[0053] In some implementations, the user interface 124 is or includes a facial mask that covers the nose and mouth of the user (as shown, for example, in FIG. 2). Alternatively, the user interface 124 is or includes a nasal mask that provides air to the nose of the user or a nasal pillow mask that delivers air directly to the nostrils of the user. The user interface 124 can include a strap assembly that has a plurality of straps (e.g., including hook and loop fasteners) for positioning and / or stabilizing the user interface 124 on a portion of the user interface 124on a desired location of the user (e.g., the face), and a conformal cushion (e.g., silicone, plastic, foam, etc.) that aids in providing an air-tight seal between the user interface 124 and the user. In some implementations, the user interface 124 may include a connector 127 and one or more vents 125. The one or more vents 125 can be used to permit the escape of carbon dioxide and other gases exhaled by the user. In some implementations, the user interface 124 includes a mouthpiece (e.g., a night guard mouthpiece molded to conform to the user’s teeth, a mandibular repositioning device, etc.). In some implementations, the connector 127 is distinct from, but couplable to, the user interface 124 (and / or conduit 126). The connector 127 is configured to connect and fluidly couple the user interface 124 to the conduit 126.

[0054] The conduit 126 allows the flow of air between two components of a respiratory therapy system 120, such as the respiratory therapy device 122 and the user interface 124. In some implementations, there can be separate limbs of the conduit for inhalation and exhalation. In some implementations, a single limb conduit is used for both inhalation and exhalation. Generally, the respiratory therapy system 120 forms an air pathway that extends between a motor of the respiratory therapy device 122 and the user and / or the user’s airway. Thus, the air pathway generally includes at least a motor of the respiratory therapy device 122, the user interface 124, and the conduit 126.

[0055] One or more of the respiratory therapy device 122, the user interface 124, the conduit 126, the display device 128, and the humidification tank 129 can contain one or more sensors (e.g., a pressure sensor, a flow rate sensor, or more generally any of the other sensors 130 described herein). These one or more sensors can be used, for example, to measure the air pressure and / or flow rate of pressurized air supplied by the respiratory therapy device 122.

[0056] The display device 128 is generally used to display image(s) including still images, video images, or both and / or information regarding the respiratory therapy device 122. For example, the display device 128 can provide information regarding the status of the respiratory therapy device 122 (e.g., whether the respiratory therapy device 122 is on / off, the pressure of the air being delivered by the respiratory therapy device 122, the temperature of the air being delivered by the respiratory therapy device 122, etc.) and / or other information (e.g., a sleep score or a therapy score (such as a my Air® score, such as described in WO 2016 / 061629 and US 2017 / 0311879, each of which is hereby incorporated by reference herein in its entirety), the current date / time, personal information for the user, a questionnaire for the user, etc.). In some implementations, the display device 128 acts as a human-machine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) as an input interface. The display device 128 can be an LED display, an OLED display, an LCD display, or the like.The input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the respiratory therapy device 122.

[0057] The humidification tank 129 is coupled to or integrated in the respiratory therapy device 122 and includes a reservoir of water that can be used to humidify the pressurized air delivered from the respiratory therapy device 122. The respiratory therapy device 122 can include a heater to heat the water in the humidification tank 129 in order to humidify the pressurized air provided to the user. Additionally, in some implementations, the conduit 126 can also include a heating element (e.g., coupled to and / or imbedded in the conduit 126) that heats the pressurized air delivered to the user. The humidification tank 129 can be fluidly coupled to a water vapor inlet of the air pathway and deliver water vapor into the air pathway via the water vapor inlet, or can be formed in-line with the air pathway as part of the air pathway itself. In some implementations, the respiratory therapy device 122 or the conduit 126 can include a waterless humidifier. The waterless humidifier can incorporate sensors that interface with other sensor positioned elsewhere in system 100.

[0058] In some implementations, the system 100 can be used to deliver at least a portion of a substance from the receptacle 182 to the air pathway of the user based at least in part on the physiological data, the sleep-related parameters, other data or information, or any combination thereof. Generally, modifying the delivery of the portion of the substance into the air pathway can include (i) initiating the delivery of the substance into the air pathway, (ii) ending the delivery of the portion of the substance into the air pathway, (iii) modifying an amount of the substance delivered into the air pathway, (iv) modifying a temporal characteristic of the delivery of the portion of the substance into the air pathway, (v) modifying a quantitative characteristic of the delivery of the portion of the substance into the air pathway, (vi) modifying any parameter associated with the delivery of the substance into the air pathway, or (vii) a combination of (i)-(vi).

[0059] Modifying the temporal characteristic of the delivery of the portion of the substance into the air pathway can include changing the rate at which the substance is delivered, starting and / or finishing at different times, continuing for different time periods, changing the time distribution or characteristics of the delivery, changing the amount distribution independently of the time distribution, etc. The independent time and amount variation ensures that, apart from varying the frequency of the release of the substance, one can vary the amount of substance released each time. In this manner, a number of different combination of release frequencies and release amounts (e.g., higher frequency but lower release amount, higherfrequency and higher release amount, lower frequency and higher release amount, lower frequency and lower release amount, etc.) can be achieved. Other modifications to the delivery of the portion of the substance into the air pathway can also be utilized.

[0060] The respiratory therapy system 120 can be used, for example, as a ventilator or a positive airway pressure (PAP) system, such as a continuous positive airway pressure (CPAP) system, an automatic positive airway pressure system (APAP), a bi-level or variable positive airway pressure system (BPAP or VPAP), or any combination thereof. The CPAP system delivers a predetermined air pressure (e.g., determined by a sleep physician) to the user. The APAP system automatically varies the air pressure delivered to the user based at least in part on, for example, respiration data associated with the user. Such respiration data can, for example, indicate the occurrence, or absence, of respiration events such as flow limitations. The BPAP or VPAP system is configured to deliver a first predetermined pressure (e.g., an inspiratory positive airway pressure or IPAP) and a second predetermined pressure (e.g., an expiratory positive airway pressure or EPAP) that is lower than the first predetermined pressure.

[0061] Referring to FIG. 2, a portion of the system 100 (FIG. 1), according to some implementations, is illustrated. A user 210 of the respiratory therapy system 120 and a bed partner 220 are located in a bed 230 and are laying on a mattress 232. The user interface 124 (e.g., a full facial mask) can be worn by the user 210 during a sleep session. The user interface 124 is fluidly coupled and / or connected to the respiratory therapy device 122 via the conduit 126. In turn, the respiratory therapy device 122 delivers pressurized air to the user 210 via the conduit 126 and the user interface 124 to increase the air pressure in the throat of the user 210 to aid in preventing the airway from closing and / or narrowing during sleep. The respiratory therapy device 122 can include the display device 128, which can allow the user to interact with the respiratory therapy device 122. The respiratory therapy device 122 can also include the humidification tank 129, which stores the water used to humidify the pressurized air. The respiratory therapy device 122 can be positioned on a nightstand 240 that is directly adjacent to the bed 230 as shown in FIG. 2, or more generally, on any surface or structure that is generally adjacent to the bed 230 and / or the user 210. The user can also wear the blood pressure device 180 and the activity tracker 190 while lying on the mattress 232 in the bed 230.

[0062] Referring back to FIG. 1, the one or more sensors 130 of the system 100 include a pressure sensor 132, a flow rate sensor 134, temperature sensor 136, a motion sensor 138, a microphone 140, a speaker 142, a radio-frequency (RF) receiver 146, an RF transmitter 148, a camera 150, an infrared (IR) sensor 152, a photoplethysmogram (PPG) sensor 154, anelectrocardiogram (ECG) sensor 156, an electroencephalography (EEG) sensor 158, a capacitive sensor 160, a force sensor 162, a strain gauge sensor 164, an electromyography (EMG) sensor 166, an oxygen sensor 168, an analyte sensor 174, a moisture sensor 176, a light detection and ranging (LiDAR) sensor 178, or any combination thereof. Generally, each of the one or sensors 130 are configured to output sensor data that is received and stored in the memory device 114 or one or more other memory devices. The sensors 130 can also include, an electrooculography (EOG) sensor, a peripheral oxygen saturation (SpO?) sensor, a galvanic skin response (GSR) sensor, a carbon dioxide (CO2) sensor, or any combination thereof.

[0063] While the one or more sensors 130 are shown and described as including each of the pressure sensor 132, the flow rate sensor 134, the temperature sensor 136, the motion sensor 138, the microphone 140, the speaker 142, the RF receiver 146, the RF transmitter 148, the camera 150, the IR sensor 152, the PPG sensor 154, the ECG sensor 156, the EEG sensor 158, the capacitive sensor 160, the force sensor 162, the strain gauge sensor 164, the EMG sensor 166, the oxygen sensor 168, the analyte sensor 174, the moisture sensor 176, and the LiDAR sensor 178, more generally, the one or more sensors 130 can include any combination and any number of each of the sensors described and / or shown herein.

[0064] The one or more sensors 130 can be used to generate, for example physiological data, acoustic data, or both, that is associated with a user of the respiratory therapy system 120 (such as the user 210 of FIG. 2), the respiratory therapy system 120, both the user and the respiratory therapy system 120, or other entities, objects, activities, etc. Physiological data generated by one or more of the sensors 130 can be used by the control system 110 to determine a sleepwake signal associated with the user during the sleep session and one or more sleep-related parameters. The sleep-wake signal can be indicative of one or more sleep stages (sometimes referred to as sleep states), including sleep, wakefulness, relaxed wakefulness, microawakenings, or distinct sleep stages such as a rapid eye movement (REM) stage (which can include both a typical REM stage and an atypical REM stage), a first non-REM stage (often referred to as “Nl”), a second non-REM stage (often referred to as “N2”), a third non-REM stage (often referred to as “N3”), or any combination thereof. Methods for determining sleep stages from physiological data generated by one or more of the sensors, such as sensors 130, are described in, for example, WO 2014 / 047310, US 10,492,720, US 10,660,563, US 2020 / 0337634, WO 2017 / 132726, WO 2019 / 122413, US 2021 / 0150873, WO 2019 / 122414, US 2020 / 0383580, each of which is hereby incorporated by reference herein in its entirety.

[0065] The sleep-wake signal can also be timestamped to indicate a time that the user enters the bed, a time that the user exits the bed, a time that the user attempts to fall asleep, etc. Thesleep-wake signal can be measured one or more of the sensors 130 during the sleep session at a predetermined sampling rate, such as, for example, one sample per second, one sample per 30 seconds, one sample per minute, etc. Examples of the one or more sleep-related parameters that can be determined for the user during the sleep session based at least in part on the sleepwake signal include a total time in bed, a total sleep time, a total wake time, a sleep onset latency, a wake-after-sleep-onset parameter, a sleep efficiency, a fragmentation index, an amount of time to fall asleep, a consistency of breathing rate, a fall asleep time, a wake time, a rate of sleep disturbances, a number of movements, or any combination thereof.

[0066] Physiological data and / or acoustic data generated by the one or more sensors 130 can also be used to determine a respiration signal associated with the user during a sleep session. The respiration signal is generally indicative of respiration or breathing of the user during the sleep session. The respiration signal can be indicative of, for example, a respiration rate, a respiration rate variability, an inspiration amplitude, an expiration amplitude, an inspirationexpiration amplitude ratio, an inspiration-expiration duration ratio, a number of events per hour, a pattern of events, pressure settings of the respiratory therapy device 122, or any combination thereof. The event(s) can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, RERAs, a flow limitation (e.g., an event that results in the absence of the increase in flow despite an elevation in negative intrathoracic pressure indicating increased effort), a mask leak (e.g., from the user interface 124), a restless leg, a sleeping disorder, choking, an increased heart rate, a heart rate variation, labored breathing, an asthma attack, an epileptic episode, a seizure, a fever, a cough, a sneeze, a snore, a gasp, the presence of an illness such as the common cold or the flu, an elevated stress level, etc. Events can be detected by any means known in the art such as described in, for example, US 5,245,995, US 6,502,572, WO 2018 / 050913, WO 2020 / 104465, each of which is incorporated by reference herein in its entirety.

[0067] The pressure sensor 132 outputs pressure data that can be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. In some implementations, the pressure sensor 132 is an air pressure sensor (e.g., barometric pressure sensor) that generates sensor data indicative of the respiration (e.g., inhaling and / or exhaling) of the user of the respiratory therapy system 120 and / or ambient pressure. In such implementations, the pressure sensor 132 can be coupled to or integrated in the respiratory therapy device 122. The pressure sensor 132 can be, for example, a capacitive sensor, an electromagnetic sensor, an inductive sensor, a resistive sensor, a piezoelectric sensor, a strain-gauge sensor, an opticalsensor, a potentiometric sensor, or any combination thereof. In one example, the pressure sensor 132 can be used to determine a blood pressure of the user.

[0068] The flow rate sensor 134 outputs flow rate data that can be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. In some implementations, the flow rate sensor 134 is used to determine an air flow rate from the respiratory therapy device 122, an air flow rate through the conduit 126, an air flow rate through the user interface 124, or any combination thereof. In such implementations, the flow rate sensor 134 can be coupled to or integrated in the respiratory therapy device 122, the user interface 124, or the conduit 126. The flow rate sensor 134 can be a mass flow rate sensor such as, for example, a rotary flow meter (e.g., Hall effect flow meters), a turbine flow meter, an orifice flow meter, an ultrasonic flow meter, a hot wire sensor, a vortex sensor, a membrane sensor, or any combination thereof.

[0069] The temperature sensor 136 outputs temperature data that can be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. In some implementations, the temperature sensor 136 generates temperatures data indicative of a core body temperature of the user, a skin temperature of the user 210, a temperature of the air flowing from the respiratory therapy device 122 and / or through the conduit 126, a temperature in the user interface 124, an ambient temperature, or any combination thereof. The temperature sensor 136 can be, for example, a thermocouple sensor, a thermistor sensor, a silicon band gap temperature sensor or semiconductor-based sensor, a resistance temperature detector, or any combination thereof.

[0070] The motion sensor 138 outputs motion data that can be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. The motion sensor 138 can be used to detect movement of the user during the sleep session, and / or detect movement of any of the components of the respiratory therapy system 120, such as the respiratory therapy device 122, the user interface 124, or the conduit 126. The motion sensor 138 can include one or more inertial sensors, such as accelerometers, gyroscopes, and magnetometers. The motion sensor 138 can be used to detect motion or acceleration associated with arterial pulses, such as pulses in or around the face of the user and proximal to the user interface 124, and configured to detect features of the pulse shape, speed, amplitude, or volume. In some implementations, the motion sensor 138 alternatively or additionally generates one or more signals representing bodily movement of the user, from which may be obtained a signal representing a sleep state of the user; for example, via a respiratory movement of the user.

[0071] The microphone 140 outputs acoustic data that can be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. The acoustic data generatedby the microphone 140 is reproducible as one or more sound(s) during a sleep session (e.g., sounds from the user) to determine (e.g., using the control system 110) one or more sleep- related parameters, as described in further detail herein. The acoustic data from the microphone 140 can also be used to identify (e.g., using the control system 110) an event experienced by the user during the sleep session, as described in further detail herein. In some implementations, the acoustic data from the microphone 140 is representative of noise associated with the respiratory therapy system 120. In some implementations, the acoustic data from the microphone 140 can be analyzed to detect the presence of liquid in the respiratory therapy system 120, in particular in the user interface 124 and / or the conduit 126, as explained in further detail herein. In some implementations, the system 100 includes a plurality of microphones (e.g., two or more microphones and / or an array of microphones with beamforming) such that sound data generated by each of the plurality of microphones can be used to discriminate the sound data generated by another of the plurality of microphones. The microphone 140 can be coupled to or integrated in the respiratory therapy system 120 (or the system 100) generally in any configuration. For example, the microphone 140 can be disposed inside the respiratory therapy device 122, the user interface 124, the conduit 126, or other components. The microphone 140 can also be positioned adjacent to or coupled to the outside of the respiratory therapy device 122, the outside of the user interface 124, the outside of the conduit 126, or outside of any other components. The microphone 140 could also be a component of the user device 170 (e.g., the microphone 140 is a microphone of a smart phone). The microphone 140 can be integrated into the user interface 124, the conduit 126, the respiratory therapy device 122, or any combination thereof. In general, the microphone 140 can be located at any point within or adjacent to the air pathway of the respiratory therapy system 120, which includes at least the motor of the respiratory therapy device 122, the user interface 124, and the conduit 126. Thus, the air pathway can also be referred to as the acoustic pathway.

[0072] The speaker 142 outputs sound waves that are typically audible to the user. In some implementations, the sound waves can be audible to a user of the system 100 or inaudible to the user of the system (e.g., ultrasonic sound waves). The speaker 142 can be used, for example, as an alarm clock or to play an alert or message to the user (e.g., in response to an event). In some implementations, the speaker 142 can be used to communicate the acoustic data generated by the microphone 140 to the user. The speaker 142 can be coupled to or integrated in the respiratory therapy device 122, the user interface 124, the conduit 126, or the user device 170.

[0073] The microphone 140 and the speaker 142 can be used as separate devices. In some implementations, the microphone 140 and the speaker 142 can be combined into an acoustic sensor 141 (e.g., a SONAR sensor), as described in, for example, WO 2018 / 050913 and WO 2020 / 104465, each of which is hereby incorporated by reference herein in its entirety. In such implementations, the speaker 142 generates or emits sound waves at a predetermined interval and / or frequency, and the microphone 140 detects the reflections of the emitted sound waves from the speaker 142. The sound waves generated or emitted by the speaker 142 have a frequency that is not audible to the human ear (e.g., below 20 Hz or above around 18 kHz) so as not to disturb the sleep of the user or a bed partner of the user (such as bed partner 220 in FIG. 2). Based at least in part on the data from the microphone 140 and / or the speaker 142, the control system 110 can determine a location of the user and / or one or more of the sleep-related parameters described in herein, such as, for example, a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a sleep stage, pressure settings of the respiratory therapy device 122, a mouth leak status, or any combination thereof. In this context, a SONAR sensor may be understood to concern an active acoustic sensing, such as by generating / transmitting ultrasound or low frequency ultrasound sensing signals (e.g., in a frequency range of about 17- 23 kHz, 18-22 kHz, or 17-18 kHz, for example), through the air. Such a system may be considered in relation to WO 2018 / 050913 and WO 2020 / 104465 mentioned above. In some implementations, the speaker 142 is a bone conduction speaker. In some implementations, the one or more sensors 130 include (i) a first microphone that is the same or similar to the microphone 140, and is integrated into the acoustic sensor 141 and (ii) a second microphone that is the same as or similar to the microphone 140, but is separate and distinct from the first microphone that is integrated into the acoustic sensor 141.

[0074] The RF transmitter 148 generates and / or emits radio waves having a predetermined frequency and / or a predetermined amplitude (e.g., within a high frequency band, within a low frequency band, long wave signals, short wave signals, etc.). The RF receiver 146 detects the reflections of the radio waves emitted from the RF transmitter 148, and this data can be analyzed by the control system 110 to determine a location of the user and / or one or more of the sleep-related parameters described herein. An RF receiver (either the RF receiver 146 and the RF transmitter 148 or another RF pair) can also be used for wireless communication between the control system 110, the respiratory therapy device 122, the one or more sensors 130, the user device 170, or any combination thereof. While the RF receiver 146 and RF transmitter 148 are shown as being separate and distinct elements in FIG. 1, in someimplementations, the RF receiver 146 and RF transmitter 148 are combined as a part of an RF sensor 147 (e.g., a RADAR sensor). In such implementations, the RF sensor 147 includes a control circuit. The specific format of the RF communication could be WiFi, Bluetooth, etc.

[0075] In some implementations, the RF sensor 147 is a part of a mesh system. One example of a mesh system is a WiFi mesh system, which can include mesh nodes, mesh router(s), and mesh gateway(s), each of which can be mobile / movable or fixed. In such implementations, the WiFi mesh system includes a WiFi router and / or a WiFi controller and one or more satellites (e.g., access points), each of which include an RF sensor that the is the same as, or similar to, the RF sensor 147. The WiFi router and satellites continuously communicate with one another using WiFi signals. The WiFi mesh system can be used to generate motion data based at least in part on changes in the WiFi signals (e.g., differences in received signal strength) between the router and the satellite(s) due to an object or person moving partially obstructing the signals. The motion data can be indicative of motion, breathing, heart rate, gait, falls, behavior, etc., or any combination thereof.

[0076] The camera 150 outputs image data reproducible as one or more images (e.g., still images, video images, thermal images, or a combination thereof) that can be stored in the memory device 114. The image data from the camera 150 can be used by the control system 110 to determine one or more of the sleep-related parameters described herein. For example, the image data from the camera 150 can be used to identify a location of the user, to determine a time when the user enters the user’s bed (such as bed 230 in FIG. 2), and to determine a time when the user exits the bed 230. The camera 150 can also be used to track eye movements, pupil dilation (if one or both of the user’s eyes are open), blink rate, or any changes during REM sleep. The camera 150 can also be used to track the position of the user, which can impact the duration and / or severity of apneic episodes in users with positional obstructive sleep apnea.

[0077] The IR sensor 152 outputs infrared image data reproducible as one or more infrared images (e.g., still images, video images, or both) that can be stored in the memory device 114. The infrared data from the IR sensor 152 can be used to determine one or more sleep-related parameters during the sleep session, including a temperature of the user and / or movement of the user. The IR sensor 152 can also be used in conjunction with the camera 150 when measuring the presence, location, and / or movement of the user. The IR sensor 152 can detect infrared light having a wavelength between about 700 nm and about 1 mm, for example, while the camera 150 can detect visible light having a wavelength between about 380 nm and about 740 nm.

[0078] The IR sensor 152 outputs infrared image data reproducible as one or more infrared images (e.g., still images, video images, or both) that can be stored in the memory device 114. The infrared data from the IR sensor 152 can be used to determine one or more sleep-related parameters during the sleep session, including a temperature of the user and / or movement of the user. The IR sensor 152 can also be used in conjunction with the camera 150 when measuring the presence, location, and / or movement of the user. The IR sensor 152 can detect infrared light having a wavelength between about 700 nm and about 1 mm, for example, while the camera 150 can detect visible light having a wavelength between about 380 nm and about 740 nm.

[0079] The PPG sensor 154 outputs physiological data associated with the user that can be used to determine one or more sleep-related parameters, such as, for example, a heart rate, a heart rate pattern, a heart rate variability, a cardiac cycle, respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, estimated blood pressure parameter(s), or any combination thereof. The PPG sensor 154 can be worn by the user, embedded in clothing and / or fabric that is worn by the user, embedded in and / or coupled to the user interface 124 and / or its associated headgear (e.g., straps, etc.), etc.

[0080] The ECG sensor 156 outputs physiological data associated with electrical activity of the heart of the user. In some implementations, the ECG sensor 156 includes one or more electrodes that are positioned on or around a portion of the user during the sleep session. The physiological data from the ECG sensor 156 can be used, for example, to determine one or more of the sleep-related parameters described herein.

[0081] The EEG sensor 158 outputs physiological data associated with electrical activity of the brain of the user. In some implementations, the EEG sensor 158 includes one or more electrodes that are positioned on or around the scalp of the user during the sleep session. The physiological data from the EEG sensor 158 can be used, for example, to determine a sleep stage of the user at any given time during the sleep session. In some implementations, the EEG sensor 158 can be integrated in the user interface 124 and / or the associated headgear (e.g., straps, etc.).

[0082] The capacitive sensor 160, the force sensor 162, and the strain gauge sensor 164 output data that can be stored in the memory device 114 and used by the control system 110 to determine one or more of the sleep-related parameters described herein. The EMG sensor 166 outputs physiological data associated with electrical activity produced by one or more muscles. The oxygen sensor 168 outputs oxygen data indicative of an oxygen concentration of gas (e.g., in the conduit 126 or at the user interface 124). The oxygen sensor 168 can be, for example, anultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or any combination thereof. In some implementations, the one or more sensors 130 also include a galvanic skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a sphygmomanometer sensor, an oximetry sensor, or any combination thereof.

[0083] The analyte sensor 174 can be used to detect the presence of an analyte in the exhaled breath of the user. The data output by the analyte sensor 174 can be stored in the memory device 114 and used by the control system 110 to determine the identity and concentration of any analytes in the user’s breath. In some implementations, the analyte sensor 174 is positioned near a mouth of the user to detect analytes in breath exhaled from the user’s mouth. For example, when the user interface 124 is a facial mask that covers the nose and mouth of the user, the analyte sensor 174 can be positioned within the facial mask to monitor the user mouth breathing. In some implementations, such as when the user interface 124 is a nasal mask or a nasal pillow mask, the analyte sensor 174 can be positioned near the nose of the user to detect analytes in breath exhaled through the user’s nose. In some implementations, the analyte sensor 174 can be positioned near the user’s mouth when the user interface 124 is a nasal mask or a nasal pillow mask. In these implementations, the analyte sensor 174 can be used to detect whether any air is inadvertently leaking from the user’s mouth. In some implementations, the analyte sensor 174 is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds, such as carbon dioxide. In some implementations, the analyte sensor 174 can also be used to detect whether the user is breathing through their nose or mouth. For example, if the data output by an analyte sensor 174 positioned near the mouth of the user or within the facial mask (in implementations where the user interface 124 is a facial mask) detects the presence of an analyte, the control system 110 can use this data as an indication that the user is breathing through their mouth.

[0084] The moisture sensor 176 outputs data that can be stored in the memory device 114 and used by the control system 110. The moisture sensor 176 can be used to detect moisture in various areas surrounding the user (e.g., inside the conduit 126 or the user interface 124, near the user’s face, near the connection between the conduit 126 and the user interface 124, near the connection between the conduit 126 and the respiratory therapy device 122, etc.). Thus, in some implementations, the moisture sensor 176 can be coupled to or integrated into the user interface 124 or in the conduit 126 to monitor the humidity of the pressurized air from the respiratory therapy device 122. In some implementations, the moisture sensor 176 is placed near any area where moisture levels need to be monitored. The moisture sensor 176 can alsobe used to monitor the humidity of the ambient environment surrounding the user, for example the air inside the user’s bedroom. The moisture sensor 176 can also be used to track the user’s biometric response to environmental changes.

[0085] One or more LiDAR sensors 178 can be used for depth sensing. This type of optical sensor (e.g., laser sensor) can be used to detect objects and build three dimensional (3D) maps of the surroundings, such as of a living space. LiDAR can generally utilize a pulsed laser to make time of flight measurements. LiDAR is also referred to as 3D laser scanning. In an example of use of such a sensor, a fixed or mobile device (such as a smartphone) having a LiDAR sensor 178 can measure and map an area extending 5 meters or more away from the sensor. The LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor, for example. The LiDAR sensor 178 may also use artificial intelligence (Al) to automatically geofence RADAR systems by detecting and classifying features in a space that might cause issues for RADAR systems, such a glass windows (which can be highly reflective to RADAR). LiDAR can also be used to provide an estimate of the height of a person, as well as changes in height when the person sits down, or falls down, for example. LiDAR may be used to form a 3D mesh representation of an environment. In a further use, for solid surfaces through which radio waves pass (e.g., radio-translucent materials), the LiDAR may reflect off such surfaces, thus allowing a classification of different type of obstacles.

[0086] While shown separately in FIG. 1, any combination of the one or more sensors 130 can be integrated in and / or coupled to any one or more of the components of the system 100, including the respiratory therapy device 122, the user interface 124, the conduit 126, the humidification tank 129, the control system 110, the user device 170, or any combination thereof. For example, the acoustic sensor 141 and / or the RF sensor 147 can be integrated in and / or coupled to the user device 170. In such implementations, the user device 170 can be considered a secondary device that generates additional or secondary data for use by the system 100 (e.g., the control system 110) according to some aspects of the present disclosure. In some implementations, the pressure sensor 132 and / or the flow rate sensor 134 are integrated into and / or coupled to the respiratory therapy device 122. In some implementations, at least one of the one or more sensors 130 is not coupled to the respiratory therapy device 122, the control system 110, or the user device 170, and is positioned generally adjacent to the user during the sleep session (e.g., positioned on or in contact with a portion of the user, worn by the user, coupled to or positioned on the nightstand, coupled to the mattress, coupled to the ceiling, etc.). More generally, the one or more sensors 130 can be positioned at any suitable location relativeto the user such that the one or more sensors 130 can generate physiological data associated with the user and / or the bed partner 220 during one or more sleep session.

