Systems and methods for analyzing use of a mandibular repositioning device
The system analyzes MRD use to recommend alternative therapies and transition timing, addressing therapy suitability and compliance challenges for sleep-related disorders, enhancing treatment effectiveness.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- RESMED PTY LTD
- Filing Date
- 2025-10-15
- Publication Date
- 2026-04-23
AI Technical Summary
Existing systems struggle to determine suitable alternative therapies for individuals with sleep-related and respiratory disorders, such as Obstructive Sleep Apnea, and to identify when transitioning from one therapy to another is appropriate.
A system and method for analyzing the use of a mandibular repositioning device (MRD) that includes data collection, analysis, and recommendation for transitioning to alternative therapies based on individual data, using a control system with processors and memory devices to identify suitability and readiness for therapy changes.
Enables personalized therapy recommendations and effective transitions between therapies, improving compliance and treatment efficacy for individuals with sleep-related disorders.
Smart Images

Figure AU2025051160_23042026_PF_FP_ABST
Abstract
Description
SYSTEMS AND METHODS FOR ANALYZING USE OF A MANDIBULAR REPOSITIONING DEVICECROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of, and priority to, U.S. Provisional Patent Application No. 63 / 707,616 filed on October 15, 2024, which is hereby incorporated by reference herein in its entirety.TECHNICAL FIELD
[0002] The present disclosure relates generally to systems and methods for analyzing use of a mandibular repositioning device, and more particularly, to systems and methods for analyzing individuals to determine suitability for using a mandibular repositioning device, and for analyzing an individual’s use of the mandibular repositioning device to determine a further recommendation for therapy.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.
[0004] 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. Incertain situations, the individual may have less than desirable compliance with the individual’s prescribed use of the respiratory therapy system for a variety of factors. However, it can be difficult to determine what other types of therapy (such as use of a dental appliance or mandibular repositioning device (MRD), hypoglossal nerve stimulation, positional therapy, etc.) may be suitable for such individuals. In addition, once an individual has begun a different type of therapy, it can be difficult to determine when might be the best time to encourage the individual to try the respiratory therapy system again. The present disclosure is directed to solving this and other problems.SUMMARY
[0005] According to some implementations of the present disclosure, a method for recommending therapy includes identifying a group of one or more individuals. The group includes (i) at least one individual that has stopped using a respiratory therapy device, (ii) at least one individual that has not started to use a respiratory therapy device, or (iii) both (i) and (ii). The method further includes collecting data associated with each of the one or more individuals. The method further includes, for each respective individual of the one or more individuals, determining whether to recommend an alternative therapy based on the data associated with the respective individual
[0006] According to some implementations of the present disclosure, a method for monitoring an individual who is using a mandibular repositioning device (MRD) includes receiving data associated with the individual during a period of time where the individual used the MRD during one or more sleep sessions. The method further includes analyzing the data to determine a readiness of the individual to transition from the use of the MRD to an alternative therapy. The method further includes, based on the analysis, transmitting a recommendation to the individual to (i) transition to the alternative therapy and discontinue using the MRD, or (ii) continue using the MRD.
[0007] According to some implementations of the present disclosure, a system for recommending therapy includes a control system having one or more processors, and a memory device having stored thereon machine-readable instructions. The one or more processors of the control system are configured to execute the machine-readable instructions to identify a group of one or more individuals. The group includes (i) at least one individual that has stopped using a respiratory therapy device, (ii) at least one individual that has not started to use a respiratory therapy device, or (iii) both (i) and (ii). The one or more processors of the control system are further configured to execute the machine-readable instructions to collect data associated witheach of the one or more individuals. The one or more processors of the control system are further configured to execute the machine-readable instructions to, for each respective individual of the one or more individuals, determine whether to recommend an alternative therapy based on the data associated with the respective individual.
[0008] According to some implementations of the present disclosure, a system for monitoring an individual who is using a mandibular repositioning device (MRD) includes a control system having one or more processors, and a memory device having stored thereon machine-readable instructions. The one or more processors of the control system are configured to execute the machine-readable instructions to receive data associated with the individual during a period of time where the individual used the MRD during one or more sleep sessions. The one or more processors of the control system are further configured to execute the machine-readable instructions to analyze the data to determine a readiness of the individual to transition from the use of the MRD to an alternative therapy. The one or more processors of the control system are further configured to execute the machine-readable instructions to, based on the analysis, transmit a recommendation to the individual to (i) transition to the alternative therapy and discontinue using the MRD, or (ii) continue using the MRD.
[0009] The above summary is not intended to represent each implementation or every aspect of the present disclosure. Additional features and benefits of the present disclosure are apparent from the detailed description and figures set forth below.BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. l is a functional block diagram of a system for recommending therapy and / or for monitoring an individual who is using a mandibular repositioning device, according to some implementations of the present disclosure.
[0011] 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.
[0012] FIG. 3 illustrates an exemplary timeline for a sleep session, according to some implementations of the present disclosure.
[0013] FIG. 4 illustrates an exemplary hypnogram associated with the sleep session of FIG. 3, according to some implementations of the present disclosure.
[0014] FIG. 5A is a perspective view of an oral appliance, according to some implementations of the present disclosure.
[0015] FIG. 5B is a perspective view of the oral appliance of FIG. 4A when placed in a user’smouth, according to some implementations of the present disclosure.
[0016] FIG. 6 is a process flow diagram of a method for recommending therapy, according to some implementations of the present disclosure.
[0017] FIG. 7 is a process flow diagram of a method for monitoring an individual who is using a mandibular repositioning device, according to some implementations of the present disclosure.
[0018] 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
[0019] 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.
[0020] 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.
[0021] 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.
[0022] 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.
[0023] 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).
[0024] 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 individual 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 (e.g., an oxygen desaturation index indicative of how frequently the user’s oxygen levels dropped below a predetermined threshold) to indicate the severity of Obstructive Sleep Apnea. Oxygen Desaturation Index (ODI) is another measure of the severity of sleep-disordered breathing, and is calculated as the number of times an individual’s blood oxygen level drops by a predetermined percentage (e.g., 3% or 4%) per hour of sleep.
[0025] Referring to FIG. 1, according to some implementations of the present disclosure, a system 10 can include any one or more of an oral appliance therapy system 100, a control system 124, a memory device 128, a user device 140, and one or more sensors 210. The system 10 can be used to analyze individuals for potential recommendation / use of the oral appliance 110, and / or to analyze an individual’s use of the oral appliance 110.
[0026] The oral appliance therapy system 100 may include an oral appliance 110 and an oral appliance receptacle 112. The oral appliance 110 can be worn to help prevent the collapse of the tongue and soft tissues in the back of the throat by supporting the jaw (mandible) and / or the tongue in a forward position, keeping the individual’s airway open during sleep. In general, the oral appliance 110 is a mandibular repositioning device (MRD), which pulls the lower jawforward. As used herein, the terms oral appliance and MRD are generally used interchangeably, unless otherwise specified. The oral appliance 110 includes upper and lower portions that are sized and / or shaped to receive the user’s teeth as the user bites down on the oral appliance 110, similar to a mouthguard. The upper and lower portions are coupled so that the lower portion is positioned forward of the upper portion. In this manner, when the oral appliance 110 is positioned in the user’s mouth with the user’s teeth received in the upper and lower portions, the lower portion of the oral appliance 110 holds the user’s jaw forward to aid in preventing the user’s airway from closing and / or narrowing during sleep. In general, the term oral appliance is used to refer to any device that an individual wears in their mouth at night that aids in preventing the user’s airway from closing and / or narrowing during sleep by physically adjusting a position of the user’s jaw, tongue, or other body part. The oral appliance receptacle 112 is used for storing the oral appliance 110 when not in use.
[0027] In some cases, oral appliance therapy (the wearing of the oral appliance 110 at night) may be especially useful for individuals with lower body mass index (BMI) and lower apnea hypopnea index (AHI). Oral appliance therapy can be especially effective for positional (e.g., supine dependent) obstructive sleep apnea.
[0028] In some implementations, the oral appliance therapy system 100 is a “dumb” system where the oral appliance receptacle 112 is a simple container or receptacle for receiving the oral appliance 110, and the oral appliance 110 is purely a mechanical device. In these implementations, the oral appliance 110 may include some physical adjustment mechanisms (for example, to modify the position of the lower portion relative to the upper portion to thereby adjust the position into which the user’s lower jaw is placed) that require manual operation.
[0029] In other implementations, the oral appliance therapy system 100 is a “smart” system where the oral appliance 110 and / or the oral appliance receptacle 112 include various electronic and / or controllable components. For example, the oral appliance 110 could include one or more actuators that can be driven to adjust the position of the lower portion relative to the upper portion. Any suitable actuators can be used, including electromechanical actuator, a piezoelectric actuator, a linear actuator, a rotational actuator, a motor, a servo, a pump, a screw drive, an electromagnetic actuator, or the like. The actuators can be driven using a control system (such as control system 124), which could be an on-board control system or a control system located external to the oral appliance 110. In another example, the oral appliance 110 could include a stimulator (such as an electrical stimulator) with a voltage source and electrodes for conveying voltage from the voltage source to muscles and / or tissues in the user’s mouth, in order to stimulate these muscles / tissues to stop, avoid, reduce, or minimize a respiratory event.
[0030] In a further example, the oral appliance 110 could also include one or more sensors configured to generate data associated with the oral appliance 110 (e.g., data associated with the position of the lower portion, data associated with use of the oral appliance 110), etc. This data could be stored in a memory device located within the oral appliance 110, and / or a memory device located external to the oral appliance 110. Data generated by the sensors of the oral appliance 110 during use could be transmitted in real-time to any suitable location (e.g., the memory device 128, the user device 140, etc.), and / or could be transmitted after a sleep session when the oral appliance 110 is placed back in the oral appliance receptacle 112. In yet another example, the oral appliance 110 includes any required communication components for transmitting and / or receiving data, such as electronic interfaces, wireless and wired communication interfaces, etc.
[0031] Similarly, the oral appliance receptacle 112 can include any number of electronic and / or controllably components in implementations where the oral appliance therapy system 100 is a smart system. For example, the oral appliance receptacle 112 may include one or more actuators (in addition to or as an alternative to any actuators of the oral appliance 110) that can be driven to adjust the position of the lower portion of the oral appliance 110 relative to the upper portion. Any suitable actuators can be used, including electromechanical actuator, a piezoelectric actuator, a linear actuator, a rotational actuator, a motor, a servo, a pump, a screw drive, an electromagnetic actuator, or the like, and could be controlled by a control system (such as control system 124) located in the oral appliance receptacle 112 or external to the oral appliance receptacle 112.
[0032] In another example, the oral appliance receptacle 112 includes one or more sensors configured to generate data associated with the oral appliance receptacle 112 (e.g., data indicating the presence of the oral appliance 110 in the oral appliance receptacle 112, data associated with the position of the lower portion of the oral appliance 110, data associated with use of the oral appliance receptacle 112), etc. This data could be stored in a memory device located within the oral appliance receptacle 112, and / or a memory device located external to the oral appliance receptacle 112. In yet another example, the oral appliance receptacle 112 includes any required communication components for transmitting and / or receiving data, such as electronic interfaces, wireless and wired communication interfaces, etc.
[0033] The oral appliance 110 and / or the oral appliance receptacle 112 may include a power source for charging various components, and / or each other. For example, the oral appliance 110 could include a rechargeable battery that is configured to provide power to components of the oral appliance 110 such as actuators, sensors, etc., and is charged by the oral appliancereceptacle 112 when the oral appliance 110 is placed in the oral appliance receptacle 112. The oral appliance receptacle 112 could include its own rechargeable battery and / or any components required for connection to mains / grid power. Additional details related to oral appliances and oral appliance receptacles are described in, for example, WO 2022 / 074627, which is hereby incorporated by reference herein in its entirety.
[0034] As shown in FIG. 2, the oral appliance 110 can be used to treat a user 20. In this example, the user 20 and a bed partner 30 are in a bed 40 and are laying on a mattress 42. The oral appliance 110 can be worn by the user 20 during a sleep session to aid in preventing the user 20’ s airway from closing and / or narrowing during sleep. The oral appliance receptacle 112 could be placed nearby (such as on the nightstand 44) in implementations where the oral appliance 110 and the oral appliance receptacle 112 communicate during the sleep session (such as implementations where the oral appliance 110 wirelessly transmits data to the oral appliance receptacle 112). The oral appliance 110 is generally a less cumbersome option than a respiratory therapy device, which would need to be positioned on a nightstand 44 directly adjacent to the bed 40 or somewhere else nearby, and would require the user 20 to wear a user interface connected to the respiratory therapy device via a conduit.
[0035] The control system 124 is configured to control the operations of various components of the system 10, such as the oral appliance therapy system 100, the user device 140, any of the sensors 210, etc. The control system 124 may also be used to analyze data obtained and / or generated by any of the components of the system 10. For example, in some implementations, the control system 124 is used to analyze individuals to determine whether they are suitable for use of the oral appliance 110, and / or to analyze an individual’s use of the oral appliance 110 during one or more sleep sessions. The control system 24 may further be configured to carry out one or more steps of any of the methods described and / or claimed herein.
[0036] The processor 126 can be a general or special purpose processor or microprocessor. While one processor 126 is illustrated in FIG. 1, the control system 124 can include any 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. The control system 124 (or any other control system) or a portion of the control system 124 such as the processor 126 (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, alone or in conjunction with the user device 140 and / or any other components of the system 10. The control system 124 can be coupled to and / or positioned within the oral appliance therapy system 100 (e.g., as part of the oral appliance 110 and / or the oral appliance receptacle 112), a housing of the user device140 (e.g., as part of a smartphone application), within a housing of one or more of the sensors 210, in the cloud (e.g., in a remote device or system connected to various components of the system 10). The control system 124 can be centralized (within one such housing or location) or decentralized (within two or more of such housings or locations, which are physically distinct). In such implementations including two or more housings containing the control system 124, the housings can be located proximately and / or remotely from each other.
[0037] The memory device 128 stores machine-readable instructions that are executable by the processor 126 of the control system 124. The memory device 128 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 128 is shown in FIG. 1, the system 10 can include any suitable number of memory devices 128 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). The control system 124 can be coupled to and / or positioned within the oral appliance therapy system 100 (e.g., as part of the oral appliance 110 and / or the oral appliance receptacle 112), a housing of the user device 140 (e.g., as part of a smartphone application), within a housing of one or more of the sensors 210, in the cloud (e.g., in a remote device or system connected to various components of the system 10). Thus, like the control system 124, the memory device 128 can be centralized (within one such housing) or decentralized (within two or more of such housings).
[0038] In some implementations, the memory device 128 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); image data associated with the user’s head, neck, jaw, and / or mouth; ultrasound data associated with the user’s head, next, jaw, and / or mouth; 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 geographic location of the user, a relationship status, 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 multiple sleep latency test (MSLT) result or score and / or a Pittsburgh Sleep Quality Index (PSQI) score or value. The self-reported user feedback can include informationindicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a selfreported 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.
[0039] The processor 126 and / or memory device 128 can receive data (e.g., physiological data and / or audio data) from the one or more sensors 210 such that the data is stored in the memory device 128 and / or for analysis by the processor 126. The processor 126 and / or memory device 128 can communicate with the one or more sensors 210 using a wired connection or a wireless connection (e.g., using an RF communication protocol, a Wi-Fi communication protocol, a Bluetooth communication protocol, over a cellular network, etc.). In some implementations, the system 10 can include an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof. Such components can be coupled to or integrated within a housing of the control system 124 (e.g., in the same housing as the processor 126 and / or memory device 128)
[0040] While the control system 124 and the memory device 128 are described and shown in FIG. 1 as being a separate and distinct component of the system 10, in some implementations, the control system 124 and / or the memory device 128 are integrated together, such as part of the oral appliance therapy system 100, the user device 140, etc. Thus, the control system 124 and / or the memory device 128 can be disposed within the oral appliance 110, the oral appliance receptacle 112, and / or the user device 140 (and / or in any other component of the system 10). Alternatively, in some implementations, the control system 124 or a portion thereof (e.g., the processor 126) 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. Moreover, while system 10 is shown as including all of the components described above, more or fewer components can be included in the system 10.
[0041] The user device 140 includes a display device 142. The user device 140 can be, for example, a mobile device such as a smartphone, a tablet computer, a gaming console, a smartwatch, a laptop computer, or the like. In some implementations, the user device 140 is a portable device, such as a smart phone, a tablet computer, a smart watch, a laptop computer, etc. Alternatively, the user device 140 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®-enable devices, etc.). In some implementations, the user device is a wearable device (e.g., a smart watch). Thedisplay device 142 is generally used to display image(s) including still images, video images, or both. In some implementations, the display device 142 acts as a human-machine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) and an input interface. The display device 142 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 140. In some implementations, one or more user devices can be used by and / or included in the system 10. In some implementations, the user device 140 is used to communicate with other components of the system 10, including the oral appliance therapy system 100, the control system 124, the memory device 128, and any of the sensors 210.
[0042] The one or more sensors 210 include a pressure sensor 212, a flow rate sensor 214, temperature sensor 216, a motion sensor 218, a microphone 220, a speaker 222, a radiofrequency (RF) receiver 226, a RF transmitter 228, a camera 232, an infrared (IR) sensor 234, a photopl ethy smogram (PPG) sensor 236, an electrocardiogram (ECG) sensor 238, an electroencephalography (EEG) sensor 240, a capacitive sensor 242, a force sensor 244, a strain gauge sensor 246, an electromyography (EMG) sensor 248, an oxygen sensor 250, an analyte sensor 252, a moisture sensor 254, a Light Detection and Ranging (LiDAR) sensor 256, or any combination thereof. Generally, each of the one or more sensors 210 are configured to output sensor data that is received and stored in the memory device 128 and / or any other suitable location.
[0043] While the sensors 210 are shown in FIG. 1 as being separate from the other components of the system 10, in some implementations, any of the sensors 210 may be coupled to and / or positioned within any of the components of the system 10, such as the oral appliance therapy system 100 (e.g., the oral appliance 110 and / or the oral appliance receptacle 112), the user device 140, etc. Further, the sensors 210 may include multiple of a given type of sensor, with at least one sensor of that type coupled to and / or positioned in one location (e.g., the oral appliance 110), and at least one other sensor of that type coupled to and / or positioned within another component of the system 10 e.g., the oral appliance receptacle 112).