[0087] The data from the one or more sensors 130 can be analyzed to determine one or more sleep-related parameters, which can include a respiration signal, a respiration rate, a respiration pattern, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, an occurrence of one or more events, a number of events per hour, a pattern of events, an average duration of events, a range of event durations, a ratio between the number of different events, a sleep stage, an apnea-hypopnea index (AHI), or any combination thereof. The one or more events can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, an intentional user interface leak, an unintentional user interface leak, a mouth leak, a cough, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, increased blood pressure, hyperventilation, or any combination thereof. Many of these sleep-related parameters are physiological parameters, although some of the sleep-related parameters can be considered to be non-physiological parameters. Other types of physiological and non-physiological parameters can also be determined, either from the data from the one or more sensors 130, or from other types of data.

[0088] The user device 170 includes a display device 172. The user device 170 can be, for example, a mobile device such as a smart phone, a tablet, a laptop, a gaming console, a smart watch, or the like. Alternatively, the user device 170 can be an external sensing system, a television (e.g., a smart television) or another smart home device (e.g., a smart speaker(s) such as Google Home®, Google Nest®, Amazon Echo®, Amazon Echo Show®, Alexa®-enabled devices, etc.). In some implementations, the user device 170 is a wearable device (e.g., a smart watch). The display device 172 is generally used to display image(s) including still images, video images, or both. In some implementations, the display device 172 acts as a humanmachine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) and an input interface. The display device 172 can be an LED display, an OLED display, an LCD display, or the like. The input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the user device 170. In some implementations, one or more user devices 170 can be used by and / or included in the system 100.

[0089] The blood pressure device 180 is generally used to aid in generating physiological data for determining one or more blood pressure measurements associated with a user. The blood pressure device 180 can include at least one of the one or more sensors 130 to measure, for example, a systolic blood pressure component and / or a diastolic blood pressure component.

[0090] In some implementations, the blood pressure device 180 is a sphygmomanometer including an inflatable cuff that can be worn by a user and a pressure sensor (e.g., the pressure sensor 132 described herein). For example, as shown in the example of FIG. 2, the blood pressure device 180 can be worn on an upper arm of the user. In such implementations where the blood pressure device 180 is a sphygmomanometer, the blood pressure device 180 also includes a pump (e.g., a manually operated bulb) for inflating the cuff. In some implementations, the blood pressure device 180 is coupled to the respiratory therapy device 122 of the respiratory therapy system 120, which in turn delivers pressurized air to inflate the cuff. More generally, the blood pressure device 180 can be communicatively coupled with, and / or physically integrated in (e.g., within a housing), the control system 110, the memory device 114, the respiratory therapy system 120, the user device 170, and / or the activity tracker 190.

[0091] The activity tracker 190 is generally used to aid in generating physiological data for determining an activity measurement associated with the user. The activity measurement can include, for example, a number of steps, a distance traveled, a number of steps climbed, a duration of physical activity, a type of physical activity, an intensity of physical activity, time spent standing, a respiration rate, an average respiration rate, a resting respiration rate, a maximum respiration rate, a respiration rate variability, a heart rate, an average heart rate, a resting heart rate, a maximum heart rate, a heart rate variability, a number of calories burned, blood oxygen saturation, electrodermal activity (also known as skin conductance or galvanic skin response), or any combination thereof. The activity tracker 190 includes one or more of the sensors 130 described herein, such as, for example, the motion sensor 138 (e.g., one or more accelerometers and / or gyroscopes), the PPG sensor 154, and / or the ECG sensor 156.

[0092] In some implementations, the activity tracker 190 is a wearable device that can be worn by the user, such as a smartwatch, a wristband, a ring, or a patch. For example, referring to FIG. 2, the activity tracker 190 is worn on a wrist of the user. The activity tracker 190 can also be coupled to or integrated a garment or clothing that is worn by the user. Alternatively, still, the activity tracker 190 can also be coupled to or integrated in (e.g., within the same housing) the user device 170. More generally, the activity tracker 190 can be communicatively coupled with, or physically integrated in (e.g., within a housing), the control system 110, the memory device 114, the respiratory therapy system 120, the user device 170, and / or the blood pressure device 180.

[0093] While the control system 110 and the memory device 114 are described and shown in FIG. 1 as being a separate and distinct component of the system 100, in some implementations,the control system 110 and / or the memory device 114 are integrated in the user device 170 and / or the respiratory therapy device 122. Alternatively, in some implementations, the control system 110 or a portion thereof (e.g., the processor 112) can be located in a cloud (e.g., integrated in a server, integrated in an Internet of Things (loT) device, connected to the cloud, be subject to edge cloud processing, etc.), located in one or more servers (e.g., remote servers, local servers, etc., or any combination thereof.

[0094] While system 100 is shown as including all of the components described above, more or fewer components can be included in a system according to implementations of the present disclosure. For example, a first alternative system includes the control system 110, the memory device 114, and at least one of the one or more sensors 130. As another example, a second alternative system includes the control system 110, the memory device 114, at least one of the one or more sensors 130, and the user device 170. As yet another example, a third alternative system includes the control system 110, the memory device 114, the respiratory therapy system 120, at least one of the one or more sensors 130, and the user device 170. As a further example, a fourth alternative system includes the control system 110, the memory device 114, the respiratory therapy system 120, at least one of the one or more sensors 130, the user device 170, and the blood pressure device 180 and / or activity tracker 190. Thus, various systems for modifying pressure settings can be formed using any portion or portions of the components shown and described herein and / or in combination with one or more other components.

[0095] Referring again to FIG. 2, in some implementations, the control system 110, the memory device 114, any of the one or more sensors 130, or a combination thereof can be located on and / or in any surface and / or structure that is generally adjacent to the bed 230 and / or the user 210. For example, in some implementations, at least one of the one or more sensors 130 can be located at a first position on and / or in one or more components of the respiratory therapy system 120 adjacent to the bed 230 and / or the user 210. The one or more sensors 130 can be coupled to the respiratory therapy system 120, the user interface 124, the conduit 126, the display device 128, the humidification tank 129, or a combination thereof.

[0096] Alternatively, or additionally, at least one of the one or more sensors 130 can be located at a second position on and / or in the bed 230 (e.g., the one or more sensors 130 are coupled to and / or integrated in the bed 230). Further, alternatively or additionally, at least one of the one or more sensors 130 can be located at a third position on and / or in the mattress 232 that is adjacent to the bed 230 and / or the user 210 (e.g., the one or more sensors 130 are coupled to and / or integrated in the mattress 232). Alternatively, or additionally, at least one of the one ormore sensors 130 can be located at a fourth position on and / or in a pillow that is generally adjacent to the bed 230 and / or the user 210.

[0097] Alternatively, or additionally, at least one of the one or more sensors 130 can be located at a fifth position on and / or in the nightstand 240 that is generally adjacent to the bed 230 and / or the user 210. Alternatively, or additionally, at least one of the one or more sensors 130 can be located at a sixth position such that the at least one of the one or more sensors 130 are coupled to and / or positioned on the user 210 (e.g., the one or more sensors 130 are embedded in or coupled to fabric, clothing, and / or a smart device worn by the user 210). More generally, at least one of the one or more sensors 130 can be positioned at any suitable location relative to the user 210 such that the one or more sensors 130 can generate sensor data associated with the user 210.

[0098] In some implementations, a primary sensor, such as the microphone 140, is configured to generate acoustic data associated with the user 210 during a sleep session. The acoustic data can be based on, for example, acoustic signals in the conduit 126 of the respiratory therapy system 120. For example, one or more microphones (the same as, or similar to, the microphone 140 of FIG. 1) can be integrated in and / or coupled to (i) a circuit board of the respiratory therapy device 122, (ii) the conduit 126, (iii) a connector between components of the respiratory therapy system 120, (iv) the user interface 124, (v) a headgear (e.g., straps) associated with the user interface, or (vi) a combination thereof. In some implementations, the microphone 140 is in fluid communication with the airflow pathway (e.g., an airflow pathway between the flow generator / motor and the distal end of the conduit). By fluid communication, it is intended to also include configurations wherein the microphone is in acoustic communication with the airflow pathway without being in direct or physical contact with the airflow. For example, in some implementations, the microphone is positioned on a circuit board and in fluid communication, optionally via a duct sealed by a membrane, to the airflow pathway.

[0099] In some implementations, one or more secondary sensors may be used in addition to the primary sensor to generate additional data. In some such implementations, the one or more secondary sensors include: a microphone (e.g., the microphone 140 of the system 100), a flow rate sensor (e.g., the flow rate sensor 134 of the system 100), a pressure sensor (e.g., the pressure sensor 132 of the system 100), a temperature sensor (e.g., the temperature sensor 136 of the system 100), a camera (e.g., the camera 150 of the system 100), a vane sensor (VAF), a hot wire sensor (MAF), a cold wire sensor, a laminar flow sensor, an ultrasonic sensor, an inertial sensor, or a combination thereof.

[0100] Additionally, or alternatively, one or more microphones (the same as, or similar to, the microphone 140 of FIG. 1) can be integrated in and / or coupled to a co-located smart device, such as the user device 170, a TV, a watch (e.g., a mechanical watch or another smart device worn by the user), a pendant, a headset (such as a VR / AR headset), ear phones or ear buds, the mattress 232, the bed 230, beddings positioned on the bed 230, a pillow, a speaker (e.g., the speaker 142 of FIG. 1), a radio, a tablet device, a waterless humidifier, or a combination thereof. A co-located smart device can be any smart device that is within range for detecting sounds emitted by the user, the respiratory therapy system 120, and / or any portion of the system 100. In some implementations, the co-located smart device is a smart device that is in the same room as the user during the sleep session.

[0101] Additionally, or alternatively, in some implementations, one or more microphones (the same as, or similar to, the microphone 140 of FIG. 1) can be remote from the system 100 (FIG. 1) and / or the user 210 (FIG. 2), so long as there is an air passage allowing acoustic signals to travel to the one or more microphones. For example, the one or more microphones can be in a different room from the room containing the system 100.

[0102] As used herein, a sleep session can be defined in a number of ways based at least in part on, for example, an initial start time and an end time. In some implementations, a sleep session is a duration where the user is asleep, that is, the sleep session has a start time and an end time, and during the sleep session, the user does not wake until the end time. That is, any period of the user being awake is not included in a sleep session. From this first definition of sleep session, if the user wakes ups and falls asleep multiple times in the same night, each of the sleep intervals separated by an awake interval is a sleep session.

[0103] Alternatively, in some implementations, a sleep session has a start time and an end time, and during the sleep session, the user can wake up, without the sleep session ending, so long as a continuous duration that the user is awake is below an awake duration threshold. The awake duration threshold can be defined as a percentage of a sleep session. The awake duration threshold can be, for example, about twenty percent of the sleep session, about fifteen percent of the sleep session duration, about ten percent of the sleep session duration, about five percent of the sleep session duration, about two percent of the sleep session duration, etc., or any other threshold percentage. In some implementations, the awake duration threshold is defined as a fixed amount of time, such as, for example, about one hour, about thirty minutes, about fifteen minutes, about ten minutes, about five minutes, about two minutes, etc., or any other amount of time.

[0104] In some implementations, a sleep session is defined as the entire time between the time in the evening at which the user first entered the bed, and the time the next morning when user last left the bed. Put another way, a sleep session can be defined as a period of time that begins on a first date (e.g., Monday, January 6, 2020) at a first time (e.g., 10:00 PM), that can be referred to as the current evening, when the user first enters a bed with the intention of going to sleep (e.g., not if the user intends to first watch television or play with a smart phone before going to sleep, etc.), and ends on a second date (e.g., Tuesday, January 7, 2020) at a second time (e.g., 7:00 AM), that can be referred to as the next morning, when the user first exits the bed with the intention of not going back to sleep that next morning.

[0105] In some implementations, the user can manually define the beginning of a sleep session and / or manually terminate a sleep session. For example, the user can select (e.g., by clicking or tapping) one or more user-selectable element that is displayed on the display device 172 of the user device 170 (FIG. 1) to manually initiate or terminate the sleep session.

[0106] Referring to FIG. 3, an exemplary timeline 300 for a sleep session is illustrated. The timeline 300 includes an enter bed time (tbed), a go-to-sleep time (tors), an initial sleep time (tsieep), a first micro-awakening MAi, a second micro-awakening MA2, an awakening A, a wake-up time (twake), and a rising time (trise).

[0107] The enter bed time tbed is associated with the time that the user initially enters the bed (e.g., bed 230 in FIG. 2) prior to falling asleep (e.g., when the user lies down or sits in the bed). The enter bed time tbed can be identified based at least in part on a bed threshold duration to distinguish between times when the user enters the bed for sleep and when the user enters the bed for other reasons (e.g., to watch TV). For example, the bed threshold duration can be at least about 10 minutes, at least about 20 minutes, at least about 30 minutes, at least about 45 minutes, at least about 1 hour, at least about 2 hours, etc. While the enter bed time tbed is described herein in reference to a bed, more generally, the enter time tbed can refer to the time the user initially enters any location for sleeping (e.g., a couch, a chair, a sleeping bag, etc.).

[0108] The go-to-sleep time (GTS) is associated with the time that the user initially attempts to fall asleep after entering the bed (tbed). For example, after entering the bed, the user may engage in one or more activities to wind down prior to trying to sleep (e.g., reading, watching TV, listening to music, using the user device 170, etc.). The initial sleep time (tsieep) is the time that the user initially falls asleep. For example, the initial sleep time (tsieep) can be the time that the user initially enters the first non-REM sleep stage.

[0109] The wake-up time twake is the time associated with the time when the user wakes up without going back to sleep (e.g., as opposed to the user waking up in the middle of the nightand going back to sleep). The user may experience one of more unconscious microawakenings (e.g., microawakenings MAi and MA2) having a short duration (e.g., 5 seconds, 10 seconds, 30 seconds, 1 minute, etc.) after initially falling asleep. In contrast to the wake-up time twake, the user goes back to sleep after each of the microawakenings MAi and MA2. Similarly, the user may have one or more conscious awakenings (e.g., awakening A) after initially falling asleep (e.g., getting up to go to the bathroom, attending to children or pets, sleep walking, etc.). However, the user goes back to sleep after the awakening A. Thus, the wake-up time twake can be defined, for example, based at least in part on a wake threshold duration (e.g., the user is awake for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.).

[0110] Similarly, the rising time trise is associated with the time when the user exits the bed and stays out of the bed with the intent to end the sleep session (e.g., as opposed to the user getting up during the night to go to the bathroom, to attend to children or pets, sleep walking, etc.). In other words, the rising time trise is the time when the user last leaves the bed without returning to the bed until a next sleep session (e.g., the following evening). Thus, the rising time trise can be defined, for example, based at least in part on a rise threshold duration (e.g., the user has left the bed for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.). The enter bed time tbed time for a second, subsequent sleep session can also be defined based at least in part on a rise threshold duration (e.g., the user has left the bed for at least 4 hours, at least 6 hours, at least 8 hours, at least 12 hours, etc.).

[0111] As described above, the user may wake up and get out of bed one more times during the night between the initial tbed and the final trise. In some implementations, the final wake-up time twake and / or the final rising time trise that are identified or determined based at least in part on a predetermined threshold duration of time subsequent to an event (e.g., falling asleep or leaving the bed). Such a threshold duration can be customized for the user. For a standard user which goes to bed in the evening, then wakes up and goes out of bed in the morning any period (between the user waking up (twake) or raising up (trise), and the user either going to bed (tbed), going to sleep (tors), or falling asleep (tsieep) of between about 12 and about 18 hours can be used. For users that spend longer periods of time in bed, shorter threshold periods may be used (e.g., between about 8 hours and about 14 hours). The threshold period may be initially selected and / or later adjusted based at least in part on the system monitoring the user’s sleep behavior.

[0112] The total time in bed (TIB) is the duration of time between the time enter bed time tbed and the rising time trise. The total sleep time (TST) is associated with the duration between the initial sleep time and the wake-up time, excluding any conscious or unconscious awakenings and / or micro-awakenings therebetween. Generally, the total sleep time (TST) will be shorterthan the total time in bed (TIB) (e.g., one minute short, ten minutes shorter, one hour shorter, etc.). For example, referring to the timeline 300 of FIG. 3, the total sleep time (TST) spans between the initial sleep time tsieepand the wake-up time twake, but excludes the duration of the first micro-awakening MAi, the second micro-awakening MA2, and the awakening A. As shown, in this example, the total sleep time (TST) is shorter than the total time in bed (TIB).

[0113] In some implementations, the total sleep time (TST) can be defined as a persistent total sleep time (PTST). In such implementations, the persistent total sleep time excludes a predetermined initial portion or period of the first non-REM stage (e.g., light sleep stage). For example, the predetermined initial portion can be between about 30 seconds and about 20 minutes, between about 1 minute and about 10 minutes, between about 3 minutes and about 5 minutes, etc. The persistent total sleep time is a measure of sustained sleep, and smooths the sleep-wake hypnogram. For example, when the user is initially falling asleep, the user may be in the first non-REM stage for a very short time (e.g., about 30 seconds), then back into the wakefulness stage for a short period (e.g., one minute), and then goes back to the first non- REM stage. In this example, the persistent total sleep time excludes the first instance (e.g., about 30 seconds) of the first non-REM stage.

[0114] In some implementations, the sleep session is defined as starting at the enter bed time (tbed) and ending at the rising time (trise), i.e., the sleep session is defined as the total time in bed (TIB). In some implementations, a sleep session is defined as starting at the initial sleep time (tsieep) and ending at the wake-up time (twake). In some implementations, the sleep session is defined as the total sleep time (TST). In some implementations, a sleep session is defined as starting at the go-to-sleep time (tors) and ending at the wake-up time (twake). In some implementations, a sleep session is defined as starting at the go-to-sleep time (tors) and ending at the rising time (trise). In some implementations, a sleep session is defined as starting at the enter bed time (tbed) and ending at the wake-up time (twake). In some implementations, a sleep session is defined as starting at the initial sleep time (tsieep) and ending at the rising time (trise).

[0115] Referring to FIG. 4, an exemplary hypnogram 400 corresponding to the timeline 300 (FIG. 3), according to some implementations, is illustrated. As shown, the hypnogram 400 includes a sleep-wake signal 401, a wakefulness stage axis 410, a REM stage axis 420, a light sleep stage axis 430, and a deep sleep stage axis 440. The intersection between the sleep-wake signal 401 and one of the axes 410-440 is indicative of the sleep stage at any given time during the sleep session.

[0116] The sleep-wake signal 401 can be generated based at least in part on physiological data associated with the user (e.g., generated by one or more of the sensors 130 described herein).The sleep-wake signal can be indicative of one or more sleep stages, including wakefulness, relaxed wakefulness, microawakenings, a REM stage, a first non-REM stage, a second non- REM stage, a third non-REM stage, or any combination thereof. In some implementations, one or more of the first non-REM stage, the second non-REM stage, and the third non-REM stage can be grouped together and categorized as a light sleep stage or a deep sleep stage. For example, the light sleep stage can include the first non-REM stage and the deep sleep stage can include the second non-REM stage and the third non-REM stage. While the hypnogram 400 is shown in FIG. 4 as including the light sleep stage axis 430 and the deep sleep stage axis 440, in some implementations, the hypnogram 400 can include an axis for each of the first non- REM stage, the second non-REM stage, and the third non-REM stage. In some implementations, the sleep-wake signal can also be indicative of a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration amplitude ratio, an inspiration-expiration duration ratio, a number of events per hour, a pattern of events, or any combination thereof. Information describing the sleep-wake signal can be stored in the memory device 114.

[0117] The hypnogram 400 can be used to determine one or more sleep-related parameters, such as, for example, a sleep onset latency (SOL), wake-after-sleep onset (WASO), a sleep efficiency (SE), a sleep fragmentation index, sleep blocks, or any combination thereof.

[0118] The sleep onset latency (SOL) is defined as the time between the go-to-sleep time (tors) and the initial sleep time (tsieep). In other words, the sleep onset latency is indicative of the time that it took the user to actually fall asleep after initially attempting to fall asleep. In some implementations, the sleep onset latency is defined as a persistent sleep onset latency (PSOL). The persistent sleep onset latency differs from the sleep onset latency in that the persistent sleep onset latency is defined as the duration time between the go-to-sleep time and a predetermined amount of sustained sleep. In some implementations, the predetermined amount of sustained sleep can include, for example, at least 10 minutes of sleep within the second non-REM stage, the third non-REM stage, and / or the REM stage with no more than 2 minutes of wakefulness, the first non-REM stage, and / or movement therebetween. In other words, the persistent sleep onset latency requires up to, for example, 8 minutes of sustained sleep within the second non- REM stage, the third non-REM stage, and / or the REM stage. In some implementations, the predetermined amount of sustained sleep can include at least 10 minutes of sleep within the first non-REM stage, the second non-REM stage, the third non-REM stage, and / or the REM stage subsequent to the initial sleep time. In such implementations, the predetermined amountof sustained sleep can exclude any micro-awakenings (e.g., a ten second micro-awakening does not restart the 10-minute period).

[0119] The wake-after-sleep onset (WASO) is associated with the total duration of time that the user is awake between the initial sleep time and the wake-up time. Thus, the wake-after- sleep onset includes short and micro-awakenings during the sleep session (e.g., the microawakenings MAi and MA2 shown in FIG. 4), whether conscious or unconscious. In some implementations, the wake-after-sleep onset (WASO) is defined as a persistent wake-after- sleep onset (PWASO) that only includes the total durations of awakenings having a predetermined length (e.g., greater than 10 seconds, greater than 30 seconds, greater than 60 seconds, greater than about 5 minutes, greater than about 10 minutes, etc.)

[0120] The sleep efficiency (SE) is determined as a ratio of the total time in bed (TIB) and the total sleep time (TST). For example, if the total time in bed is 8 hours and the total sleep time is 7.5 hours, the sleep efficiency for that sleep session is 93.75%. The sleep efficiency is indicative of the sleep hygiene of the user. For example, if the user enters the bed and spends time engaged in other activities (e.g., watching TV) before sleep, the sleep efficiency will be reduced (e.g., the user is penalized). In some implementations, the sleep efficiency (SE) can be calculated based at least in part on the total time in bed (TIB) and the total time that the user is attempting to sleep. In such implementations, the total time that the user is attempting to sleep is defined as the duration between the go-to-sleep (GTS) time and the rising time described herein. For example, if the total sleep time is 8 hours (e.g., between 11 PM and 7 AM), the go- to-sleep time is 10:45 PM, and the rising time is 7: 15 AM, in such implementations, the sleep efficiency parameter is calculated as about 94%.

[0121] The fragmentation index is determined based at least in part on the number of awakenings during the sleep session. For example, if the user had two micro-awakenings (e.g., micro-awakening MAi and micro-awakening MA2 shown in FIG. 4), the fragmentation index can be expressed as 2. In some implementations, the fragmentation index is scaled between a predetermined range of integers (e.g., between 0 and 10).

[0122] The sleep blocks are associated with a transition between any stage of sleep (e.g., the first non-REM stage, the second non-REM stage, the third non-REM stage, and / or the REM) and the wakefulness stage. The sleep blocks can be calculated at a resolution of, for example, 30 seconds.

[0123] In some implementations, the systems and methods described herein can include generating or analyzing a hypnogram including a sleep-wake signal to determine or identify the enter bed time (tbed), the go-to-sleep time (tors), the initial sleep time (tsieep), one or morefirst micro-awakenings (e.g., MAi and MA2), the wake-up time (twake), the rising time (trise), or any combination thereof based at least in part on the sleep-wake signal of a hypnogram.

[0124] In some implementations, one or more of the sensors 130 can be used to determine or identify the enter bed time (tbed), the go-to-sleep time (tors), the initial sleep time (tsieep), one or more first micro-awakenings (e.g., MAi and MA2), the wake-up time (twake), the rising time (trise), or any combination thereof, which in turn define the sleep session. For example, the enter bed time tbed can be determined based at least in part on, for example, data generated by the motion sensor 138, the microphone 140, the camera 150, or any combination thereof. The go- to-sleep time can be determined based at least in part on, for example, data from the motion sensor 138 (e.g., data indicative of no movement by the user), data from the camera 150 (e.g., data indicative of no movement by the user and / or that the user has turned off the lights), data from the microphone 140 (e.g., data indicative of the using turning off a TV), data from the user device 170 (e.g., data indicative ofthe user no longer using the user device 170), data from the pressure sensor 132 and / or the flow rate sensor 134 (e.g., data indicative of the user turning on the respiratory therapy device 122, data indicative of the user donning the user interface 124, etc.), or any combination thereof.

[0125] Generally, a user who is prescribed usage of the respiratory therapy system 120 will tend to experience higher quality sleep and less fatigue during the day after using the respiratory therapy system 120 during the sleep compared to not using the respiratory therapy system 120 (especially when the user suffers from sleep apnea or other sleep related disorders). For example, the user 210 may suffer from obstructive sleep apnea and rely on the user interface 124 (e.g., a full face mask) to deliver pressurized air from the respiratory therapy device 122 via conduit 126. The respiratory therapy device 122 can be a continuous positive airway pressure (CPAP) machine used to increase air pressure in the throat of the user 210 to prevent the airway from closing and / or narrowing during sleep. For someone with sleep apnea, her airway can narrow or collapse during sleep, reducing oxygen intake, and forcing her to wake up and / or otherwise disrupt her sleep. The CPAP machine prevents the airway from narrowing or collapsing, thus minimizing the occurrences where she wakes up or is otherwise disturbed due to reduction in oxygen intake. While the respiratory therapy device 122 strives to maintain a medically prescribed air pressure or pressures during sleep, the user can experience sleep discomfort due to the therapy.

[0126] When the respiratory therapy system 120 is used with the respiratory therapy device 122 operating as an APAP device, the respiratory therapy device 122 will often utilize a feature (which may be part of the AutoSet™ feature of the respiratory therapy device 122) that causesthe therapy pressure to increase if respiratory events (such as flow limitations, which may be understood as any event that limits the flow of air into the user’s lungs due to a restriction, blockage or collapse of the upper airway) are detected, and subsequently causes the therapy pressure to decrease when a further event is not detected. In some cases, the decrease is set as a certain amount of pressure decrease for every breath the user takes. The respiratory therapy device 122 effectively searches for a pressure where a threshold number of events occur (e.g., 0 events, a specific number of events per minute, etc.), which is often referred to as the critical therapy pressure of the individual using the respiratory therapy device 122.

[0127] FIG. 5 illustrates two example pressure moderation curves 502A and 502B that show the therapy pressure response to the detection of respiratory events during standard modes of operation. The current therapy pressure (e.g., the current therapy pressure value), at which the respiratory events may be detected, is plotted on the horizontal axis, and a moderation factor is plotted on the vertical axis. The moderation factor is a number between 0 and 1 by which a baseline therapy pressure increase is multiplied, resulting in the actual therapy pressure increase that occurs. A larger value for this moderation factor results in less moderation of the therapy pressure increase, and thus a larger therapy pressure increase. A smaller value results in more moderation of the therapy pressure increase, and thus a smaller therapy pressure increase. As used herein, a “smaller” (or “slower”) therapy pressure increase can refer to the therapy pressure increasing at a smaller rate, the therapy pressure increasing to a smaller increased therapy pressure (e.g., a therapy pressure increase of a smaller magnitude or size), the therapy pressure increasing in smaller increments, other modifications, or combinations of any these effects. As used herein, a “larger” (or “faster”) therapy pressure increase can refer to the therapy pressure increasing at a larger rate, the therapy pressure increasing to a larger increased therapy pressure (e.g., a therapy pressure increase of a larger magnitude or size), the therapy pressure increasing in larger increments, other modifications, or combinations of any these effects.

[0128] As shown, both pressure moderation curves 502A and 502B are generally flat at a moderation factor of 1 when the therapy pressure is between about 0 cm H2O and about 10 cm H2O (units of cm H2O (wherein 1 cm H2O = 98.0665 Pa) are used for illustrative purposes, but any suitable units can be used). Thus, in response to the detection of a respiratory event when the therapy pressure is anywhere between 0 cm H2O and 10 cm H2O, the same baseline therapy pressure increase will occur. Pressure moderation curve 502A decreases from 1 at a therapy pressure above 10 cm H2O, and reaches a minimum of 0 at a therapy pressure of 20 cm H2O (in other examples, the minimum moderation factor may be slightly larger than 0). Pressuremoderation curve 502A decreases in a substantially linear fashion, meaning that the amount of moderation applied to the baseline therapy pressure increase is substantially linearly increased between 10 cm H2O and 20 cm H2O. Once the therapy pressure is at 20 cm H2O, the therapy pressure will not be increased even if a respiratory event is detected. Pressure moderation curve 502B is similar to pressure moderation curve 502A, except that pressure moderation curve 502B decreases slower between 10 cm H2O and 15 cm H2O, flattens about between 15 cm H2O and about 19cm H2O, and then decreases faster between 19 cm H2O and 20 cm H2O. Other values for where the moderation curves begin to decrease and where the moderation curves flatten out may also be used.

[0129] These standard modes of operation can be used with individuals that do not have a single critical therapy pressure, or have a single critical therapy pressure that is not equal to the standard critical therapy pressure value that is used. However, these standard modes may be sub-optimal for such individuals in terms of user experience (e.g., user comfort). For example, both pressure moderation curves 502A and 502B show the moderation factor beginning to decrease at 10 cm H2O, and reaching 0 at 20 cm H2O. However, if the actual critical therapy pressure(s) of the individual is not 10 cm H2O, then beginning to moderate the therapy pressure increase at 10 cm H2O may impact the user experience and may decrease the individual’s sleep quality and / or therapy compliance (e.g., by keeping the therapy pressure unnecessarily too high, which may include therapy pressures higher than required to achieve adequate suppression of respiratory events, etc.). Thus, individuals with different critical therapy pressures often will benefit from having different amounts of moderation of the therapy pressure increase than occur in the standard modes of operation employed pressure moderation curves 502A and 502B. It is noted that these standard modes of operation typically also employ fixed pressure decay constants, meaning that therapy pressure decreases, which occur in the absence of respiratory events, occur at a same rate irrespective of the current pressure level. In contrast to the alternative modes of operation disclosed herein, the standard modes of operation are not tailored to the individual, except that they react to respiratory events experienced by the individual during a sleep session, and as such do not learn from the individual’s previous therapy sessions. As disclosed herein, the alternative modes of operation are based on unique moderation curves and decay constant curves that respectively determine the therapy pressure increases or decreases in response to the occurrence or absence of respiratory events. Thus, the alternative modes of operation disclosed herein advantageously provide tailored, adaptable therapy pressure adjustments which thereby can improve the individual’s sleep, comfort, and / or compliance with their prescribed therapy.

[0130] FIGS. 6A and 6B show pressure distribution curves of recorded therapy pressures for two individuals during one or more sleep sessions that illustrate the existence of one or two critical therapy pressures. Critical therapy pressures for the two individuals can be represented by peaks in these pressure distributions curves. In some implementations, the pressure distribution curves show the number of times that the therapy pressure had a specific value during the one or more sleep sessions (e.g., if the curve has a value of n at a pressure of 6 cm H2O, then there were n separate times during the one or more sleep sessions where the air provided by the respiratory therapy system had a pressure of 6 cm H2O). In some of these implementations, the therapy pressure value is recorded once every epoch, where every epoch has a specific length of time (in other words, the therapy pressure values are sampled according to a sampling rate). The epoch may be 1 second, 2 seconds, 5 seconds, 10 seconds, 30 seconds, 1 minute, etc. In other implementations, the pressure distributions curves show the number of times that the therapy pressure had a specific value when a respiratory event occurred during the one or more sleep sessions (e.g., if the curve has a value of n at a pressure of 6 cm H2O, then there were n separate times during the one or more sleep sessions where a respiratory event occurred when the air provided by the respiratory therapy system had a pressure of 6 cm H2O). The therapy pressure value may be recorded for every event that occurs, or once for every epoch in which an event occurs (which could be the therapy pressure value of the first event of the epoch, the average therapy pressure value of events in the epoch, etc.).

[0131] In either case, the peaks of the pressure distribution curves can represent critical therapy pressures for a specific individual upon which various different modes of operation for that individual, such as the modes of operation described herein, can be based. It is also noted that although the pressure distribution curves in FIGS. 6A and 6B are described with respect to two different individuals, it is possible that similar pressure distribution curves may relate to the same individual, such as determined from different sleep sessions or different cohorts of sleep sessions.

[0132] In FIG. 6A, pressure distribution curve 600 shows a single peak 602 (about 11 cm H2O), and in FIG. 6B, pressure distribution curve 650 shows two different peaks 652A (about 9 cm H2O) and 652B (about 13 cm H2O). For either individual, the standard (or noncustomized) automatic adjustment of the therapy pressure in response to the occurrence of or lack of respiratory events may not properly maintain the therapy pressure near the critical therapy pressure represented by the single peak 602 or near one of the two critical therapy pressures represented by the two peaks 652A and 652B, and may maintain the therapy pressureat higher or lower than desired levels in response to the occurrence of or lack of respiratory events.

[0133] Peaks corresponding to critical therapy pressure(s) may be identified, e.g., estimated, using a peak finding algorithm. For example, in some implementations, peaks are identified based on the slope (or derivative) of the pressure distribution curve being zero. This typically returns a number of peaks and their corresponding peak heights (where the peak height is associated with how frequently a given therapy pressure occurred). The peaks may be filtered based on a required minimum distance between the peaks, where peaks that are too close together are identified, and at least one of those peaks removed.

[0134] Thus, pressure distribution curves can be analyzed to identify the peaks and the pressure values represented by the peaks. Analysis of the pressure distribution curves may show one peak (indicating the individual has one critical therapy pressure), two peaks (indicating that the individual has two critical therapy pressures), or more than two peaks (indicating that the individual has more than two critical therapy pressures). As discussed in more detail herein, the parameters of different modes of operation of the respiratory therapy system can be determined by analyzing pressure distribution curves (such as pressure distribution curves 600 and 650). For a given individual, a single pressure distribution curve covering multiple sleep sessions (and / or portions of multiple sleep session) may be analyzed, or one or more separate pressure distribution curves each representing a single sleep session (and / or a portion of a single sleep session) may be analyzed. While FIGS. 6 A and 6B illustrate actual curves that are plotted, in some cases the data itself (e.g., individual pressure values and the count for each pressure value) is analyzed to identify the peaks (and the pressures values of the peaks), without the pressure distribution curves actually being plotted or otherwise formed. In general, references to analyzing pressure distribution curves generally refers to analyzing pressure data in any suitable format.

[0135] Referring now to FIGS. 7A-7C, an alternative mode of operation for the respiratory therapy device 122 (or the respiratory therapy system 120 as a whole) is shown that is associated with a different set of rules than the above-described standard automatic adjustment mode of operation. The alternative mode of operation shown in FIGS. 7A-7C can be used with individuals having a single critical therapy pressure. In general, this alternative mode of operation will bias the therapy pressure toward the individual’s critical therapy pressure. The term “standard mode of operation” is used herein to refer to a standard automatic adjustment of the therapy pressure in response to respiratory events and the lack thereof. These standard modes will generally utilize the fixed pressure moderation curves that are not customized to anindividual’s actual critical therapy pressure, and fixed pressure decay constants. The pressure moderation curves 502A and 502B in FIG. 5 represent two examples of a standard mode of operation. The term “first mode of operation” is used to refer to the alternative mode of operation that can be used when the individual has only one critical therapy pressure. As will be understood by those of skill in the art, as described herein, when an individual is determined to have one critical therapy pressure, this is understood to mean only one critical therapy pressure as opposed to one of two (or more) critical therapy pressures.

[0136] During the first mode of operation, the moderation of therapy pressure increases will be based on the value of current therapy pressure relative to the patient’s critical therapy pressure, and the resulting therapy pressure increases will generally be smaller than those that would occur at the same therapy pressure with the example of the standard mode represented by moderation curve 502A. Similarly, the rate, size, magnitude, etc. of subsequent therapy pressure decreases after a respiratory event has subsided will be based on the value of the increased therapy pressure relative to the patient’s critical therapy pressure. Thus, therapy pressure increases and decreases can be different for patients with different critical therapy pressures.

[0137] FIG. 7A shows a pressure moderation curve 702 for the first mode of operation, as well as the example pressure moderation curve 502A for a standard mode of operation. As shown, the patient has a critical therapy pressure 704 of about 7 cm H2O, which may be learned over one or more sleep sessions as described herein. The pressure moderation curve 702 begins to decrease substantially linearly at this critical therapy pressure 704, whereas the pressure moderation curve 502A does not begin to decrease until about 10 cm H2O. Thus, the moderation factor applied to the baseline therapy pressure increase begins to decrease at a lower current therapy pressure level relative to the standard mode of operation, and the resulting increase in the therapy pressure is less than the increase during the standard mode of operation. In the illustrated implementation, the pressure moderation curve 702 decreases substantially linearly (e.g., at a constant rate) until it reaches a cutoff pressure 706, which in the illustrated implementation is about 15 cm H2O. Once at the cutoff pressure 706, the pressure moderation curve 702 decreases substantially linearly at a slower rate to reach 0 at 20 cm H2O. In some implementations, the pressure moderation curve 702 may continue to decrease at the same rate past the cutoff pressure 706, until it reaches 0. The cutoff pressure 706 is thus a therapy pressure at which the slope of the pressure moderation curve 702 changes to reach a moderation factor of 0 at the same therapy pressure as the pressure moderation curve 502A.

[0138] The result of the pressure moderation curve 702 is that in response to the detection of a respiratory event while the respiratory therapy system is providing air at some therapy pressure than is greater than the critical therapy pressure 704, the respiratory therapy system in the first mode of operation is configured to cause an increase in the therapy pressure that is generally dependent on the value of the current therapy pressure relative to the patient’s specific critical therapy pressure, instead of a standard therapy pressure value used for many people as with the standard mode. Compared to the example of the standard mode represented by moderation curve 502A, the respiratory therapy system in the first mode of operation is configured to cause a more moderated increase (e.g., smaller increase) in the therapy pressure in response to the detection of a respiratory event when providing air that is greater than the critical therapy pressure 704.

[0139] The pressure moderation curve 702 also illustrates the response of the respiratory therapy system during the first mode of operation when detecting respiratory events while operating at different therapy pressures, for different therapy pressure ranges. The first therapy pressure range is less than the critical therapy pressure 704. The moderation factor within this range has a constant value (1.0 in the illustrated implementation), and thus the moderation factor applied to increases occurring when the therapy pressure is in this range is generally identical. Thus, in response to respiratory events, the respiratory therapy system is configured to cause substantially identical increases to occur when the therapy pressure is in this range, regardless of the value of the therapy pressure. In general, since the first therapy pressure range is below the critical therapy pressure 704, baseline therapy pressure increases when in the first therapy pressure range will generally have little to no moderation applied to them to thereby encourage the therapy pressure to increase toward the critical therapy pressure 704.

[0140] The second therapy pressure range is between the critical therapy pressure 704 and the cutoff pressure 706. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is between the critical therapy pressure 704 and the cutoff pressure 706, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply a smaller second moderation factor to a baseline therapy pressure increase when it is providing air at a second therapy pressure that is also between the critical therapy pressure 704 and the cutoff pressure 706 but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. As such, the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor.In embodiments, if the baseline therapy pressure increases are substantially identical for the first and second respiratory events, then the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor.

[0141] The third therapy pressure range is greater than the cutoff pressure 706. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is greater than the cutoff pressure 706, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply a smaller second moderation factor to a baseline therapy pressure increase when it is providing air at a second therapy pressure that is also greater than the cutoff pressure 706 but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. As such, the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the smaller second moderation factor. In embodiments, if the baseline therapy pressure increases are substantially identical for the first and second respiratory events, then the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the smaller second moderation factor. However, the difference in the increases from two therapy pressures a given distance apart will be smaller (e.g., the pressure moderation factor decreases more slowly) when in the third therapy pressure range as compared to the second pressure range, since the pressure moderation curve 702 is less steep in the third pressure range.

[0142] FIG. 7B shows a pressure decay curve 752 that describes how the therapy pressure decreases once the respiratory event (or series / cluster of respiratory events) subsides. The therapy pressure when the decrease begins (e.g., the therapy pressure to which the pressure was increased in response to a respiratory event) is plotted on the horizontal axis, and the time constant governing the subsequent therapy pressure decrease is plotted on the vertical axis. The time constant of the decrease at least in part determines the rate of the decrease, the step size of the decrease, the overall size of the decrease, other characteristics of the decrease, or any combinations thereof. A smaller time constant (closer to the horizontal axis) results in a faster decrease in the therapy pressure, while a larger time constant (farther away from the horizontal axis) results in a slower decrease in the therapy pressure. As used herein, a “faster” decrease generally refers to the decrease occurring at a faster rate, the decrease having a larger step size, the decrease having a larger total size, other modifications, or any combinations of any modifications. As used herein, a “slower” decrease generally refers to the decrease occurringat a slower rate, the decrease having a smaller step size, the decrease having a smaller overall size, other modifications, or any combinations of any modifications.

[0143] As shown, the pressure decay curve 752 has a constant value up to the critical therapy pressure 704, at which point the pressure decay curve 752 begins to decrease substantially linearly. In the illustrated implementation, the pressure decay curve 752 stops decreasing once the therapy pressure reaches the cutoff pressure 706, indicating that if the therapy pressure is increased to any therapy pressure equal to the cutoff pressure 706 or higher, the time constant governing the subsequent decrease will not be dependent on that therapy pressure. Thus, after the therapy pressure has been increased to some therapy pressure that is greater than the critical therapy pressure 704, the time constant governing the subsequent decrease in the therapy pressure will be dependent on the actual value of the increased therapy pressure. This is in contrast to the standard mode of operation, where the time constant governing the subsequent decrease in the therapy pressure has a generally constant value that is independent of the value of the increased therapy pressure.

[0144] The pressure decay curve 752 also illustrates the subsequent decrease in the therapy pressure after the therapy pressure has been increased to therapy pressures within different therapy pressure ranges. The first therapy pressure range is less than the critical therapy pressure 704. After the therapy pressure has been increased to an increased therapy pressure that is less than the critical therapy pressure 704 A, the time constant governing the subsequent therapy pressure decrease has a constant value that is the same for any value of the increased therapy pressure within the first therapy pressure range. In general, since the first therapy pressure range is below the critical therapy pressure 704, the decay constant tends to remain at a relatively large value to limit any decreases, such as in terms of rate and / or increments, away from the critical therapy pressure 704.

[0145] The second therapy pressure range is between the critical therapy pressure 704 and the cutoff pressure 706. After the therapy pressure has been increased to a first increased therapy pressure that is between the critical therapy pressure 704 and the cutoff pressure 706, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure that is governed by a first time constant. After the therapy pressure has been increased to a second increased therapy pressure that is between the critical therapy pressure 704 and the cutoff pressure 706 but greater than the first increased therapy pressure, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure that is governed by a second time constant, which is smaller than the first time constant, such that the second decrease is faster than the first decrease.

[0146] The third therapy pressure range is greater than the cutoff pressure 706. After the therapy pressure has been increased to an increased therapy pressure that is greater than the cutoff pressure 706, the time constant governing the subsequent therapy pressure decrease will have a constant value that is the same for any value of the increased therapy pressure within the third therapy pressure range. In general, the pressure decay curve 752 flattens at therapy pressures above the cutoff pressure 706, as faster therapy pressure decreases in this range (e.g., governed by an increasingly small time constant) may interrupt the individual’s sleep and / or comfort, even though such decreases would return the therapy pressure to the critical therapy pressure 704 faster.

[0147] FIG. 7C shows an example pressure curve 762 for the first mode of operation that illustrates the effect of the pressure moderation curve 702 and the pressure decay curve 752. The pressure curve 762 shows the therapy pressure level over time relative to the critical therapy pressure 704. As shown, the pressure curve 762 can have continual small increases and decreases (such as due to the detection of the occurrence and cessation of respiratory events, such as flow limitations), but the effect of the first mode of operation is that the system tries to maintain the therapy pressure at or near the critical therapy pressure 704. Because the amount of moderation applied to the therapy pressure increase grows as the therapy pressure is further away from the critical therapy pressure 704, the therapy pressure has a tendency to not increase above the critical therapy pressure 704, e.g., the rate and / or increments of increased pressure reduces the further the current therapy pressure is above the critical therapy pressure. In addition, the further the therapy pressure increases above the critical therapy pressure 704, the greater the tendency of the therapy pressure to decrease toward to the critical therapy pressure 704 in the absence of respiratory events, which can result from faster decreases when further away from the critical therapy pressure 704. Below the critical therapy pressure 704, the tendency of the therapy pressure to increase toward the critical therapy pressure 704 remains substantially constant irrespective of the therapy pressure.

[0148] Those of skill in the art will understand that in some cases, the standard mode of operation provided by a respiratory therapy system may be generally similar to the first mode of operation, even though the standard mode would be applied without knowledge of the individual’s critical therapy pressure(s). For example, for an individual using a respiratory therapy system operating with the moderation curve 502 happens to have a critical therapy pressure of 10 cmFFO (or a critical therapy pressure equal to the fixed critical therapy pressure of the standard mode where the moderation factor begins to decrease), the moderation of the therapy pressure increases may generally be identical under the standard mode as it would withthe first mode (where the point when the moderation factor begins to decrease is pegged to the individual’s critical therapy pressure). In general, the standard mode of operation is a mode of operation where the moderation curve is based on fixed therapy pressure values. In contrast, the second mode of operation (an example of which is represented by the pressure moderation curve 702) is a mode of operation where the moderation curve is customized to the individual’s actual critical therapy pressure.

[0149] Referring now to FIGS. 8A-8C, another alternative mode of operation for the respiratory therapy device 122 (or the respiratory therapy system 120 as a whole) is shown that is associated with a different set of rules than the above-described standard and first modes of operation. The alternative mode of operation shown in FIGS. 8A-8C can be used with individuals having two critical therapy pressures instead of one. In general, this alternative mode of operation will bias the therapy pressure toward either of the individual’s critical therapy pressures, while discouraging the therapy pressure from remaining in between the two critical therapy pressures, or remaining above the upper critical therapy pressure or below the lower critical therapy pressure. The term “second mode of operation” is used to refer to this alternative mode of operation that can be used when the individual has two critical therapy pressures.

[0150] FIG. 8 A shows a pressure moderation curve 802 for the second mode of operation, as well as the pressure moderation curve 502A for an example of the standard mode of operation. As shown, the patient has a first critical therapy pressure 804A of about 7 cm H2O (the low critical therapy pressure), and a second critical therapy pressure 804B of about 14 cm H2O (the high critical therapy pressure). The pressure moderation curve 802 begins to decrease substantially linearly at the first critical therapy pressure 804A, similar to the pressure moderation curve 702 of FIG. 7A. However, once the pressure moderation curve 802 reaches a midpoint 805 between the first critical therapy pressure 804A and the second critical therapy pressure 804B, the pressure moderation curve begins to increase substantially linearly. When the pressure moderation curve 802 reaches the second critical therapy pressure 804B, the pressure moderation curve 802 again starts to decrease substantially linearly. Finally, once the pressure moderation curve 802 reaches the cutoff pressure 806, it decreases substantially linearly to 0, but less rapidly. In the illustrated implementation, the cutoff pressure 806 is about 17 cm H2O. However, those of skill in the art will understand that the specific pressure values shown in FIGS. 8A-8C are for illustrative purposes only.

[0151] When the respiratory therapy system is providing air at a therapy pressure between the first critical therapy pressure 804A and the midpoint 805 (e.g., between the first and secondcritical therapy pressures 804A and 804B and closer to the first critical therapy pressure 804A), the pressure moderation applied by the respiratory therapy system is similar to the first mode of operation, and will generally be less than the example of the standard mode of operation represented by moderation curve 502A. The resulting increase in the therapy pressure will thus generally be smaller than during the example of the standard mode of operation represented by moderation curve 502A.

[0152] When the respiratory therapy system is providing air at a therapy pressure between the midpoint 805 and the second critical therapy pressure 804B (e.g., between the first and second critical therapy pressures 804A and 804B and closer to the second critical therapy pressure 804B), the amount pressure moderation applied by the respiratory therapy system differs from the first mode of operation. Because the pressure moderation curve 802 begins to increase again past the midpoint 805, there will generally be (i) a first range of pressures above the midpoint 805 where the therapy pressure increase during the second mode of operation is less (e.g., more moderation) than during the example of the standard mode of operation represented by moderation curve 502A, and (ii) a second range of pressures above the midpoint 805 where the therapy pressure increase during the second mode of operation is greater (e.g., less moderation) than during the example of the standard mode of operation represented by moderation curve 502A.

[0153] In the illustrated implementation, the pressure moderation curve 502A (which represents an example of the standard mode of operation) intersects with the pressure moderation curve 802 approximately halfway between the midpoint 805 and the second critical therapy pressure 804B. Thus, if a respiratory event is detected when the therapy pressure is between the midpoint 805 and the second critical therapy pressure 804B, but closer to the midpoint 805, the resulting therapy pressure increase will be smaller during the second mode of operation than during the example of the standard mode of operation represented by moderation curve 502A. However, if a respiratory event is detected when the therapy pressure is between the midpoint 805 and the second critical therapy pressure 804B, but closer to the second critical therapy pressure 804B, the resulting therapy pressure increase will be larger during the second mode of operation than the example of the standard mode of operation represented by moderation curve 502A. In some implementations, this transition may occur at different therapy pressures between the midpoint 805 and the second critical therapy pressure 804B, and that the described comparison to the standard mode of operation represented by moderation curve 502A is for illustration purposes.

[0154] When the respiratory therapy system is providing air at a therapy pressure that is larger than the second critical therapy pressure 804B, the moderation factor applied by the respiratory therapy system again begins to decrease substantially linearly (e.g., more moderation is applied to the baseline therapy pressure increase). However, similar to when the therapy pressure was between the midpoint 805 and the second critical therapy pressure 804B, the therapy pressure increase in response to the detection of a respiratory event may be larger or smaller during the second mode of operation as compared to the example of the standard mode of operation represented by moderation curve 502A, depending on where the pressure moderation curves 502A and 802 intersect. In the illustrated implementation, because the pressure moderation curves 502A and 802 intersect between the second critical therapy pressure 804B and the cutoff pressure 806, there will generally be (i) a first range of pressures above the second critical therapy pressure 804B where the therapy pressure increase during the second mode of operation is greater than during the example of the standard mode of operation represented by moderation curve 502A, and (ii) a second range of pressures above the second critical therapy pressure 804B where the therapy pressure increase during the second mode of operation is less than during the example of the standard mode of operation represented by moderation curve 502A.

[0155] Moreover, those of skill in the art will understand that the therapy pressure increases during the second mode of operation relative to the standard mode of operation may be different for different moderation curves used with the standard mode of operation. For example, the pressure moderation curve 802 may intersect a different moderation curve for the standard mode of operation at a different location than that shown in FIG. 8A.

[0156] The pressure moderation curve 802 also illustrates the response of the respiratory therapy system during the second mode of operation when detecting respiratory events while operating at different therapy pressures, for different therapy pressure ranges. The first therapy pressure range is less than the first critical therapy pressure 804A. The moderation factor within this range has a constant value (1.0 in the illustrated implementation), and thus the moderation factor applied to therapy pressure increases is generally identical for different current therapy pressures in this range. Thus, in response to respiratory events, the respiratory therapy system is configured to cause substantially identical increases to occur when the therapy pressure is in this range, regardless of the value of the therapy pressure. In general, since the first therapy pressure range is below the first critical therapy pressure 804A, baseline therapy pressure increases when in the first therapy pressure range will generally have little to no moderationapplied to them to thereby encourage the therapy pressure to increase toward the first critical therapy pressure 804A.

[0157] The second therapy pressure range is between the first critical therapy pressure 804A and the midpoint 805. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is between the first critical therapy pressure 804A and the midpoint 805, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply a smaller second moderation factor to a baseline therapy pressure increase when it is providing air at a second therapy pressure that is also between the first critical therapy pressure 804A and the midpoint 805 but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. As such, the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor. In embodiments, if the baseline therapy pressure increases for the first and second respiratory events are substantially identical, then the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor.

[0158] The third therapy pressure range is between the midpoint 805 and the second critical therapy pressure 804B. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is between the midpoint 805 and the second critical therapy pressure 804B, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply a larger second moderation factor to a baseline therapy pressure increase when it is providing air at a second therapy pressure that is also between the midpoint 805 and the second critical therapy pressure 804B but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. As such, the second increase in the therapy pressure will be larger than the first increase in the therapy pressure due to the application of the larger second moderation factor. In embodiments, if the baseline therapy pressure increases for the first and second respiratory events are substantially identical, then the second increase in the therapy pressure will be larger than the first increase in the therapy pressure due to the application of the larger second moderation factor.

[0159] The fourth therapy pressure range is between the second critical therapy pressure 804B and the cutoff pressure 806. In response to a first respiratory event, the respiratory therapysystem is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is between the second critical therapy pressure 804B and the cutoff pressure 806, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply a smaller second moderation factor to a baseline therapy pressure increase when it is providing air at a second therapy pressure that is also between the second critical therapy pressure 804B and the cutoff pressure 806 but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. As such, the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor. In embodiments, if the baseline therapy pressure increases for the first and second respiratory events are substantially identical, then the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor.

[0160] The fifth therapy pressure range is greater than the cutoff pressure 806. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is greater than the cutoff pressure 806, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply a smaller second moderation factor to a baseline therapy pressure increase when it is providing air at a second therapy pressure that is also greater than the cutoff pressure 806 but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. If the first and second respiratory events are substantially identical and the baseline therapy pressure increases are substantially identical, then the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor. However, the difference (such as in response to substantially identical respiratory events) in the increases from two therapy pressures a given distance apart will be smaller (e.g., the pressure moderation factor decreases more slowly) when in the fifth therapy pressure range as compared to the second and fourth pressure ranges, since the pressure moderation curve 802 is less steep in the fifth pressure range.

[0161] As shown by comparing the third therapy pressure range and the fourth therapy pressure range, in the illustrated implementations there are locations along the pressure moderation curve 802 where the moderation factor (and the resulting increase if respiratory events are substantially identical) to be applied is identical, even if the two therapy pressures are in different therapy pressure ranges. For example, if the pressure moderation curve 802 issymmetric about the midpoint 805, the moderation factor applied when the therapy pressure in the third therapy pressure range (between the first critical therapy pressure 804A and the midpoint 805) may be identical to the moderation factor applied when the therapy pressure is in the fourth therapy pressure range (between the midpoint 805 and the second critical therapy pressure 804B) if the two therapy pressures are equidistant from the midpoint 805. The applied moderation factors will not be identical if they are not equidistant from the midpoint 805 (although the resulting increase could be substantially identical in some cases if the respiratory events are different and different applied moderation factors results in the same increase). In general, any increases from points on the opposite sides of the midpoint 805 will be subject to the same moderation factor.

[0162] Additionally, there are locations along the pressure moderation curve 802 where the applied moderation factor is larger (e.g., less moderation), even if the starting therapy pressure from which the increase occurs is larger. For example, the moderation factor applied when increasing from a smaller therapy pressure in the third therapy pressure range may be less than the moderation factor applied when increasing from a larger therapy pressure in the fourth therapy pressure range if the larger therapy pressure is sufficiently close to the second critical therapy pressure 804B, such that the pressure moderation curve 802 is higher at that point.

[0163] Moreover, in some implementations, the point at which the pressure moderation curve 802 begins to again increase when between the first critical therapy pressure 804A and the second critical therapy pressure 804B may not be the precise midpoint 805 between those two therapy pressures. Instead, in some cases, this increase occurs at a therapy pressure that is closer to the first critical therapy pressure 804A than the second critical therapy pressure 804B, or closer to the second critical therapy pressure 804B than the first critical therapy pressure 804A, so that the therapy pressure is biased slightly more towards one of the two critical therapy pressures 804 A and 804B.