[0044] While the one or more sensors 210 are shown and described as including each of the pressure sensor 212, the flow rate sensor 214, the temperature sensor 216, the motion sensor 218, the microphone 220, the speaker 222, the RF receiver 226, the RF transmitter 228, the camera 232, the IR sensor 234, the PPG sensor 236, the ECG sensor 238, the EEG sensor 240, the capacitive sensor 242, the force sensor 244, the strain gauge sensor 246, the EMG sensor248, the oxygen sensor 250, the analyte sensor 252, the moisture sensor 254, and the LiDAR sensor 256, more generally, the one or more sensors 210 can include any combination and any number of each of the sensors described and / or shown herein.
[0045] As described herein, the system 10 can be used to analyze individuals for potential recommendation / use of the oral appliance 110, and / or to analyze an individual’s use of the oral appliance 110. The sensors 210 can be used to generate data associated with the user that may be used in this analysis, including data associated with the oral appliance 110 itself, data associated with the use while using the oral appliance, data associated with the user while not wearing the oral appliance 110, etc.
[0046] In some implementations, the sensor data is physiological data that can be analyzed to generate one or more sleep-related parameters, which can include any parameter, measurement, etc. related to the user during the sleep session, while wearing the oral appliance 110 or not. The one or more sleep-related parameters that can be determined for the user 20 during the sleep session include, for example, an Apnea-Hypopnea Index (AHI) score, a sleep score, a flow signal, 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 stage, pressure settings of a respiratory therapy device used by the user when not wearing the oral appliance 110, a heart rate, a heart rate variability, movement of the user, temperature, EEG activity, EMG activity, arousal, snoring, choking, coughing, whistling, wheezing, or any combination thereof.
[0047] The data generated by one or more of the sensors 210 (e.g., physiological data, audio data, etc.) can also be used to determine a sleep-wake 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 states, including wakefulness, relaxed wakefulness, microawakenings, or distinct sleep stages such as, for example, a rapid eye movement (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 states and / or sleep stages from physiological data generated by one or more sensors, such as the one or more sensors 210, are described in, for example, WO 2014 / 047310, U.S. Patent Pub. No. 2014 / 0088373, WO 2017 / 132726, WO 2019 / 122413, WO 2019 / 122414, U.S. Patent Pub. No. 2020 / 0383580, and WO 2022 / 249013, each of which is hereby incorporated by reference herein in its entirety.
[0048] In some implementations, the sleep-wake signal described herein can be timestamped to indicate a time that the user enters the bed, a time that the user exits the bed, a time that theuser attempts to fall asleep, etc. The sleep-wake signal can be measured by the one or more sensors 210 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. 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 ratio, a number of events per hour, a pattern of events, pressure settings of a respiratory therapy device used by the user when not wearing the oral appliance 110, or any combination thereof during the sleep session. The event(s) can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak (e.g., from a user interface of a respiratory therapy device used by the user when not wearing the oral appliance 110), 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. The one or more sleep-related parameters that can be determined for the user during the sleep session based on the sleep-wake signal include, for example, a total time in bed, a total sleep time, a sleep onset latency, a wake- after-sleep-onset parameter, a sleep efficiency, a fragmentation index, or any combination thereof. As described in further detail herein, the data and / or the sleep-related parameters can be analyzed to determine one or more sleep-related scores (e.g., a sleep score and / or a therapy score, also referred to as a my Air™ score, such as described in WO 2016 / 061629 and U.S. Patent Pub. No. 2017 / 0311879, which are hereby incorporated by reference herein in their entireties).
[0049] Data generated by the one or more sensors 210 (e.g., physiological data, audio data, etc.) can also be used to determine a respiration signal associated with a 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 and / or analyzed to determine (e.g., using the control system 124) one or more sleep-related parameters, such as, for example, a respiration rate, a respiration rate variability, 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, a sleep state, a sleep stage, an apnea-hypopnea index (AHI), pressure settings of a respiratory therapy device used by the user when not wearing the oral appliance 110, or any combination thereof. The one or more events can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak (e.g., from a user interface of a respiratory therapy device used by the user when not wearing the oral appliance 110), a cough, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, increased bloodpressure, or any combination thereof. Many of the described 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 / or non-physiological parameters can also be determined, either from the data from the one or more sensors 210, or from other types of data.
[0050] The pressure sensor 212 outputs pressure data that can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. In some implementations, the pressure sensor 212 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. In some implementations, the pressure sensor 212 can be coupled to or integrated in the oral appliance 110, and / or a respiratory therapy device used by the user when not wearing the oral appliance 110. The pressure sensor 212 can be, for example, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain-gauge sensor, an optical sensor, a potentiometric sensor, or any combination thereof. In some examples, the pressure sensor 212 can be used to determine a blood pressure of a user.
[0051] The flow rate sensor 214 outputs flow rate data that can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. Examples of flow rate sensors (such as, for example, the flow rate sensor 214) are described in International Publication No. WO 2012 / 012835 and U.S. Patent No. 10,328,219, both of which are hereby incorporated by reference herein in their entireties. In some implementations where the user uses a respiratory therapy device, the flow rate sensor 214 is used to determine an air flow rate from the respiratory therapy device, an air flow rate through a user interface worn by the user, an air flow rate through a conduit connecting the user interface to the respiratory therapy device, or any combination thereof. In such implementations, the flow rate sensor 214 can be coupled to or integrated in the respiratory therapy device, the user interface, or the conduit. The flow rate sensor 214 may also be coupled to or integrated in the oral appliance 110. The flow rate sensor 214 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. In implementations where the user uses a respiratory therapy device, the flow rate sensor 214 is configured to measure a vent flow (e.g., intentional “leak”), an unintentional leak (e.g., mouth leak and / or mask leak), a patient flow (e.g., air into and / or out of lungs), or any combination thereof. In some implementations, the flow rate data can be analyzed to determine cardiogenic oscillations of the user.
[0052] The temperature sensor 216 outputs temperature data that can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. In some implementations, the temperature sensor 216 generates temperatures data indicative of a core body temperature of the user, a skin temperature of the user, a temperature of the oral appliance 110 (e.g., the temperature during use), a temperature of the air flowing in a respiratory therapy system used by the user when not wearing the oral appliance 110, an ambient temperature, or any combination thereof. The temperature sensor 216 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.
[0053] The motion sensor 218 outputs motion data that can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. The motion sensor 218 can be used to detect movement of the user 20 during the sleep session, movement of the oral appliance 110, movement of the oral appliance receptacle 112, or any other item or object (such as components of a respiratory therapy system used by the user when not wearing the oral appliance 110). The motion sensor 218 can include one or more inertial sensors, such as accelerometers, gyroscopes, and magnetometers. In some implementations, the motion sensor 218 can comprise an acoustic sensor (such as the acoustic sensor 224 discussed herein) and / or an RF sensor (such as the RF sensor 230 discussed herein), which can generate motion data as further discussed herein. In such implementations, the motion sensor 218, the acoustic sensor, and / or the RF sensor can be disposed in a portable device, such as the user device 140. In some implementations, the motion sensor 218 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. In some implementations, the motion data from the motion sensor 218 can be used in conjunction with additional data from another one of the sensors 210 to determine the sleep state of the user. In some implementation, the motion sensor 218 can be used to detect motion or acceleration associated with arterial pulses, such as pulses in or around the face of the user, and configured to detect features of the pulse shape, speed, amplitude, or volume.
[0054] The microphone 220 outputs sound and / or audio data that can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. The audio data generated by the microphone 220 is reproducible as one or more sound(s) during a sleep session (e.g., sounds from the user 20). The audio data form the microphone 220 can also be used to identify (e.g., using the control system 200) an event experienced by the user during the sleep session, as described in further detail herein. The microphone 220 can be coupled to orintegrated in the oral appliance 110, the oral appliance receptacle 112, the user device 140, a respiratory therapy device used by the user when not wearing the oral appliance 110, and / or any other component. The microphone 220 can be coupled to or integrated in a wearable device, such as a smartwatch, smart glasses, earphones or ear buds, or other head wearable device. In some implementations, the system 10 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. In some implementations, the acoustic data from the microphone 220 is representative of noise associated with manufacture and / or use of the oral appliance 110 and / or the oral appliance receptacle 112.
[0055] The speaker 222 outputs sound waves that are audible to a user of the system 10 (e.g., the user 20 of FIG. 2). The speaker 222 can be used, for example, as an alarm clock or to play an alert or message to the user 20 (e.g., in response to an event). In some implementations, the speaker 222 can be used to communicate the audio data generated by the microphone 220 to the user. The speaker 222 can be coupled to or integrated in the oral appliance 110, the oral appliance receptacle 112, the user device 140, a respiratory therapy device used by the user when not wearing the oral appliance 110, and / or any other component, and / or can be coupled to or integrated in a wearable device, such as a smartwatch, smart glasses, earphones or ear buds, or other head wearable device.
[0056] The microphone 220 and the speaker 222 can be used as separate devices. In some implementations, the microphone 220 and the speaker 222 can be combined into an acoustic sensor 224 (e.g., a sonar sensor), as described in, for example, WO 2018 / 050913, WO 2020 / 104465, U.S. Pat. App. Pub. No. 2022 / 0007965, each of which is hereby incorporated by reference herein in its entirety. In such implementations, the speaker 222 generates or emits sound waves at a predetermined interval and the microphone 220 detects the reflections of the emitted sound waves from the speaker 222. The sound waves generated or emitted by the speaker 222 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 20 or the bed partner 30. Based at least in part on the data from the microphone 220 and / or the speaker 222, the control system 124 can determine a location of the user 20 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 state, a sleep stage, pressure settings of a respiratory therapy device used by the user when not wearing the oral appliance 110, or any combination thereof.In such a context, a sonar sensor may be understood to concern an active acoustic sensing, such as by generating and / or transmitting ultrasound and / 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.
[0057] In some implementations, the sensors 210 include (i) a first microphone that is the same as, or similar to, the microphone 220, and is integrated in the acoustic sensor 224 and (ii) a second microphone that is the same as, or similar to, the microphone 220, but is separate and distinct from the first microphone that is integrated in the acoustic sensor 224.
[0058] The RF transmitter 228 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 226 detects the reflections of the radio waves emitted from the RF transmitter 228, and this data can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. This data can be analyzed 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 226 and the RF transmitter 228 or another RF pair) can also be used for wireless communication between the oral appliance therapy system 100, the control system 124, the user device 140, the sensors 210, or any combination thereof. While the RF receiver 226 and RF transmitter 228 are shown as being separate and distinct elements in FIG. 1, in some implementations, the RF receiver 226 and RF transmitter 228 are combined as a part of an RF sensor 230 (e.g., a RADAR sensor). In some such implementations, the RF sensor 230 includes a control circuit. The format of the RF communication can be Wi-Fi, Bluetooth, or the like.
[0059] In some implementations, the RF sensor 230 is a part of a mesh system. One example of a mesh system is a Wi-Fi 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 Wi-Fi mesh system includes a Wi-Fi router and / or a Wi-Fi 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 230. The Wi-Fi router and satellites continuously communicate with one another using Wi-Fi signals. The Wi-Fi mesh system can be used to generate motion data based on changes in the Wi-Fi 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.
[0060] The camera 232 outputs image data reproducible as one or more images (e.g., still images, video images, thermal images, or any combination thereof) that can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. The image data from the camera 232 can be used by the control system 124 to determine one or more of the sleep-related parameters described herein, such as, for example, one or more events (e.g., periodic limb movement or restless leg syndrome), 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 state, a sleep stage, or any combination thereof. Further, the image data from the camera 232 can be used to, for example, identify a location of the user, to determine chest movement of the user, to determine air flow of the mouth and / or nose of the user, to determine a time when the user enters the bed, and to determine a time when the user exits the bed. In some implementations, the camera 232 includes a wide-angle lens or a fisheye lens. 230. The camera 232 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 232 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.
[0061] The IR sensor 234 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 128, and / or analyzed by the processor 126 of the control system 124. The infrared data from the IR sensor 234 can be used to determine one or more sleep-related parameters during a sleep session, including a temperature of the user 20 and / or movement of the user 20. The IR sensor 234 can also be used in conjunction with the camera 232 when measuring the presence, location, and / or movement of the user 20. The IR sensor 234 can detect infrared light having a wavelength between about 700 nm and about 1 mm, for example, while the camera 232 can detect visible light having a wavelength between about 380 nm and about 740 nm.
[0062] The PPG sensor 236 outputs physiological data associated with the user 20 that can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. This physiological data can be used to determine one or more sleep-related parameters, such as, for example, a heart rate, a heart rate variability, a cardiac cycle, respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, estimated blood pressure param eter(s), or any combination thereof. The PPG sensor 236 can be worn by the user 20, embedded in clothing and / or fabric that is worn by the user 20, positioned within and / or coupled to the oral appliance 110, etc.
[0063] The ECG sensor 238 outputs physiological data associated with electrical activity of the heart of the user 20, which can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. In some implementations, the ECG sensor 238 includes one or more electrodes that are positioned on or around a portion of the user 20 during the sleep session. The physiological data from the ECG sensor 238 can be used, for example, to determine one or more of the sleep-related parameters described herein.
[0064] The EEG sensor 240 outputs physiological data associated with electrical activity of the brain of the user 20, which can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. In some implementations, the EEG sensor 240 includes one or more electrodes that are positioned on or around the scalp of the user 20 during the sleep session. The physiological data from the EEG sensor 240 can be used, for example, to determine a sleep state and / or a sleep stage of the user 20 at any given time during the sleep session. In some implementations, the EEG sensor 240 can be integrated into a user interface or associated headgear (e.g., straps, etc.) of a respiratory therapy system used by the user when not wearing the oral appliance 110, into a head band or other head-worn sensor device, etc.
[0065] The capacitive sensor 242, the force sensor 244, and the strain gauge sensor 246 output data that can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. This data can be analyzed to determine, for example, one or more of the sleep-related parameters described herein. The EMG sensor 248 outputs physiological data associated with electrical activity produced by one or more muscles. The oxygen sensor 250 outputs oxygen data indicative of an oxygen concentration of gas. The oxygen sensor 250 can be, for example, an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, a pulse oximeter (e.g., SpCh sensor), or any combination thereof.
[0066] The analyte sensor 252 can be used to detect the presence of an analyte in the exhaled breath of the user 20. The data output by the analyte sensor 252 can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124, and can be used to determine the identity and concentration of any analytes in the breath of the user. In some implementations, the analyte sensor 252 is positioned near a mouth of the user to detect analytes in breath exhaled from the user’s mouth. For example, the analyte sensor 252 can be coupled to and / or positioned within the oral appliance 110 to monitor the user’s mouth breathing. In some implementations, the analyte sensor 252 is a volatile organic compound (VOC) sensor that can be used to detect carbon -based chemicals or compounds. In some implementations, the analyte sensor 252 can also be used to detect whether the user is breathing through theirnose or mouth. For example, if the data output by an analyte sensor 252 positioned near the mouth of the user (e.g., within or coupled to the oral appliance 110) detects the presence of an analyte, the control system 124 can use this data as an indication that the user is breathing through their mouth.
[0067] The moisture sensor 254 outputs data that can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124. The moisture sensor 254 can be used to detect moisture in various areas such as in and around the oral appliance 110, in and around the oral appliance receptacle 112, and other locations. Thus, in some implementations, the moisture sensor 254 can be coupled to or integrated in the oral appliance 110, the oral appliance receptacle 112, the user device 140, or other components of system 10. In other implementations, the moisture sensor 254 is placed near any area where moisture levels need to be monitored. The moisture sensor 254 can also be used to monitor the humidity of the ambient environment surrounding the user, for example, the air inside the bedroom. The moisture sensor 254 can also be used to track the user’s biometric response to environmental changes.
[0068] The LiDAR sensor 256 outputs data that can be stored in the memory device 128, and / or analyzed by the processor 126 of the control system 124, which 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 256 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(s) 256 can 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.
[0069] In some implementations, the one or more sensors 210 also includes a galvanic skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, asphygmomanometer sensor, an oximetry sensor, a sonar sensor, a RADAR sensor, a blood glucose sensor, a color sensor, a pH sensor, an air quality sensor, a tilt sensor, a rain sensor, a soil moisture sensor, a water flow sensor, an alcohol sensor, a vane sensor (VAF), a hot wire sensor (MAF), a cold wire sensor, a laminar flow sensor, an ultrasonic sensor, an inertial sensor, or any combination thereof.
[0070] While shown separately in FIG. 1, any combination of the one or more sensors 210 can be integrated in and / or coupled to any one or more of the components of the system 10, including the oral appliance therapy system 100 (including the oral appliance 110 and / or the oral appliance receptacle 112), the control system 123, the user device 140, or any combination thereof. For example, the microphone 220 and the speaker 222 can be integrated in and / or coupled to the user device 140. In some implementations, at least one of the one or more sensors 210 is not coupled to the oral appliance 110, the oral appliance receptacle 112, the control system 124, or the user device 140, 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 210 can be positioned at any suitable location relative to the user such that the one or more sensors 210 can generate physiological data associated with the user and / or the bed partner during one or more sleep sessions.
[0071] The data from the one or more sensors 210 can be analyzed (e.g., by the control system 124) 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 ration between the number of different events, a sleep state, 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, a mask 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, 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 210, or from other types of data.
[0072] Oral appliance therapy can in some cases be utilized in addition to or as an alternative to respiratory pressure therapy. Respiratory pressure therapy refers to the application of asupply 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).
[0073] In some implementations, system 10 includes a respiratory therapy system 150 for implementing respiratory pressure therapy. The respiratory therapy system 150 includes a respiratory therapy device 152 that generates pressurized air that is delivered to a user interface 154 fluidly coupled to the respiratory therapy device 152 via a conduit 156. The respiratory therapy device 152 may generate continuous constant pressure, two or more different pressures, a variety of pressures within a given range, air flow at a predetermined flow rate, etc.
[0074] The user interface 154 engages a portion of the user’s face and delivers pressurized air from the respiratory therapy device 152 to the user’s airway to aid in preventing the airway from narrowing and / or collapsing during sleep. The user interface 154 may be or include a facial mask that covers the nose and mouth of the user, 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 154 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 154 on 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 154 and the user. In some implementations, the user interface 154 may include a connector and one or more vents to permit the escape of carbon dioxide and other gases exhaled by the user. The connector is configured to connect and fluidly couple the user interface 154 to the conduit 156.
[0075] The respiratory therapy device 152 may include a humidification tank with a reservoir of water that can be used to humidify the pressurized air delivered from the respiratory therapy device 152, and may also include a heater to heat the water in the humidification tank. The conduit 156 could also include a heating element that heats the pressurized air delivered to the user.
[0076] Generally, the respiratory therapy system 150 forms an air pathway that extends between a motor of the respiratory therapy device 152 and the user and / or the user’s airway. Thus, the air pathway generally includes at least a motor of the respiratory therapy device 152, the user interface 154, and the conduit 156. The humidification tank 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 other implementations, the respiratory therapy device 152 or the conduit 156 can include a waterless humidifier.
[0077] The respiratory therapy system 150 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. 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.
[0078] In some implementations, the system 10 includes an electronic interface configured to receive data (e.g., physiological data and / or acoustic data) from the one or more sensors 210 such that the data can be stored in the memory device 128 and / or analyzed by the processor 126 of the control system 124. The electronic interface can communicate with the one or more sensors 210 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 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 can also include one more processors and / or one more memory devices that are the same as, or similar to, the processor 126 and the memory device 128 described herein. In some implementations, the electronic interface is coupled to or integrated in the user device 140. In other implementations, the electronic interface is coupled to or integrated (e.g., in a housing) with the control system 124 and / or the memory device 128.
[0079] In some implementations, the system 10 includes an activity tracker that may be used to aid in generating physiological data associated with the user. The physiological data can be used to determine an activity measurement that 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 may includes one or more of the sensors 210 described herein, such as, forexample, the motion sensor 218 (e.g., one or more accelerometers and / or gyroscopes), the PPG sensor 236, and / or the ECG sensor 238.
[0080] In some implementations, the activity tracker is a wearable device that can be worn by the user, such as a smartwatch, a wristband, a ring, or a patch. The activity tracker can also be coupled to or integrated in a garment or clothing that is worn by the user. Alternatively, still, the activity tracker can also be coupled to or integrated in (e.g., within the same housing) the user device 140. More generally, the activity tracker can be communicatively coupled with, or physically integrated in (e.g., within a housing), the oral appliance therapy system 100, the oral appliance 110, the oral appliance receptacle 112, the control system 124 the memory device 128, the user device 140, etc.
[0081] Referring again to FIG. 2, in some implementations, the control system 124, the memory device 128, any of the one or more sensors 210, or a combination thereof can be located on and / or in any surface and / or structure that is generally adjacent to the bed 40 and / or the user 20. For example, in some implementations, at least one of the one or more sensors 210 can be located at a first position on and / or in the bed 40 (e.g., the one or more sensors 210 are coupled to and / or integrated in the bed 40). Further, alternatively or additionally, at least one of the one or more sensors 210 can be located at a second position on and / or in the mattress 42 that is adjacent to the bed 40 and / or the user 20 (e.g., the one or more sensors 210 are coupled to and / or integrated in the mattress 42). Alternatively, or additionally, at least one of the one or more sensors 210 can be located at a third position on and / or in a pillow that is generally adjacent to the bed 40 and / or the user 20. Alternatively, or additionally, at least one of the one or more sensors 210 can be located at a fourth position on and / or in the nightstand 44 that is generally adjacent to the bed 40 and / or the user 20 (e.g., located directly on or in the nightstand 44, located on or in the oral appliance receptacle 112 that is resting on or in the nightstand, etc.). Alternatively, or additionally, at least one of the one or more sensors 210 can be located at a fifth position such that the at least one of the one or more sensors 210 are coupled to and / or positioned on the user 20 (e.g., the one or more sensors 210 are embedded in or coupled to fabric, clothing, and / or a smart device worn by the user 20). More generally, at least one of the one or more sensors 210 can be positioned at any suitable location relative to the user 20 such that the one or more sensors 210 can generate sensor data associated with the user 20.
[0082] Additionally, or alternatively, one or more microphones (the same as, or similar to, the microphone 220 of FIG. 1) can be integrated in and / or coupled to a co-located smart device, such as the user device 140, a TV, a watch (e.g., a mechanical watch or another smart device worn by the user), a pendant, the mattress 42, the bed 40, beddings positioned on the bed 40,the pillow, a speaker (e.g., the speaker 222 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, and / or any portion of the system 10. 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.
[0083] Additionally, or alternatively, in some implementations, one or more microphones (the same as, or similar to, the microphone 220 of FIG. 1) can be remote from the system 10 (FIG. 1) and / or the user 20 (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 10.
[0084] Referring now to FIG. 3, as used herein, a sleep session can be defined multiple ways. For example, a sleep session can be defined by 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.
[0085] 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.
[0086] 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 beforegoing 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.
[0087] 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 142 of the user device 140 (FIG. 1) to manually initiate or terminate the sleep session.
[0088] Generally, the sleep session includes any point in time after the user has laid or sat down in the bed (or another area or object on which they intend to sleep) and has (i) placed the oral appliance 110 in their mouth or (ii) turned on the respiratory therapy device 152 of the respiratory therapy system 150 and donned the user interface 154. The sleep session can thus include time periods (i) when the user is using the oral appliance 110 or the respiratory therapy system 150, but before the user attempts to fall asleep (for example when the user lays in the bed reading a book); (ii) when the user begins trying to fall asleep but is still awake; (iii) when the user is in a light sleep (also referred to as stage 1 and stage 2 of non-rapid eye movement (NREM) sleep); (iv) when the user is in a deep sleep (also referred to as slow-wave sleep, SWS, or stage 3 of NREM sleep); (v) when the user is in rapid eye movement (REM) sleep; (vi) when the user is periodically awake between light sleep, deep sleep, or REM sleep; or (vii) when the user wakes up and does not fall back asleep. The sleep session may also be referred to as a therapy session, or may comprise a therapy session, which can be understood to be the period of time within the sleep session during which the individual is engaged in oral appliance therapy (e.g., the wearing of the oral appliance 110) or respiratory therapy (e.g., the use of a respiratory therapy system 150).
[0089] The sleep session is generally defined as ending once the user removes the oral appliance 110 and gets out of bed; or once the user removes the user interface 154, turns off the respiratory therapy device 152, and gets out of bed. In some implementations, the sleep session can include additional periods of time, or can be limited to only some of the abovedisclosed time periods. For example, the sleep session can be defined to encompass a period of time beginning when the oral appliance 110 is placed in the user’ s mouth (and / or the respiratory therapy device 152 begins supplying the pressurized air to the airway or the user), ending when the oral appliance 110 is removed from the user’s mouth (and / or the respiratory therapy device 152 stops supplying the pressurized air to the airway of the user), and including some or all of the time points in between, when the user is asleep or awake.
[0090] FIG. 3 illustrates an exemplary timeline 300 for a sleep session. 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 (tnse).
[0091] The enter bed time tbed is associated with the time that the user initially enters the bed (e.g., bed 40 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.).
[0092] 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 140, 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.
[0093] 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 night and 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.).
[0094] Similarly, the rising time tnse 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 tnse is the time when the user last leaves the bed without returningto the bed until a next sleep session (e.g., the following evening). Thus, the rising time tnse 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.).
[0095] 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 tnse. In some implementations, the final wake-up time twake and / or the final rising time tnse 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 (tnse), 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.
[0096] The total time in bed (TIB) is the duration of time between the time enter bed time tbed and the rising time tnse. 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 shorter than the total time in bed (TIB) (e.g., one minute short, ten minutes shorter, one hour shorter, etc.). For example, as shown in the timeline 300, the total sleep time (TST) spans between the initial sleep time tsieep and the wake-up time twake, but excludes the duration of the first microawakening 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).
[0097] 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 thewakefulness 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.
[0098] In some implementations, the sleep session is defined as starting at the enter bed time (tbed) and ending at the rising time (tnse), 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 (tnse). 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 (tnse).
[0099] Referring to FIG. 4, an exemplary hypnogram 400 corresponding to the timeline 300 of 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.
[0100] 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 210 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 other 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 patternof events, or any combination thereof. Information describing the sleep-wake signal can be stored in the memory device 158.
[0101] 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.
[0102] 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 other 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 amount of sustained sleep can exclude any micro-awakenings (e.g., a ten second micro-awakening does not restart the 10-minute period).
[0103] 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.)
[0104] 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 spendstime 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%.
[0105] 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).
[0106] 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.
[0107] 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 more first micro-awakenings (e.g., MAi and MA2), the wake-up time (twake), the rising time (tnse), or any combination thereof based at least in part on the sleep-wake signal of a hypnogram.
[0108] In other implementations, one or more of the sensors 210 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 (tnse), 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 218, the microphone 220, the camera 232, 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 218 (e.g., data indicative of no movement by the user), data from the camera 232 (e.g., data indicative of no movement by the user and / or that the user has turned off the lights), data from the microphone 220 (e.g., data indicative of the using turning off a TV), data from the user device 140 (e.g., data indicative of the user no longer using the user device 140), data from the oral appliance 110 (e.g., data indicative of the oral appliance 110 being placed in the user’smouth), data from the oral appliance receptacle 112 (e.g., data indicative of the oral appliance 110 being removed from the oral appliance receptacle 112), data from the pressure sensor 212 and / or the flow rate sensor 214, or any combination thereof.
[0109] FIG. 5 A shows an MRD 500 used to set and / or adjust the position of the user’s lower jaw, and FIG. 5B shows a transparent view of the MRD 500 when placed in the user’s mouth.. The MRD 500 is an example of the oral appliance 110 of system 10. As shown, the MRD 500 includes an upper portion 510 and a lower portion 520 that are connected via two connecting rods 530A and 530B. The upper portion 510 and the lower portion 520 have arcuate shapes generally designed to follow the curve of the user’s teeth. The upper portion 510 defines a groove 512 that receives the user’s upper teeth, and the lower portion 520 defines a groove 522 that receives the user’s lower teeth. Within the groove 512, the upper portion 510 may be molded to generally conform to the user’s upper teeth. Similarly, within the groove 522, the lower portion 520 may be molded to generally conform to the user’s lower teeth. As can be seen in FIG. 5B specifically, the grooves 512 and 522 may terminate on either side of the user’s front upper teeth and front lower teeth, such that portions of the user’s front upper teeth and front lower teeth are not disposed within the grooves 512 and 522 respectively.
[0110] The connecting rods 530A and 530B hingedly connects the upper portion 510 and the lower portion 520 to allow the user some ability to open and close their jaw when wearing the MRD 500. The connecting rods 530A and 530B set the position of the lower portion 520 relative to the upper portion 510, and thus the position of the user’s lower jaw relative to the rest of their mouth. In some implementations, different connecting rods 530A and 530B are used to set the lower portion 520 in different positions. For example, a first pair of connecting rods 530A and 530B having a first size will set the lower portion 520 in a first position relative to the upper portion 510, a second pair of connecting rods 530A and 530B having a second size (e.g., smaller or shorter than the first size) will set the lower portion 520 in a second position (e.g., closer than the first position) relative to the upper portion 510, etc.
[0111] In some implementations, a single pair of connecting rods 530A and 530B may be used to set the lower portion 520 in different positions relative to the upper portion 510. In some of these implementations, the locations on the upper portion 510 and / or the lower portion 520 where the connecting rods 530A and 530B are attached may be altered to adjust the position. In others of these implementations, the connecting rods 530A and 530B remain attached to the same locations on the upper portion 510 and the lower portion 520, but are themselves adjustable to changes their own size.
[0112] Generally, an individual who is prescribed usage of the respiratory therapy system 150 will tend to experience higher quality sleep and less fatigue during the day after using the respiratory therapy system 150 during the sleep compared to not using the respiratory therapy system 150 (especially when the individual suffers from sleep apnea or other sleep related disorders). For example, the user 20 may suffer from obstructive sleep apnea and rely on the user interface 154 (e.g., a full face mask) to deliver pressurized air from the respiratory therapy device 152 via conduit 156. The respiratory therapy device 152 can be a continuous positive airway pressure (CPAP) machine used to increase air pressure in the throat of the user 20 to prevent the airway from closing and / or narrowing during sleep. For someone with sleep apnea, their airway can narrow or collapse during sleep, reducing oxygen intake, and forcing them to wake up and / or otherwise disrupt their sleep. The CPAP machine prevents the airway from narrowing or collapsing, thus minimizing the occurrences where they wake up or are otherwise disturbed due to reduction in oxygen intake. While the respiratory therapy device 152 strives to maintain a medically prescribed air pressure or pressures during sleep, the individual can experience sleep discomfort due to the therapy.
[0113] Such discomfort can cause individuals to stop using the respiratory therapy device 152, even though they may have been prescribed such use by their healthcare provider. Other individual may even hesitate to start using the respiratory therapy device 152 after they have been recommended to do so, out of fear or apprehension for any discomfort that may be caused by the respiratory therapy device. FIG. 5 illustrates a method 600 for recommending therapy to individuals who may be more suited to therapies to treat SDB (and / or other sleep-related disorders) other than use of a respiratory therapy device.
[0114] Step 602 of method 600 includes identifying a group of one or more individuals. The group of one or more individuals will generally include at least one individual that has stopped using a respiratory therapy device, at least one individual who has not yet started to use a respiratory therapy device, or both. In some implementations, the at least one individual that has stopped using the respiratory therapy device is an individual(s) who stopped using the respiratory therapy device after using the respiratory therapy device for a threshold period of time. For example, the threshold period of time may be 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 year, or any other suitable period of time. In some implementations, the at least one individual who has not started to use the respiratory therapy device is an individual(s) that was diagnosed with SDB (and / or another sleep-related disorder) and received a recommendation to use the respiratory therapy device, but has not begun to use the respiratory therapy device within a threshold period of time. For example, the thresholdperiod of time may be 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 year, or any other suitable period of time. In some implementations, the requisite threshold periods of time for the two groups is the same, and in other implementations the threshold periods of time are different.
[0115] Step 604 of method 600 includes collecting data associated with each of the one or more individuals. Any suitable type of data could be collected. In some implementations, the collected data includes image data associated with the head, neck, face, and / or interior of the mouth of each individual (which may be from a single image of the individual or a plurality of separate images of the individual). In some implementations, the data includes data associated with past use of the respiratory therapy device. In some implementations, the data includes medical data for the individual associated with the healthcare provider’s diagnosis of SDB and recommendation to use the respiratory therapy device.
[0116] In some implementations, the data includes data associated with physical characteristics of the individual. This data may include data associated with the value of one or more physical parameters associated with the head, neck, face, and / or mouth of the individual, such as neck width, neck circumference, j aw width, a Mallampati score, tongue size, the presence or absence of malocclusion in the individual’s teeth, the presence or absence of worn teeth, a presence or absence of a deviated septum, other physical parameters, or any combinations thereof.
[0117] In some implementations, the data includes personal data associated with the individual, which may include demographic data (e.g., age, sex, location, ethnicity, data about personal habits, etc.), medical data (which may include the medical data associated with the healthcare provider’s prior recommendation to use a respiratory therapy device and / or other medical data), the usage data, and other types of data.
[0118] Step 606 of method 600 includes, for each respective individual, determining whether to recommend an alternative therapy based on the data associated with the respective individual. In some cases, the alternative therapy includes the use of a mandibular repositioning device (MRD) during sleep sessions, positional therapy, hypoglossal nerve stimulation, the use of medications (such as GLP-1 type medications, which can include Glucagon-Like Peptide- 1 (GLP-1) receptor agonists, e.g., Ozempic™ or Wegovy™), other therapies, or any combinations thereof. In some implementations, the alternative therapy that is recommended includes multiple alternative therapies, such as use of the respiratory therapy device and use of an MRD. This alternative therapy may include alternating between the respiratory therapy device and the MRD (e.g., every sleep session, every week, every month, etc.). This alternative therapy may also include simultaneous use of both the respiratory therapy device and the MRD.In cases of simultaneous use, the recommendation for alternative therapy may include a recommendation for a specific use interface for the respiratory therapy device that is compatible with the MRD. In some implementations, the alternative therapy includes use of the respiratory therapy device at a lower therapy pressure. In some implementations, the alternative therapy could include the use of medication with the MRD or with the respiratory therapy device.
[0119] In some implementations, step 606 includes determining whether to recommend a first alternative therapy (e.g., use of an MRD) or a second alternative therapy (e.g., hypoglossal nerve stimulation therapy, positional therapy, etc.), and then method 600 further includes transmitting such recommendation to each of the individuals.
[0120] In implementations where the collected data includes image data of the individual’s head, neck, face, and / or mouth, step 606 can include analyzing such image data to determine if the individual is suitable for use of the MRD. In some implementations, the image data can be analyzed to select either a first type of MRD (e.g., an MRD where the upper and lower portions are movably coupled to each other) or a second type of MRD (e.g., an MRD where the upper and lower portions are separate from each other but include alignment / registration mechanisms to maintain them in place relative to each other).
[0121] In some implementations, the image data is analyzed to (i) identify anatomical features of the individual’s head, neck, face, interior of the mouth, etc., and / or to (ii) determine one or more measurements associated with the individual’s head, neck, face, interior of the mouth, etc. (such as a range of motion of the individual’s jaw). In some implementations, analyzing the image data includes generating a three-dimensional (3D) model of the individual’s face based on the anatomical features and / or the determined measurements. In some implementations, a Mallampati score is determined based on any one or more of the anatomical features, the determined measurements, and the 3D model. The determination of whether to recommend alternative therapy and / or what alternative therapy is recommended can then be based on any one or more of the anatomical features, the determined measurements, the 3D model, the Mallampati score, and any other data or information.
[0122] In some implementations where the data includes image data and usage data associated with past use of a respiratory therapy device, determining whether to recommend use of the MRD can be based on both the image data and the usage data. In some implementations where the data includes image data and medical data associated with the previous recommendation to use the respiratory therapy device, determining whether to recommend use of the MRD can be based on both the image data and the medical data.