[0164] FIG. 8B shows a pressure decay curve 852 that describes how the therapy pressure decreases once the respiratory event (or series / cluster of respiratory events) subsides. The therapy pressure at which the respiratory event subsides is plotted on the horizontal axis, and the time constant governing the subsequent therapy pressure decrease is plotted on the vertical axis. A smaller time constant (closer to the horizontal axis) results in a faster decrease in the therapy pressure, while a larger time constant (farther away from the horizontal axis) results in a slower decrease in the therapy pressure.

[0165] As shown, the pressure decay curve 852 has a constant value up to the first critical therapy pressure 804A, at which point the pressure decay curve 852 begins to decreasesubstantially linearly, similar to the pressure decay curve 752. However, once the pressure decay curve 852 reaches the midpoint 805 between the first critical therapy pressure 804A and the second critical therapy pressure 804B, the pressure decay curve 852 begins to increase substantially linearly . When the pressure decay curve 852 reaches the second critical therapy pressure 804B, the pressure decay curve 852 again starts to decrease substantially linearly. Finally, once the pressure decay curve 852 reaches the cutoff pressure 806 it flattens out and does not change any further.

[0166] Thus, after the therapy pressure has been increased to some therapy pressure that is between the first critical therapy pressure 804A and the cutoff pressure 806, the time constant governing the subsequent decrease in the therapy pressure will have a value that is dependent on the actual value of the increased therapy pressure. This is in contrast to the example of the standard mode of operation, where the time constant governing the subsequent decrease in the therapy pressure has a generally constant value that is independent of the value of the increased therapy pressure. The pressure decay curve 852 also shows that if the therapy pressure is increased to a therapy pressure that is less than the first critical therapy pressure 804A or greater than the cutoff pressure 806, the time constant governing the subsequent decrease of the therapy pressure will have a generally constant value that is independent from the value of the increased therapy pressure. However, the constant value of the time constant will be higher when decreasing from a therapy pressure greater than the cutoff pressure 806, and lower when decreasing from a therapy pressure less than the first critical therapy pressure 804A.

[0167] The pressure decay curve 852 also illustrates the subsequent decrease in the therapy pressure after the therapy pressure has been increased to therapy pressures within different therapy pressure ranges. The first therapy pressure range is less than the first critical therapy pressure 804A. After the therapy pressure has been increased to an increased therapy pressure that is less than the first critical therapy pressure 804A, the time constant governing the subsequent therapy pressure decrease has a constant value that is the same for any value of the increased therapy pressure within the first therapy pressure range. In general, because the first therapy pressure range is below the first critical therapy pressure 804A, the decay constant tends to remain at a relatively large value to limit any decreases away from the first critical therapy pressure 804A.

[0168] The second therapy pressure range is between the first critical therapy pressure 804A and the midpoint 805. After the therapy pressure has been increased to a first increased therapy pressure that is between the first critical therapy pressure 804 and the midpoint 805, the respiratory therapy system is configured to subsequently cause a first decrease in the therapypressure that is governed by a first time constant. After the therapy pressure has been increased to a second increased therapy pressure that is between the first critical therapy pressure 804A and the midpoint 805 but greater than the first increased therapy pressure, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure that is governed by a smaller second time constant such that the second decrease is faster than the first decrease.

[0169] The third therapy pressure range is between the midpoint 805 and the second critical therapy pressure 804B. After the therapy pressure has been increased to a first increased therapy pressure that is between the midpoint 805 and the second critical therapy pressure 804B, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure that is governed by a first time constant. After the therapy pressure has been increased to a second increased therapy pressure that is between the midpoint 805 and the second critical therapy pressure 804B but greater than the first increased therapy pressure, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure that is governed by a larger second time constant such that the second decrease is slower than the first decrease.

[0170] The fourth therapy pressure range is between the second critical therapy pressure 804B and the cutoff pressure 806. After the therapy pressure has been increased to a first increased therapy pressure that is between the second critical therapy pressure 804B and the cutoff pressure 806, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure that is governed by a first time constant. After the therapy pressure has been increased to a second increased therapy pressure that is between the second critical therapy pressure 804B and the cutoff pressure 806 but greater than the first increased therapy pressure, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure that is governed by a smaller second time constant such that the second decrease is faster than the first decrease.

[0171] The fifth therapy pressure range is greater than the cutoff pressure 806. After the therapy pressure has been increased to an increased therapy pressure that is greater than the cutoff pressure 806, the time constant governing the subsequent therapy pressure decrease will have a constant value that is the same for any value of the increased therapy pressure within the fifth therapy pressure range. In general, the pressure decay curve 852 flattens at therapy pressures above the cutoff pressure 806, as increasingly faster therapy pressure decreases in this range (e.g., governed by an increasingly small time constant) may interrupt the individual’s sleepand / or comfort, even though such decreases would return the therapy pressure to the second critical therapy pressure 804B faster.

[0172] As shown by comparing the third therapy pressure range and the fourth therapy pressure range, there are locations along the pressure decay curve 852 where the time constant governing the subsequent decrease (and the subsequent decrease itself) may be identical, even if the two therapy pressures are in different therapy pressure ranges. For example, if the pressure decay curve 852 is symmetric about the midpoint 805, the time constant governing a first decrease from a therapy pressure in the third therapy pressure range (between the first critical therapy pressure 804A and the midpoint 805) may be identical to the time constant governing a second decrease from a therapy pressure in the fourth therapy pressure range (between the midpoint 805 and the second critical therapy pressure 804B) if the two therapy pressures are equidistant from the midpoint 805. The time constants governing the two pressure decreases will not be identical if they are not equidistant from the midpoint 805. In general, as indicated in by the decay curve in Fig. 8B, any decreases from corresponding points on the opposite sides of the midpoint 805 will be governed by the same time constant.

[0173] Additionally, there are locations along the pressure decay curve 852 where the time constant governing the subsequent therapy pressure decrease is larger, even if the decrease began at a larger therapy pressure. For example, a therapy pressure decrease from a smaller therapy pressure in the third therapy pressure range may be governed by a larger time constant than a therapy pressure decrease from a larger therapy pressure in the fourth therapy pressure range if the larger therapy pressure is sufficiently close to the second critical therapy pressure 804B such that the pressure decay curve 852 is higher at that point.

[0174] Moreover, in some implementations, the point at which the pressure decay curve 852 begins to again increase when between the first critical therapy pressure 804A and the second critical therapy pressure 804B may not be the precise midpoint 805 between those two therapy pressures. Instead, in some cases, this increase occurs at a therapy pressure that is closer to the first critical therapy pressure 804A than the second critical therapy pressure 804B, or closer to the second critical therapy pressure 804B than the first critical therapy pressure 804A, so that the therapy pressure is biased slightly more towards one of the two critical therapy pressures 804 A and 804B.

[0175] FIG. 8C shows an example pressure curve 862 for the second mode of operation that illustrates the effect of the pressure moderation curve 802 and the pressure decay curve 852. The pressure curve 862 shows the therapy pressure level over time relative to the first critical therapy pressure 804A and the second critical therapy pressure 804B. As shown, the pressurecurve 862 can have continual small increases and decreases (due to the constant detection of the occurrence and cessation of respiratory events such as flow limitations) around the first critical therapy pressure 804A, but eventually jumps up to the second critical therapy pressure 804B (which may be due to the presence of a respiratory event of relatively more severity, more respiratory events occurring within a certain timeframe, and / or other factors). However, because the pressure moderation curve 802 and the pressure decay curve 852 do not try to bring the therapy pressure level back down to the first critical therapy pressure 804A, the pressure curve 862 remains centered around the second critical therapy pressure 804B. The pressure curve 862 does eventually fall back down to the first critical therapy pressure 804A, which could be caused, for example, by an absence of respiratory events for some period of time.

[0176] The pressure curve 862 is also indicative of the tendency of the therapy pressure to increase or decrease when in different pressure levels during the second mode of operation. The further the therapy pressure increases above the first critical therapy pressure 804A and towards the midpoint 805, the greater the tendency of the therapy pressure to decrease toward to the first critical therapy pressure 804A, which can result from smaller increases and faster decreases when further away from the first critical therapy pressure 804A. Similarly, the further the therapy pressure decreases below the second critical therapy pressure 804B and towards the midpoint 805, the greater the tendency of the therapy pressure to increase toward the second critical therapy pressure 804B, which can result from larger increases and slower decreases when further away from the second critical therapy pressure 804B.

[0177] However, at the midpoint between the first critical therapy pressure 804A and the second critical therapy pressure 804B (or at another point therebetween depending on the pressure moderation curve 802 and the pressure decay curve 852), these tendencies flip. A therapy pressure increase from the first critical therapy pressure 804A, which passes the midpoint, will tend to keep increasing toward the second critical therapy pressure 804B instead of decreasing toward the first critical therapy pressure 804A, and a therapy pressure decrease from the second critical therapy pressure 804B, which passes the midpoint, will tend to keep decreasing toward the first critical therapy pressure 804A instead of increasing toward the second critical therapy pressure 804B.

[0178] The tendencies below the first critical therapy pressure 804A and above the second critical therapy pressure 804B are similar to the tendencies in FIG. 7C about the critical therapy pressure 704. The further the therapy pressure increases above the second critical therapy pressure 804B, the greater the tendency of the therapy pressure to decrease toward to the second critical therapy pressure 804B, which can result from faster decreases when further away fromthe second critical therapy pressure 804B. Below the first critical therapy pressure 804A, the tendency of the therapy pressure to increase toward the first critical therapy pressure 804A remains substantially constant irrespective of the therapy pressure.

[0179] Referring now to FIGS. 9A-9C, another alternative mode of operation for the respiratory therapy device 122 (or the respiratory therapy system 120 as a whole) is shown that is associated with a different set of rules than the above-described standard, first, and second modes of operation. The alternative mode of operation shown in FIGS. 9A-9C can be used with individuals that do not have one or two stable critical therapy pressures, which may include individuals with more than two critical therapy pressures, individuals with two critical therapy pressures that vary significantly between sleep sessions (such as successive sleep sessions), individuals with generally no identifiable critical therapy pressures (e.g., individuals where no peaks were identified using a peak finding algorithm, for example as a result of no peaks satisfying the predetermined peak height threshold). In this mode of operation, lower and upper therapy pressure bounds are determined, which define a general acceptable therapy pressure range. Instead of trying to keep the therapy pressure stable around a first critical therapy pressure or a second critical therapy pressure, the respiratory therapy system according to this mode of operation attempts to keep the therapy pressure somewhere within the range defined by the lower and upper therapy pressure bounds. The term “third mode of operation” is used to refer to this alternative mode of operation that can be used when the individual does not have two stable critical therapy pressures.

[0180] FIG. 9 A shows a pressure moderation curve 902 for the third mode of operation, as well as the example pressure moderation curve 502A for the standard mode of operation. As shown, the patient has a lower therapy pressure bound 904 A of about 11 cm H2O, and an upper therapy pressure bound 904B of about 14 cm H2O. The patient also has a cutoff pressure 906 of about 17 cm H2O. Those of skill in the art will understand that the specific pressure values shown in FIGS. 9A-9C are for illustrative purposes only.

[0181] At pressures below the lower therapy pressure bound 904A, the pressure moderation curve 902 remains at a constant maximum value, similar to the pressure moderation curve 802 below the first critical therapy pressure 804A. The pressure moderation curve 902 decreases substantially linearly between the upper therapy pressure bound 904B and the cutoff pressure 906 — similar to the pressure moderation curve 802 decreasing between the first critical therapy pressure 804A and the midpoint 805, and between the second critical therapy pressure 804B and the cutoff pressure 806. The pressure moderation curve 902 decreases substantially linearlybut less rapidly after the cutoff pressure 906, similar to the pressure moderation curve 802 decreasing less rapidly after the cutoff pressure 806.

[0182] However, instead of increasing after the lower therapy pressure bound 904A (like, for example, the pressure moderation curve 802 increasing after the midpoint 805), the pressure moderation curve 902 remains at a constant value until the therapy pressure reaches the upper therapy pressure bound 904B. The moderation factor applied to the baseline therapy pressure increase thus does not change with the value of the therapy pressure between the lower therapy pressure bound 904 A and the upper therapy pressure bound 904B. Thus, instead of trying to pull the therapy pressure down to the lower therapy pressure bound 904A or push the therapy pressure up to the upper therapy pressure bound 904B, the respiratory therapy system instead urges the therapy pressure to be maintained therebetween.

[0183] When the respiratory therapy system is providing air at a therapy pressure below the lower therapy pressure bound 904 A, the pressure moderation applied by the respiratory therapy system is similar to the first mode of operation below the critical therapy pressure 704, and the second mode of operation below the first critical therapy pressure 804A. When a respiratory event is detected, the moderation applied to the subsequent baseline therapy pressure increase will be the same irrespective of the current therapy pressure value.

[0184] When the respiratory therapy system is providing air at a therapy pressure between the lower therapy pressure bound 904A and the upper therapy pressure bound 904B, the amount pressure moderation applied by the respiratory therapy system differs from the second mode of operation. Because the pressure moderation curve 902 remains level, the amount of moderation of any therapy pressure increases will be same, regardless of the actual value of the therapy pressure. And again, as shown in the example of FIG. 9A, the therapy pressure increase during the third mode of operation will be smaller than the therapy pressure increase that would occur during the example of the standard mode of operation represented by moderation curve 502A.

[0185] When the respiratory therapy system is providing air at a therapy pressure that is greater than the upper therapy pressure bound 904B, the moderation factor applied by the respiratory therapy system again begins to decrease substantially linearly again (e.g., more moderation is applied to the baseline therapy pressure increase). However, the moderation factor in this range is still less than it is the example of the standard mode of operation represented by moderation curve 502A, such that the therapy pressure increase here will be smaller than the therapy pressure increase that would occur during the example of the standard mode of operation represented by moderation curve 502A. Once the therapy pressure reaches the cutoff pressure906, the pressure moderation curve 902 flattens out slightly, but is still less than the moderation curve 502.

[0186] The pressure moderation curve 902 also illustrates the response of the respiratory therapy system during the third mode of operation when detecting respiratory events while operating at different therapy pressures, for different therapy pressure ranges. The first therapy pressure range is less than the lower therapy pressure bound 904A. The moderation factor within this range has a constant value (1.0 in the illustrated implementation), and thus the moderation factor applied to therapy pressure increases occurring when the therapy pressure is in this range is generally identical. Thus, in response to respiratory events, the respiratory therapy system is configured to cause substantially identical increases to occur when the therapy pressure is in this range, regardless of what value of the therapy pressure is. In general, since the first therapy pressure range is below the lower therapy pressure bound 904 A, baseline therapy pressure increases when in the first therapy pressure range will generally have little to no moderation applied to them to thereby encourage the therapy pressure to increase toward the lower therapy pressure bound 904A.

[0187] The second therapy pressure range is between the lower therapy pressure bound 904A and the upper therapy pressure bound 904B. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is between the lower therapy pressure bound 904A and the upper therapy pressure bound 904B, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply an identical second moderation factor to a baseline therapy pressure increase (because the pressure moderation curve 902 is flat in the second therapy pressure range) when it is providing air at a second therapy pressure that is also between the lower therapy pressure bound 904A and the upper therapy pressure bound 904B but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. If the first and second respiratory events are identical and the baseline therapy pressure increases are identical, then the second increase in the therapy pressure will be identical to the first increase in the therapy pressure due to the application of the identical moderation factors.

[0188] The third therapy pressure range is between the upper therapy pressure bound 904B and the cutoff pressure 906. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is between the upper therapy pressure bound 904B and the cutoff pressure 906, resulting in a first increase in the therapy pressure. Inresponse to a second respiratory event, the respiratory therapy system is configured to apply a smaller second moderation factor to a baseline therapy pressure increase when it is providing air at a second therapy pressure that is also between the upper therapy pressure bound 904B and the cutoff pressure 906 but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. If the first and second respiratory events are identical and the baseline therapy pressure increases are identical, then the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor.

[0189] The fourth therapy pressure range is greater than the cutoff pressure 906. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is greater than the cutoff pressure 906, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply a smaller second moderation factor to a baseline therapy pressure increase when it is providing air at a second therapy pressure that is also greater than the cutoff pressure 906 but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. If the first and second respiratory events are identical and the baseline therapy pressure increases are identical, then the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor. However, the difference (such as in response to substantially identical respiratory events) in the increases from two therapy pressures a given distance apart will be smaller (e.g., the pressure moderation factor decreases more slowly) when in the fourth therapy pressure range as compared to the third pressure range, since the pressure moderation curve 902 is less steep in the fourth pressure range.

[0190] FIG. 9B shows a pressure decay curve 952 that describes how the therapy pressure decreases once the respiratory event (or series / cluster of respiratory events) subsides. The therapy pressure at which the respiratory event subsides is plotted on the horizontal axis, and the time constant of the therapy pressure decay is plotted on the vertical axis. A smaller time constant (closer to the horizontal axis) results in a faster decrease in the therapy pressure, while a larger time constant (farther away from the horizontal axis) results in a slower decrease in the therapy pressure.

[0191] The pressure decay curve 952 has a constant value up to the lower therapy pressure bound 904A, at which point the pressure decay curve 952 instantaneously decreases to a lower value. Between the lower therapy pressure bound 904A and the upper therapy pressure bound904B, the pressure decay curve 952 is flat and remains constant (in contrast to the pressure decay curve 852 which increases again past the midpoint 805), but at a lower value than at therapy pressures less than the lower therapy pressure bound 904A. When the pressure decay curve 952 reaches the upper therapy pressure bound 904B, the pressure decay curve 952 begins to decrease substantially linearly. Finally, once the pressure decay curve 952 reaches the cutoff pressure 906, it flattens out and does not change any further.

[0192] Thus, the time constant governing subsequent therapy pressure decreases will have a constant value at therapy pressures below the lower therapy pressure bound 904 A, between the lower therapy pressure bound 904A and the upper therapy pressure bound 904B, and above the cutoff pressure 906. However, the value of this time constant will be highest below the lower therapy pressure bound 904A, lowest above the cutoff pressure 906, and in between when between the lower therapy pressure bound 904 A and the upper therapy pressure bound 904B. After the therapy pressure has been increased to some therapy pressure that is between the upper therapy pressure bound 904B and the cutoff pressure 906, the time constant governing the subsequent decrease in the therapy pressure will have a changing value that is dependent on the actual value of the increased therapy pressure. This is in contrast to the example of the standard mode of operation, where the time constant governing the subsequent decrease in the therapy pressure has a generally constant value that is independent of the value of the increased therapy pressure.

[0193] The pressure decay curve 952 also illustrates the subsequent decrease in the therapy pressure after the therapy pressure has been increased to therapy pressures within different therapy pressure ranges. The first therapy pressure range is less than the lower therapy pressure bound 904A. After the therapy pressure has been increased to an increased therapy pressure that is less than the lower therapy pressure bound 904A, the time constant governing the subsequent therapy pressure decrease has a constant value that is the same for any value of the increased therapy pressure within the first therapy pressure range. In general, because the first therapy pressure range is below the lower therapy pressure bound 904A, the decay constant tends to remain at a relatively large value to limit any decreases away from the lower therapy pressure bound 904A.

[0194] However, all decreases when the therapy pressure is at or below the lower therapy pressure bound 904A are generally undesirable, even comparing decreases from just below the lower therapy pressure bound 904A or from well below the lower therapy pressure bound 904A. Thus, decreases from anywhere below the lower therapy pressure bound 904A are governed by the same relatively larger time constant, to minimize (or virtually eliminate)decreases when the therapy pressure is at or below the lower therapy pressure bound 904A. This behavior is similar to decreases from below the critical therapy pressure 704 in the first mode (FIG. 7B) and from below the first critical therapy pressure 804A in the second mode (FIG. 8B).

[0195] The second therapy pressure range is between the lower therapy pressure bound 904A and the upper therapy pressure bound 904B. After the therapy pressure has been increased to a first increased therapy pressure that is between the lower therapy pressure bound 904A and the upper therapy pressure bound 904B, the time constant governing the subsequent therapy pressure decrease has a constant value that is the same for any value of the increased therapy pressure within the second therapy pressure range.

[0196] The third therapy pressure range is between the upper therapy pressure bound 904B and the cutoff pressure 906. After the therapy pressure has been increased to a first increased therapy pressure that is between the upper therapy pressure bound 904B and cutoff pressure 906, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure that is governed by a first time constant. After the therapy pressure has been increased to a second increased therapy pressure that is between the upper therapy pressure bound 904B and the cutoff pressure 906 but greater than the first increased therapy pressure, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure that is governed by a smaller second time constant such that the second decrease is faster than the first decrease.

[0197] The fourth therapy pressure range is greater than the cutoff pressure 906. After the therapy pressure has been increased to an increased therapy pressure that is greater than the cutoff pressure 906, the time constant governing the subsequent therapy pressure decrease will have a constant value that is the same for any value of the increased therapy pressure within the fourth therapy pressure range. In general, the pressure decay curve 852 flattens at therapy pressures above the cutoff pressure 906, as faster therapy pressure decreases in this range (e.g., governed by an increasingly small time constant) may interrupt the individual’s sleep and / or comfort, even though such decreases would return the therapy pressure to the upper therapy pressure bound 904B faster.

[0198] FIG. 9C shows an example pressure curve 962 for the third mode of operation that illustrates the effect of the pressure moderation curve 902 and the pressure decay curve 952. The pressure curve 962 shows the therapy pressure level over time relative to the lower therapy pressure bound 904 A and the upper therapy pressure bound 904B. As shown, the pressure curve 962 is not centered around the lower therapy pressure bound 904A or the upper therapypressure bound 904B, but instead is maintained between the lower therapy pressure bound 904A and the upper therapy pressure bound 904B, due to the effects of the pressure moderation curve 902 and the pressure decay curve 952 as described above. And because the pressure moderation curve 902 and the pressure decay curve 952 do not try to bring the therapy pressure level to either the lower therapy pressure bound 904A or the upper therapy pressure bound 904B, the pressure curve 962 is urged to remain within this range.

[0199] Referring now to FIG. 10, a flowchart of a method 1000 of operating (or determining operations of) a respiratory therapy system (such as the respiratory therapy system 120) is illustrated. Generally, a control system having one or more processors (such as control system 110 of system 100) is configured to carry out the steps of method 1000. A memory device (such as memory device 114 of system 100) can be used to store machine-readable instructions that are executed by the control system to carry out the steps of method 1000. The memory device can also store any type of data utilized in the steps of method 1000. Generally, method 1000 can be implemented using a system (such as system 100) that includes the respiratory therapy system, the control system, and the memory device.

[0200] Method 1000 can be used to determine whether the respiratory therapy system should be operated according to the first mode of operation (described herein with respect to FIGS. 7A-7C), the second mode of operation (described herein with respect to FIGS. 8A-8C), or the third mode of operation (described herein with respect to FIGS. 9A-9C). Step 1002 of method 1000 includes receiving data associated with one or more (e.g., a plurality) of sleep sessions of the individual while the individual uses the respiratory therapy system. In some implementations, the data includes a distribution of therapy pressures provided by the respiratory therapy system during each respective sleep session. In general, the respiratory therapy system may be operating according to a standard mode of operation (e.g., a noncustomized mode of operation such as the example modes represented by the pressure moderation curves 502A and 502B in FIG. 5) as this data is gathered. However, the respiratory therapy system can generally operate according to any mode of operation, such as the first, second or third modes of operation described herein, so long as the appropriate data can be collected (e.g., the distribution of therapy pressures during the sleep sessions).

[0201] Step 1004 includes analyzing the data to determine the number of critical therapy pressures (#ctP) for the individual. In some implementations, step 1004 includes analyzing the distribution of pressures within each respective sleep session to determine the number of therapy pressure peaks for each respective sleep session, where one or more peaks may be derived based on from the distribution of pressures, and where each critical therapy pressurecorresponds to a peak. Critical therapy pressures may be estimated as local maxima of an overnight (or multiple nights) pressure distribution. In some implementations, the number of critical therapy pressures for the individual is determined by determining the portion (or other measure) of the plurality of sleep sessions for which the individual had one critical therapy pressure, two critical therapy pressures, more than two critical therapy pressures, or any combination thereof.

[0202] In some implementations, the distribution of pressures is in the form of a pressure distribution curve, where pressures are plotted on the horizontal axis and a variable associated with the frequency of occurrence of the pressures is plotted on the vertical axis (e.g., pressure distribution curves 600 and 650 in FIGS. 6A and 6B). The variable associated with the frequency of occurrence may be a variable associated with a total count, a variable associated with a normalized count, a variable associated with a density (such as estimated from a kernel density estimation), and others. As discussed above, the peaks may be identified using a peak finding algorithm, such as an algorithm that identifies pressures on the pressure distribution curve where the slope (or derivative) is zero. In some implementations, the pressure at any point where the slope (or derivative) is zero is considered to be a critical therapy pressure for that sleep session.

[0203] Also as discussed above, in some implementations the identified peaks are further filtered to ensure there is a minimum distance between the peaks. In some cases, this filtering includes defining a minimum distance between peaks and, for any two peaks where the distance between them is less than the minimum distance (e.g., 0.5, 1, 1.5, 2, or 2.5 cm H2O, the smaller peak can be removed. For example, if the slope values identify peaks at pressures of 8 cm H2O, 9 cm H2O, and 14 cm H2O with heights of 0.3, 0.2, and 0.5 respectively, and the minimum distance between peaks is 1.5 cm H2O, then the peaks at 8 cm H2O and 9cm H2O are subject to the filtering, because the distance between them is less than 1.5 cm H2O. Because the peak at 9 cm H2O (0.2) is smaller than the peak at 8 cm H2O (0.3), the peak at 9 cm H2O will be removed.

[0204] Peak heights may be based on the aforementioned variable associated with the frequency of occurrence of the pressures. As will be understood by those skilled in the art, such peak heights may be based on count values, normalized count values, density measures (such as estimated from kernel density estimation), etc. Further, a threshold peak height may be set which a peak must exceed in order to be counted as an actual peak that may correspond to a critical therapy pressure, rather than just a small blip or bump. This threshold peak height in some cases is a certain percentage of the combined height of all identified peaks. For example,if three peaks are identified having heights of 0.7, 0.25, and 0.05, the combined total height of the peaks is 1. If the required percentage is 10%, then the third peak is removed, because the height of the third peak (0.05) is less than 10% of the combined peak height (.1).

[0205] If the portion of the plurality of sleep sessions where the individual had one critical therapy pressure satisfies a predetermined threshold, then the individual is determined to have one critical therapy pressure, and method 1000 proceeds to step 1010. In some implementations, the threshold is a specific percentage of the plurality of sleep sessions wherein the individual is determined to have one critical therapy pressure, such as about 65%, about 70%, about 75%, about 60% to about 80%, about 65% to about 75%, etc.

[0206] At step 1010, the spread of the values of the one critical therapy pressure across the plurality of sleep sessions (or a subset of the plurality of sleep sessions, if less than all of the sleep sessions had one critical therapy pressure) is determined, and compared to a threshold spread. For example, each sleep session with one critical therapy pressure will have a specific pressure value of the one critical therapy pressure, which can be measured in cm H2O. Each of these pressure values can be analyzed to determine the spread of the one critical therapy pressure across the sleep sessions. In general, depending on how the threshold value is defined, the threshold can be satisfied if the spread is less than the threshold value, less than or equal to the threshold value, greater than the threshold value, or greater than or equal to the threshold value.

[0207] In some implementations, the spread is measured by determining the standard deviation of the values of the one critical therapy pressure across the plurality of sleep sessions. In these implementations, the threshold spread is a maximum standard deviation against which the determined standard deviation of the one critical therapy pressure is compared. In some of these implementations, the maximum standard deviation is 1 cm H2O. This maximum standard deviation is satisfied if the standard deviation for the one critical therapy pressure is less than or equal to 1 cm H2O. In some implementations, the spread can be measured by determining the variance of the values of the one critical therapy pressure across the plurality of sleep session. In these implementations, the threshold spread is a threshold variance against which the determined variance is compared.

[0208] If the spread of the values of the one critical therapy pressure across the plurality of sleep sessions satisfies the threshold spread, method 1000 can advance to step 1012. At step 1012, the respiratory therapy system is operated according to the first mode of operation that is described herein with respect to FIGS. 7A-7C.

[0209] If it is determined at step 1004 that the individual has two critical therapy pressures, method 1000 proceeds to step 1020. In some implementations, the individual is determined to have two critical therapy pressures if the portion of the plurality of sleep sessions where the individual had one critical therapy pressure does not satisfy the predetermined threshold (to confirm that the individual has one critical therapy pressure) but the sum of the portions of the plurality of sleep sessions where the individual had one critical therapy pressure and two critical therapy pressures does satisfy the predetermined threshold. This can be particularly useful for individuals having position-related sleep disordered breathing (such as positional OSA), which is typically associated with two critical therapy pressures. However, such an individual may sleep in only one sleeping position during a sleep session and thus may demonstrate one and two critical therapy pressures. In some implementations, the individual is determined to have two critical therapy pressures if the portion of the plurality of sleep sessions where the individual had two critical therapy pressures satisfies a predetermined threshold (which may be the same as the predetermined threshold for determining one critical therapy pressure, or different).

[0210] In some implementations, the predetermined threshold for (i) the sum of the portion with one critical therapy pressure and two critical therapy pressures or (ii) the portion with two critical therapy pressures is the same as the predetermined threshold for the portion with one critical therapy pressure. For example, if both the predetermined threshold of sleep sessions with one critical therapy pressure and the predetermined threshold of sleep sessions with two critical therapy pressures are percentages that are less than 70%, (or some other threshold) but the sum of the individual percentages is greater than or equal to 70% (or some other threshold), then the individual is determined to have two critical therapy pressures. Alternatively, if the portion of the sleep session with two critical therapy pressures is a percentage that is greater than or equal to 70% (or some other threshold), then the individual is determined to have two critical therapy pressures.

[0211] If it is determined that the individual has two critical therapy pressures, method 1000 proceeds to step 1020. At step 1020, the spread of the values of each of the two critical therapy pressures across the plurality of sleep sessions (or a subset of the plurality of sleep sessions, if less than all of the sleep session had two critical therapy pressures) is determined, and the spread of each of the two critical therapy pressures is compared to a respective threshold spread. For example, each sleep session with two critical therapy pressures will have a specific pressure value for a lower critical therapy pressure and an upper critical therapy pressure, which can be measured in cm H2O. All pressure values for the lower critical therapy pressure can be analyzedto determine the spread of the lower critical therapy pressure across the sleep sessions, and all pressure values for the upper critical therapy pressure can be analyzed to determine the spread of the upper critical therapy pressure across the sleep sessions. In general, depending on how the threshold spread is defined, the threshold spread for each of the two critical therapy pressures can be satisfied if the spread is less than the threshold spread, less than or equal to the threshold spread, greater than the threshold spread, or greater than or equal to the threshold spread.

[0212] In some implementations, the spread is measured by determining the standard deviation of the values of each of the upper and lower critical therapy pressures across the plurality of sleep sessions. In these implementations, the respective threshold spread for each of the two critical therapy pressures is a respective standard deviation against which the determined standard deviations of the two critical therapy pressures are compared. In some of these implementations, the threshold standard deviation for the upper critical therapy pressure is 1.5 cm H2O. This respective threshold standard deviation could be satisfied if the standard deviation for the upper critical therapy pressure is less than 1.5 cm H2O, or less than or equal to 1.5 cm H2O. In some of these implementations, the threshold standard deviation for the lower critical therapy pressure is 1 cm H2O. This respective threshold standard deviation could be satisfied if the standard deviation for the lower critical therapy pressure is less than 1 cm H2O, or less than or equal to 1 cm H2O. In still further of these implementations, each of the two critical therapy pressures may have the same threshold standard deviation. For example, the threshold standard deviation for either or both of the upper and the lower critical therapy pressure could be between 1 cm H2O and 1.5 cm H2O.

[0213] In some implementations, the spread can be measured by determining the variance of the values of each of the upper and lower critical therapy pressure across the plurality of sleep session. In these implementations, the threshold spreads are threshold variances against which the determined variances are compared.

[0214] In the illustrated implementation, if the spread of the values of each of the two critical therapy pressures across the plurality of sleep sessions satisfies the respective threshold spread, method 1000 can advance to step 1022. At step 1022, the respiratory therapy system is operated according to the second mode of operation that is described herein with respect to FIGS. 9A- 9C.

[0215] As shown in FIG. 10, there are also multiple instances where method 1000 can advance to step 1030. If it is determined that the individual has no critical therapy pressures (e.g., no peaks satisfying a peak height threshold were identified, no consistent critical therapy pressurewas identified, etc.) or more than two critical therapy pressures at step 1004 (e.g., it is determined that the individual does not have only one critical therapy pressure and does not have only two critical therapy pressures), method 1000 advances to step 1030. If it is determined that the spread of the one critical therapy pressure does not satisfy the threshold spread in step 1010, method 1000 advances to step 1030 (or to step 1020, and then possibly to step 1030 if the spread of one or both of the two critical therapy pressures does not satisfy the respective threshold spread in step 1020). If it is determined that the spread of the two critical therapy pressures does not satisfy the threshold spread in step 1020, method 1000 advances to step 1030. If it is determined that the spread of one or both of the two critical therapy pressures does not satisfy the respective threshold spread in step 1020, method 1000 advances to step 1030.

[0216] At step 1030, the respiratory therapy system operates according to the third mode of operation that is described herein with respect to FIGS. 9A-9C. In some implementations, the lower therapy pressure bound 904A and the upper therapy pressure bound 904B used with the third mode of operation can be determined from the distribution of therapy pressures collected in step 1002. For example, these bounds could be the average maximum and minimum therapy pressures across the one or more (e.g., plurality) of sleep sessions, the average of a certain percentage (e.g., 90%) of the maximum and minimum therapy pressures across the one or more (e.g., plurality) of sleep sessions.

[0217] In some implementations, the respiratory therapy system transitions to the third mode of operation if the individual has two critical therapy pressures that vary too much (e.g., spread exceeds a threshold) to be suitable for the second mode of operation. In these implementations, the lower and upper therapy pressure bounds can be determined in a number of ways. In one example, the upper therapy pressure bound is the average of all of the upper critical therapy pressures, and the lower therapy pressure bound is the average of all of the lower critical therapy pressures. In another example, the upper therapy pressure bound is the largest of all of the upper critical therapy pressures, and the lower therapy pressure bound is the smallest of all of the lower critical therapy pressures. In a further example, the upper therapy pressure bound is the smallest of all of the upper critical therapy pressures, and the lower therapy pressure bound is the largest of all of the lower critical therapy pressures.

[0218] In some implementations, the respiratory therapy system transitions to the third mode of operation if the individual has a generally defined band of critical therapy pressures across the sleep sessions, even if that band includes more than two critical therapy pressures. In these implementations, the lower and upper pressure bounds can be determined in a number of ways.In one example, the upper therapy pressure bound is the largest of all the critical therapy pressures, and the lower therapy pressure bound is the smallest of all the critical therapy pressures. In another example, the upper therapy pressure bound is the average of all the critical therapy pressures that are greater than a mean or median critical therapy pressure, and the lower therapy pressure bound is the smallest of all the critical therapy pressures that are less than the mean or median critical therapy pressure.

[0219] In some implementations, the respiratory therapy system remains operating according to the standard mode of operation if the number of critical therapy pressures of the individual is larger than some threshold value. In some implementations, the respiratory therapy system remains operating according to the standard mode of operation if there is no defined band of critical therapy pressures across the sleep sessions, or if the band of critical therapy pressures is too large.

[0220] In some implementations, method 1000 can be implemented over a period of time to allow information about the individual to be learned. For example, the individual can initially use the respiratory therapy system according to the standard mode of operation (and / or one or more of the first, second and third modes of operation). After one or more sleep sessions with the standard mode of operation, data from the one or more sleep session can be analyzed to select the firs, second, or third mode of operation for future sleep sessions. However, data can continually be generated during these sleep sessions so that the respiratory therapy system can be updated based on further data regarding the individual’s critical therapy pressure / pressures. For example, in some implementations, the respiratory therapy system can be updated after each sleep session for the subsequent sleep session. In some of these implementations, the mode of operation for the subsequent sleep session is based only on data from the immediately prior sleep session. In others of these implementations, the mode of operation for the subsequent sleep session is based on a rolling average of data from prior sleep sessions, such as a 7-day rolling average or a 14-day rolling average. In some implementations, the respiratory therapy system is updated during a sleep session that is ongoing. Thus, in general, method 1000 can be used to update the mode of operation of the respiratory therapy system for a subsequent sleep session portion, which can include a subsequent portion of the current sleep session and / or any portion of any subsequent sleep session. Moreover, the respiratory therapy system could be updated to the selected mode of operation at any time, including as soon as the mode of operation needed for the individual is determined or shortly thereafter, when the respiratory therapy system is activated for use during the subsequent sleep session portion, or any other suitable time.

[0221] Referring now to FIGS. 11A-11C, in some implementations another alternative mode of operation for the respiratory therapy device 122 (or the respiratory therapy system 120 as a whole) may be based on both the peaks(s) in the pressure distribution curve(s) for an individual, as well as percentiles of the pressure distribution curve(s) for the individual. This alternative mode of operation will utilize pressure moderation curves and pressure decay curves that are based on a lower therapy pressure bound, an upper therapy pressure bound, and a cutoff pressure, similar to the third mode of operation discussed herein with respect to at least FIGS. 9A-9C. Notably, this alternative mode of operation can be used with individuals having one critical therapy pressure (e.g., one peak in their pressure distribution curve), two critical therapy pressures (two peaks in their pressure distribution curve), or three or more critical therapy pressures (three or more peaks in their pressure distribution curve). The term “fourth mode of operation” is used to refer to this alternative mode of operation where the lower and upper therapy pressure bounds and the cutoff pressure are determined from the pressure distribution curves regardless of how many peaks are present.

[0222] FIG. 11 A shows a pressure distribution curve 1100 for an individual having one critical therapy pressure. The pressure distribution curve 1100 may represent pressure values of the air provided by the respiratory therapy system at which a respiratory event occurred across one or more sleep sessions, or pressures values of the air provided by the respiratory therapy system in general during the one or more sleep sessions (e.g., both when respiratory events occurred and when respiratory events did not occur). As shown, the pressure distribution curve 1100 has only one peak 1102. In individuals with a single peak, the lower therapy pressure bound can be based on the pressure value of the single peak 1102. The upper therapy pressure bound and the cutoff pressure can then be based on percentiles of the pressure distribution curve 1100 that are greater than the pressure value of the peak 1102. In FIG. 11 A, an upper therapy pressure bound percentile 1104 and a cutoff pressure percentile 1106 of the pressure distribution curve 1100 have been identified. The upper therapy pressure bound can be based on the pressure value of the upper therapy pressure bound percentile 1104, and the cutoff pressure can be based on the pressure value of cutoff pressure percentile 1106.

[0223] In some implementations, the numerical percentile represented by the upper therapy pressure bound percentile 1104 and the cutoff pressure percentile 1106 can be any suitable percentile that is greater than the pressure value of the single peak 1102. In some implementations, upper therapy pressure bound percentile 1104 upon which the upper therapy pressure bound is based is (i) between about a 50th percentile and a 100th percentile, (ii) between about a 50th percentile and a 90th percentile, (iii) between about a 60th percentile anda 100th percentile, (iv) between about the 60th percentile and the 90th percentile, (v) between about the 60th percentile and an 80th percentile, (vi) between about the 70th percentile and the 90th percentile, (vii) between about the 70th percentile and the 80th percentile, or (viii) about a 75th percentile. In some implementations, cutoff pressure percentile 1106 upon which the cutoff pressure is based is (i) between about an 80th percentile and about a 100th percentile, (ii) between about the 80th percentile and about a 90th percentile, (iii) between about the 90th percentile and about the 100th percentile, (iv) between about the 90th percentile and about a 95th percentile, (v) between about the 95th percentile and about the 100 percentile, (vi) between about the 95th percentile and about the 99th percentile, (vii) between about the 95th percentile and about the 100th percentile, (viii) between about the 99th percentile and about the 100th percentile, (ix) about the 99th percentile, or (x) about the 100th percentile.

[0224] Generally, the upper therapy pressure bound percentile 1104 will be greater than the single peak 1102, such that the therapy pressure value represented by the upper therapy pressure bound percentile 1104 is greater than the therapy pressure value represented by the single peak 1102. In these cases, there will be some range between the resulting lower therapy pressure bound and upper therapy pressure bound. However, this range can be narrow or large depending on the actual value of the pressure distribution curve 1100. In some implementations, this range may be 0, or may effectively be 0 if the respiratory therapy system is not capable of outputting pressurized air at the two distinct therapy pressure values (e.g., if the lower therapy pressure bound is 10.0 cm H2O and the upper therapy pressure bound is 10.01 cm H2O, but the respiratory therapy system is only capable of changing the therapy pressure in increments larger than .01 cm H2O). In these implementations, the resulting mode of operation effectively will be the first mode of operation represented by FIGS. 7A-7C, where the therapy pressure value representing the lower therapy pressure bound and the upper therapy pressure bound operates as the critical therapy pressure 704 and the therapy pressure value representing the cutoff pressure percentile operates as the cutoff pressure 706.

[0225] FIG. 1 IB shows a pressure distribution curve 1110 for an individual having two critical therapy pressures. The pressure distribution curve 1110 represents pressure values of the air provided by the respiratory therapy system at which a respiratory event occurred across one or more sleep sessions, or pressures values of the air provided by the respiratory therapy system in general during the one or more sleep sessions (e.g., both when respiratory events occurred and when respiratory events did not occur). As shown, the pressure distribution curve 1110 has two peaks 1112A and 1112B. In individuals with two peaks, the lower therapy pressure bound can be based on the pressure value of the lower peak 1112A, and the upper therapy pressurebound can be based on the pressure value of the higher peak 1112B. When referring to these peaks, the terms “lower” and “higher” do not refer to the height of the peaks, but rather the numerical pressure value of the peaks. Thus, in an example with a first peak at 10 cm H2O with a height of 20, and a second peak at 20 cm H2O with a height of 10, the first peak is the lower peak and the second peak is the higher peak, even though the first peak is taller and the second peak is shorter. The cutoff pressure can then be based on a percentile of the pressure distribution curve 1110 that is greater than the pressure values of the peaks 1112A and 1112B. In FIG. 1 IB, the cutoff pressure percentile 1114 of the pressure distribution curve 1110 has been identified. The cutoff pressure can be based on the pressure value of percentile 1114.

[0226] The numerical percentile represented by the cutoff pressure percentile 1114 can be any suitable percentile that is greater than the pressure value of the higher peak 1112B (e.g., the peak representing the upper therapy pressure bound). In some implementations, the cutoff pressure percentile 1114 upon which the cutoff pressure is based is (i) between about an 80th percentile and about a 100th percentile, (ii) between about the 80th percentile and about a 90th percentile, (iii) between about the 90th percentile and about the 100th percentile, (iv) between about the 90th percentile and about a 95th percentile, (v) between about the 95th percentile and about the 100 percentile, (vi) between about the 95th percentile and about the 99th percentile, (vii) between about the 95th percentile and about the 100th percentile, (viii) between about the 99th percentile and about the 100th percentile, (ix) about the 99th percentile, or (x) about the 100th percentile.

[0227] FIG. 11C shows a pressure distribution curve 1120 for an individual having three critical therapy pressures. The pressure distribution represents pressure values of the air provided by the respiratory therapy system at which a respiratory event occurred across one or more sleep sessions, or pressures values of the air provided by the respiratory therapy system in general during the one or more sleep sessions (e.g., both when respiratory events occurred and when respiratory events did not occur). As shown, the pressure distribution curve 1120 has three peaks 1122A, 1122B, and 1122C. In individuals with three peaks, the lower therapy pressure bound can be based on the pressure value of the lowest peak 1122A, and the upper therapy pressure bound can be based on the pressure value of the highest peak 1122C. Similar to FIG. 1 IB, when referring to these peaks, the terms “lowest” and “highest” do not refer to the height of the peaks, but rather the numerical pressure value of the peaks. The cutoff pressure can then be based on a percentile of the pressure distribution curve 1120 that is greater than the pressure values of the peaks 1122A, 1122B, and 1122C. In FIG. 11C, the cutoff pressure percentile 1124 of the pressure distribution curve 1120 has been identified. The cutoff pressurecan be based on the pressure value of the cutoff pressure percentile 1124. The process for identifying the peaks and percentiles for an individual having more than three critical therapy pressures is generally the same as that illustrated in FIG. 11C. Regardless of how many peaks are identified, the lowest peak is determined to be the peak representing the lower therapy pressure bound, and the highest peak is determined to be the peak representing the upper therapy pressure bound. Any peaks between the lowest peak and the highest peak are discarded, whether there is one peak between the lowest and highest, or multiple peaks between the lowest and highest.

[0228] The numerical percentile represented by the cutoff pressure percentile 1124 can be any suitable percentile that is greater than the pressure value of the highest peak 1122C. In some implementations, the cutoff pressure percentile 1124 upon which the cutoff pressure is based is (i) between about an 80th percentile and about a 100th percentile, (ii) between about the 80th percentile and about a 90th percentile, (iii) between about the 90th percentile and about the 100th percentile, (iv) between about the 90th percentile and about a 95th percentile, (v) between about the 95th percentile and about the 100 percentile, (vi) between about the 95th percentile and about the 99th percentile, (vii) between about the 95th percentile and about the 100th percentile, (viii) between about the 99th percentile and about the 100th percentile, (ix) about the 99th percentile, or (x) about the 100th percentile.

[0229] In general, each critical therapy pressure of an individual is a respective pressure value that corresponds to one of the peaks in the pressure distribution curve. In some cases, the pressure distribution curves for an individual may include additional peaks that do not correspond to a critical therapy pressure of the individual. In these cases, the lower therapy pressure bound may be equal to the pressure value of the lowest peak (in terms of pressure value, e.g., the lowest pressure value), and the upper therapy pressure bound may be equal to the pressure value of the highest peak (in terms of pressure value, e.g., the highest pressure value). There will thus in some cases be peaks of the pressure distribution curve that are not used to define the pressure moderation curve and the pressure decay curve, even if they may be considered to be a critical therapy pressure.

[0230] An example determination of the peaks is as follows. First, the pressure distribution curve is divided into a number of equal-width bins, such as 80. The value of each bin is the number of events that occurred at the pressures within each bin. The pressure distribution curve is then smoothed by passing a rolling average hamming window over the bins. The output of the window reflects the center point of the averaged values within the window. The smoothed pressure distribution is then normalized. Peaks are then identified by looking at all locationson the differential of the pressure distribution where the sign changes. If any two peaks are less than 1.5 cmFFO apart, the smaller of the two peaks is removed. Filtering is then applied to remove certain peaks. First, the heights of the peaks are normalized to reflect their proportion of the total sum of peaks heights. Peaks that account for less than or equal to 5% of the total peak height are removed. Then if 2 or more peaks still remain, additional filtering is applied to the lowest peak. This peak may reflect the starting pressure the individual experiences. If the individual has a higher pressure requirement above this pressure level, there is a high probability they will experience events at this pressure. Over multiple sessions, a smaller peak may thus form at this lower pressure which does not necessary reflect a pressure at which the individual needs treatment. To perform this filtering, it is determined what percentage of the total peak height the lowest peak accounts for. If three or more peaks are present, the lowest peak must account for over 10% of the total peak height. If the lowest peak does not, it is removed, and the filtering again is applied. If the lowest peak eventually accounts for over 10% of the total peak height with 3 or more peaks, then the filtering stops, and the pressures of the highest and lowest peaks are output. If removal of the lowest peak leaves only two peaks, the lowest peak must account for over 20% of the total peak height. If it does, the pressures of the two peaks are output. If it does not, the lowest peak is removed, and the pressure of the single remaining peak is output along with the pressure value of the 75thpercentile of the pressure distribution are output.

[0231] In any implementation, once the pressure values of (i) the highest and lowest peaks (if two or more peaks) or (ii) the pressure value of the single peak and the upper therapy pressure bound percentile are determined, the upper therapy pressure bound, the lower therapy pressure bound, and the cutoff pressure are determined. In some cases, the two pressure values that are output after the pressure distribution curve is analyzed are the upper therapy pressure bound and the lower therapy pressure bound, and the cutoff pressure is the pressure value of the 99thpercentile.

[0232] In other implementations, the pressure bounds and the cutoff pressure are equal to the pressure values of the peaks and the percentiles plus an offset. In these implementations, the lower therapy pressure bound is generally equal to the pressure value of the single peak plus an offset, the lower peak plus an offset, or the lowest peak plus an offset. The upper therapy pressure bound is generally equal to the pressure value of the upper therapy pressure bound percentile plus an offset, the higher peak plus an offset, or the highest peak plus an offset. The cutoff pressure is generally equal to the pressure value of the cutoff pressure percentile plus anoffset. In some implementations, each of these offset values is the same, although in other implementations any of the offsets could be different from any of the other offsets.

[0233] In some implementations, the offset includes a data score having a numerical value that is based on the number of sleep sessions from which the pressure distribution curve used to identify the peaks and percentiles is formed. In some of these implementations, the value of the data score decreases as the pressure distribution curve is formed from an increasing number of sleep sessions. For example, there may be a maximum number of sleep sessions from which the pressure distribution curve may be formed (e.g., 14 sleep sessions measured over a 14-day rolling window). The number of sleep sessions actually used to form the pressure distribution curve can be normalized relative to the maximum number of sleep sessions, and the inverse of this value and / or a variant of this value is the data score that can be added to the relevant pressure value. For example, if the peak on which the lower therapy pressure bound is based is at 11 cm H2O and 13 sleep sessions out of a maximum of 14 sleep sessions were used to form the pressure distribution curve, then the pressure value of the lower therapy pressure bound can be 11 cm H2O + (1-13 / 14), or 11.1 cm H2O. But if only 4 sleep sessions were used to form the pressure distribution curve, then the pressure value of the lower therapy pressure bound can be 11 cm H2O + (1-4 / 14), or 11.7 cm H2O. In other implementations, a predefined data score curve is used. In one example, the data score curve decreases linearly from 1 to 0 as the number of sleep sessions used to form the pressure distribution curve increases from 0 to 3. For sleep sessions above 3, the data scores remains at 0. This data score can be used as the offset that is added to the pressure values of the peaks and the percentiles.

[0234] In some implementations, the offset includes an event severity score having a numerical value that is based on one or more respiratory events experienced by the individual within a previous period of time during the subsequent sleep session. The previous period of time may be about 30 seconds, about 1 minute, about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 30 minutes, about 1 hour, about 2 hours, about 6 hours, or any other suitable amount of time. A period of time of about 5 minutes in duration can be useful to determine a user’s recent experience of respiratory events or lack thereof. In some cases, the event severity score is simply a count of the number of respiratory events experienced by the individual during the period of time. The event severity score may further be based on the types of events the individual experiences. Determining the numerical value of the event severity score can include determining the numerical value of a first event severity sub-score that is associated with a first type of respiratory event and determining the numerical value of a second event severity sub-score that is associated with a second type of respiratory event. The sub-score with the highest value can be selected as the event severity score. In some cases, the subscores can be based only on the number of respiratory events that occurs (e.g., apneas, hypopneas, RERAs, flow limitations, etc.). In some cases, the sub-scores can be based on both the number of respiratory events that occur and the severity of the events (e.g., flow duration of the respiratory event, a flow imitation versus a full obstructive apnea, etc.). In some implementations, the type of respiratory event for which the sub-score is based only on the number of respiratory events includes apneas, hypopneas, and RERAs. In some implementations, the type of respiratory event for which the sub-score is based on the number of respiratory events and the severity of the respiratory events includes flow limitations.

[0235] In one example, the first event severity sub-score is based on a weighted average AHI of the individual over a plurality of sleep sessions, the second event severity sub-score is based on an average flow limitation of the individual over a plurality of sleep sessions, and the third event severity sub-score is based on a RERA index of the individual over a plurality of sleep sessions. To determine the weighted average AHI, the AHI for a sleep sessions multiplied by the duration of the sleep session is determined for each of the plurality of sleep sessions, these values for the plurality of sleep sessions are added together, and that sum is divided by the total duration of all of the plurality of sleep sessions. To determine the mean flow limitation, the total magnitude of flow limitation over the plurality of sleep sessions is determined and divided by the number of flow limitation events. This value may be normalized to a value between 0 and 1. To determine the RERA index (RERA events per hour), the total number of RERA events experienced over the plurality of sleep sessions is determined, and then divided by the number of hours in the plurality of sleep sessions.

[0236] Once these three values are determined, the event severity sub-score can be determined, for example using a look-up table, a predefined curve, etc. In some cases, an AHI severity subscore curve is used that increases linearly from 0 to 1 for a weighted average AHI of between 0 and 2. For weighted average AHIs above 2, the AHI severity sub-score remains constant at 1. In some cases, a flow limitation severity sub-score curve is used that increases linearly from 0 to 1 for a mean flow limitation of between 0 and 0.02. For mean flow limitations above 0.02, the flow limitation severity sub-score remains constant at 1. In some cases, a RERA severity sub-score curve is used that increases linearly from 0 to 1 for a RERA index of between 0 and 0.5. For RERA index values above 0.5, the RERA severity sub-score remains constant at 1. The maximum of these three event severity sub-scores is then taken as the event severity score.

[0237] The offset may have other components as well, such as a fixed buffer that is always added. Additionally, the data score and the event severity score may also be multiple by some scaling value, which may be the same for both scores or different.

[0238] The total value of the offset that can be applied to the peaks and / or the percentiles can thus be the numerical value of the data score, the numerical value of the data score multiple by a scaling value, the numerical value of the event severity score, the numerical value of the event severity score multiplied by a scaling value, a fixed buffer, or any combination thereof. In some cases, the offset is calculated prior to the subsequent sleep session, and remains constant during the subsequent sleep session. In other cases, the offset (or components of the offset) dynamically changes during the subsequent sleep session.

[0239] In implementations where the data score is used, by adjusting the therapy pressure bounds and the cutoff pressure upwards in response to fewer sleep sessions being used to form the pressure distribution curves, there will be relatively less moderation of therapy pressure increases and subsequent therapy pressure decreases, which can be beneficial in scenarios where the determination of an individual’s pressure bounds and cutoff pressures was based on a smaller amount of data (e.g., fewer sleep sessions). In implementations where the event severity score is used, by adjusting the therapy pressure bounds and the cutoff pressure upwards in response to more events occurring and / or events of more severity occurring, there will be relatively less moderation of therapy pressure increases and subsequent therapy pressure decreases, which can be beneficial where the individual is recently experiencing events during the subsequent sleep session.

[0240] In some implementations, the peaks / percentiles and the resulting therapy pressure bounds and cutoff pressures are determined from a single pressure distribution curve that covers multiple sleep sessions (and / or portions of sleep sessions). In other implementations, the peaks / percentiles and the resulting therapy pressure bounds and cutoff pressures are determined from a plurality of pressure distribution curves that each cover an individual sleep session (and / or a portion of an individual sleep session). In these implementations where multiple pressure distribution curves are used to determine the peaks / percentiles and the resulting therapy pressure bounds and cutoff pressures, determining whether the individual has one peak corresponding to one critical therapy pressure or multiple peaks corresponding to multiple critical therapy pressures can be determined in a similar fashion as the other modes of operation. For example, the number of pressure distribution curves and / or sleep sessions for which the individual had one peak / critical therapy pressure can be determined, as well as the number of pressure distribution curves for which the individual had two or more peaks / criticaltherapy pressures. If the number with one peak / critical therapy pressure satisfies a predetermined threshold, then it is determined that the individual has one peak / critical therapy pressure. The therapy pressure bounds and cutoff pressure can then be determined based on some or all of the pressure distribution curves having one peak. And if the number with two or more peaks / critical therapy pressures satisfies the same or a different threshold (and / or if the number with one peak / critical therapy pressure does not satisfy the threshold), then it is determined that the individual has two or more peaks / critical therapy pressures. The therapy pressure bounds and cutoff pressure can then be determined based on some or all of the pressure distribution curves having two or more peaks.