[0123] In some implementations, method 600 can include directing the individual how to generate the image data of their head, face, neck, and / or mouth. For example, collecting the data at step 604 can include transmitting instructions to each individual for performing a facial scan (e.g., using their personal device such as a smartphone) to generate the image data. The generated image data can then be received from the individual’s personal device so that it may be analyzed. In some implementations, the instructions transmitted to the individual are instead instructions to undergo a facial scan (e.g., by visiting a dentist or other healthcare provider), at which point the generated image data can be received from the individual and / or from the person or entity that performed the facial scan.
[0124] In general, method 600 can include analyzing data associated with the individual’s head, neck, face, and / or interior of the mouth to determine whether each individual is a suitable candidate for an MRD, and / or for a specific type of MRD. The data may include both image data from a facial scan, and data associated with physical characteristics of the individual’s head, neck, face, and / or interior of the mouth. If analysis of the data indicates that the individual is a suitable candidate for an MRD, then a recommendation to use an MRD (and / or to visit a healthcare provider to initiate the process for obtaining an MRD) can be transmitted. If the individual is not a suitable candidate for an MRD, then other recommendations can be transmitted, such as to use hypoglossal nerve stimulation or positional therapy, to try to use the respiratory therapy device, to visit a healthcare provider (such as a sleep apnea specialist) to review options, etc. In some implementations, method 600 may include the use of computer vision to accurately measure and document anatomical structures and necessary data points to assess the suitability of an alternative therapy, for example based on the individual’s health insurance coverage, or for insurance claims. This streamlines the workflow for healthcare providers and saves time on administrative tasks by automating measurement documentation.
[0125] FIG. 6 illustrates a method 700 for monitoring an individual who is using an MRD, and determining a suitable time to try and persuade the individual to attempt using a respiratory therapy device. In general, method 700 can be utilized for individuals who previously used a respiratory therapy device but stopped (e.g., due to discomfort), or for individuals that were recommended to use a respiratory therapy device (e.g., by their healthcare provider) but never started using the respiratory therapy device. Instead, these individuals use an MRD at night to treat their sleep-related disorder, such as SDB. Method 700 can be used to determine when it would be appropriate to recommend to the individual that they start trying to use the respiratory therapy device (and / or a different therapy), which is generally more effective at treating the sleep-related disorder than the MRD. Method 700 may be implemented generally at any timewhen the individual is using the MRD, such as immediately when the individual begins to use the MRD, after the individual has used the MRD for a certain period of time and / or number of sleep sessions, etc.
[0126] Step 702 of method 700 includes receiving data associated with the individual during a period of time when the individual used the MRD during one or more sleep sessions. Generally, the individual’s use of the MRD will occur both when the individual is awake during the sleep sessions (e.g., at the beginning of the sleep session when the individual is attempting to fall asleep, when the individual wakes up in the middle of the night, etc.) and when the individual is asleep.
[0127] In some implementations, the data includes usage data associated with the individual’s use of the MRD during the period of time. The usage data may indicate how frequent and / or how low the individual used the MRD, and may include the values of parameters such as the average hours (or other unit of time) of use of the MRD per sleep session of the one or more sleep sessions, the number of sleep sessions during the period of time that the MRD was used by the individual, the amount of hours (or other unit of time) the MRD was used in each sleep session of the one or more sleep sessions, and any other suitable parameter.
[0128] In some implementations, the received data includes data that is indicative of the value of one or more different metrics. These metrics may include metrics associated with the health of the individual, such as weight, blood pressure, step count, daytime tiredness level, amount of sleep, snore volume, snore frequency, etc. These metrics may additionally or alternatively include metrics indicative of whether the individual is practicing a healthy habit, such as calorie tracking, weight tracking, blood pressure tracking, step count tracking, participation in a weight loss program, participation in an exercise regimen, signing up for a gym membership, scheduling an appointment with a healthcare provider (which could be any healthcare provider, or a specific healthcare provider such as a nutritionist, a dietician, a sleep apnea specialist, a diabetes management specialist, etc.). The metrics may additionally or alternatively include metrics associated with the efficacy of the MRD in maintaining the individual’s airway.
[0129] Thus, the data received at step 702 can generally include any suitable type of data, including physiological data, blood pressure data, blood oxygen data, activity data, motion data, audio data, optical data, tension / force data, personal data, etc.
[0130] In some implementations, the data received at step 702 includes data generated by one or more wearable sensors, which may include a smart watch, a smart ring, a sensor worn on the jaw, a sensor mounted on and / or in the MRD, a sensor configured to generate data indicative of the individual’s blood oxygen level, a sensor configured to generate data indicative of theindividual’s heart rate, a sensor configured to generate data indicative of snoring by the individual, a sensor configured to generate data indicative of the jaw position of the individual, a sensor configured to generate data indicative of the jaw movement of the individual, a sensor configured to generate data indicative of jaw tension of the individual, other sensors, and any combinations thereof. The data received at step 702 may additionally or alternatively include data generated by non-wearable sensors, which may include non-wearable sensors configured to generate the same data as any of the wearable sensors mentioned herein. Any of the wearable and / or non-wearable sensors used to generate any of the data at step 702 may include any of the sensors 130 discussed herein.
[0131] Step 704 of method 700 includes analyzing the data to determine the individual’s readiness to transition from the use of the MRD to an alternative therapy, such as use of a respiratory therapy device (instead of or in addition to use of the MRD), use of a different MRD that advances the individual’s jaw a different amount, etc. Step 706 of method 700 includes transmitting a recommendation to the individual to either (i) transition to the alternative therapy and discontinue use of the MRD or (ii) continue using the MRD. In some implementations, the transmitted recommendation could also be a recommendation to transition to the alternative therapy but continue using the MRD. The alternative therapy may be any suitable alternative therapy (such as those suitable for treating SDB and / or OSA, or any other sleep-related disorder), such as use of a respiratory therapy device (e.g., a CPAP device), hypoglossal nerve stimulation therapy, positional therapy, use of a different type of MRD, medication (e.g., GLP- 1 type drugs), other therapies, or any combinations of therapies. The recommendation may additionally or alternatively include a recommendation for the individual to meet with a healthcare provider.
[0132] In some implementations, the recommendation to transition to the alternative therapy and discontinue use of the MRD is transmitted to the individual in response to the analysis of the data at step 704 indicates that the individual’s use of the MRD satisfied a threshold amount of use. In these implementations, once the individual’s use of the MRD has satisfied the threshold, the individual may be ready to attempt to use the respiratory therapy device again (or for the first time), and thus the recommendation to transition to the alternative therapy can be transmitted.
[0133] The threshold amount of use can be (i) a threshold average hours of use of the MRD per sleep session of the one or more sleep sessions, (ii) at least one use of the MRD during each sleep session of the one or more sleep sessions, (iii) at least one use of the MRD during each of a threshold number of sleep sessions of the one or more sleep sessions; (iv) a thresholdamount of time of use of the MRD during each sleep session of the one or more sleep sessions, (v) a threshold amount of time of use of the MRD during each of a threshold number of sleep sessions of the one or more sleep sessions, (vi) a threshold average hours of use of the MRD per sleep session of the one or more sleep session and a use of the MRD during each sleep session of the one or more sleep sessions, or (vii) any combination of (i)-(vi).
[0134] As noted above, the received data may include data that is indicative of the value of one or more different metrics associated with the health of the individual. In some implementations, if the value of any one or more of these metrics indicates that the health of the individual has started to improve following the use of the MRD, that the health of the individual has stopped improving after using the MRD for a period of time, or that the MRD is no longer as effective as desired / required, then the recommendation to transition to the alternative therapy can be transmitted. In general, if the individual’s health has begun to improve once they have started using the MRD, it may be determined that the individual has used the MRD for a sufficient amount of time to begin improving their health and that now is a good time to recommend they transition back to the alternative therapy, and / or that they are taking their health more seriously, meaning that they would be more receptive to a recommendation to transition to the alternative therapy
[0135] In other implementations, if the value of the metric indicates that (i) the individual’s health was improving but has now stopped and that the MRD is now less effective and / or (ii) the efficacy of the MRD in maintaining the individual’s airway has decreased, the individual may be more receptive to the recommendation to transition to the alternative therapy because of the ineffectiveness of the MRD and the possibility of the alternative therapy resulting in their health again starting to improve.
[0136] In further implementations, the individual may be required to have used the MRD for a sufficient amount of time before the recommendation to transition to the alternative therapy is transmitted. In these implementations, if the value of the metric indicates that the individual’s health has started to improve or stopped improving before the individual has used the MRD for at least a threshold amount of time, then the recommendation transmitted to the individual is the recommendation to continue using the MRD. But if the individual has used the MRD for at least the threshold amount of time and their health is improving or has stopped improving, then the recommendation to transition to the alternative therapy can be transmitted. The threshold amount of time could be a number of sleep sessions, a number of days, a number of weeks, a number of months, a cumulative amount of time of use of the MRD, etc.
[0137] In some implementations, if the value of the metric indicates that the individual’s health is unchanged, then the recommendation to continue using the MRD may be transmitted to the individual. In these implementations, as the individual has not yet started to see any benefit from the MRD, it can be determined that they are ready to try and transition back to the alternative therapy. In some cases, if the individual’s health is unchanged before a threshold amount of time of use of the MRD, then the recommendation can be to continue using the MRD (to allow the individual to see some benefit from the MRD). However, if the individual’s health is unchanged after the threshold amount of time of use of the MRD, then the recommendation can be to transition to the alternative therapy, as it may be determined that the individual has used the MRD for too long without seeing any benefit, and may be receptive to trying the alternative therapy.
[0138] If the metric is the individual’s weight, if the individual’s weight has begun to decrease during the period of time or stopped decreasing during the period of time, then the recommendation transmitted to the individual may be the recommendation to transition to the alternative therapy and discontinue use of the MRD. If the individual’s weight is unchanged during the period of time, then the recommendation transmitted to the individual may be the recommendation to continue using the MRD.
[0139] If the metric is the individual’s blood pressure, if the individual’s blood pressure has begun to decrease during the period of time or stopped decreasing during the period of time, then the recommendation transmitted to the individual may be the recommendation to transition to the alternative therapy and discontinue use of the MRD. If the individual’s blood pressure is unchanged during the period of time, then the recommendation transmitted to the individual may be the recommendation to continue using the MRD.
[0140] If the metric is the individual’s step count, if the individual’s step count has begun to increase during the period of time or stopped increasing during the period of time, then the recommendation transmitted to the individual may be the recommendation to transition to the alternative therapy and discontinue use of the MRD. If the individual’s step count is unchanged during the period of time, then the recommendation transmitted to the individual may be the recommendation to continue using the MRD.
[0141] If the metric is the individual’s daytime tiredness level, if the individual’s daytime tiredness level has begun to decrease during the period of time or stopped decreasing during the period of time, then the recommendation transmitted to the individual may be the recommendation to transition to the alternative therapy and discontinue use of the MRD. If the individual’s daytime tiredness level is unchanged during the period of time, then therecommendation transmitted to the individual may be the recommendation to continue using the MRD.
[0142] If the metric is the individual’s amount of sleep obtained (e.g., amount of sleep per sleep session), if the individual’s amount of sleep obtained has begun to increase during the period of time or stopped during the period of time, then the recommendation transmitted to the individual may be the recommendation to transition to the alternative therapy and discontinue use of the MRD. If the individual’s amount of sleep obtained is unchanged during the period of time, then the recommendation transmitted to the individual may be the recommendation to continue using the MRD.
[0143] If the metric is the individual’s snore volume, if the individual’s snore volume has begun to decrease during the period of time or stopped decreasing during the period of time, then the recommendation transmitted to the individual may be the recommendation to transition to the alternative therapy and discontinue use of the MRD. If the individual’s snore volume is unchanged during the period of time, then the recommendation transmitted to the individual may be the recommendation to continue using the MRD.
[0144] If the metric is the individual’s snore frequency, if the individual’s snore frequency has begun to decrease during the period of time or stopped decreasing during the period of time, then the recommendation transmitted to the individual may be the recommendation to transition to the alternative therapy and discontinue use of the MRD. If the individual’s snore frequency is unchanged during the period of time, then the recommendation transmitted to the individual may be the recommendation to continue using the MRD.
[0145] In some implementations, if the metric indicates that the individual has begun practicing a healthy habit, then it may be determined that the individual will be more receptive to a recommendation to transition to the alternative therapy and discontinue use of the MRD. In other implementations, if the metric indicates that the individual has not begun practicing a healthy habit, it may be determined that the individual is not ready to transition to the alternative therapy, and thus the recommendation transmitted to the individual can be the recommendation to continue using the MRD.
[0146] In further implementations, the individual may be required to have used the MRD for a sufficient amount of time before the commencement and / or practice of a healthy habit is sufficient to recommend transitioning to the alternative therapy and discontinue using the MRD. In these implementations, if the metric indicates that the individual has begun to practice the healthy habits before the individual has used the MRD for at least a threshold amount of time, then the recommendation transmitted to the individual is the recommendation to continueusing the MRD. But if the individual has begun to practice a healthy habit (or practiced a healthy habit for a sufficient amount of time) and used the MRD for at least the threshold amount of time, then the recommendation to transition to the alternative therapy can be transmitted. The threshold amount of time could be a number of sleep sessions, a number of days, a number of weeks, a number of months, a cumulative amount of time of use of the MRD, etc.
[0147] If the metric is the presence or absence of calorie tracking, if the data indicates that the individual has begun to track their calories, then the recommendation transmitted to the individual can be the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0148] If the metric is the presence or absence of weight tracking, if the data indicates that the individual has begun to track their weight, then the recommendation transmitted to the individual can be the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0149] If the metric is the presence or absence of blood pressure tracking, if the data indicates that the individual has begun to track their blood pressure, then the recommendation transmitted to the individual can be the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0150] If the metric is the presence or absence of step count tracking, if the data indicates that the individual has begun to track their calories, then the recommendation transmitted to the individual can be the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0151] If the metric is participation in a weight loss program, if the data indicates that the individual has commenced a weight loss program, then the recommendation transmitted to the individual can be the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0152] If the metric is participation in an exercise regimen, if the data indicates that the individual has commenced an exercise regiment, then the recommendation transmitted to the individual can be the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0153] If the metric is signing up for a gym membership, if the data indicates that the individual has signed up for a gym membership, then the recommendation transmitted to the individual can be the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0154] If the metric is making an appointment with a healthcare provider, if the data indicates that the individual has made an appointment with a healthcare provider, then the recommendation transmitted to the individual can be the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0155] As noted, in some implementations, the metric is indicative of the efficacy of the MRD in maintaining the individual’s airway. The metric can include, for example, any one or more of at least one metric associated with snoring by the individual while using the MRD, at least one metric associated with a jaw of the individual while using the MRD, at least one metric associated with respiratory events experienced by the individual while using the MRD, at least one metric associated with a blood oxygen level of the individual while using the MRD, and at least one metric associated with comfort of the individual while using the MRD.
[0156] In some implementations, if the metric or metrics indicate that the efficacy of the MRD has increased during the period of time or is unchanged, the recommendation transmitted to the individual will generally be to continue using the MRD. In some implementations, if the metric or metrics indicate that the efficacy of the MRD has decreased, the recommendation transmitted to the individual will generally be to transition to the alternative therapy (which may include starting or re-starting use of the respiratory therapy device). In some implementations, if the MRD efficacy has decreased, the alternative therapy that is recommended may depend on how long the individual has used the MRD. If the MRD efficacy has decreased and the individual has not used the MRD for at least a threshold amount of time, the alternative therapy may be use of a different MRD (e.g., an MRD that is configured to advance the jaw of the individual further to improve the efficacy the MRD). If the MRD efficacy has decreased and the individual has used the MRD at least the threshold amount of time, the alternative therapy may be use of the respiratory therapy device. Any suitable threshold amount of time may be used, such as a number of sleep sessions, as a number of days, as a number of weeks, as a number of months, a cumulative amount of time spent using the MRD, combinations thereof, etc.
[0157] The at least one metric associated with snoring by the individual while using the MRD may include any one or more of an average volume of the snores during one or more sleep sessions, a maximum volume of the snores during one or more sleep sessions, a total amount of time spent snoring during one or more sleep sessions, and an average amount of time spent snoring per sleep session across one or more sleep sessions. In some implementations, if the snoring metric or metrics indicate that the individual’s snoring has improved during the period of time using the MRD and / or is unchanged during the period of time, the efficacy of the MRDhas increased or is unchanged, and the recommendation transmitted to the individual will generally be to continue using the MRD. But if the snoring metric or metrics indicate that the individual’s snoring has worsened during the period of time, the efficacy of the MRD has decreased, and the recommendation transmitted to the individual will generally be to transition to the alternative therapy (which may include starting or re-starting use of the respiratory therapy device).
[0158] The at least one metric associated with respiratory events experienced by the individual while using the MRD may include any one or more of a total amount of respiratory events experienced during one or more sleep sessions, an average amount of respiratory events experienced during one or more sleep sessions, a maximum severity of respiratory events experienced during one or more sleep sessions, an average severity of respiratory events experienced during one or more sleep sessions, an AHI for the individual during one or more sleep sessions, an ODI for the individual during one or more sleep sessions, etc. In some implementations, if the respiratory event metric or metrics indicate that the amount and / or severity of the respiratory events have improved during the period of time using the MRD and / or is unchanged during the period of time, the efficacy of the MRD has increased or is unchanged, and the recommendation transmitted to the individual will generally be to continue using the MRD. But if the respiratory event metric or metrics indicate that the amount and / or severity of the respiratory events have worsened during the period of time, the efficacy of the MRD has decreased, and the recommendation transmitted to the individual will generally be to transition to the alternative therapy (which may include starting or re-starting use of the respiratory therapy device).
[0159] The at least one metric associated with the individual’s blood oxygen level while using the MRD may include any one or more of an average blood oxygen level of the individual per sleep session during the one or more sleep sessions, a minimum blood oxygen level of the individual per sleep session during the one or more sleep sessions, and an average of the minimum blood oxygen level of the individual for each of the one or more sleep sessions. In some implementations, if the blood oxygen level metric or metrics indicate that the individual’ s blood oxygen levels while wearing the MRD have improved during the period of time using the MRD and / or is unchanged during the period of time, the efficacy of the MRD has increased or is unchanged, and the recommendation transmitted to the individual will generally be to continue using the MRD. But if the blood oxygen level metric or metrics indicate that the individual’s blood oxygen levels while wearing the MRD have worsened during the period of time, the efficacy of the MRD has decreased, and the recommendation transmitted to theindividual will generally be to transition to the alternative therapy (which may include starting or re-starting use of the respiratory therapy device).