[0241] Similar to the pressure distribution curves of FIGS. 6A and 6B, while FIGS. 11 A-l 1C illustrate actual curves that are plotted, in some cases the data itself (e.g., individual pressure values and the count for each pressure value) is analyzed to identify the peaks (and the pressures values of the peaks), without the pressure distribution curves actually being plotted or otherwise formed. In general, references to analyzing pressure distribution curves generally refers to analyzing pressure data in any suitable format.

[0242] Referring now to FIGS. 12A-12C, once the pressure values of the lower therapy pressure bound, the upper therapy pressure bound, and the cutoff pressure are determined, the fourth mode of operation operates similarly to the third mode of operation.

[0243] FIG. 12A shows a pressure moderation curve 1202 for the fourth mode of operation, as well as the example pressure moderation curve 502A for the standard mode of operation. As shown, the patient has a lower therapy pressure bound 1204 A (determined based on the single peak of a pressure distribution curve with one peak or the lower / lowest peak of a pressure distribution curve with two or more peaks) of about 11 cm H2O, and an upper therapy pressure bound 1204B (determined based on the upper therapy pressure bound percentile of a pressure distribution curve with one peak or the higher / highest peak of a pressure distribution curve with two or more peaks) of about 14 cm H2O. The patient also has a cutoff pressure 1206 (determined based on the cutoff pressure percentile of a pressure distribution curve with one peak or the cutoff pressure percentile of a pressure distribution curve with two or more peaks) of about 17 cm H2O. Those of skill in the art will understand that the specific pressure values shown in FIGS. 12A-12C are for illustrative purposes only.

[0244] At pressures below the lower therapy pressure bound 1204 A, the pressure moderation curve 1202 remains at a constant maximum value, similar to the pressure moderation curve 902 below the therapy pressure bound 904A. Between the lower therapy pressure bound 1204A and the upper therapy pressure bound 1204B, the pressure moderation curve 1202 remains at aconstant value that is less than the constant value for therapy pressures below the lower therapy pressure bound 1204A, similar to the pressure moderation curve 902 between the lower therapy pressure bound 904 A and the upper therapy pressure bound 904B. The pressure moderation curve 1202 decreases substantially linearly between the upper therapy pressure bound 1204B and the cutoff pressure 1206, similar to the pressure moderation curve 902 decreasing between the upper therapy pressure bound 904B and the cutoff pressure 906. The pressure moderation curve 1202 also decreases substantially linearly after the cutoff pressure 1206 but less rapidly, similar to the pressure moderation curve 902 decreasing less rapidly after the cutoff pressure 906.

[0245] Thus, like the third mode of operation, the respiratory therapy system operating according to the fourth mode of operation generally urges the therapy pressure to be maintained between the lower therapy pressure bound 904A and the upper therapy pressure bound 904B, instead of trying to urge the therapy pressure to the lower therapy pressure bound 1204 A or to the upper therapy pressure bound 1204B.

[0246] When the respiratory therapy system is providing air at a therapy pressure below the lower therapy pressure bound 1204 A, the pressure moderation applied by the respiratory therapy system is similar to the first mode of operation below the critical therapy pressure 704, the second mode of operation below the first critical therapy pressure 804 A, and the third mode of operation below the lower therapy pressure bound 904A. When a respiratory event is detected, the moderation applied to the subsequent baseline therapy pressure increase will be the same irrespective of the current therapy pressure value.

[0247] When the respiratory therapy system is providing air at a therapy pressure between the lower therapy pressure bound 1204A and the upper therapy pressure bound 1204B, the amount pressure moderation applied by the respiratory therapy system differs from the second mode of operation and is similar to the third mode of operation. Because the pressure moderation curve 1202 remains level between the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B, the amount of moderation of any therapy pressure increases will be same, regardless of the actual value of the therapy pressure within this range. And again, as shown in the example of FIG. 12 A, the therapy pressure increase during the fourth mode of operation will be smaller than the therapy pressure increase that would occur during the example of the standard mode of operation represented by moderation curve 502A.

[0248] When the respiratory therapy system is providing air at a therapy pressure that is greater than the upper therapy pressure bound 1204B, the moderation factor applied by the respiratory therapy system again begins to decrease substantially linearly (e.g., more moderation is applied-n -to the baseline therapy pressure increase). However, the moderation factor in this range is still less than it is the example of the standard mode of operation represented by moderation curve 502A, such that the therapy pressure increase here will be smaller than the therapy pressure increase that would occur during the example of the standard mode of operation represented by moderation curve 502A. Once the therapy pressure reaches the cutoff pressure 1206, the pressure moderation curve 1202 flattens out slightly (e.g., decreases substantially linearly but at a slower rate), but is still less than the moderation curve 502.

[0249] The pressure moderation curve 1202 also illustrates the response of the respiratory therapy system during the fourth mode of operation when detecting respiratory events while operating at different therapy pressures, for different therapy pressure ranges. The first therapy pressure range is less than the lower therapy pressure bound 1204A. The moderation factor within this range has a constant value (1.0 in the illustrated implementation), and thus the moderation factor applied to increases occurring when the therapy pressure is in this range is generally identical. Thus, in response to respiratory events, the respiratory therapy system is configured to cause substantially identical increases to occur when the therapy pressure is in this range, regardless of what value of the therapy pressure is. In general, since the first therapy pressure range is below the lower therapy pressure bound 1204A, baseline therapy pressure increases when in the first therapy pressure range will generally have little to no moderation applied to them to thereby encourage the therapy pressure to increase toward the lower therapy pressure bound 1204 A.

[0250] The second therapy pressure range is between the lower therapy pressure bound 1204A and the upper therapy pressure bound 1204B. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is between the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply an identical second moderation factor to a baseline therapy pressure increase (because the pressure moderation curve 1202 is flat in the second therapy pressure range) when it is providing air at a second therapy pressure that is also between the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. If the first and second respiratory events are identical and the baseline therapy pressure increases are identical, then the second increase in the therapy pressure will be identical to the first increase in the therapy pressure due to the application of the identical moderation factors.

[0251] The third therapy pressure range is between the upper therapy pressure bound 1204B and the cutoff pressure 1206. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is between the upper therapy pressure bound 1204B and the cutoff pressure 1206, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply a smaller second moderation factor to a baseline therapy pressure increase when it is providing air at a second therapy pressure that is also between the upper therapy pressure bound 1204B and the cutoff pressure 1206 but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. If the first and second respiratory events are identical and the baseline therapy pressure increases are identical, then the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor.

[0252] The fourth therapy pressure range is greater than the cutoff pressure 1206. In response to a first respiratory event, the respiratory therapy system is configured to apply a first moderation factor to a baseline therapy pressure increase when it is providing air at a first therapy pressure that is greater than the cutoff pressure 1206, resulting in a first increase in the therapy pressure. In response to a second respiratory event, the respiratory therapy system is configured to apply a smaller second moderation factor to a baseline therapy pressure increase when it is providing air at a second therapy pressure that is also greater than the cutoff pressure 1206 but larger than the first therapy pressure, resulting in a second increase in the therapy pressure. If the first and second respiratory events are identical and the baseline therapy pressure increases are identical, then the second increase in the therapy pressure will be smaller than the first increase in the therapy pressure due to the application of the smaller second moderation factor. However, the difference (such as in response to substantially identical respiratory events) in the increases from two therapy pressures a given distance apart will be smaller (e.g., the pressure moderation factor decreases more slowly) when in the fourth therapy pressure range as compared to the third pressure range, since the pressure moderation curve 1202 is less steep in the fourth pressure range.

[0253] While the pressure moderation curve 1202 remains constant between the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B in the illustrated implementation, in other implementations, the pressure moderation curve 1202 may vary between these two points. For example, the value of the pressure moderation curve 1202 may decrease for therapy pressures between the lower therapy pressure bound 1204 A and a pointbetween the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B, and then remain constant for therapy pressures between this point and the upper therapy pressure bound 1204B. In some cases, this point may be the midpoint between the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B. Thus, an increasing amount of pressure moderation may be applied to therapy pressure increases from therapy pressures that are at or slightly greater than the lower therapy pressure bound 1204 A. But once the therapy pressure reaches some point between the lower therapy pressure bound 1204A and the upper therapy pressure bound 1204B, the amount of pressure moderation applied to therapy pressure increases remains constant. When the therapy pressure is at a first therapy pressure between the lower therapy pressure bound 1204A and this point, the resultant therapy pressure increase following a first respiratory event will be larger (e.g., moderated less) than the resultant therapy pressure increase following a generally identical second respiratory event occurring when the therapy pressure is at a second therapy pressure that is closer to this point. And the resultant pressure increase will generally be the same following two generally identical respiratory events that occur when the therapy pressure is at two different therapy pressures between this point and the upper therapy pressure bound 1204B.

[0254] FIG. 12B shows a pressure decay curve 1252 that describes how the therapy pressure decreases once the respiratory event (or series / cluster of respiratory events) subsides. The therapy pressure at which the respiratory event subsides is plotted on the horizontal axis, and the time constant of the therapy pressure decay is plotted on the vertical axis. A smaller time constant (closer to the horizontal axis) results in a faster decrease in the therapy pressure, while a larger time constant (farther away from the horizontal axis) results in a slower decrease in the therapy pressure.

[0255] The pressure decay curve 1252 has a constant value up to the lower therapy pressure bound 1204 A, at which point the pressure decay curve 1252 instantaneously decreases to a lower value. Between the lower therapy pressure bound 1204A and the upper therapy pressure bound 1204B, the pressure decay curve 1252 is flat and remains constant (like the pressure decay curve 952 between the lower therapy pressure bound 902A and the upper therapy pressure bound 902B), but at a lower value than at therapy pressures less than the lower therapy pressure bound 1204 A. When the pressure decay curve 1252 reaches the upper therapy pressure bound 1204B, the pressure decay curve 1252 begins to decrease again. Finally, once the pressure decay curve 1252 reaches the cutoff pressure 1206, it flattens out and does not change any further.

[0256] Thus, the time constant governing subsequent therapy pressure decreases will have a constant value at therapy pressures below the lower therapy pressure bound 1204 A, between the lower therapy pressure bound 1204A and the upper therapy pressure bound 1204B, and above the cutoff pressure 1206. However, the value of this time constant will be highest below the lower therapy pressure bound 1204 A, lowest above the cutoff pressure 1206, and in between when between the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B. After the therapy pressure has been increased to some therapy pressure that is between the upper therapy pressure bound 1204B and the cutoff pressure 1206, the time constant governing the subsequent decrease in the therapy pressure will have a changing value that is dependent on the actual value of the increased therapy pressure. This is in contrast to the example of the standard mode of operation, where the time constant governing the subsequent decrease in the therapy pressure has a generally constant value that is independent of the value of the increased therapy pressure.

[0257] The pressure decay curve 1252 also illustrates the subsequent decrease in the therapy pressure after the therapy pressure has been increased to therapy pressures within different therapy pressure ranges. The first therapy pressure range is less than the lower therapy pressure bound 1204 A. After the therapy pressure has been increased to an increased therapy pressure that is less than the lower therapy pressure bound 1204A, the time constant governing the subsequent therapy pressure decrease has a constant value that is the same for any value of the increased therapy pressure within the first therapy pressure range. In general, because the first therapy pressure range is below the lower therapy pressure bound 1204A, the decay constant tends to remain at a relatively large value to limit any decreases away from the lower therapy pressure bound 1204 A.

[0258] However, all decreases when the therapy pressure is at or below the lower therapy pressure bound 1204A are generally undesirable, even comparing decreases from just below the lower therapy pressure bound 1204 A or from well below the lower therapy pressure bound 1204 A. Thus, decreases from anywhere below the lower therapy pressure bound 1204 A are governed by the same relatively larger time constant, to minimize (or virtually eliminate) decreases when the therapy pressure is at or below the lower therapy pressure bound 1204A. This behavior is similar to decreases from below the critical therapy pressure 704 in the first mode (FIG. 7B), from below the first critical therapy pressure 804A in the second mode (FIG. 8B), and from below the lower therapy pressure bound 904A in the third mode (FIG. 9B).

[0259] The second therapy pressure range is between the lower therapy pressure bound 1204A and the upper therapy pressure bound 1204B. After the therapy pressure has been increased toa first increased therapy pressure that is between the lower therapy pressure bound 1204A and the upper therapy pressure bound 1204B, the time constant governing the subsequent therapy pressure decrease has a constant value that is the same for any value of the increased therapy pressure within the second therapy pressure range.

[0260] The third therapy pressure range is between the upper therapy pressure bound 1204B and the cutoff pressure 1206. After the therapy pressure has been increased to a first increased therapy pressure that is between the upper therapy pressure bound 1204B and cutoff pressure 1206, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure that is governed by a first time constant. After the therapy pressure has been increased to a second increased therapy pressure that is between the upper therapy pressure bound 1204B and the cutoff pressure 1206 but greater than the first increased therapy pressure, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure that is governed by a smaller second time constant such that the second decrease is faster than the first decrease.

[0261] The fourth therapy pressure range is greater than the cutoff pressure 1206. After the therapy pressure has been increased to an increased therapy pressure that is greater than the cutoff pressure 1206, the time constant governing the subsequent therapy pressure decrease will have a constant value that is the same for any value of the increased therapy pressure within the fourth therapy pressure range. In general, the pressure decay curve 852 flattens at therapy pressures above the cutoff pressure 1206, as faster therapy pressure decreases in this range (e.g., governed by an increasingly small time constant) may interrupt the individual’s sleep and / or comfort, even though such decreases would return the therapy pressure to the upper therapy pressure bound 1204B faster.

[0262] FIG. 12C shows an example pressure curve 1262 for the third mode of operation that illustrates the effect of the pressure moderation curve 1202 and the pressure decay curve 1252. The pressure curve 1262 shows the therapy pressure level over time relative to the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B. As shown, the pressure curve 1262 is not centered around the lower therapy pressure bound 1204A or the upper therapy pressure bound 1204B, but instead is maintained between the lower therapy pressure bound 1204A and the upper therapy pressure bound 1204B, due to the effects of the pressure moderation curve 1202 and the pressure decay curve 1252 as described above. And because the pressure moderation curve 1202 and the pressure decay curve 1252 do not try to bring the therapy pressure level to either the lower therapy pressure bound 1204 A or the upper therapy pressure bound 1204B, the pressure curve 1262 is urged to remain within this range.

[0263] In some implementations, the pressure moderation curve 1202 and the pressure decay curve 1252 may be adjusted from their baseline values. In these implementations, therapy pressure values where the curves change direction / gradient will generally remain the same, but the actual value of the moderation factor and the time constant (represented by the vertical axis in FIGS. 12A and 12B) can be adjusted. In some implementations, the data score discussed herein is used to adjust the moderation factor and the decay constant. In these implementations, the numerical value of the data score can be added to some baseline value of the moderation factor, such that the pressure moderation curve 1202 is shifted upwards by an amount equal to, or in proportion with, the data score. The numerical value of the data score can also be added to some baseline value of the time constant, such that the pressure decay curve 1252 is shifted upwards by an amount equal to, or in proportion with, the data score.

[0264] In some implementations, the event severity score discussed herein is used to adjust the moderation factor and the decay constant. In these implementations, the numerical value of the event severity score can be added to an initial value of the moderation factor, such that the pressure moderation curve 1202 is shifted upwards by an amount equal to, or in proportion with, the event severity score. The numerical value of the event severity score can also be added to an initial value of the time constant, such that the pressure decay curve 1252 is shifted upwards by an amount equal to, or in proportion with, the event severity score.

[0265] In further implementations, both the data score and the event severity score are used to adjust the pressure moderation curve 1202 and the pressure decay curve 1252. In these implementations, the numerical value of the data score and the numerical value of the event severity score are both added to the baseline values of the moderation factor and the time constant, such that the pressure moderation curve 1202 and the pressure decay curve 1252 are both shifted upwards by an amount equal to, or in proportion with, a sum of the numerical value of the data score and the numerical value of the event severity score.

[0266] In implementations where the data score is used, by adjusting the pressure moderation curve 1202 and the pressure decay curve 1252 upwards in response to fewer sleep sessions being used to form the pressure distribution curves, there will be relatively less moderation of therapy pressure increases and subsequent therapy pressure decreases, which can be beneficial in scenarios where the determination of an individual’s pressure bounds and cutoff pressures was based on a smaller amount of data (e.g., fewer sleep sessions) and, for example, the individual’s optimal therapy pressure range represented by the lower therapy pressure bound and the upper therapy pressure bound may be less certain. In implementations where the event severity score is used, by adjusting the pressure moderation curve 1202 and the pressure decaycurve 1252 upwards in response to more events occurring and / or events of more severity occurring, there will be relatively less moderation of therapy pressure increases and subsequent therapy pressure decreases, which can be beneficial where the individual is recently experiencing events during the subsequent sleep session.

[0267] In any of the modes described herein, multiple moderation curves and pressure decay curves may be used to address different types of respiratory events within the mode. For example, the moderation curve applicable a pressure increase following an apnea may differ from the moderation curve applicable to a pressure increase following a flow limitation, which both may differ from the moderation curve applicable to a pressure increase following a snore. However, the upper therapy pressure bound and the lower therapy pressure bound of any of these moderation curves and pressure decay curves will generally be based on the peaks and / or percentiles of the pressure distribution curve. Moreover, the comparisons herein regarding the resultant pressure increase following two events generally hold at least when discussing two events of the same type. In some cases, different types of events may utilize the same pressure moderation curves and pressure decay curves.

[0268] In some implementations, any of the pressure distribution curve, the pressure moderation curve, and the pressure decay curve can be modified in real-time during a sleep session if the individual is experiencing an undesirable amount of events, and / or events with an undesirable severity. As discussed herein, pressure distribution curves for individuals generally include one peak, two peaks, or three or more peaks, which reflect distinct levels at which individuals may require therapy pressure. The pressure moderation curves and pressure decay curves discussed herein will generally the therapy pressure for each individual toward a personal range defined by the lower therapy pressure bound and the upper therapy pressure bound.

[0269] However, there may be certain periods during a sleep session in which the lower therapy pressure bound is no longer sufficient to treat the individual. For example, for an individual with positional sleep apnea (POSA), the lower therapy pressure bound may represent their therapy pressure when sleeping on their side, and the upper therapy pressure bound may represent their therapy pressure when sleeping on their back. If this individual turns onto their back, the lower therapy pressure bound will be insufficient for treatment. In another example, the sleep stage of an individual can affect muscle activity in the upper airway, which can in turn affect the therapy pressure required to avoid a respiratory obstruction. In further examples, factors such as illness and food / alcohol consumption can affect the therapy pressure required to avoid a respiratory obstruction. To address these periods of time when an individual’stherapy pressures may differ from their pressure distribution curve, in some implementations, the pressure moderation curve can be adjusted in response to too many events occurring or too severe of events occurring.

[0270] In some cases, the pressure moderation curve can be shifted toward higher therapy pressures, such that the therapy pressure increase following a respiratory event experienced while at a given therapy pressure will be moderated generally less than prior to the shifting. For example, with reference to the pressure moderation curve 1202 in FIG. 12 A, shifting the pressure moderation curve 1202 rightwards would cause both the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B to now be higher therapy pressures. If a certain therapy pressure was between these two prior to the shifting but less than the lower therapy pressure bound 1204 A after the shifting, than the resultant therapy pressure increase will be moderated less. In general, the moderation of therapy pressure increases (e.g., the moderation factor to be applied being less than 1.0) will not begin until higher therapy pressures after the pressure moderation curve is shifted toward higher therapy pressures.

[0271] In other cases, the pressure moderation curve is shifted and / or compressed toward higher moderation factors. For example, with reference to the pressure moderation curve 1202 in FIG. 12 A, shifting the pressure moderation curve 1202 upwards could cause the moderation factor between the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B to fall between 0.6 and 0.8, instead of 0.4 and 0.6. The pressure moderation curve 1202 could be shifted upwards such that the moderation factor for therapy pressures less than the lower therapy pressure bound 1204A is greater than 1, or the curve pressure moderation 1202 could be compressed upwards so that the moderation factor for therapy pressures less than the lower therapy pressure bound 1204A remains at 1. In any case, by shifting the pressure moderation curve upwards, the moderation of the therapy pressure increases (e.g., the moderation factor to be applied being less than 1.0) would still begin at the lower therapy pressure bound 1204 A, but the actual moderation factor applied would increase, such that the therapy pressure increases are moderated less.

[0272] In still other cases, the shape of the pressure moderation curve can be adjusted. For example, with reference to the pressure moderation curve 1202 in FIG. 12 A, the flat portion between the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B could be changed so that the pressure moderation curve 1202 gradually decreases starting at the lower therapy pressure bound 1204 A instead of instantaneously decreasing. The pressure moderation curve 1202 could linearly decrease between the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B. Alternatively, the pressure moderationcurve 1202 could linearly decrease between the lower therapy pressure bound 1204A and a point between the lower therapy pressure bound 1204 A and the upper therapy pressure bound 1204B (e.g., the midpoint), and then be flat between this point and the upper therapy pressure bound 1204B. In any case, the shape of the pressure moderation curve can be adjusted so that therapy pressure increases are generally moderated less than what they would be prior to the adjustment of the shape.

[0273] Any sort of mechanism for triggering the adjustment of the pressure moderation curve can be used. In some implementations, the value of an amount indicator and a severity indicator can be determined, and adjustments can be made based on these value.

[0274] The amount indicator may be, in some cases, indicative of the number of respiratory events experienced by the individual during the sleep session. For example, the amount indicator could be a rolling average number of respiratory events experienced by the individual over a prior window of time. This prior window of time could be any suitable amount of time, such as about 30 seconds, about 1 minute, about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 30 minutes, about 1 hour, about 2 hours, or about 6 hours. The value of the rolling average number of respiratory events could also be periodically updated, such as every 2 minutes. In some implementations, the amount indicator only looks at certain types of respiratory events. For example, in some cases the amount indicator may be a single rolling average number of apneas (a blocked airway), hypopneas (a narrowed airway), and RERAs (increased respiratory effort leading to arousal from sleep).

[0275] The severity indicator may be, in some cases, an average magnitude of flow limitation due to respiratory events experienced by the individual during the sleep session. The magnitude of flow limitation generally refers to the actual amount that the individual’s inspiration and expiration is limited by due to respiratory events, e.g., how much the flow rate into and / or out of their airway is reduced. In some implementations, the respiratory events for which the severity indicator is determined includes only flow limitation events. As discussed herein, the individual may experience a variety of different types of respiratory events during a sleep session, including apneas, hypopneas, RERAs, and snores. Another type of respiratory event is a flow limitation, which is an event characterized by the absence of an increase in flow despite an elevation in negative intrathoracic pressure indicating increased inspiration effort. The severity indicator thus in some implementations is the average amount that the individual’s flow into their airway is limited across all flow limitation events (which in some cases is characterized as events that are not apnea events, hypopnea events, RERA events, or snoreevents). In some cases, the severity is the actual value of the magnitude of flow limitation. In other cases, a filter may be applied to the value, such as an IIR (infinite impulse response) filter.

[0276] In some implementations, the values of the amount indicator and the severity indicator can be compared to respective threshold values to determine whether and how to adjust the shape of the pressure moderation curve. One example implementation is discussed herein. In this implementation, the amount indicator and the severity indicator are periodically compared to respective first threshold values. If either of the two indicators exceed their first threshold values, then a first stage is triggered. At the first stage, the current therapy pressure is compared to the pressure distribution curve. Specifically, the next peak in the pressure distribution curve that is at a therapy pressure larger than the current therapy pressure is identified. If this next highest peak exists (e.g., if the current therapy pressure is less than the upper therapy pressure bound), then a first adjustment to the pressure moderation curve is made. In some cases, this first adjustment can include shifting the pressure moderation curve a first amount toward higher therapy pressures and / or larger moderation factors.

[0277] If the next highest peak does not exist (e.g., if the current therapy pressure is equal to or greater than the upper therapy pressure bound, then a second stage is triggered. Thus, the second stage is triggered if the therapy pressure is already fairly high when the amount and / or severity indicators exceed their first thresholds. At the second stage, the amount indicator and the severity indicator are compared to respective second thresholds. If either of the indicators exceeds its second threshold, a second adjustment to the pressure moderation curve is made. In some cases, this second adjustment can include shifting the pressure moderation curve a second amount toward higher therapy pressures and / or larger moderation factors, where the second amount is greater than the first amount.

[0278] If the third stage is triggered, this means that one or both of the amount indicator has exceeded its first threshold and neither have exceed its second threshold, but the therapy pressure is already at or above the upper therapy pressure bound. Because the second thresholds have not been exceeded and the therapy pressure is already high, minimal changes are made to the pressure moderation curve. In some cases, the adjustment to the pressure moderation curve made at the third stage includes adjusting the shape of the pressure moderation curve. For example, the adjustment of this shape can include changing the shape of the pressure moderation curve between the lower therapy pressure bound and the upper therapy pressure bound to a gradually decreasing slope instead of a flat step, changing the shape of the pressure moderation curve between the upper therapy pressure bound and the cutoff pressure to a stepper slope, and / or any other suitable changes.

[0279] Referring now to FIGS. 13A-13C, in some implementations, the respiratory therapy system can implement a therapy pressure ramp at the beginning of the sleep session to aid the individual in falling asleep. Often, the minimum therapy pressure to be implemented during a sleep session is too high to allow the individual to comfortably fall asleep. The respiratory therapy system can thus gradually ramp the therapy pressure up to the standard minimum therapy pressure over a period of time. However, as described herein, a single standard minimum therapy pressure is often unsuitable for many individuals. Instead, the individual’s lower therapy pressure bound can be used.

[0280] FIG. 13 A is a plot 1300 illustrating the therapy pressure over time when a ramp setting of the respiratory therapy system is set to On. Plot 1300 shows both a specific therapy pressure level 1302 A for the individual, and the standard therapy pressure level 1302B. Both therapy pressure levels 1302A and 1302B start at a starting therapy pressure 1304A (in this example about 4.0 cmH20), and gradually begin to rise. The standard therapy pressure level 1302B rises to a minimum therapy pressure 1304B (in this example about 6.0 cmH20), which is less than the lower therapy pressure bound 1304C of the individual. The specific therapy pressure level 1302 A on the other hand rises slightly more rapidly so that it reaches the lower therapy pressure bound 1304C (in this example about 9 cmH20) at the same time the standard therapy pressure level 1302B reaches the minimum therapy pressure 1304B. However, the standard therapy pressure level 1302B only stays at the minimum therapy pressure 1304B for a short time, after which it rises to the lower therapy pressure bound 1304C, generally in response to the individual experiencing respiratory events. The standard therapy pressure level 1302B then stays at a higher level near the lower therapy pressure bound 1304C, similar to the specific therapy pressure level 1302 A. Thus, by having the therapy pressure automatically increase to the lower therapy pressure bound 1304C instead of the minimum therapy pressure 1304B, the individual can spend less time at a therapy pressure that is insufficient for treatment.

[0281] FIG. 13B is a plot 1310 illustrating the therapy pressure over time when a ramp setting of the respiratory therapy system is set to Off. Plot 1310 shows both a specific therapy pressure level 1312A for the individual, and the standard therapy pressure level 1312B. The specific therapy pressure level 1312A begins at the lower therapy pressure bound 1304C, whereas the standard therapy pressure level 1312B begins at the lower minimum therapy pressure 1304B. Both of these therapy pressures are greater the starting therapy pressure 1304 A shown in FIG. 13 A. However, the standard therapy pressure level 1312B begins to increase toward the lower therapy pressure bound 1304C after only a short time, generally in response to the individual experiencing respiratory events. The standard therapy pressure level 1312B then stays at ahigher level near the lower therapy pressure bound 1304C, similar to the specific therapy pressure level 1312A. Thus, by having the therapy pressure begin at the lower therapy pressure bound 1304C instead of the minimum therapy pressure 1304B, the individual can spend less time at a therapy pressure that is insufficient for treatment.

[0282] FIG. 13C is a plot 1320 illustrating the therapy pressure over time when a ramp setting of the respiratory therapy system is set to Auto. With this setting, the respiratory therapy system keeps the therapy pressure at the starting therapy pressure 1304A until it is detected that the individual has fallen asleep. Plot 1320 shows both a specific therapy pressure level 1322A for the individual, and the standard therapy pressure level 1322B. Both therapy pressure levels begin at the starting therapy pressure 1304A and stay there until sleep onset is detected at time 1326. The specific therapy pressure level 1322A begins to gradually rise to the lower therapy pressure bound 1304C, whereas the standard therapy pressure level 1322B rises only to the minimum therapy pressure 1304B. However, the standard therapy pressure level 1322B begins to increase toward the lower therapy pressure bound 1304C after only a short time, generally in response to the individual experiencing respiratory events. The standard therapy pressure level 1322B then stays at a higher level near the lower therapy pressure bound 1304C, similar to the specific therapy pressure level 1322A. Thus, by having the therapy pressure increase to the lower therapy pressure bound 1304C instead of the minimum therapy pressure 1304B when sleep onset is detected, the individual can spend less time at a therapy pressure that is insufficient for treatment.

[0283] Any of the methods herein, once any modes of operation, pressure distribution curves, pressure moderation curves, moderation factors, pressure decay curves, decay constants, or any other setting are determined, the method may further include one or more steps to actually implement such mode / curve / factor / constant / setting on a respiratory therapy system for use in a sleep session. Such steps may include actively adjusting and / or updating the respiratory therapy system. Such steps may additionally or alternatively include sending instructions to the individual and / or a third party (e.g., a healthcare provider, a caretaker, etc.) to adjust and / or update the respiratory therapy system. Such steps may additionally or alternatively include sending a message or indication to the individual and / or a third party, that when confirmed and / or accepted by the individual and / or the third party, causes the adjustment / update to be implemented on the respiratory therapy system.

[0284] Generally, the methods disclosed herein can be implemented using a system having a control system with one or more processors, and a memory device storing machine readable instructions. The control system can be coupled to the memory device, and the methodsdisclosed herein can be implemented when the machine readable instructions are executed by at least one of the processors of the control system. The methods disclosed herein can also be implemented using a computer program product (such as a non-transitory computer readable medium) comprising instructions that when executed by a computer, cause the computer to carry out the steps of the methods disclosed herein.

[0285] As used herein, the term “about,” when describing any of the specific values mentioned herein (e.g., a pressure value, a percentage, a standard deviation or variance, a threshold for a specific quantity / measurement / characteristic, etc.) can refer to a value range of + / - 20%, + / - 10%, + / - 5%, + / - 1%, etc. In general, the value range will be at most + / - 20%. As used herein, “substantially”, such as in “substantially identical”, when describing associated values mentioned herein (e.g., a pressure value, a percentage, a standard deviation or variance, a threshold for a specific quantity / measurement / characteristic, etc.) can refer to a value range of + / - 20%, + / - 10%, + / - 5%, + / - 1%, etc. The phrase “substantially identical” will be understood to also include, or be equivalent to, “identical” or “same”.

[0286] One or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of claims or Alternative Implementations below can be combined with one or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of the other claims or Alternative Implementations or combinations thereof, to form one or more additional implementations and / or claims of the present disclosure.

[0287] ALTERNATIVE IMPLEMENTATIONS

[0288] Alternative Implementation 1. A method for determining operation of a respiratory therapy system, the method comprising: receiving data associated with one or more sleep sessions associated with use of the respiratory therapy system by an individual, the respiratory therapy system having provided pressurized air to the individual during the one or more sleep sessions; analyzing the data to determine, for the individual, a value of each of one or more critical therapy pressures, each of the critical therapy pressures being associated with a peak of a pressure distribution curve for the one or more sleep sessions; and determining a pressure moderation curve and a pressure decay curve for use in the operation of the respiratory therapy system during a subsequent sleep session of the individual, the pressure moderation curve and the pressure decay curve being based at least in part on the value of each of the one or more critical therapy pressures for the individual.

[0289] Alternative Implementation 2. The method of Alternative Implementation 1, wherein determining the value of each of the one or more critical therapy pressures includes determining a number of the critical therapy pressures for the individual.

[0290] Alternative Implementation 3. The method of Alternative Implementation 2, wherein determining the number of critical therapy pressures includes: determining a portion of the one or more sleep sessions for which the number of critical therapy pressures was one; and determining a portion of the one or more sleep sessions for which the number of critical therapy pressures was two or more.

[0291] Alternative Implementation 4. The method of Alternative Implementation 3, wherein the number of critical therapy pressures is determined to be one in response to the portion of the one or more sleep sessions for which the number of critical therapy pressures was one satisfying a predetermined threshold.

[0292] Alternative Implementation 5. The method of Alternative Implementation 3 or Alternative Implementation 4, wherein the number of critical therapy pressures is determined to be two or more in response to (i) the portion of the one or more sleep sessions for which the number of critical therapy pressures was two or more satisfying the predetermined threshold or (ii) the portion of the one or more sleep sessions for which the number of critical therapy pressures was one not satisfying the predetermined threshold.

[0293] Alternative Implementation 6. The method of any one of Alternative Implementations 1 to 5, where the pressure moderation curve defines a moderation factor applied to a therapy pressure increase that occurs in response to an occurrence of a respiratory therapy event experienced by the individual, the therapy pressure increase being based on the moderation factor and a therapy pressure value from which the therapy pressure increase occurs.

[0294] Alternative Implementation 7. The method of any one of Alternative Implementations 1 to 6, where the pressure decay curve defines a time constant that governs a therapy pressure decrease that occurs in response to an absence of a respiratory therapy event experienced by the individual, the therapy pressure decrease being based on the time constant and a therapy pressure value from which the therapy pressure decrease occurs.

[0295] Alternative Implementation 8. The method of any one of Alternative Implementations 1 to 7, wherein the pressure distribution curve for the one or more sleep sessions is a distribution of pressure values of the air provided by the respiratory therapy system across at least one of the one or more sleep sessions.

[0296] Alternative Implementation 9. The method of Alternative Implementation 8, wherein the pressure distribution curve for the one or more sleep sessions is the distribution of pressure values of the air provided by the respiratory therapy system across all of the one or more sleep sessions.

[0297] Alternative Implementation 10. The method of any one of Alternative Implementations 1 to 7, wherein the pressure distribution curve for the one or more sleep sessions is a distribution of pressure values of the air provided by the respiratory therapy system at which a respiratory event occurred across at least one the one or more sleep sessions.

[0298] Alternative Implementation 11. The method of any one of Alternative Implementations 1 to 10, wherein the pressure distribution curve for the one or more sleep sessions is the distribution of pressure values of the air provided by the respiratory therapy system at which a respiratory event occurred across all of the one or more sleep sessions.

[0299] Alternative Implementation 12. The method of any one of Alternative Implementations 8 to 11, wherein analyzing the data includes analyzing the pressure distribution curve to identify a pressure value of one or more peaks in the pressure distribution curve, and wherein each of the one or more critical therapy pressures is a respective pressure value corresponding to one of the one or more peaks of the pressure distribution curve.

[0300] Alternative Implementation 13. The method of Alternative Implementation 12, wherein the value of each respective one of the one or more critical therapy pressures is the pressure value of the peak corresponding to the respective one of the one or more critical therapy pressures.

[0301] Alternative Implementation 14. The method of any one of Alternative Implementations 1 to 13, further comprising determining a lower therapy pressure bound and an upper therapy pressure bound that is greater than the lower therapy pressure bound for use in the operation of the respiratory therapy system during the subsequent sleep session, the lower therapy pressure bound and the upper therapy pressure bound defining the pressure moderation curve and the pressure decay curve for use in the operation of the respiratory therapy system during the subsequent sleep session.

[0302] Alternative Implementation 15. The method of Alternative Implementation 14, wherein the individual has one critical therapy pressure corresponding to one peak in the pressure distribution curve, wherein the lower therapy pressure bound is based on a pressure value of the one peak in the pressure distribution curve, and wherein the upper therapy pressure bound is based on a pressure value of a percentile of the pressure distribution curve greater than the one peak.

[0303] Alternative Implementation 16. The method of Alternative Implementation 15, wherein the lower therapy pressure bound is equal to (i) the pressure value of the one peak in the pressure distribution curve or (ii) the pressure value of the one peak in the pressure distribution curve plus an offset.

[0304] Alternative Implementation 17. The method of Alternative Implementation 15 or Alternative Implementation 16, wherein the percentile of the pressure distribution curve greater than the one peak is (i) between about a 50th percentile and a 100th percentile, (ii) between about a 50th percentile and a 90th percentile, (iii) between about a 60th percentile and a 100th percentile, (iv) between about the 60th percentile and the 90th percentile, (v) between about the 60th percentile and an 80th percentile, (vi) between about a 70th percentile and the 90th percentile, (vii) between about the 70th percentile and the 80th percentile, or (viii) about a 75th percentile.

[0305] Alternative Implementation 18. The method of Alternative Implementation 16 or Alternative Implementation 17, wherein the upper therapy pressure bound is equal to (i) the pressure value of the percentile of the pressure distribution curve greater than the one peak or (ii) the pressure value of the percentile of the pressure distribution curve greater than the one peak plus an offset.

[0306] Alternative Implementation 19. The method of Alternative Implementation 14, wherein the individual has two or more critical therapy pressures corresponding to two or more peaks in the pressure distribution curve, wherein the lower therapy pressure bound is based on a pressure value of a first peak of the two or more peaks in the pressure distribution curve that has a lowest pressure value among all of the two or more peaks, and wherein the upper therapy pressure bound is based on a pressure value of a second peak of the two or more peaks in the pressure distribution curve that has a highest pressure value among all of the two or more peaks.

[0307] Alternative Implementation 20. The method of Alternative Implementation 19, wherein the lower therapy pressure bound is equal to (i) the pressure value of the first peak or (ii) the pressure value of the first peak plus an offset.

[0308] Alternative Implementation 21. The method of Alternative Implementation 19 or Alternative Implementation 20, wherein the upper therapy pressure bound is equal to (i) the pressure value of the second peak or (ii) the pressure value of the second peak plus an offset.

[0309] Alternative Implementation 22. The method of any one of Alternative Implementations 14 to 21, further comprising determining a cutoff pressure that is greater than the upper therapy pressure bound.

[0310] Alternative Implementation 23. The method of Alternative Implementation 22, wherein the individual has one critical therapy pressure corresponding to one peak in the pressure distribution curve, and wherein the cutoff pressure is based on a pressure value of a cutoff percentile of the pressure distribution curve that is greater than the percentile of the pressure distribution curve corresponding to the upper therapy pressure bound.

[0311] Alternative Implementation 24. The method of Alternative Implementation 22, wherein the individual has two or more critical therapy pressures corresponding to two or more peaks in the pressure distribution curve, and wherein the cutoff pressure is based on a pressure value of a cutoff percentile of the pressure distribution curve that is greater than a highest peak of the two or more peaks corresponding to the upper therapy pressure bound.

[0312] Alternative Implementation 25. The method of Alternative Implementation 23 or Alternative Implementation 24, wherein the cutoff percentile of the pressure distribution curve is (i) between about an 80th percentile and about a 100th percentile, (ii) between about the 80th percentile and about a 90th percentile, (iii) between about the 90th percentile and about the 100th percentile, (iv) between about the 90th percentile and about a 95th percentile, (v) between about the 95th percentile and about the 100 percentile, (vi) between about the 95th percentile and about the 99th percentile, (vii) between about the 95th percentile and about the 100th percentile, (viii) between about the 99th percentile and about the 100th percentile, (ix) about the 99th percentile, or (x) about the 100th percentile.

[0313] Alternative Implementation 26. The method of any one of Alternative Implementations 23 to 25, wherein the cutoff pressure is equal to (i) the pressure value of the cutoff percentile of the pressure distribution curve or (ii) the pressure value of the cutoff percentile plus an offset.

[0314] Alternative Implementation 27. The method of any one of Alternative Implementations 16, 18, 20, 21, and 26, wherein the offset includes an event severity score having a numerical value that is based at least on one or more respiratory events experienced by the individual within a previous period of time.

[0315] Alternative Implementation 28. The method of Alternative Implementation 27, wherein the event severity score is further based at least in part on a type of the one or more respiratory events.

[0316] Alternative Implementation 29. The method of Alternative Implementation 28, further comprising determining the numerical value of the event severity score by: determining a numerical value of a first event severity sub-score associated with a first type of respiratory event; determining a numerical value of a second event severity sub-score associated with a second type of respiratory event; and selecting as the event severity score the one of the first event severity sub-score and the second event severity sub-score having a higher numerical value.

[0317] Alternative Implementation 30. The method of Alternative Implementation 29, wherein the first event severity sub-score is based on an amount of the first type of respiratory event experienced by the individual within the previous period of time.

[0318] Alternative Implementation 31. The method of Alternative Implementation 29 or Alternative Implementation 30, wherein the second event severity sub-score is based on an amount of the second type of respiratory event experienced by the individual within the previous period of time and a severity of each of the second type of respiratory event experienced by the individual within the previous period of time.

[0319] Alternative Implementation 32. The method of any one of Alternative Implementations 27 to 31, wherein the previous period of time immediately precedes a respiratory event resulting in a therapy pressure increase to be applied according to the pressure moderation curve.

[0320] Alternative Implementation 33. The method of any one of Alternative Implementations 27 to 32, wherein the previous period of time is about 30 seconds, about 1 minute, about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 30 minutes, about 1 hour, about 2 hours, or about 6 hours.

[0321] Alternative Implementation 34. The method of any one of Alternative Implementations 16, 18, 20, 21, and 26 to 33, wherein the offset further includes a data score having a numerical value based on a number of the one or more sleep sessions from which the pressure distribution curve is formed.

[0322] Alternative Implementation 35. The method of Alternative Implementation 34, wherein the numerical value of the data score decreases with the pressure distribution curve being formed from an increasing number of the one or more sleep sessions.

[0323] Alternative Implementation 36. The method of any one of Alternative Implementations 14 to 35, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is between the lower and upper therapy pressure bounds, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is between the lower and upper therapy pressure bounds and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is substantially identical to the first increase.

[0324] Alternative Implementation 37. The method of Alternative Implementation 36, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is between the lower and upper therapy pressure bounds, the respiratory therapy system is configured to subsequently cause the pressure of the air todecrease at a first rate, a first amount, or both, and after the therapy pressure is increased to a second increased therapy pressure that is between the lower and upper therapy pressure bounds and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is substantially identical to the first rate, a second amount that is substantially identical to the first amount, or both.

[0325] Alternative Implementation 38. The method of any one of Alternative Implementations 14 to 37, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is less than the lower therapy pressure bound, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is less than the lower therapy pressure bound and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is different than the first increase.

[0326] Alternative Implementation 39. The method of Alternative Implementation 38, wherein the first increase in the therapy pressure includes increasing the pressure at a first rate, increasing the pressure a first amount, or both, and wherein the second increase in the therapy pressure includes increasing the pressure at a second rate that is less than the first rate, increasing the pressure a second amount that is less than the first amount, or both.

[0327] Alternative Implementation 40. The method of Alternative Implementation 38 or Alternative Implementation 39, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is less than the lower therapy pressure bound, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both, and after the therapy pressure is increased to a second increased therapy pressure that is less than the lower therapy pressure bound and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is substantially identical to the first rate, a second amount that is substantially identical to the first amount, or both.

[0328] Alternative Implementation 41. The method of any one of Alternative Implementations 14 to 40, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system isproviding air at a first therapy pressure that is greater than the upper therapy pressure bound, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is greater than the upper therapy pressure bound and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is different than the first increase.

[0329] Alternative Implementation 42. The method of Alternative Implementation 41, wherein the first increase in the therapy pressure includes increasing the pressure at a first rate, increasing the pressure a first amount, or both, and wherein the second increase in the therapy pressure includes increasing the pressure at a second rate that is less than the first rate, increasing the pressure a second amount that is less than the first amount, or both.

[0330] Alternative Implementation 43. The method of Alternative Implementation 41 or Alternative Implementation 42, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is greater than the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both and after the therapy pressure is increased to a second increased therapy pressure that is greater than the upper therapy pressure bound and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is greater than the first rate, a second amount that is greater than the first amount, or both.

[0331] Alternative Implementation 44. The method of any one of Alternative Implementations 14 to 43, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is between the upper therapy pressure bound and the cutoff pressure, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is between the upper therapy pressure bound and the cutoff pressure and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is different than the first increase.

[0332] Alternative Implementation 45. The method of Alternative Implementation 44, wherein the first increase in the therapy pressure includes increasing the pressure at a first rate, increasing the pressure a first amount, or both, and wherein the second increase in the therapypressure includes increasing the pressure at a second rate that is less than the first rate, increasing the pressure a second amount that is less than the first amount, or both.

[0333] Alternative Implementation 46. The method of Alternative Implementation 44 or Alternative Implementation 45, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is between the upper therapy pressure bound and the cutoff pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both and after the therapy pressure is increased to a second increased therapy pressure that is between the upper therapy pressure bound and the cutoff pressure and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is greater than the first rate, a second amount that is greater than the first amount, or both.

[0334] Alternative Implementation 47. The method of any one of Alternative Implementations 14 to 46, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is greater than the cutoff pressure, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is greater than the cutoff pressure and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is different than the first increase.

[0335] Alternative Implementation 48. The method of Alternative Implementation 47, wherein the first increase in the therapy pressure includes increasing the pressure at a first rate, increasing the pressure a first amount, or both, and wherein the second increase in the therapy pressure includes increasing the pressure at a second rate that is less than the first rate, increasing the pressure a second amount that is less than the first amount, or both.

[0336] Alternative Implementation 49. The method of Alternative Implementation 47 or Alternative Implementation 48, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is greater than the cutoff pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both, and after the therapy pressure is increased to a second increased therapy pressure that is greater than the cutoff pressure and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause thepressure of the air to decrease at a second rate that is substantially identical to the first rate, a second amount that is substantially identical to the first amount, or both.

[0337] Alternative Implementation 50. The method of any one of Alternative Implementations 14 to 49, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is between (i) the lower therapy pressure bound and (ii) a pressure between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is greater than the first therapy pressure and between (i) the lower therapy pressure bound and (ii) the pressure between the lower therapy pressure bound and the upper therapy pressure bound, and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is different than the first increase.

[0338] Alternative Implementation 51. The method of Alternative Implementation 50, wherein the first increase in the therapy pressure includes increasing the pressure at a first rate, increasing the pressure a first amount, or both, and wherein the second increase in the therapy pressure includes increasing the pressure at a second rate that is less than the first rate, increasing the pressure a second amount that is less than the first amount, or both.

[0339] Alternative Implementation 52. The method of Alternative Implementation 50 or Alternative Implementation 51, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is between (i) the lower therapy pressure bound and (ii) the pressure between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both and after the therapy pressure is increased to a second increased therapy pressure that is greater than the first increased therapy pressure and between (i) the lower therapy pressure bound and (ii) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is greater than the first rate, a second amount that is greater than the first amount, or both.

[0340] Alternative Implementation 53. The method of any one of Alternative Implementations 14 to 52, wherein, during the subsequent sleep session, in response to detection of a firstrespiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is between (i) a pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is greater than the first therapy pressure and between (i) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is substantially identical to the first increase.

[0341] Alternative Implementation 54. The method of Alternative Implementation 53, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is between (i) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both, and after the therapy pressure is increased to a second increased therapy pressure that is greater than the first increased therapy pressure and between (i) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is substantially identical to the first rate, a second amount that is substantially identical to the first amount, or both.

[0342] Alternative Implementation 55. The method of any one of Alternative Implementations 50 to 54, wherein the pressure between the lower therapy pressure bound and the upper therapy pressure bound is a midpoint between the lower therapy pressure bound and the upper therapy pressure bound.

[0343] Alternative Implementation 56. The method of any one of Alternative Implementations 36 to 55, wherein the first respiratory event and the second respiratory event are an identical type of respiratory event.

[0344] Alternative Implementation 57. The method of Alternative Implementation 56, wherein the first respiratory event and the second respiratory event are both an apnea event, both a flow limitation event, or both a snore event.

[0345] Alternative Implementation 58. The method of any one of Alternative Implementations 14 to 57, wherein, during the subsequent sleep session, following detection of a respiratoryevent experienced by the individual, the respiratory therapy system is configured to apply a moderation factor to a baseline therapy pressure increase resulting in an increase in the therapy pressure, wherein a value of the moderation factor is described by the pressure moderation curve and is based at least in part on a therapy pressure at which the respiratory event was detected.

[0346] Alternative Implementation 59. The method of Alternative Implementation 58, wherein a larger value of the moderation factor results in the therapy pressure being increased, compared to a smaller value of the moderation factor, by a larger amount, at a larger rate, or both.

[0347] Alternative Implementation 60. The method of Alternative Implementation 58 or Alternative Implementation 59, wherein the value of the moderation factor is constant for therapy pressures less than or equal to the lower therapy pressure bound, wherein the value of the moderation factor is constant for therapy pressures between the lower thera...

Claims

CLAIMSWhat is claimed is:

1. A method for determining operation of a respiratory therapy system, the method comprising: receiving data associated with one or more sleep sessions associated with use of the respiratory therapy system by an individual, the respiratory therapy system having provided pressurized air to the individual during the one or more sleep sessions; analyzing the data to determine, for the individual, a value of each of one or more critical therapy pressures, each of the critical therapy pressures being associated with a peak of a pressure distribution curve for the one or more sleep sessions; and determining a pressure moderation curve and a pressure decay curve for use in the operation of the respiratory therapy system during a subsequent sleep session of the individual, the pressure moderation curve and the pressure decay curve being based at least in part on the value of each of the one or more critical therapy pressures for the individual.

2. The method of claim 1, wherein determining the value of each of the one or more critical therapy pressures includes determining a number of the critical therapy pressures for the individual.

3. The method of claim 2, wherein determining the number of critical therapy pressures includes: determining a portion of the one or more sleep sessions for which the number of critical therapy pressures was one; and determining a portion of the one or more sleep sessions for which the number of critical therapy pressures was two or more.

4. The method of claim 3, wherein the number of critical therapy pressures is determined to be one in response to the portion of the one or more sleep sessions for which the number of critical therapy pressures was one satisfying a predetermined threshold.

5. The method of claim 3 or claim 4, wherein the number of critical therapy pressures is determined to be two or more in response to (i) the portion of the one or more sleep sessions for which the number of critical therapy pressures was two or more satisfying the predetermined threshold or (ii) the portion of the one or more sleep sessions for which the number of critical therapy pressures was one not satisfying the predetermined threshold.

6. The method of any one of claims 1 to 5, where the pressure moderation curve defines a moderation factor applied to a therapy pressure increase that occurs in response to an occurrence of a respiratory therapy event experienced by the individual, the therapy pressure increase being based on the moderation factor and a therapy pressure value from which the therapy pressure increase occurs.

7. The method of any one of claims 1 to 6, where the pressure decay curve defines a time constant that governs a therapy pressure decrease that occurs in response to an absence of a respiratory therapy event experienced by the individual, the therapy pressure decrease being based on the time constant and a therapy pressure value from which the therapy pressure decrease occurs.

8. The method of any one of claims 1 to 7, wherein the pressure distribution curve for the one or more sleep sessions is a distribution of pressure values of the air provided by the respiratory therapy system across at least one of the one or more sleep sessions.

9. The method of claim 8, wherein the pressure distribution curve for the one or more sleep sessions is the distribution of pressure values of the air provided by the respiratory therapy system across all of the one or more sleep sessions.

10. The method of any one of claims 1 to 7, wherein the pressure distribution curve for the one or more sleep sessions is a distribution of pressure values of the air provided by the respiratory therapy system at which a respiratory event occurred across at least one the one or more sleep sessions.

11. The method of any one of claims 1 to 10, wherein the pressure distribution curve for the one or more sleep sessions is the distribution of pressure values of the air provided by therespiratory therapy system at which a respiratory event occurred across all of the one or more sleep sessions.

12. The method of any one of claims 8 to 11, wherein analyzing the data includes analyzing the pressure distribution curve to identify a pressure value of one or more peaks in the pressure distribution curve, and wherein each of the one or more critical therapy pressures is a respective pressure value corresponding to one of the one or more peaks of the pressure distribution curve.

13. The method of claim 12, wherein the value of each respective one of the one or more critical therapy pressures is the pressure value of the peak corresponding to the respective one of the one or more critical therapy pressures.

14. The method of any one of claims 1 to 13, further comprising determining a lower therapy pressure bound and an upper therapy pressure bound that is greater than the lower therapy pressure bound for use in the operation of the respiratory therapy system during the subsequent sleep session, the lower therapy pressure bound and the upper therapy pressure bound defining the pressure moderation curve and the pressure decay curve for use in the operation of the respiratory therapy system during the subsequent sleep session.

15. The method of claim 14, wherein the individual has one critical therapy pressure corresponding to one peak in the pressure distribution curve, wherein the lower therapy pressure bound is based on a pressure value of the one peak in the pressure distribution curve, and wherein the upper therapy pressure bound is based on a pressure value of a percentile of the pressure distribution curve greater than the one peak.

16. The method of claim 15, wherein the lower therapy pressure bound is equal to (i) the pressure value of the one peak in the pressure distribution curve or (ii) the pressure value of the one peak in the pressure distribution curve plus an offset.

17. The method of claim 15 or claim 16, wherein the percentile of the pressure distribution curve greater than the one peak is (i) between about a 50th percentile and a 100th percentile, (ii) between about a 50th percentile and a 90th percentile, (iii) between about a 60th percentile and a 100th percentile, (iv) between about the 60th percentile and the 90th percentile, (v) between about the 60th percentile and an 80th percentile, (vi) between about a 70th percentileand the 90th percentile, (vii) between about the 70th percentile and the 80th percentile, or (viii) about a 75th percentile.

18. The method of claim 16 or claim 17, wherein the upper therapy pressure bound is equal to (i) the pressure value of the percentile of the pressure distribution curve greater than the one peak or (ii) the pressure value of the percentile of the pressure distribution curve greater than the one peak plus an offset.

19. The method of claim 14, wherein the individual has two or more critical therapy pressures corresponding to two or more peaks in the pressure distribution curve, wherein the lower therapy pressure bound is based on a pressure value of a first peak of the two or more peaks in the pressure distribution curve that has a lowest pressure value among all of the two or more peaks, and wherein the upper therapy pressure bound is based on a pressure value of a second peak of the two or more peaks in the pressure distribution curve that has a highest pressure value among all of the two or more peaks.

20. The method of claim 19, wherein the lower therapy pressure bound is equal to (i) the pressure value of the first peak or (ii) the pressure value of the first peak plus an offset.

21. The method of claim 19 or claim 20, wherein the upper therapy pressure bound is equal to (i) the pressure value of the second peak or (ii) the pressure value of the second peak plus an offset.

22. The method of any one of claims 14 to 21, further comprising determining a cutoff pressure that is greater than the upper therapy pressure bound.

23. The method of claim 22, wherein the individual has one critical therapy pressure corresponding to one peak in the pressure distribution curve, and wherein the cutoff pressure is based on a pressure value of a cutoff percentile of the pressure distribution curve that is greater than the percentile of the pressure distribution curve corresponding to the upper therapy pressure bound.

24. The method of claim 22, wherein the individual has two or more critical therapy pressures corresponding to two or more peaks in the pressure distribution curve, and whereinthe cutoff pressure is based on a pressure value of a cutoff percentile of the pressure distribution curve that is greater than a highest peak of the two or more peaks corresponding to the upper therapy pressure bound.

25. The method of claim 23 or claim 24, wherein the cutoff percentile of the pressure distribution curve is (i) between about an 80th percentile and about a 100th percentile, (ii) between about the 80th percentile and about a 90th percentile, (iii) between about the 90th percentile and about the 100th percentile, (iv) between about the 90th percentile and about a 95th percentile, (v) between about the 95th percentile and about the 100 percentile, (vi) between about the 95th percentile and about the 99th percentile, (vii) between about the 95th percentile and about the 100th percentile, (viii) between about the 99th percentile and about the 100th percentile, (ix) about the 99th percentile, or (x) about the 100th percentile.