[0160] The at least one metric associated with the individual’s comfort while using the MRD may include any one or more of a self-reported comfort for during the one or more sleep session, a self-reported pain score during the one or more sleep sessions, and a metric associated with the MRD being inserted into and / or removed from the individual’s mouth during the one or more sleep sessions. The metric associated with the MRD being inserted into and / or removed from the individual’s mouth may include the number of times the MRD was inserted into and / or removed from the mouth of the individual during the one or more sleep sessions, the number of times per sleep session the MRD was inserted into and / or removed from the mouth of the individual during the one or more sleep sessions, or both. In some implementations, if the user comfort metric or metrics indicate that the individual’s comfort while wearing the MRD has improved during the period of time using the MRD and / or is unchanged during the period of time, the efficacy of the MRD has increased or is unchanged, and the recommendation transmitted to the individual will generally be to continue using the MRD. But if the user comfort metric or metrics indicate that the individual’s comfort while wearing the MRD has worsened during the period of time, the efficacy of the MRD has decreased, and the recommendation transmitted to the individual will generally be to transition to the alternative therapy (which may include starting or re-starting use of the respiratory therapy device).
[0161] The at least one metric associated with the individual’s jaw while using the MRD may include any one or more of the tension in the individual’s jaw while using the MRD, and the amount that the individual’s jaw is advanced while using the MRD. In some implementations, if the jaw metric or metrics indicate that the tension in the individual’s jaw and / or the amount that the individual’s jaw is advanced are greater than a threshold amount (e.g., one or both of them being greater than a corresponding threshold for tension or jaw advancement), this indicates that the MRD is sufficiently placing the individual’s jaw in the desired position, and the recommendation transmitted to the individual will generally be to continue using the MRD. But if the jaw metric or metrics indicate that one or both of the tension in the individual’s jaw and / or the amount that the individual’s jaw is advanced are less than the threshold amount, this indicates that the MRD is not sufficiently placing the individual’s jaw in the desired position, and the recommendation transmitted to the individual will generally be to transition to the alternative therapy (which may include starting or re-starting use of the respiratory therapy device, using a different MRD that advances the jaw a different amount, etc.).
[0162] In some implementations, the jaw metric(s) may be combined with at least one other MRD efficacy metric (e.g., associated with snoring, respiratory events, blood oxygen levels, comfort, etc.) to determine whether to recommend continued use of the MRD or to recommend transitioning to the alternative therapy (e.g., a different MRD, the respiratory therapy device, a combination , etc.) based on whether sufficient jaw tension / advancement has been achieved. A threshold for jaw tension / advancement can be used, which indicates a sufficient and / or appropriate amount of jaw tension / advancement (e.g., jaw tension / advancement above the threshold may be regarded as too painful and / or uncomfortable and thus use of an MRD to try and achieve jaw tension / advancement above the threshold would not be recommended, even if the current MRD is ineffective).
[0163] In a first example, if the jaw metric or metrics indicate that the jaw tension and / or the jaw advancement satisfy the threshold (e.g., are greater than the corresponding threshold), and at least one of the other MRD efficacy metrics indicates that the efficacy of the MRD has increased or is unchanged during the period of time, then the recommendation transmitted to the individual will generally be to continue using the MRD, because the MRD is working and the MRD has achieved sufficient jaw tension and / or advancement. In some cases though, the recommendation transmitted to the individual may include a recommendation to transition to an alternative therapy that includes use of a different type of MRD configured to advance the individual’s jaw further to try and increase the efficacy of the MRD even more. Alternatively, the alternative therapy could include use of a different type of MRD configured to advance the individual’s jaw less to try and improve the individual’s comfort while wearing the MRD.
[0164] In a second example, if the jaw metric or metrics indicate that the jaw tension and / or the jaw advancement do not satisfy the threshold (e.g., are less than the corresponding threshold), and at least one of the other MRD efficacy metrics indicates that the efficacy of the MRD has increased or is unchanged during the period of time, then the recommendation transmitted to the individual will generally be to continue using the MRD, because the MRD is working even without achieving sufficient jaw tension and / or advancement.
[0165] In a third example, if the jaw metric or metrics indicate that the jaw tension and / or the jaw advancement satisfy the threshold (e.g., are greater than the corresponding threshold), and at least one of the other MRD efficacy metrics indicates that the efficacy of the MRD has decreased during the period of time, then the recommendation transmitted to the individual will generally be to transition to the respiratory therapy device, because the MRD is not working even though the MRD has achieved sufficient jaw tension and / or advancement.
[0166] In a fourth example, if the jaw metric or metrics indicate that the jaw tension and / or the jaw advancement do not satisfy the threshold (e.g., are less than the corresponding threshold), and at least one of the other MRD efficacy metrics indicates that the efficacy of the MRD has decreased during the period of time, then the recommendation transmitted to the individual will generally be to transition to a different type of MRD that is configured to advance the individual’s jaw farther. This recommendation is because while the MRD is not working, sufficient jaw tension and / or advancement has not yet been achieved, and a different MRD may be more effective in maintaining the individual’s airway by achieving sufficient jaw tension and / or advancement.
[0167] The third and fourth examples may essentially be combined into a single example where the alternative therapy that is recommended is based on whether the thresholds are satisfied. For example, if at least one of the other MRD efficacy metrics indicates that the efficacy of the MRD has decreased during the period of time, the jaw metric or metrics can be compared to their respective thresholds. If the jaw metric or metrics do not satisfy the thresholds (e.g., are less than the corresponding threshold), then the recommendation transmitted to the individual will generally be to transition to the different type of MRD that is configured to advance the individual’s jaw farther. But if the jaw metric or metrics do satisfy the thresholds (e.g., are greater than the corresponding threshold), then the recommendation transmitted to the individual will generally be to transition to the respiratory therapy device.
[0168] In a fifth example, the recommendation when the MRD is effective is based on whether multiple thresholds are satisfied. If at least one of the other MRD efficacy metrics indicates that the efficacy of the MRD has increased or is unchanged during the period of time, the jaw metric or metrics can be compared to corresponding first (lower) thresholds and to corresponding second (higher) thresholds. If the jaw metric or metrics indicate that the jaw tension and / or the jaw advancement do not satisfy the corresponding first thresholds (e.g., are less than the corresponding first thresholds), the jaw tension / advancement may be considered to be too low. Given that there is room for more j aw tension / advancement without causing pain or discomfort, the recommendation transmitted to the individual can be to transition to a different type of MRD configured to advance the individual’s jaw farther, to see if the efficacy can be improved even more.
[0169] If the jaw metric or metrics indicate that the jaw tension and / or the jaw advancement satisfy the corresponding first thresholds but do not satisfy the corresponding second thresholds (e.g., are greater than the corresponding first thresholds but are less than the corresponding second thresholds), the jaw tension / advancement may be considered to be an appropriateamount. The recommendation transmitted to the individual can be to continue using the current MRD, since the MRD is effective and the jaw tension / advancement is acceptable. If the jaw metric or metrics indicate that the jaw tension and / or the jaw advancement satisfy both the corresponding first thresholds and the corresponding second thresholds (e.g., are greater than both the corresponding first thresholds and the corresponding second thresholds), the jaw tension / advancement may be considered to be too high. Because the MRD is still effective, the recommendation transmitted to the individual can be to transition to a different type of MRD configured to advance the individual’s jaw less, to see if the efficacy of the MRD can be maintained while causing less pain / discomfort.
[0170] In a sixth example, the recommendation when the MRD is not effective is based on whether multiple thresholds are satisfied. If at least one of the other MRD efficacy metrics indicates that the efficacy of the MRD has decreased during the period of time, the jaw metric or metrics can be compared to corresponding first (lower) thresholds and to corresponding second (higher) thresholds. If the jaw metric or metrics indicate that the jaw tension and / or the jaw advancement do not satisfy the corresponding first thresholds (e.g., are less than the corresponding first thresholds), the jaw tension / advancement may be considered to be too low. Given that there is room for more jaw tension / advancement without causing pain or discomfort, the recommendation transmitted to the individual can be to transition to a different type of MRD configured to advance the individual’s jaw farther, to see if the efficacy can be improved.
[0171] If the jaw metric or metrics indicate that the jaw tension and / or the jaw advancement satisfy the corresponding first thresholds but do not satisfy the corresponding second thresholds (e.g., are greater than the corresponding first thresholds but are less than the corresponding second thresholds), the jaw tension / advancement may be considered to not be unacceptably high. Because there is still some room to increase the jaw tension / advancement, the recommendation transmitted to the individual can be to use a different type of MRD that is configured to advance the individual’s jaw farther, which may be by the same amount as the recommendation when the corresponding first thresholds are not satisfied, or a different amount. If the jaw metric or metrics indicate that the jaw tension and / or the jaw advancement satisfy both the corresponding first thresholds and the corresponding second thresholds (e.g., are greater than both the corresponding first thresholds and the corresponding second thresholds), the jaw tension / advancement may be considered to be too high. Because the MRD is not effective and an increase in jaw tension / advancement would likely cause pain and / or discomfort, the recommendation transmitted to the individual will generally be to discontinue use of an MRD entirely and transition to use of the respiratory therapy device.
[0172] In any of these examples that utilize thresholds for the jaw tension and / or the jaw advancement, in some implementations these thresholds may be relative to baseline amounts of jaw tension and / or advancement that occur when the individual is not using any MRD. Thus, in these implementations, the baseline amount of jaw tension and / or advancement for the specific individual with any MRD is first measured or otherwise determined so that the thresholds can be set / determined, and then the amount of jaw tension and / or advancement with the MRD can be compared to the thresholds.
[0173] In any implementation where the recommendation is to begin use of a different type of MRD that is configured to advance the jaw of the individual a second amount that is greater than the first amount of advancement achieved by the current MRD, the specific recommendation may include discarding the MRD and begin using an entirely new MRD, or may include adjusting the MRD so that the adjusted MRD is configured to advance the jaw of the individual a different amount. In some implementations, once the new or adjusted MRD is obtained, the method can include verifying that the second amount of advancement is actually achieved by the new or adjusted MRD. In some implementations, the baseline position of the jaw of the individual when not using an MRD is first determined, and the first amount and / or the second amount of jaw advancement are based on this baseline amount of jaw advancement. The second amount may be based on the baseline amount, the first amount, or both.
[0174] In the above manner, method 700 can include monitoring the trend of various efficacy metrics over time to determine if and when the effectiveness of the MRD begins to decrease. Instead of analyzing the efficacy metric during a time period to see if the MRD effectiveness increased or decreased during the time period, trends can be used to determine when a recommendation to transition to an alternative therapy should be made. Thresholds can be used to trigger a recommendation to switch regardless of how long the MRD has been used. Different thresholds could be used. For example, if the efficacy metric includes the individual’s AHI for each sleep session, the threshold could be some minimum AHI for a given threshold (e.g., if the AHI for a given sleep session drops below the threshold, the recommendation is triggered). The threshold could also require an AHI below a certain value for at least a predetermined period of time (e.g., a number of sleep sessions), so that a single sleep session with a low AHI does not trigger the recommendation, but multiple sleep sessions with a low AHI does.
[0175] In some implementations, the time that a metric is below a certain threshold may also be analyzed. For example, if the metric is blood oxygen level, then the time spent below thresholds (e.g., 90%, 80%, etc.) can be analyzed and used to determine whether to recommendalternative therapy. Thus, the values of the metrics may be weighed based on how long or frequently they are below a threshold. If the value of a metric is below a threshold value for at least a threshold period of time, then the recommendation for alternative therapy can be triggered.
[0176] The trends of multiple efficacy metrics could also be used. In some implementations, the recommendation is triggered only if multiple efficacy metrics dip below their threshold. For example, if a snoring metric indicates that the individual has started snoring more, but a respiratory metric indicates their AHI is still acceptable, the recommendation may not be triggered. But if both of these metrics drop below their thresholds, the recommendations can be triggered.
[0177] In some implementations, contrasting trends in different metrics can be used to determine whether to recommend alternative therapy. For example, if the trend in one metric indicates that the effectiveness of the MRD is decreasing, but the trend in another metric indicates that the effectiveness of the MRD is increasing, the recommendation may not be triggered. In another example, if the trend in one metric indicates that the effectiveness of the MRD is decreasing, the recommendation for alternative therapy may be sent only if the trend in another metric does not indicate that the effectiveness of the MRD is increasing (e.g., the recommendation would be sent of that second metric indicates the effectiveness is unchanging).
[0178] In some of these implementations, different types of metrics could be weighed differently based on a variety of factors. In one example, the value of the metric relative to its threshold could be used to determine whether to trigger the recommendation. For example, if one metric has just dipped below its threshold (e.g., the value is 1% less than the threshold value), but another metric is well above its threshold (e.g., the value is 30% more than the threshold value), then the recommendation may not be triggered.
[0179] In a second example, the metrics could be weighted based on how important they are in determining the MRD effectiveness. For example, a metric associated with the individual’s AHI or blood oxygen levels may be accorded more weight than a metric associated with the individual’s snoring or jaw tension / advancement. If the important metric is above its threshold and the less important metric is below its threshold, the recommendation could not be triggered. In still another example, a single important metric falling below its threshold could trigger the recommendation for alternative therapy, but multiple less important metrics may be required to fall below their thresholds to trigger the recommendation for alternative therapy. In another example, the recommendation may be triggered based on a specific number of metrics falling below their thresholds (e.g., one metric below its threshold does not trigger therecommendation, but two or more will). In another example, the net number of metrics falling above or below their thresholds may be used to determine whether to trigger the recommendation. In some implementations, thresholds may be used both for the decreasing efficacy and increasing efficacy. For example, one metric rising above a higher threshold may cancel out another metric falling below a lower thresholds.
[0180] In some cases, the data may be compared to data from previous periods of time before the individual began using the MRD. For example, the individual may have used the respiratory therapy device (and not used the MRD) during a first previous period of time, and then stopped using the respiratory therapy device (while still not using the MRD) during a second previous period of time after the first previous period of time, which are both before the current period of time. In these implementations, method 700 can further include analyzing the data from the current period of time, the first previous period of time, and / or the second previous period of time to determine the value of any metric being used from all of the periods of time, and then comparing these values.
[0181] If the value during the current period of time (during use of the MRD) is generally equal to the value during the first previous period of time (meaning that the individual’ s health and / or practicing of healthy habits is generally equivalent to when they were previously using the respiratory therapy device), this may indicate that the individual is now ready to try using the respiratory therapy device again, and thus the recommendation may be to transition to the use of the respiratory therapy device. But if the value during the current period of time is not generally equal to the value during the first previous period of time (meaning that the individual’s health and / or practicing of healthy habits is generally worse than when they were previously using the respiratory therapy device), this may indicate that the individual may not be receptive to a recommendation to transition back to the respiratory therapy device, and thus the recommendation may be to continue using the MRD.
[0182] If the value during the current period of time shows that the individual’s health and / or practicing of health habits has improved relative to the second previous period of time (when the individual was not using the respiratory therapy device or the MRD), then this may indicate that the individual has gotten back on track health-wise, and that they may be more receptive to trying the respiratory therapy device again. Thus, the recommendation may be to transition to the use of the respiratory therapy device.
[0183] If the value during the current period has not improved relative to the value during the second previous period of time (before the MRD was used) before a threshold amount of time has passed since the individual began using the MRD, this may indicate that the individual hasnot used the MRD long enough to see any benefit, and thus may not be receptive to a recommendation to try the respiratory therapy device again. Thus, the recommendation may be to continue using the MRD. But if the value during the current period has not improved relative to the value during the second previous period of time and the threshold amount of time has passed since the individual began using the MRD, this may indicate that the individual is not seeing any improvement after using the MRD for a while, and thus they may be receptive to again trying the respiratory therapy device. Thus, the recommendation can be to transition back to the respiratory therapy device and discontinue using the MRD.
[0184] In some implementations, method 700 can include determining which sleep sessions are “treated” sleep sessions (e.g., the individual wore the MRD during the sleep session), and which sleep sessions are “untreated” sleep sessions (e.g., the individual did not wear the MRD during the sleep session). This determination can be based on any suitable data. For example, data generated by sensors used to measure jaw tension and / or advancement can be analyzed to determine the jaw tension or jaw advancement for a sleep session. If the jaw tension / advancement is minimal and / or comparable to a baseline determined for the individual, then it is determined that the sleep session was an untreated sleep session. But if the jaw tension / advancement is elevated and / or above the individual’s baseline, then it is determined that the sleep session is a treated sleep session. Other types of data may also be used. For example, as noted herein the oral appliance 110 (e.g., the MRD) and / or the oral appliance receptacle 112 (e.g., a case for the MRD) may include sensors that generate data indicative of whether the oral appliance 110 is currently received in the oral appliance receptacle 112. Thus, if the data indicates that the MRD remained in the case during a sleep session, then it is determined that the sleep session was untreated. In a further example, the individual may additionally or alternatively be able to provide input (e.g., to the control system 124, to the user device 140, etc.) indicating whether a given sleep session was treated or untreated. The determination of each sleep session as treated or untreated could be automatic in some implementations (e.g., data indicative of whether the individual wore the MRD for the sleep session can be automatically analyzed after the conclusion of the sleep session). This determination could also be non-automatic (e.g., requiring the individual and / or a third party to perform and / or initiate the determination) or semi-automatic (e.g., automatically analyzing the data but requiring input and / or confirmation from the individual and / or the third party).
[0185] The determination of whether a sleep session is treated or untreated can be used to weigh the data that is associated with the individual during the period of time they are using the MRD. For example, any of the data received at step 702 that is associated directly with asleep session itself (e.g., MRD efficacy metrics such as blood oxygen levels, respiratory events, etc.) can be disregarded and not used in the analysis if it was generated during an untreated sleep sessions. This allows for a more accurate analysis of the effect of the MRD on the individual. The determination of each sleep session as treated or untreated can itself be data that is analyzed at step 704 to determine the individual’s readiness to transition from the MRD. For example, if the individual had a large number of treated sleep sessions when they first received the MRD but then began to have more untreated sleep sessions, this may be an indication that the individual should transition to an alternative therapy. In some implementations, the reason for an untreated sleep session may be taken into account. For example, if untreated sleep sessions are used as indicative of the individual not being receptive to the MRD and / or the MRD being less effective (and therefore a reason to recommend alternative therapy), the individual could indicate that an untreated sleep sessions occurred due to an unrelated reason, such as the individual traveling somewhere, being congested or otherwise sick so that the MRD would have been uncomfortable, etc. Untreated sleep sessions with a valid reasons for being untreated could then be ignored.
[0186] In some implementations, the triggering of the recommendation could be partially based on the current therapy that the individual is engaging in. For example, the analysis of the efficacy metrics may be adjusted if the individual is using an MRD that is configured to advance the individual’s jaw a lesser amount versus an MRD configured to advance the individual’s jaw a greater amount. If the individual is using the first MRD, the thresholds to trigger a recommendation to the second MRD may be higher (e.g., easier to meet), because stepping up to the second MRD may not be that large of a change in therapy. But if the individual is already wearing the second MRD, then the thresholds to trigger a recommendation to change to an alternative therapy (e.g., the respiratory therapy device) may be lower (e.g., harder to meet), because such a change is considered to be more impactful to the individual and the recommendation for transition should not be triggered too easily.
[0187] Generally, a control system having one or more processors (such as control system 124 of system 10) is configured to carry out the steps of methods 600 and 700. A memory device (such as memory device 128 of system 10) can be used to store machine-readable instructions that are executed by the control system to carry out the steps of methods 600 and 700. The memory device can also store any type of data utilized in the steps of methods 600 and 700. In some cases, methods 600 and 700 can be implemented using a system (such as system 10) that includes the oral appliance therapy system (or just the oral appliance), the control system, and the memory device.
[0188] Generally, methods 600 and 700 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 methods 600 and 700 can be implemented when the machine-readable instructions are executed by at least one of the processors of the control system. Methods 600 and 700 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 methods 600 and 700.
[0189] 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.
[0190] ALTERNATIVE IMPLEMENTATIONS
[0191] Alternative Implementation 1. A method for recommending therapy, the method comprising: identifying a group of one or more individuals, the group including (i) at least one individual that has stopped using a respiratory therapy device, (ii) at least one individual that has not started to use a respiratory therapy device, or (iii) both (i) and (ii); collecting data associated with each of the one or more individuals; and for each respective individual of the one or more individuals, determining whether to recommend an alternative therapy based on the data associated with the respective individual.
[0192] Alternative Implementation 2. The method of Alternative Implementation 1, wherein the at least one individual that has stopped using the respiratory therapy device includes at least one individual that previously used the respiratory therapy device but has not used the respiratory therapy device for at least a first threshold period of time.
[0193] Alternative Implementation 3. The method of Alternative Implementation 2, wherein the first threshold period of time is 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, or 1 year.
[0194] Alternative Implementation 4. The method of Alternative Implementation 2 or Alternative Implementation 3, wherein the at least one individual that has not started to use the respiratory therapy device includes at least one individual that has not begun to use the respiratory therapy device within a second threshold period of time after a diagnosis of sleep- disordered breathing and a recommendation to begin using the respiratory therapy device.
[0195] Alternative Implementation 5. The method of Alternative Implementation 4, wherein the second threshold period of time is 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, or 1 year.
[0196] Alternative Implementation 6. The method of Alternative Implementation 4 or Alternative Implementation 5, wherein the first threshold period of time and the second threshold period of time are equal.
[0197] Alternative Implementation 7. The method of Alternative Implementation 4 or Alternative Implementation 5, wherein the first threshold period of time and the second threshold period of time are different.
[0198] Alternative Implementation 8. The method of any one of Alternative Implementations 1 to 7, wherein determining whether to recommend the alternative therapy includes determining whether to recommend first alternative therapy or a second alternative therapy.
[0199] Alternative Implementation 9. The method of Alternative Implementation 8, wherein the first alternative therapy includes use of a mandibular repositioning device (MRD).
[0200] Alternative Implementation 10. The method of Alternative Implementation 9, wherein the second alternative therapy includes hypoglossal nerve stimulation, positional therapy, or both.
[0201] Alternative Implementation 11. The method of any one of Alternative Implementations 8 to 10, further comprising transmitting to each respective individual a recommendation to use either the first alternative therapy or the second alternative therapy.
[0202] Alternative Implementation 12. The method of any one of Alternative Implementations 1 to 11, wherein the alternative therapy includes both use of the respiratory therapy device and use of a mandibular repositioning device.
[0203] Alternative Implementation 13. The method of Alternative Implementation 12, wherein the alternative therapy include alternating between the respiratory therapy device and the MRD.
[0204] Alternative Implementation 14. The method of Alternative Implementation 13, wherein the alternative therapy includes alternating between the respiratory therapy device and the MRD every sleep session.
[0205] Alternative Implementation 15. The method of Alternative Implementation 13, wherein the alternative therapy includes alternating between the respiratory therapy device and the MRD every week.
[0206] Alternative Implementation 16. The method of Alternative Implementation 12, wherein the alternative therapy includes simultaneous use of both the respiratory therapy device and the MRD.
[0207] Alternative Implementation 17. The method of Alternative Implementation 16, wherein the recommendation of the alternative therapy includes a recommendation to use a user interface with the respiratory therapy device that is compatible with the MRD.
[0208] Alternative Implementation 18. The method of any one of Alternative Implementations 1 to 17, wherein the alternative therapy includes use of the respiratory therapy device at a lower therapy pressure than a prior recommendation received by the respective individual.
[0209] Alternative Implementation 19. The method of any one of Alternative Implementations 1 to 11, wherein the data includes, for each respective individual, image data associated with a head of the respective individual, a neck of the respective individual, a face of the respective individual, an interior of a mouth of the respective individual, or any combination thereof.
[0210] Alternative Implementation 20. The method of Alternative Implementation 19, wherein the alternative therapy includes use of an MRD, and wherein determining whether to recommend the use of the MRD is based at least in part on an analysis of the image data.
[0211] Alternative Implementation 21. The method of Alternative Implementation 20, further comprising selecting between the use of a first type of MRD and a second type of MRD based at least in part on the analysis of the image data.
[0212] Alternative Implementation 22. The method of Alternative Implementation 20 or Alternative Implementation 21, wherein the data further includes data associated with one or more past uses of the respiratory therapy device by the at least one individual that has stopped using the respiratory therapy device, and wherein determining whether to recommend the use of the MRD is based at least in part on the image data and the data associated with the one or more past uses of the respiratory therapy device.
[0213] Alternative Implementation 23. The method of any one of Alternative Implementations 20 to 22, wherein the data further includes medical data associated with a prior recommendation to begin using the respiratory therapy device given to the at least one individual that has not started to use the respiratory therapy device, and wherein determining whether to recommend the use of the MRD is based at least in part on the image data and the medical data.
[0214] Alternative Implementation 24. The method of any one of Alternative Implementations 19 to 23, wherein collecting the data associated with each of the one or more individuals includes: transmitting, to each respective individual, instructions for performing a facial scan using a personal device to generate the image data; and receiving the image data from the personal device of each respective individual.
[0215] Alternative Implementation 25. The method of any one of Alternative Implementations 19 to 24, wherein collecting the data associated with each of the one or more individuals includes: transmitting, to each respective individual, instructions to undergo a facial scan; and receiving the image data associated with each respective individual following the facial scan of each respective individual.
[0216] Alternative Implementation 26. The method of any one of Alternative Implementations 19 to 25, further comprising analyzing the image data for each respective individual to (i) identify one or more anatomical features on the head, the neck, the face, the interior of the mouth, or any combination thereof, (ii) determine one or more measurements associated with the head, the neck, the face, the interior of the mouth, or any combination thereof, or (iii) both (i) and (ii), wherein the determination of whether to recommend the alternative therapy is based at least in part on the identified anatomical features, the determined measurements, or both.
[0217] Alternative Implementation 27. The method of Alternative Implementation 26, wherein the one or more measurements includes a range of motion of a jaw of the respective individual.
[0218] Alternative Implementation 28. The method of Alternative Implementation 26 or Alternative Implementation 27, further comprising generating, for each respective individual, a three-dimensional model of the face of the respective individual based at least in part on the identified anatomical features, the determined measurements, or both, wherein the determination of whether to recommend the alternative therapy is based at least in part on the three-dimensional model.
[0219] Alternative Implementation 29. The method of any one of Alternative Implementations 26 to 28, further comprising generating a Mallampati score based at least in part on the identified anatomical features, the determined measurements, the three-dimensional model, or any combination thereof, wherein the determination of whether to recommend the alternative therapy is based at least in part on the Mallampati score.
[0220] Alternative Implementation 30. The method of any one of Alternative Implementations 19 to 29, wherein the image data includes a plurality of separate images of the face of the respective individual.
[0221] Alternative Implementation 31. The method of any one of Alternative Implementations 1 to 30, wherein the data includes, for each respective individual of the one or more individuals, image data associated with a head of the respective individual, image data associated with a neck of the respective individual, image data associated with a face of the respective individual, image data associated with an interior of a mouth of the respective individual, data associatedwith one or more physical characteristics of the respective individual, personal data associated with the respective individual, or any combination thereof.
[0222] Alternative Implementation 32. The method of Alternative Implementation 31, wherein the data associated with the one or more physical characteristics of the respective individual includes data associated with a value of one or more physical parameters associated with the head of the respective individual, data associated with a value of one or more physical parameters associated with the neck of the respective individual, data associated with a value of one or more physical parameters associated with the face of the respective individual, data associated with a value of one or more physical parameters associated with the interior of the mouth of the respective individual, or any combination thereof.
[0223] Alternative Implementation 33. The method of Alternative Implementation 31 or Alternative Implementation 32, wherein the data associated with one or more physical characteristics of the respective individual includes a neck width of the respective individual, a neck circumference of the respective individual, a jaw width of the respective individual, a Mallampati score of the respective individual, a tongue size of the respective individual, a presence of malocclusion in teeth of the respective individual, a presence of worn teeth in the respective individual, an indication that the respective individual has a deviated septum, or any combination thereof.
[0224] Alternative Implementation 34. The method of any one of Alternative Implementations 31 to 33, wherein the personal data associated with the respective individual includes demographic data associated with the respective individual, medical data associated with the respective individual, usage data associated with past use of the respiratory therapy device by the respective individual, or any combination thereof.
[0225]
[0226]
[0227] 35. A method for monitoring an individual who is using a mandibular repositioning device (MRD), the method comprising: receiving data associated with the individual during a period of time where the individual used the MRD during one or more sleep sessions; analyzing the data to determine a readiness of the individual to transition from the use of the MRD to an alternative therapy; and based on the analysis, transmitting a recommendation to the individual to (i) transition to the alternative therapy and discontinue using the MRD, or (ii) continue using the MRD.
[0228] Alternative Implementation 36. The method of Alternative Implementation 35, wherein the alternative therapy includes use of a respiratory therapy device, hypoglossal nervestimulation therapy, positional therapy, use of a different type of MRD, or any combination thereof.
[0229] Alternative Implementation 37. The method of Alternative Implementation 35, wherein the recommendation transmitted to the individual can further include a recommendation to begin the alternative therapy while continuing to use the MRD.
[0230] Alternative Implementation 38. The method of Alternative Implementation 35, wherein the recommendation transmitted to the individual can further include a recommendation to transition to a different alternative therapy and discontinue using the MRD.
[0231] Alternative Implementation 39. The method of Alternative Implementation 38, wherein the alternative therapy includes use of a respiratory therapy device, and wherein the different alternative therapy includes hypoglossal nerve stimulation therapy, positional therapy, use of a different type of MRD, or any combination thereof.
[0232] Alternative Implementation 40. The method of any one of Alternative Implementations 35 to 39, wherein the data associated with the individual includes usage data associated with the use of the MRD by the individual during the period of time.
[0233] Alternative Implementation 41. The method of any one of Alternative Implementations 35 to 40, wherein the recommendation to transition to the alternative therapy and discontinue using the MRD is transmitted in response to the usage data indicating that a threshold amount of use of the MRD was satisfied.
[0234] Alternative Implementation 42. The method of Alternative Implementation 41, wherein the threshold amount of use of the MRD includes (i) a threshold average hours of use of the MRD per sleep session of the one or more sleep sessions, (ii) at least one use of the MRD during each sleep session of the one or more sleep sessions, (iii) at least one use of the MRD during each of a threshold number of sleep sessions of the one or more sleep sessions, (iv) a threshold amount of time of use of the MRD during each sleep session of the one or more sleep sessions, (v) a threshold amount of time of use of the MRD during each of a threshold number of sleep sessions of the one or more sleep sessions, (vi) a threshold average hours of use of the MRD per sleep session of the one or more sleep sessions and a use of the MRD during each sleep session of the one or more sleep sessions, or (vii) any combination of (i)-(vi).
[0235] Alternative Implementation 43. The method of any one of Alternative Implementations 35 to 42, wherein the data is indicative of a value of one or more metrics, and wherein analyzing the data includes determining the value of the one or more metrics and transmitting the recommendation to the individual based at least in part on the value of the one or more metrics.
[0236] Alternative Implementation 44. The method of Alternative Implementation 43, wherein one or more metrics includes at least one metric associated with a health of the individual.
[0237] Alternative Implementation 45. The method of Alternative Implementation 44, wherein in response to the value of the at least one metric indicating that the health of the individual has begun to improve during the period of time or stopped improving during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0238] Alternative Implementation 46. The method of Alternative Implementation 44 or Alternative Implementation 45, wherein in response to the value of the at least one metric indicating that the health of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0239] Alternative Implementation 47. The method of any one of Alternative Implementations 44 to 46, wherein in response to the value of the at least one metric indicating that the health of the individual has begun to improve or has stopped improving and the individual has used the MRD for at least a threshold amount of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0240] Alternative Implementation 48. The method of Alternative Implementation 47, wherein in response to the value of the at least one metric indicating that the health of the individual has begun to improve or has stopped improving before the individual has used the MRD for at least a threshold amount of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0241] Alternative Implementation 49. The method of Alternative Implementation 47 or Alternative Implementation 48, wherein the threshold amount of time is a number of sleep sessions, a number of days, a number of weeks, a number of months, a cumulative amount of time of use of the MRD, or any combination thereof.
[0242] Alternative Implementation 50. The method of any one of Alternative Implementations 44 to 49, wherein the at least one metric associated with the health of the individual includes a weight of the individual, a blood pressure of the individual, a step count of the individual, a daytime tiredness level of the individual, an amount of sleep obtained by the individual, a snore volume of the individual, a snore frequency of the individual, or any combination thereof.
[0243] Alternative Implementation 51. The method of Alternative Implementation 50, wherein in response to value of the at least one metric indicating that the weight of the individual hasbegun to decrease during the period of time or stopped decreasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0244] Alternative Implementation 52. The method of Alternative Implementation 50 or 51, wherein in response to the value of the at least one metric indicating that the weight of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0245] Alternative Implementation 53. The method of Alternative Implementation 52, wherein in response to value of the at least one metric indicating that the blood pressure of the individual has begun to decrease during the period of time or stopped decreasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0246] Alternative Implementation 54. The method of any one of Alternative Implementations 50 to 53, wherein in response to the value of the at least one metric indicating that the blood pressure of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0247] Alternative Implementation 55. The method of any one of Alternative Implementations 50 to 54, wherein in response to value of the at least one metric indicating that the step count of the individual has begun to increase during the period of time or stopped increasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0248] Alternative Implementation 56. The method of any one of Alternative Implementations 50 to 55, wherein in response to the value of the at least one metric indicating that the step count of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0249] Alternative Implementation 57. The method of any one of Alternative Implementations 50 to 56, wherein in response to value of the at least one metric indicating that the daytime tiredness level of the individual has begun to decrease during the period of time or stopped decreasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0250] Alternative Implementation 58. The method of any one of Alternative Implementations 50 to 57, wherein in response to the value of the at least one metric indicating that the daytime tiredness level of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0251] Alternative Implementation 59. The method of any one of Alternative Implementations 50 to 58, wherein in response to value of the at least one metric indicating that the amount of sleep obtained by the individual has begun to increase during the period of time or stopped increasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0252] Alternative Implementation 60. The method of any one of Alternative Implementations 50 to 59, wherein in response to the value of the at least one metric indicating that the amount of sleep obtained by the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0253] Alternative Implementation 61. The method of any one of Alternative Implementations 50 to 60, wherein in response to value of the at least one metric indicating that the snore volume of the individual has begun to decrease during the period of time or stopped decreasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0254] Alternative Implementation 62. The method of any one of Alternative Implementations 50 to 61, wherein in response to the value of the at least one metric indicating that the snore volume of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0255] Alternative Implementation 63. The method of any one of Alternative Implementations 50 to 62, wherein in response to value of the at least one metric indicating that the snore frequency of the individual has begun to decrease during the period of time or stopped decreasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0256] Alternative Implementation 64. The method of any one of Alternative Implementations 50 to 63, wherein in response to the value of the at least one metric indicating that the snore frequency of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0257] Alternative Implementation 65. The method of any one of Alternative Implementations 43 to 64, wherein the one or more metrics include at least one metric indicative of the individual practicing a healthy habit.
[0258] Alternative Implementation 66. The method of Alternative Implementation 65, wherein in response to the value of the at least one metric indicating that the individual has begun to practice the healthy habit during the period of time, the recommendation transmitted to theindividual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0259] Alternative Implementation 67. The method of Alternative Implementation 65 or Alternative Implementation 66, wherein in response to the value of the at least one metric indicating that the individual has not begun the healthy habit during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0260] Alternative Implementation 68. The method of any one of Alternative Implementations 65 to 67, wherein in response to the value of the at least one metric indicating that the individual has begun to practice the healthy habit and the individual has used the MRD for at least a threshold amount of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0261] Alternative Implementation 69. The method of any one of Alternative Implementations 65 to 68, wherein in response to the value of the at least one metric indicating that the individual has begun to practice the healthy habit before the individual has used the MRD for at least a threshold amount of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0262] Alternative Implementation 70. The method of Alternative Implementation 69, wherein the threshold amount of time is a number of sleep sessions, a number of days, a number of weeks, a number of months, or any combination thereof.