26. The method of any one of claims 23 to 25, wherein the cutoff pressure is equal to (i) the pressure value of the cutoff percentile of the pressure distribution curve or (ii) the pressure value of the cutoff percentile plus an offset.

27. The method of any one of claims 16, 18, 20, 21, and 26, wherein the offset includes an event severity score having a numerical value that is based at least on one or more respiratory events experienced by the individual within a previous period of time.

28. The method of claim 27, wherein the event severity score is further based at least in part on a type of the one or more respiratory events.

29. The method of claim 28, further comprising determining the numerical value of the event severity score by: determining a numerical value of a first event severity sub-score associated with a first type of respiratory event; determining a numerical value of a second event severity sub-score associated with a second type of respiratory event; and selecting as the event severity score the one of the first event severity sub-score and the second event severity sub-score having a higher numerical value.

30. The method of claim 29, wherein the first event severity sub-score is based on an amount of the first type of respiratory event experienced by the individual within the previous period of time.

31. The method of claim 29 or claim 30, wherein the second event severity sub-score is based on an amount of the second type of respiratory event experienced by the individual within the previous period of time and a severity of each of the second type of respiratory event experienced by the individual within the previous period of time.

32. The method of any one of claims 27 to 31, wherein the previous period of time immediately precedes a respiratory event resulting in a therapy pressure increase to be applied according to the pressure moderation curve.

33. The method of any one of claims 27 to 32, wherein the previous period of time is about 30 seconds, about 1 minute, about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 30 minutes, about 1 hour, about 2 hours, or about 6 hours.

34. The method of any one of claims 16, 18, 20, 21, and 26 to 33, wherein the offset further includes a data score having a numerical value based on a number of the one or more sleep sessions from which the pressure distribution curve is formed.

35. The method of claim 34, wherein the numerical value of the data score decreases with the pressure distribution curve being formed from an increasing number of the one or more sleep sessions.

36. The method of any one of claims 14 to 35, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is between the lower and upper therapy pressure bounds, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is between the lower and upper therapy pressure bounds and greater than the first therapy pressure, the respiratory therapy system is configured to cause asecond increase in the therapy pressure to occur that is substantially identical to the first increase.

37. The method of claim 36, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is between the lower and upper therapy pressure bounds, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both, and after the therapy pressure is increased to a second increased therapy pressure that is between the lower and upper therapy pressure bounds and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is substantially identical to the first rate, a second amount that is substantially identical to the first amount, or both.

38. The method of any one of claims 14 to 37, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is less than the lower therapy pressure bound, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is less than the lower therapy pressure bound and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is different than the first increase.

39. The method of claim 38, wherein the first increase in the therapy pressure includes increasing the pressure at a first rate, increasing the pressure a first amount, or both, and wherein the second increase in the therapy pressure includes increasing the pressure at a second rate that is less than the first rate, increasing the pressure a second amount that is less than the first amount, or both.

40. The method of claim 38 or claim 39, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is less than the lower therapy pressure bound, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both, and after the therapy pressure is increased to a second increased therapy pressure that is less than the lower therapypressure bound and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is substantially identical to the first rate, a second amount that is substantially identical to the first amount, or both.

41. The method of any one of claims 14 to 40, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is greater than the upper therapy pressure bound, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is greater than the upper therapy pressure bound and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is different than the first increase.

42. The method of claim 41, wherein the first increase in the therapy pressure includes increasing the pressure at a first rate, increasing the pressure a first amount, or both, and wherein the second increase in the therapy pressure includes increasing the pressure at a second rate that is less than the first rate, increasing the pressure a second amount that is less than the first amount, or both.

43. The method of claim 41 or claim 42, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is greater than the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both and after the therapy pressure is increased to a second increased therapy pressure that is greater than the upper therapy pressure bound and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is greater than the first rate, a second amount that is greater than the first amount, or both.

44. The method of any one of claims 14 to 43, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is between the upper therapy pressure bound and the cutoff pressure, the respiratory therapy system is configured tocause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is between the upper therapy pressure bound and the cutoff pressure and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is different than the first increase.

45. The method of claim 44, wherein the first increase in the therapy pressure includes increasing the pressure at a first rate, increasing the pressure a first amount, or both, and wherein the second increase in the therapy pressure includes increasing the pressure at a second rate that is less than the first rate, increasing the pressure a second amount that is less than the first amount, or both.

46. The method of claim 44 or claim 45, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is between the upper therapy pressure bound and the cutoff pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both and after the therapy pressure is increased to a second increased therapy pressure that is between the upper therapy pressure bound and the cutoff pressure and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is greater than the first rate, a second amount that is greater than the first amount, or both.

47. The method of any one of claims 14 to 46, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is greater than the cutoff pressure, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is greater than the cutoff pressure and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is different than the first increase.

48. The method of claim 47, wherein the first increase in the therapy pressure includes increasing the pressure at a first rate, increasing the pressure a first amount, or both, and wherein the second increase in the therapy pressure includes increasing the pressure at a second rate that is less than the first rate, increasing the pressure a second amount that is less than the first amount, or both.

49. The method of claim 47 or claim 48, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is greater than the cutoff pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both, and after the therapy pressure is increased to a second increased therapy pressure that is greater than the cutoff pressure and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is substantially identical to the first rate, a second amount that is substantially identical to the first amount, or both.

50. The method of any one of claims 14 to 49, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is between (i) the lower therapy pressure bound and (ii) a pressure between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is greater than the first therapy pressure and between (i) the lower therapy pressure bound and (ii) the pressure between the lower therapy pressure bound and the upper therapy pressure bound, and greater than the first therapy pressure, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is different than the first increase.

51. The method of claim 50, wherein the first increase in the therapy pressure includes increasing the pressure at a first rate, increasing the pressure a first amount, or both, and wherein the second increase in the therapy pressure includes increasing the pressure at a second rate that is less than the first rate, increasing the pressure a second amount that is less than the first amount, or both.

52. The method of claim 50 or claim 51, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is between (i) the lower therapy pressure bound and (ii) the pressure between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both and after the therapy pressure is increased to a second increased therapy pressure that is greater than the first increased therapy pressure and between (i) the lower therapy pressure bound and (ii) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and greater than the first therapy pressure, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is greater than the first rate, a second amount that is greater than the first amount, or both.

53. The method of any one of claims 14 to 52, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual while the respiratory therapy system is providing air at a first therapy pressure that is between (i) a pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to cause a first increase in the therapy pressure to occur, and in response to detection of a second respiratory event experienced by the individual while the respiratory therapy system is providing air at a second therapy pressure that is greater than the first therapy pressure and between (i) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to cause a second increase in the therapy pressure to occur that is substantially identical to the first increase.

54. The method of claim 53, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first increased therapy pressure that is between (i) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a first rate, a first amount, or both, and after the therapy pressure is increased to a second increased therapy pressure that is greater than the first increased therapy pressure and between (i) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, therespiratory therapy system is configured to subsequently cause the pressure of the air to decrease at a second rate that is substantially identical to the first rate, a second amount that is substantially identical to the first amount, or both.

55. The method of any one of claims 50 to 54, wherein the pressure between the lower therapy pressure bound and the upper therapy pressure bound is a midpoint between the lower therapy pressure bound and the upper therapy pressure bound.

56. The method of any one of claims 36 to 55, wherein the first respiratory event and the second respiratory event are an identical type of respiratory event.

57. The method of claim 56, wherein the first respiratory event and the second respiratory event are both an apnea event, both a flow limitation event, or both a snore event.

58. The method of any one of claims 14 to 57, wherein, during the subsequent sleep session, following detection of a respiratory event experienced by the individual, the respiratory therapy system is configured to apply a moderation factor to a baseline therapy pressure increase resulting in an increase in the therapy pressure, wherein a value of the moderation factor is described by the pressure moderation curve and is based at least in part on a therapy pressure at which the respiratory event was detected.

59. The method of claim 58, wherein a larger value of the moderation factor results in the therapy pressure being increased, compared to a smaller value of the moderation factor, by a larger amount, at a larger rate, or both.

60. The method of claim 58 or claim 59, wherein the value of the moderation factor is constant for therapy pressures less than or equal to the lower therapy pressure bound, wherein the value of the moderation factor is constant for therapy pressures between the lower therapy pressure bound and the upper therapy pressure bound, wherein the value of the moderation factor decreases substantially linearly at a first rate for therapy pressures between the upper therapy pressure bound and the cutoff pressure, and wherein the value of the moderation factor decreases substantially linearly at a second rate that is less than the first rate for therapy pressures greater than the cutoff pressure.

61. The method of any one of claims 58 to 60, wherein the value of the moderation factor is constant for therapy pressures between the lower therapy pressure bound and the upper therapy pressure bound, and wherein the value of the moderation factor decreases generally linearly for therapy pressures greater than the upper therapy pressure bound.

62. The method of any one of claims 58 to 60, wherein the value of the moderation factor is constant for therapy pressures between the lower therapy pressure bound and the upper therapy pressure bound.

63. The method of any one of claims 58 to 62, wherein the value of the moderation factor for therapy pressures between the lower therapy pressure bound and the upper therapy pressure bound is (i) less than the value of the moderation factor for therapy pressures below the lower therapy pressure bound, (ii) greater than the value of the moderation factor for therapy pressures above the upper therapy pressure bound, or (iii) both (i) and (ii).

64. The method of claim 63, wherein the value of the moderation factor for therapy pressures between the upper therapy pressure bound and the cutoff pressure is greater than the value of the moderation factor for therapy pressures above the cutoff pressure.

65. The method of any one of claims 58, 59, 63, and 64, wherein the value of the moderation factor decreases substantially linearly for therapy pressures between (i) the lower therapy pressure bound and (ii) a pressure between the lower therapy pressure bound and the upper therapy pressure bound, and wherein the value of the moderation factor is constant for therapy pressures between (i) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound.

66. The method of claim 65, wherein the pressure between the lower therapy pressure bound and the upper therapy pressure bound is a midpoint between the lower therapy pressure bound and the upper therapy pressure bound.

67. The method of any one of claims 58 to 66, wherein determining the pressure moderation curve for use in the operation of the respiratory therapy system during the subsequent sleep session includes:determining an event severity score based at least on one or more respiratory events experienced by the individual within a previous period of time; and adjusting the value of the moderation factor based on the event severity score.

68. The method of claim 67, wherein adjusting the value of the moderation factor based on the event severity score includes increasing the lower therapy pressure bound, the upper therapy pressure bound, the cutoff pressure, or any combination based on the event severity score.

69. The method of claim 68, wherein the event severity score is associated with a numerical value, and wherein increasing the lower therapy pressure bound, the upper therapy pressure bound, the cutoff pressure, or any combination based on the event severity score includes adding the numerical value of the event severity score to the lower therapy pressure bound, the upper therapy pressure bound, the cutoff pressure, or any combination thereof.

70. The method of any one of claims 67 to 69, wherein the event severity score is further based at least in part on a type of the one or more respiratory events.

71. The method of claim 70, wherein determining the event severity score includes: determining a numerical value of a first event severity sub-score associated with a first type of event; determining a numerical value of a second event severity sub-score associated with a second type of event; and selecting as the event severity score the one of the first event severity sub-score and the second event severity sub-score having a higher numerical value.

72. The method of claim 71, wherein the first event severity sub-score is based on an amount of the first type of event experienced by the individual within the previous period of time.

73. The method of claim 71 or claim 72, wherein the second event severity sub-score is based on an amount of the second type of event experienced by the individual within the previous period of time and a severity of each of the second type of event experienced by the individual within the previous period of time.

74. The method of any one of claims 67 to 73, wherein the previous period of time immediately precedes a respiratory event resulting in a therapy pressure increase to which the adjusted moderation factor is applied.

75. The method of any one of claims 67 to 74, wherein the previous period of time is about 1 minute, about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 30 minutes, about 1 hour, about 2 hours, or about 6 hours.

76. The method of any one of claims 67 to 75, wherein determining the pressure moderation curve for use in the operation of the respiratory therapy system during the subsequent sleep session includes: determining a data score having a numerical value based on a number of the one or more sleep sessions from which the pressure distribution curve is formed; and adjusting the value of the moderation factor based on the data score.

77. The method of claim 76, wherein the numerical value of the data score decreases with the pressure distribution curve being formed from an increasing number of the one or more sleep sessions.

78. The method of any one of claims 58 to 77, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual at a first therapy pressure that is less than the lower therapy pressure bound, the respiratory therapy system is configured to apply a first moderation factor to a therapy pressure increase associated with the first respiratory event, and in response to detection of a second respiratory event experienced by the individual at a second therapy pressure that is greater than the first therapy pressure and less than the lower therapy pressure bound, the respiratory therapy system is configured to apply a second moderation factor to a therapy pressure increase associated with the second respiratory event that is substantially identical to the first moderation factor.

79. The method of any one of claims 58 to 78, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual at a first therapy pressure that is between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to apply a first moderation factorto a therapy pressure increase associated with the first respiratory event, and in response to detection of a second respiratory event experienced by the individual at a second therapy pressure that is different than the first therapy pressure and between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to apply a second moderation factor to a therapy pressure increase associated with the second respiratory event that is substantially identical to the first moderation factor.

80. The method of any one of claims 58 to 79, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual at a first therapy pressure that is between the upper therapy pressure bound and the cutoff pressure, the respiratory therapy system is configured to apply a first moderation factor to a therapy pressure increase associated with the first respiratory event, and in response to detection of a second respiratory event experienced by the individual at a second therapy pressure that is greater than the first therapy pressure and between the upper therapy pressure bound and the cutoff pressure, the respiratory therapy system is configured to apply a second moderation factor to a therapy pressure increase associated with the second respiratory event that is less than the first moderation factor.

81. The method of any one of claims 58 to 80, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual at a first therapy pressure that is greater than the cutoff pressure, the respiratory therapy system is configured to apply a first moderation factor to a therapy pressure increase associated with the first respiratory event, and in response to detection of a second respiratory event experienced by the individual at a second therapy pressure that is greater than both the first therapy pressure and the cutoff pressure, the respiratory therapy system is configured to apply a second moderation factor to a therapy pressure increase associated with the second respiratory event that is less than the first moderation factor.

82. The method of any one of claims 58 to 81, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual at a first therapy pressure that is between (i) the lower therapy pressure bound and (ii) a pressure between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to apply a first moderation factor to a therapy pressure increase associated with the first respiratory event, and in response to detection of a secondrespiratory event experienced by the individual at a second therapy pressure that is greater than the first therapy pressure and between (i) the lower therapy pressure bound and (ii) the pressure between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to apply a second moderation factor to a therapy pressure increase associated with the second respiratory event that is less than the first moderation factor.

83. The method of any one of claims 58 to 82, wherein, during the subsequent sleep session, in response to detection of a first respiratory event experienced by the individual at a first therapy pressure that is between (i) a pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to apply a first moderation factor to a therapy pressure increase associated with the first respiratory event, and in response to detection of a second respiratory event experienced by the individual at a second therapy pressure that is greater than the first therapy pressure and between (i) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to apply a second moderation factor to a therapy pressure increase associated with the second respiratory event that is substantially equal to the first moderation factor.

84. The method of claim 82 or claim 83, wherein the pressure between the lower therapy pressure bound and the upper therapy pressure bound is a midpoint between the lower therapy pressure bound and the upper therapy pressure bound.

85. The method of any one of claims 78 to 84, wherein the first respiratory event and the second respiratory event are an identical type of respiratory event.

86. The method of claim 85, wherein the first respiratory event and the second respiratory event are both an apnea event, both a flow limitation event, or both a snore event.

87. The method of any one of claims 14 to 71, wherein, during the subsequent sleep session, after the therapy pressure has been increased in response to detection of a respiratory event, the respiratory therapy system is configured to subsequently cause a decrease in the therapy pressure to occur according to a time constant, the time constant determining at least in part arate of the decrease, a step size of the decrease, an overall size of the decrease, or any combination thereof.

88. The method of claim 87, wherein a larger value of the time constant results in the therapy pressure being decreased, compared to a smaller value of the time constant, at a larger rate, with a larger step size, with a larger overall size, or any combination thereof.

89. The method of claim 87 or claim 88, wherein a value of the time constant is described by the pressure decay curve and is based at least in part on a therapy pressure value from which the decrease occurs.

90. The method of any one of claims 87 to 89, wherein the value of the time constant is constant for therapy pressures less than or equal to the lower therapy pressure bound, wherein the value of the time constant is constant for therapy pressures between the lower therapy pressure bound and the upper therapy pressure bound, wherein the value of the time constant decreases substantially linearly for therapy pressures between the upper therapy pressure bound and the cutoff pressure, and wherein the value of the time constant is constant for therapy pressures greater than the cutoff pressure.

91. The method of any one of claims 87 to 90, wherein the value of the time constant for therapy pressures less than or equal to the lower therapy pressure bound changes instantaneously at the lower therapy pressure bound to the value of the time constant for therapy pressures between the lower therapy pressure bound and the upper therapy pressure bound.

92. The method of any one of claims 87 to 91, wherein the value of the time constant is constant for therapy pressures between the lower therapy pressure bound and the upper therapy pressure bound.

93. The method of any one of claims 87 to 92, wherein the value of the time constant for therapy pressures between the lower therapy pressure bound and the upper therapy pressure bound is (i) less than the value of the time constant for therapy pressures below the lower therapy pressure bound, (ii) greater than the value of the time constant for therapy pressures above the upper therapy pressure bound, or (iii) both (i) and (ii).

94. The method of claim 93, wherein the value of the time constant for therapy pressures between the upper therapy pressure bound and the cutoff pressure is greater than the value of the time constant for therapy pressures above the cutoff pressure.

95. The method of any one of claims 87-89, 93, and 94, wherein the value of the time constant for decreases substantially linearly for therapy pressures between (i) the lower therapy pressure bound and (ii) a pressure between the lower therapy pressure bound and the upper therapy pressure bound, and wherein the value of the time constant is constant for therapy pressures between (i) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound.

96. The method of claim 95, wherein the pressure between the lower therapy pressure bound and the upper therapy pressure bound is a midpoint between the lower therapy pressure bound and the upper therapy pressure bound.

97. The method of any one of claims 87 to 96, wherein determining the pressure decay curve for use in the operation of the respiratory therapy system during the subsequent sleep session includes: determining an event severity score based at least on one or more respiratory events experienced by the individual within a previous period of time; and adjusting the value of the time constant based on the event severity score.

98. The method of claim 97, wherein adjusting the value of the time constant based on the event severity score includes increasing the lower therapy pressure bound, the upper therapy pressure bound, the cutoff pressure, or any combination based on the event severity score.

99. The method of claim 97 or claim 98, wherein the event severity score is associated with a numerical value, and wherein increasing the lower therapy pressure bound, the upper therapy pressure bound, the cutoff pressure, or any combination based on the event severity score includes adding the numerical value of the event severity score to the lower therapy pressure bound, the upper therapy pressure bound, the cutoff pressure, or any combination thereof.

100. The method of any one of claims 97 to 99, wherein the event severity score is further based at least in part on a type of the one or more respiratory events.

101. The method of claim 100, wherein determining the event severity score includes: determining a numerical value of a first event severity sub-score associated with a first type of event; determining a numerical value of a second event severity sub-score associated with a second type of event; and selecting as the event severity score the one of the first event severity sub-score and the second event severity sub-score having a higher numerical value.

102. The method of claim 101, wherein the first event severity sub-score is based on an amount of the first type of event experienced by the individual within the previous period of time.

103. The method of claim 101 or claim 102, wherein the second event severity sub-score is based on an amount of the second type of event experienced by the individual within the previous period of time and a severity of each of the second type of event experienced by the individual within the previous period of time.

104. The method of any one of claims 97 to 103, wherein the previous period of time immediately precedes a respiratory event resulting in a therapy pressure increase to which the adjusted moderation factor is applied.

105. The method of any one of claims 97 to 104, wherein the previous period of time is about 1 minute, about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 30 minutes, about 1 hour, about 2 hours, or about 6 hours.

106. The method of any one of claims 97 to 105, wherein determining the pressure decay curve for use in the operation of the respiratory therapy system during the subsequent sleep session includes: determining a data score having a numerical value based on a number of the one or more sleep sessions from which the pressure distribution curve is formed; and adjusting the value of the decay constant based on the data score.

107. The method of claim 76, wherein the numerical value of the data score decreases with the pressure distribution curve being formed from an increasing number of the one or more sleep sessions.

108. The method of any one of claims 87 to 107, wherein after the therapy pressure is increased to a first therapy pressure that is less than the lower therapy pressure bound, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure to occur according to a first time constant, and wherein after the therapy pressure is increased to a second therapy pressure that is different than the first therapy pressure and less than the lower therapy pressure bound, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure according to a second time constant that is substantially identical to the first time constant.

109. The method of any one of claims 87 to 108, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first therapy pressure that is between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure to occur according to a first time constant, and after the therapy pressure is increased to a second therapy pressure that is different than the first therapy pressure and between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure according to a second time constant that is substantially identical to the first time constant.

110. The method of any one of claims 87 to 109, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first therapy pressure that is between the upper therapy pressure bound and the cutoff pressure, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure to occur according to a first time constant, and after the therapy pressure is increased to a second therapy pressure that is greater than the first therapy pressure and between the upper therapy pressure bound and the cutoff pressure, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure according to a second time constant that is less than the first time constant.

111. The method of any one of claims 87 to 110, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first therapy pressure that is greater than the cutoff pressure, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure to occur according to a first time constant, and after the therapy pressure is increased to a second therapy pressure that is different than the first therapy pressure and greater than the cutoff pressure, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure according to a second time constant that is substantially identical to the first time constant.

112. The method of any one of claims 87 to 111, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first therapy pressure that is between (i) the lower therapy pressure bound and (ii) a pressure between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure to occur according to a first time constant, and after the therapy pressure is increased to a second therapy pressure that is greater than the first therapy pressure and between (i) the lower therapy pressure bound and (ii) the pressure between the lower therapy pressure bound and the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure according to a second time constant that is less than the first time constant.

113. The method of any one of claims 87 to 112, wherein, during the subsequent sleep session, after the therapy pressure is increased to a first therapy pressure that is between (i) a pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause a first decrease in the therapy pressure to occur according to a first time constant, and after the therapy pressure is increased to a second therapy pressure that is different than the first therapy pressure and between (i) the pressure between the lower therapy pressure bound and the upper therapy pressure bound and (ii) the upper therapy pressure bound, the respiratory therapy system is configured to subsequently cause a second decrease in the therapy pressure according to a second time constant that is substantially identical to the first time constant.

114. The method of claim 112 or claim 113, wherein the pressure between the lower therapy pressure bound and the upper therapy pressure bound is a midpoint between the lower therapy pressure bound and the upper therapy pressure bound.

115. The method of any one of claims 108 to 114, wherein the first respiratory event and the second respiratory event are an identical type of respiratory event.

116. The method of claim 115, wherein the first respiratory event and the second respiratory event are both an apnea event, both a flow limitation event, or both a snore event.

117. The method of any one of claims 14 to 116, further comprising: receiving data associated with use of the respiratory therapy system by the individual during the subsequent sleep session; analyzing the data to determine (i) an amount indicator that is indicative of a number of respiratory events experienced by the individual during the subsequent sleep session, (ii) a severity indicator that is indicative of a severity of respiratory events experienced by the individual during the subsequent sleep session, or (iii) both (i) and (ii); and adjusting the pressure moderation curve based on a value of the amount indicator, a value of the severity indication, or both.

118. The method of claim 117, wherein the amount indicator is a rolling average number of respiratory events experienced by the individual over a prior window of time.

119. The method of claim 118, wherein the prior window of time is about 30 seconds, about 1 minute, about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 30 minutes, about 1 hour, about 2 hours, or about 6 hours.

120. The method of claim 118 or claim 119, further comprising periodically updating the rolling average number of respiratory events experienced by the individual.

121. The method of claim 120, wherein the rolling average number of respiratory events experienced by the individual is updated every 2 seconds.

122. The method of any one of claims 117 to 121, wherein the severity indicator is an average magnitude of flow limitation due to the respiratory events experienced by the individual during the subsequent sleep session.

123. The method of claim 122, wherein the severity indicator is the average magnitude of flow limitation due to flow limitation events that are not apnea events, hypopnea events, respiratory effort-related arousal (RERA) events, or snore events.

124. The method of any one of claims 117 to 119, wherein adjusting the pressure moderation curve includes (i) shifting the pressure moderation curve toward higher therapy pressures, (ii) shifting the pressure moderation curve toward larger moderation factors, (iii) adjusting a shape of the pressure moderation curve, or (iv) any combination of (i)-(iii), such that a therapy pressure increase following a respiratory event experienced at a given therapy pressure will be moderated less than prior to the adjusting.

125. The method of any one of claims 117 to 124, wherein adjusting the pressure moderation curve includes: determining whether the amount indicator or the severity indicator exceed respective first threshold values; in response to determining that either of the respective first threshold values are exceeded, comparing a current therapy pressure to the upper therapy pressure bound; and in response to the current therapy pressure being less than or equal to the upper therapy pressure bound, shifting the pressure moderation curve a first amount toward higher therapy pressures and / or larger moderation factors.

126. The method of claim 125, further comprising, in response to the current therapy pressure being greater than the upper therapy pressure bound: determining whether the amount indicator or the severity indicator exceed respective second threshold values that are greater than the respective first threshold values; and in response to determining that either of the respective second threshold values are exceeded, shifting the pressure moderation curve a second amount towardhigher therapy pressures and / or larger moderation factor that is greater than the first amount.

127. The method of claim 126, further comprising, in response to determining that neither of the respective second threshold values are exceeded, adjusting a shape of the pressure moderation curve between the lower therapy pressure bound and the upper therapy pressure bound.

128. The method of any one of claims 1 to 122, further comprising configuring the respiratory therapy system to: initially supply pressurized air at a starting therapy pressure that is less than the lower therapy pressure bound at a beginning of the subsequent sleep session; and gradually increase a pressure of the pressurized air from the starting therapy pressure to the lower therapy pressure bound over a period of time.

129. The method of claim 128, further comprising configuring the respiratory therapy system to: receive data associated with use of the respiratory therapy system by the individual during the subsequent sleep session; analyze the data to determine when the individual falls asleep during the subsequent sleep session,; begin to increase the pressure of the pressurized air from the starting therapy pressure to the lower therapy pressure bound in response to determining that the individual has fallen asleep.

130. The method of claim 128, wherein the pressure of the pressurized air begins to increase from the starting therapy pressure to the lower therapy pressure bound according to a predetermined schedule.

131. The method of any one of claims 1 to 130, further comprising configuring the respiratory therapy system to initially supply pressurized air at the lower therapy pressure bound at a beginning of the subsequent sleep session.

132. A computer program product comprising instructions which, when executed by a computer, cause the computer to carry out the method of any one of claims 1 to 131.

133. The computer program product of claim 132, wherein the computer program product is a non-transitory computer readable medium.

134. A system for determining operation of a respiratory therapy system, the system comprising a control system configured to implement the method of any one of claims 1 to131.

135. A system for determining operation of a respiratory therapy system, the system comprising: a memory device having stored thereon machine-readable instructions; and a control system including one or more processors configured to execute the machine- readable instructions to: receive data associated with one or more sleep sessions associated with use of the respiratory therapy system by an individual, the respiratory therapy system having provided pressurized air to the individual during the one or more sleep sessions; analyze the data to determine, for the individual, a value of each of one or more critical therapy pressures, each of the critical therapy pressures being associated with a peak of a pressure distribution curve for the one or more sleep sessions; and determine a pressure moderation curve and a pressure decay curve for use in the operation of the respiratory therapy system during a subsequent sleep session of the individual, the pressure moderation curve and the pressure decay curve being based at least in part on the value of each of the one or more critical therapy pressures for the individual.

136. The system of claim 135, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions to implement the method of any one of claims 2 to 131.

137. The system of any one of claims 134 to 136, further comprising the respiratory therapy system.

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