[0263] Alternative Implementation 71. The method of any one of Alternative Implementations 65 to 70, wherein the metric indicative of the individual practicing a healthy habit includes (i) a presence or absence of calorie tracking by the individual, (ii) a presence or absence of weight tracking by the individual, (iii) a presence or absence of blood pressure tracking by the individual, (iv) a presence or absence of step count tracking by the individual, (v) participation in a weight loss program by the individual, (vi) participation an exercise regimen by the individual, (vii) an indication of the individual signing up for a gym membership, (viii) an indication of the individual scheduling an appointment with a healthcare provider, or (ix) any combination of (i)-(viii).
[0264] Alternative Implementation 72. The method of Alternative Implementation 71, wherein in response to the analysis of the data indicating that the individual has begun tracking calories, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0265] Alternative Implementation 73. The method of Alternative Implementation 71 or Alternative Implementation 72, wherein in response to the analysis of the data indicating that the individual has begun tracking their weight, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0266] Alternative Implementation 74. The method of any one of Alternative Implementations 71 to 73, wherein in response to the analysis of the data indicating that the individual has begun tracking their blood pressure, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0267] Alternative Implementation 75. The method of any one of Alternative Implementations 71 to 74, wherein in response to the analysis of the data indicating that the individual has begun tracking the step count, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0268] Alternative Implementation 76. The method of any one of Alternative Implementations 71 to 75, wherein in response to the analysis of the data indicating that the individual has commenced a weight loss program, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0269] Alternative Implementation 77. The method of any one of Alternative Implementations 71 to 76, wherein in response to the analysis of the data indicating that the individual has commenced an exercise regimen, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0270] Alternative Implementation 78. The method of any one of Alternative Implementations 71 to 77, wherein in response to the analysis of the data indicating that the individual has signed up for a gym membership, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0271] Alternative Implementation 79. The method of any one of Alternative Implementations 71 to 78, wherein in response to the analysis of the data indicating that the individual has scheduled an appointment with the healthcare provider, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0272] Alternative Implementation 80. The method of any one of Alternative Implementations 43 to 79, wherein the MRD is configured to aid in maintaining an airway of the individual, and wherein the metric includes at least one metric associated with an efficacy of the MRD in maintaining the airway of the individual.
[0273] Alternative Implementation 81. The method of Alternative Implementation 80, wherein in response to the value of the at least one metric indicating that the efficacy of the MRD has increased during the period of time or has remained constant during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0274] Alternative Implementation 82. The method of Alternative Implementation 80 or Alternative Implementation 81, wherein in response to the value of the at least one metric indicating that the efficacy of the MRD has decreased during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0275] Alternative Implementation 83. The method of Alternative Implementation 82, wherein in response to the individual having used the MRD for at least a threshold amount of time, the alternative therapy is use of a respiratory therapy device, and wherein in response to the individual not having used the MRD for at least a threshold amount of time, the alternative therapy is use of a different type of MRD.
[0276] Alternative Implementation 84. The method of Alternative Implementation 83, wherein the different type of MRD is configured to advance a jaw of the individual farther than the MRD.
[0277] Alternative Implementation 85. The method of Alternative Implementation 83 or Alternative Implementation 84, wherein the threshold amount of time is a number of sleep sessions, a number of days, a number of weeks, a number of months, a cumulative amount of time of use of the MRD, or any combination thereof.
[0278] Alternative Implementation 86. The method of any one of Alternative Implementations 80 to 85, wherein the metric associated with the efficacy of the MRD in maintaining the airway of the individual includes at least one metric associated with snoring by the individual while using the MRD, at least one metric associated with a jaw of the individual while using the MRD, at least one metric associated with respiratory events experienced by the individual while using the MRD, at least one metric associated with a blood oxygen level of the individual while using the MRD, at least one metric associated with comfort of the individual while using the MRD, or any combination thereof.
[0279] Alternative Implementation 87. The method of Alternative Implementation 86, wherein the at least one metric associated with snoring by the individual while using the MRD includes an average volume of snores by the individual during the one or more sleep sessions, a maximum volume of snores by the individual during the one or more sleep sessions, a totalamount of time spent snoring during the one or more sleep sessions, an average amount of time spent snoring per sleep session during the one or more sleep sessions, or any combination thereof.
[0280] Alternative Implementation 88. The method of Alternative Implementation 86 or Alternative Implementation 87, wherein in response to the at least one metric associated with snoring by the individual indicating that the snoring by the individual has improved during the period of time or is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0281] Alternative Implementation 89. The method of any one of Alternative Implementations 86 to 88, wherein in response to the at least one metric associated with snoring by the individual indicating that the snoring by the individual has worsened during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0282] Alternative Implementation 90. The method of any one of Alternative Implementations 86 to 89, wherein the at least one metric associated with respiratory events experienced by the individual while using the MRD includes a total amount of respiratory events experienced by the individual during the one or more sleep sessions, an average amount of respiratory events experienced by the individual per sleep session during the one or more sleep sessions, a maximum severity of respiratory events experienced by the individual during the one or more sleep sessions, an average severity of respiratory events experienced by the individual per sleep session during the one or more sleep sessions, an apnea-hypopnea index (AHI) for the individual during the one or more sleep session, or any combination thereof.
[0283] Alternative Implementation 91. The method of any one of Alternative Implementations 86 to 90, wherein in response to the at least one metric associated with the respiratory events experienced by the individual indicating that the respiratory events have improved during the period of time or are unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0284] Alternative Implementation 92. The method of any one of Alternative Implementations 86 to 91, wherein in response to the at least one metric associated with the respiratory events experienced by the individual indicating that the respiratory events have worsened during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0285] Alternative Implementation 93. The method of any one of Alternative Implementations 86 to 92, wherein the at least one metric associated the blood oxygen level of the individualwhile using the MRD includes an average blood oxygen level of the individual per sleep session during the one or more sleep sessions, a minimum blood oxygen level of the individual during the one or more sleep sessions, an average of the minimum blood oxygen level of the individual for each of the one or more sleep sessions, or any combination thereof.
[0286] Alternative Implementation 94. The method of any one of Alternative Implementations 86 to 93, wherein in response to the at least one metric associated with the blood oxygen level of the individual indicating that the blood oxygen level of the individual has improved during the period of time or is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0287] Alternative Implementation 95. The method of any one of Alternative Implementations 86 to 94, wherein in response to the at least one metric associated with the blood oxygen level of the individual indicating that the blood oxygen level of the individual has worsened during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0288] Alternative Implementation 96. The method of any one of Alternative Implementations 86 to 95, wherein the at least one metric associated with comfort of the individual while using the MRD includes a self-reported comfort score for the individual during the one or more sleep sessions, a self-reported pain score for the individual during the one or more sleep sessions, a metric associated with the MRD being inserted into and removed from a mouth of the individual during the one or more sleep sessions, or any combination thereof.
[0289] Alternative Implementation 97. The method of Alternative Implementation 96, wherein the metric associated with the MRD being inserted into and removed from a mouth of the individual during the one or more sleep sessions includes a number of times the MRD was inserted into and removed from the mouth of the individual during the one or more sleep sessions, a number of times per sleep session the MRD was inserted into and removed from the mouth of the individual during the one or more sleep sessions, or both.
[0290] Alternative Implementation 98. The method of any one of Alternative Implementations 86 to 97, wherein in response to the at least one metric associated with the comfort of the individual indicating that the comfort of the individual has improved during the period of time or is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0291] Alternative Implementation 99. The method of any one of Alternative Implementations 86 to 98, wherein in response to the at least one metric associated with the comfort of the individual indicating that the comfort of the individual has worsened during the period of time,the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0292] Alternative Implementation 100. The method of any one of Alternative Implementations 86 to 99, wherein the at least one metric associated with the jaw of the individual while using the MRD includes an amount of tension in the jaw of the individual while using the MRD, an amount that the jaw of the individual is advanced while using the MRD, or both.
[0293] Alternative Implementation 101. The method of Alternative Implementation 100, wherein in response to the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is greater than a threshold amount, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0294] Alternative Implementation 102. The method of Alternative Implementation 100 or Alternative Implementation 101, wherein in response to the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is less than a threshold amount, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
[0295] Alternative Implementation 103. The method of any one of Alternative Implementations 100 to 102, wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is greater than a threshold amount and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has increased during the period of time or is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD or the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of a different type of MRD configured advance the jaw of the individual farther than the MRD.
[0296] Alternative Implementation 104. The method of any one of Alternative Implementations 100 to 103, wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is less than the threshold amount and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD inmaintaining the airway of the individual indicating that the efficacy of the MRD has increased during the period of time or is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0297] Alternative Implementation 105. The method of any one of Alternative Implementations 100 to 104 wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is greater than a threshold amount and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has decreased during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of the respiratory therapy device.
[0298] Alternative Implementation 106. The method of any one of Alternative Implementations 100 to 105, wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is less than the threshold amount and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has decreased during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of a different type of MRD configured advance the jaw of the individual farther than the MRD.
[0299] Alternative Implementation 107. The method of any one of Alternative Implementations 100 to 106, wherein in response to (i) the at least one metric associated with the j aw of the individual indicating that the amount of tension in the j aw of the individual and / or the amount that the jaw of the individual is advanced is less than both a first threshold amount and a second threshold amount, and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has decreased during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of a first different type of MRD configured advance the jaw of the individual farther than the MRD by a first amount.
[0300] Alternative Implementation 108. The method of Alternative Implementation 107, wherein in response to (i) the at least one metric associated with the jaw of the individualindicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is greater than the first threshold amount and less than the second threshold amount, and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has worsened during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of a second different type of MRD configured advance the jaw of the individual farther than the MRD by a second amount that is greater than the first amount.
[0301] Alternative Implementation 109. The method of Alternative Implementation 107 or Alternative Implementation 108, wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is greater than both the first threshold amount and the second threshold amount, and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has worsened during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of the respiratory therapy device.
[0302] Alternative Implementation 110. The method of any one of Alternative Implementations 101 to 108, further comprising determine a baseline amount of jaw tension when the individual is not using the MRD, a baseline amount of jaw advancement when the individual is not using the MRD, or both, wherein the threshold amount of jaw tension is based at least in part on the baseline amount of jaw tension, and wherein the threshold amount of jaw advancement is based at least in part on the baseline amount of jaw advancement.
[0303] Alternative Implementation 111. The method of any one of Alternative Implementations 103 to 109, wherein the at least one other of the one or more metrics associated with the efficacy of the MRD includes at least one metric associated with snoring by the individual while using the MRD, at least one metric associated with respiratory events experienced by the individual while using the MRD, at least one metric associated with a blood oxygen level of the individual while using the MRD, at least one metric associated with comfort of the individual while using the MRD.
[0304] Alternative Implementation 112. The method of any one of Alternative Implementations 80 to 111, wherein the MRD is configured to advance a jaw of the individuala first amount, and wherein the alternative therapy includes use of a different type of MRD that is configured to advance a jaw of the individual a second amount that is different than the first amount.
[0305] Alternative Implementation 113. The method of Alternative Implementation 112, wherein use of the different type of MRD includes (i) discarding the MRD and using a new MRD that is configured to advance the jaw of the individual the second amount, or (ii) adjusting the MRD so that the adjusted MRD is configured to advance the jaw of the individual the second amount.
[0306] Alternative Implementation 114. The method of Alternative Implementation 113, further comprising, subsequent to the individual obtaining the new MRD or adjusting the MRD, verifying that the jaw of the individual is advanced the second amount when the new MRD or the adjusted MRD is used by the individual.
[0307] Alternative Implementation 115. The method of any one of Alternative Implementations 111 to 114, further comprising determining a baseline position of the jaw of the individual while not using any MRD, wherein the second amount that the different type of MRD is configured to advance the jaw of the individual is based at least in part on the baseline position of the jaw of the individual.
[0308] Alternative Implementation 116. The method of Alternative Implementation 115, wherein the second amount that the different type of MRD is configured to advance the jaw of the individual is further based at least in part on a position of the jaw of the individual while using the MRD.
[0309] Alternative Implementation 117. The method of any one of Alternative Implementations 111 to 116, wherein the MRD is configured to advance a jaw of the individual, and wherein the method further comprises: analyzing the data to determine a recommended change to the MRD to modify an amount that the MRD advances the jaw of the individual; and transmitting the recommended change to the individual.
[0310] Alternative Implementation 118. The method of Alternative Implementation 117, wherein the recommended change includes (i) using a new MRD configured to advance the jaw of the individual a different amount or (ii) adjusting the MRD so that the adjusted MRD is configured to advance the jaw of the individual a different amount.
[0311] Alternative Implementation 119. The method of Alternative Implementation 117 or Alternative Implementation 118, wherein at least a portion of the data is generated by a wearable sensor configured to generate data indicative of a position of the jaw of the individual, movement of the jaw of the individual, or both.
[0312] Alternative Implementation 120. The method of Alternative Implementation 119, wherein the wearable sensor is worn by the individual or mounted on the MRD.
[0313] Alternative Implementation 121. The method of any one of Alternative Implementations 35 to 120, wherein the data is generated by one or more wearable sensors that include a smart watch, a smart ring, a sensor worn on a jaw of the individual, a sensor mounted on and / or in the MRD, a sensor configured to generate data indicative of a blood oxygen level of the individual, a sensor configured to generate data indicative of a heart rate of the individual, a sensor configured to generate data indicative of snoring by the individual, a sensor configured to generate data indicative of a jaw position of the individual, a sensor configured to generate data indicative of jaw movement of the individual, or any combination thereof.
[0314] Alternative Implementation 122. The method of any one of Alternative Implementations 35 to 121, wherein the alternative therapy is use of the respiratory therapy device, wherein the period of time during which the individual used the MRD is a current period of time, and wherein the individual used the respiratory therapy device and did not use the MRD during a first previous period of time that is before the current period of time.
[0315] Alternative Implementation 123. The method of Alternative Implementation 122, wherein the data is indicative of a metric associated with a health of the individual, the individual practicing a healthy habit, or both, and wherein the method further comprises: analyzing the data associated with the individual during current period of time to determine a value of the metric during the current period of time; receiving data associated with the individual during the first previous period of time; and analyzing the data associated with the individual during the first previous period of time to determine a value of the metric during the first previous period of time, wherein in response to the value of the metric during the current period of time being equal to the value of the metric during the first previous period of time, the recommendation transmitted to the individual is the recommendation to transition to the use of the respiratory therapy device and discontinue using the MRD, and wherein in response to the value of the metric during the current period of time not being equal to the value of the metric during the first previous period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0316] Alternative Implementation 124. The method of Alternative Implementation 123, wherein the individual did not use the respiratory therapy device or the MRD during a second previous period of time that is after the first previous period of time and before the current period of time, and wherein the method further comprises: receiving data associated with the individual during the second previous period of time; and analyzing the data associated withthe individual during the second previous period of time to determine a value of the metric during the second previous period of time and the current period of time, wherein in response to the value of the metric during the current period of time improving relative to the value of the metric during the second previous period of time, the recommendation transmitted to the individual is the recommendation to transition to the use of the respiratory therapy device and discontinue using the MRD.
[0317] Alternative Implementation 125. The method of Alternative Implementation 124, wherein in response to the value of the metric during the current period of time not improving relative to the value of the metric during the second previous period of time after a threshold amount of time has passed since the individual began using the MRD, the recommendation transmitted to the individual is the recommendation to transition to the use of the respiratory therapy device and discontinue using the MRD.
[0318] Alternative Implementation 126. The method of Alternative Implementation 125, wherein in response to the value of the metric during the current period of time not improving relative to the value of the metric during the second previous period of time before the threshold amount of time has passed since the individual began using the MRD, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
[0319] Alternative Implementation 127. A system comprising: a control system having one or more processors; and a memory device having stored thereon machine-readable instructions, wherein the control system is coupled to the memory device, and the method of any one of Alternative Implementations 1 to 126 is implemented when the machine-readable instructions in the memory device are executed by at least one of the one or more processors of the control system.
[0320] Alternative Implementation 128. A system comprising a control system configured to implement the method of any one of Alternative Implementations 1 to 126.
[0321] Alternative Implementation 129. A computer program product comprising instructions which, when executed by a computer, cause the computer to carry out the method of any one of Alternative Implementations 1 to 126.
[0322] Alternative Implementation 130. The computer program product of Alternative Implementation 128, wherein the computer program product is a non-transitory computer readable medium.
[0323] Alternative Implementation 131. A system for recommending therapy, the system comprising: a control system having one or more processors; and a memory device having stored thereon machine-readable instructions; wherein the control system is coupled to thememory device, and the one or more processors of the control system are configured to execute the machine-readable instructions to: identify a group of one or more individuals, the group including (i) at least one individual that has stopped using a respiratory therapy device, (ii) at least one individual that has not started to use the respiratory therapy device, or (iii) both (i) and (ii); collect data associated with each of the one or more individuals; and for each respective individual of the one or more individuals, determine whether to recommend an alternative therapy based on the data associated with the respective individual.
[0324] Alternative Implementation 132. A system for monitoring an individual who is using a mandibular repositioning device (MRD), the system comprising: a control system having one or more processors; and
[0325] a memory device having stored thereon machine-readable instructions; wherein the control system is coupled to the memory device, and the one or more processors of the control system are configured to execute the machine-readable instructions to: receive data associated with the individual during a period of time where the individual used the MRD during one or more sleep sessions; analyze the data to determine a readiness of the individual to transition from the use of the MRD to an alternative therapy; and based on the analysis, transmit a recommendation to the individual to (i) transition to the alternative therapy and discontinue using the MRD, or (ii) continue using the MRD.
[0326] While the present disclosure has been described with reference to one or more particular embodiments or implementations, those skilled in the art will recognize that many changes may be made thereto without departing from the spirit and scope of the present disclosure. Each of these implementations and obvious variations thereof is contemplated as falling within the spirit and scope of the present disclosure. It is also contemplated that additional implementations or alternative implementations according to aspects of the present disclosure may combine any number of features from any of the implementations described herein, such as, for example, in the alternative implementations described above.
Claims
CLAIMSWhat is claimed is:
1. A method for recommending therapy, the method comprising: identifying a group of one or more individuals, the group including (i) at least one individual that has stopped using a respiratory therapy device, (ii) at least one individual that has not started to use a respiratory therapy device, or (iii) both (i) and (ii); collecting data associated with each of the one or more individuals; and for each respective individual of the one or more individuals, determining whether to recommend an alternative therapy based on the data associated with the respective individual.
2. The method of claim 1, wherein the at least one individual that has stopped using the respiratory therapy device includes at least one individual that previously used the respiratory therapy device but has not used the respiratory therapy device for at least a first threshold period of time.
3. The method of claim 2, wherein the first threshold period of time is 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, or 1 year.
4. The method of claim 2 or claim 3, wherein the at least one individual that has not started to use the respiratory therapy device includes at least one individual that has not begun to use the respiratory therapy device within a second threshold period of time after a diagnosis of sleep-disordered breathing and a recommendation to begin using the respiratory therapy device.
5. The method of claim 4, wherein the second threshold period of time is 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, or 1 year.
6. The method of claim 4 or claim 5, wherein the first threshold period of time and the second threshold period of time are equal.
7. The method of claim 4 or claim 5, wherein the first threshold period of time and the second threshold period of time are different.
8. The method of any one of claims 1 to 7, wherein determining whether to recommend the alternative therapy includes determining whether to recommend first alternative therapy or a second alternative therapy.
9. The method of claim 8, wherein the first alternative therapy includes use of a mandibular repositioning device (MRD).
10. The method of claim 9, wherein the second alternative therapy includes hypoglossal nerve stimulation, positional therapy, or both.
11. The method of any one of claims 8 to 10, further comprising transmitting to each respective individual a recommendation to use either the first alternative therapy or the second alternative therapy.
12. The method of any one of claims 1 to 11, wherein the alternative therapy includes both use of the respiratory therapy device and use of a mandibular repositioning device.
13. The method of claim 12, wherein the alternative therapy include alternating between the respiratory therapy device and the MRD.
14. The method of claim 13, wherein the alternative therapy includes alternating between the respiratory therapy device and the MRD every sleep session.
15. The method of claim 13, wherein the alternative therapy includes alternating between the respiratory therapy device and the MRD every week.
16. The method of claim 12, wherein the alternative therapy includes simultaneous use of both the respiratory therapy device and the MRD.
17. The method of claim 16, wherein the recommendation of the alternative therapy includes a recommendation to use a user interface with the respiratory therapy device that is compatible with the MRD.
18. The method of any one of claims 1 to 17, wherein the alternative therapy includes use of the respiratory therapy device at a lower therapy pressure than a prior recommendation received by the respective individual.
19. The method of any one of claims 1 to 11, wherein the data includes, for each respective individual, image data associated with a head of the respective individual, a neck of the respective individual, a face of the respective individual, an interior of a mouth of the respective individual, or any combination thereof.
20. The method of claim 19, wherein the alternative therapy includes use of an MRD, and wherein determining whether to recommend the use of the MRD is based at least in part on an analysis of the image data.
21. The method of claim 20, further comprising selecting between the use of a first type of MRD and a second type of MRD based at least in part on the analysis of the image data.
22. The method of claim 20 or claim 21, wherein the data further includes data associated with one or more past uses of the respiratory therapy device by the at least one individual that has stopped using the respiratory therapy device, and wherein determining whether to recommend the use of the MRD is based at least in part on the image data and the data associated with the one or more past uses of the respiratory therapy device.
23. The method of any one of claims 20 to 22, wherein the data further includes medical data associated with a prior recommendation to begin using the respiratory therapy device given to the at least one individual that has not started to use the respiratory therapy device, and wherein determining whether to recommend the use of the MRD is based at least in part on the image data and the medical data.
24. The method of any one of claims 19 to 23, wherein collecting the data associated with each of the one or more individuals includes:transmitting, to each respective individual, instructions for performing a facial scan using a personal device to generate the image data; and receiving the image data from the personal device of each respective individual.
25. The method of any one of claims 19 to 24, wherein collecting the data associated with each of the one or more individuals includes: transmitting, to each respective individual, instructions to undergo a facial scan; and receiving the image data associated with each respective individual following the facial scan of each respective individual.
26. The method of any one of claims 19 to 25, further comprising analyzing the image data for each respective individual to (i) identify one or more anatomical features on the head, the neck, the face, the interior of the mouth, or any combination thereof, (ii) determine one or more measurements associated with the head, the neck, the face, the interior of the mouth, or any combination thereof, or (iii) both (i) and (ii), wherein the determination of whether to recommend the alternative therapy is based at least in part on the identified anatomical features, the determined measurements, or both.
27. The method of claim 26, wherein the one or more measurements includes a range of motion of a jaw of the respective individual.
28. The method of claim 26 or claim 27, further comprising generating, for each respective individual, a three-dimensional model of the face of the respective individual based at least in part on the identified anatomical features, the determined measurements, or both, wherein the determination of whether to recommend the alternative therapy is based at least in part on the three-dimensional model.
29. The method of any one of claims 26 to 28, further comprising generating a Mallampati score based at least in part on the identified anatomical features, the determined measurements, the three-dimensional model, or any combination thereof, wherein the determination of whether to recommend the alternative therapy is based at least in part on the Mallampati score.
30. The method of any one of claims 19 to 29, wherein the image data includes a plurality of separate images of the face of the respective individual.
31. The method of any one of claims 1 to 30, wherein the data includes, for each respective individual of the one or more individuals, image data associated with a head of the respective individual, image data associated with a neck of the respective individual, image data associated with a face of the respective individual, image data associated with an interior of a mouth of the respective individual, data associated with one or more physical characteristics of the respective individual, personal data associated with the respective individual, or any combination thereof.
32. The method of claim 31, wherein the data associated with the one or more physical characteristics of the respective individual includes data associated with a value of one or more physical parameters associated with the head of the respective individual, data associated with a value of one or more physical parameters associated with the neck of the respective individual, data associated with a value of one or more physical parameters associated with the face of the respective individual, data associated with a value of one or more physical parameters associated with the interior of the mouth of the respective individual, or any combination thereof.
33. The method of claim 31 or claim 32, wherein the data associated with one or more physical characteristics of the respective individual includes a neck width of the respective individual, a neck circumference of the respective individual, a jaw width of the respective individual, a Mallampati score of the respective individual, a tongue size of the respective individual, a presence of malocclusion in teeth of the respective individual, a presence of worn teeth in the respective individual, an indication that the respective individual has a deviated septum, or any combination thereof.
34. The method of any one of claims 31 to 33, wherein the personal data associated with the respective individual includes demographic data associated with the respective individual, medical data associated with the respective individual, usage data associated with past use of the respiratory therapy device by the respective individual, or any combination thereof.
35. A method for monitoring an individual who is using a mandibular repositioning device (MRD), the method comprising:receiving data associated with the individual during a period of time where the individual used the MRD during one or more sleep sessions; analyzing the data to determine a readiness of the individual to transition from the use of the MRD to an alternative therapy; and based on the analysis, transmitting a recommendation to the individual to (i) transition to the alternative therapy and discontinue using the MRD, or (ii) continue using the MRD.
36. The method of claim 35, wherein the alternative therapy includes use of a respiratory therapy device, hypoglossal nerve stimulation therapy, positional therapy, use of a different type of MRD, or any combination thereof.
37. The method of claim 35, wherein the recommendation transmitted to the individual can further include a recommendation to begin the alternative therapy while continuing to use the MRD.
38. The method of claim 35, wherein the recommendation transmitted to the individual can further include a recommendation to transition to a different alternative therapy and discontinue using the MRD.
39. The method of claim 38, wherein the alternative therapy includes use of a respiratory therapy device, and wherein the different alternative therapy includes hypoglossal nerve stimulation therapy, positional therapy, use of a different type of MRD, or any combination thereof.
40. The method of any one of claims 35 to 39, wherein the data associated with the individual includes usage data associated with the use of the MRD by the individual during the period of time.
41. The method of any one of claims 35 to 40, wherein the recommendation to transition to the alternative therapy and discontinue using the MRD is transmitted in response to the usage data indicating that a threshold amount of use of the MRD was satisfied.
42. The method of claim 41, wherein the threshold amount of use of the MRD includes (i) a threshold average hours of use of the MRD per sleep session of the one or more sleep sessions,(ii) at least one use of the MRD during each sleep session of the one or more sleep sessions,(iii) at least one use of the MRD during each of a threshold number of sleep sessions of the one or more sleep sessions, (iv) a threshold amount of time of use of the MRD during each sleep session of the one or more sleep sessions, (v) a threshold amount of time of use of the MRD during each of a threshold number of sleep sessions of the one or more sleep sessions, (vi) a threshold average hours of use of the MRD per sleep session of the one or more sleep sessions and a use of the MRD during each sleep session of the one or more sleep sessions, or (vii) any combination of (i)-(vi).
43. The method of any one of claims 35 to 42, wherein the data is indicative of a value of one or more metrics, and wherein analyzing the data includes determining the value of the one or more metrics and transmitting the recommendation to the individual based at least in part on the value of the one or more metrics.
44. The method of claim 43, wherein one or more metrics includes at least one metric associated with a health of the individual.
45. The method of claim 44, wherein in response to the value of the at least one metric indicating that the health of the individual has begun to improve during the period of time or stopped improving during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
46. The method of claim 44 or claim 45, wherein in response to the value of the at least one metric indicating that the health of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
47. The method of any one of claims 44 to 46, wherein in response to the value of the at least one metric indicating that the health of the individual has begun to improve or has stopped improving and the individual has used the MRD for at least a threshold amount of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
48. The method of claim 47, wherein in response to the value of the at least one metric indicating that the health of the individual has begun to improve or has stopped improving before the individual has used the MRD for at least a threshold amount of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
49. The method of claim 47 or claim 48, wherein the threshold amount of time is a number of sleep sessions, a number of days, a number of weeks, a number of months, a cumulative amount of time of use of the MRD, or any combination thereof.
50. The method of any one of claims 44 to 49, wherein the at least one metric associated with the health of the individual includes a weight of the individual, a blood pressure of the individual, a step count of the individual, a daytime tiredness level of the individual, an amount of sleep obtained by the individual, a snore volume of the individual, a snore frequency of the individual, or any combination thereof.
51. The method of claim 50, wherein in response to value of the at least one metric indicating that the weight of the individual has begun to decrease during the period of time or stopped decreasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
52. The method of claim 50 or 51, wherein in response to the value of the at least one metric indicating that the weight of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
53. The method of claim 52, wherein in response to value of the at least one metric indicating that the blood pressure of the individual has begun to decrease during the period of time or stopped decreasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
54. The method of any one of claims 50 to 53, wherein in response to the value of the at least one metric indicating that the blood pressure of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
55. The method of any one of claims 50 to 54, wherein in response to value of the at least one metric indicating that the step count of the individual has begun to increase during the period of time or stopped increasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
56. The method of any one of claims 50 to 55, wherein in response to the value of the at least one metric indicating that the step count of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
57. The method of any one of claims 50 to 56, wherein in response to value of the at least one metric indicating that the daytime tiredness level of the individual has begun to decrease during the period of time or stopped decreasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
58. The method of any one of claims 50 to 57, wherein in response to the value of the at least one metric indicating that the daytime tiredness level of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
59. The method of any one of claims 50 to 58, wherein in response to value of the at least one metric indicating that the amount of sleep obtained by the individual has begun to increase during the period of time or stopped increasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
60. The method of any one of claims 50 to 59, wherein in response to the value of the at least one metric indicating that the amount of sleep obtained by the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
61. The method of any one of claims 50 to 60, wherein in response to value of the at least one metric indicating that the snore volume of the individual has begun to decrease during the period of time or stopped decreasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
62. The method of any one of claims 50 to 61, wherein in response to the value of the at least one metric indicating that the snore volume of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
63. The method of any one of claims 50 to 62, wherein in response to value of the at least one metric indicating that the snore frequency of the individual has begun to decrease during the period of time or stopped decreasing during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
64. The method of any one of claims 50 to 63, wherein in response to the value of the at least one metric indicating that the snore frequency of the individual is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
65. The method of any one of claims 43 to 64, wherein the one or more metrics include at least one metric indicative of the individual practicing a healthy habit.
66. The method of claim 65, wherein in response to the value of the at least one metric indicating that the individual has begun to practice the healthy habit during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
67. The method of claim 65 or claim 66, wherein in response to the value of the at least one metric indicating that the individual has not begun the healthy habit during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
68. The method of any one of claims 65 to 67, wherein in response to the value of the at least one metric indicating that the individual has begun to practice the healthy habit and the individual has used the MRD for at least a threshold amount of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
69. The method of any one of claims 65 to 68, wherein in response to the value of the at least one metric indicating that the individual has begun to practice the healthy habit before the individual has used the MRD for at least a threshold amount of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
70. The method of claim 69, wherein the threshold amount of time is a number of sleep sessions, a number of days, a number of weeks, a number of months, or any combination thereof.
71. The method of any one of claims 65 to 70, wherein the metric indicative of the individual practicing a healthy habit includes (i) a presence or absence of calorie tracking by the individual, (ii) a presence or absence of weight tracking by the individual, (iii) a presence or absence of blood pressure tracking by the individual, (iv) a presence or absence of step count tracking by the individual, (v) participation in a weight loss program by the individual, (vi) participation an exercise regimen by the individual, (vii) an indication of the individual signing up for a gym membership, (viii) an indication of the individual scheduling an appointment with a healthcare provider, or (ix) any combination of (i)-(viii).
72. The method of claim 71, wherein in response to the analysis of the data indicating that the individual has begun tracking calories, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
73. The method of claim 71 or claim 72, wherein in response to the analysis of the data indicating that the individual has begun tracking their weight, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
74. The method of any one of claims 71 to 73, wherein in response to the analysis of the data indicating that the individual has begun tracking their blood pressure, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
75. The method of any one of claims 71 to 74, wherein in response to the analysis of the data indicating that the individual has begun tracking the step count, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
76. The method of any one of claims 71 to 75, wherein in response to the analysis of the data indicating that the individual has commenced a weight loss program, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
77. The method of any one of claims 71 to 76, wherein in response to the analysis of the data indicating that the individual has commenced an exercise regimen, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
78. The method of any one of claims 71 to 77, wherein in response to the analysis of the data indicating that the individual has signed up for a gym membership, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
79. The method of any one of claims 71 to 78, wherein in response to the analysis of the data indicating that the individual has scheduled an appointment with the healthcare provider, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
80. The method of any one of claims 43 to 79, wherein the MRD is configured to aid in maintaining an airway of the individual, and wherein the metric includes at least one metric associated with an efficacy of the MRD in maintaining the airway of the individual.
81. The method of claim 80, wherein in response to the value of the at least one metric indicating that the efficacy of the MRD has increased during the period of time or has remained constant during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
82. The method of claim 80 or claim 81, wherein in response to the value of the at least one metric indicating that the efficacy of the MRD has decreased during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
83. The method of claim 82, wherein in response to the individual having used the MRD for at least a threshold amount of time, the alternative therapy is use of a respiratory therapy device, and wherein in response to the individual not having used the MRD for at least a threshold amount of time, the alternative therapy is use of a different type of MRD.
84. The method of claim 83, wherein the different type of MRD is configured to advance a jaw of the individual farther than the MRD.
85. The method of claim 83 or claim 84, wherein the threshold amount of time is a number of sleep sessions, a number of days, a number of weeks, a number of months, a cumulative amount of time of use of the MRD, or any combination thereof.
86. The method of any one of claims 80 to 85, wherein the metric associated with the efficacy of the MRD in maintaining the airway of the individual includes at least one metric associated with snoring by the individual while using the MRD, at least one metric associated with a jaw of the individual while using the MRD, at least one metric associated with respiratory events experienced by the individual while using the MRD, at least one metric associated with a blood oxygen level of the individual while using the MRD, at least one metric associated with comfort of the individual while using the MRD, or any combination thereof.
87. The method of claim 86, wherein the at least one metric associated with snoring by the individual while using the MRD includes an average volume of snores by the individual during the one or more sleep sessions, a maximum volume of snores by the individual during the one or more sleep sessions, a total amount of time spent snoring during the one or more sleep sessions, an average amount of time spent snoring per sleep session during the one or more sleep sessions, or any combination thereof.
88. The method of claim 86 or claim 87, wherein in response to the at least one metric associated with snoring by the individual indicating that the snoring by the individual has improved during the period of time or is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
89. The method of any one of claims 86 to 88, wherein in response to the at least one metric associated with snoring by the individual indicating that the snoring by the individual has worsened during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
90. The method of any one of claims 86 to 89, wherein the at least one metric associated with respiratory events experienced by the individual while using the MRD includes a total amount of respiratory events experienced by the individual during the one or more sleep sessions, an average amount of respiratory events experienced by the individual per sleep session during the one or more sleep sessions, a maximum severity of respiratory events experienced by the individual during the one or more sleep sessions, an average severity of respiratory events experienced by the individual per sleep session during the one or more sleep sessions, an apnea-hypopnea index (AHI) for the individual during the one or more sleep session, or any combination thereof.
91. The method of any one of claims 86 to 90, wherein in response to the at least one metric associated with the respiratory events experienced by the individual indicating that the respiratory events have improved during the period of time or are unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
92. The method of any one of claims 86 to 91 , wherein in response to the at least one metric associated with the respiratory events experienced by the individual indicating that the respiratory events have worsened during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
93. The method of any one of claims 86 to 92, wherein the at least one metric associated the blood oxygen level of the individual while using the MRD includes an average blood oxygen level of the individual per sleep session during the one or more sleep sessions, a minimum blood oxygen level of the individual during the one or more sleep sessions, an average of the minimum blood oxygen level of the individual for each of the one or more sleep sessions, or any combination thereof.
94. The method of any one of claims 86 to 93, wherein in response to the at least one metric associated with the blood oxygen level of the individual indicating that the blood oxygen level of the individual has improved during the period of time or is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
95. The method of any one of claims 86 to 94, wherein in response to the at least one metric associated with the blood oxygen level of the individual indicating that the blood oxygen level of the individual has worsened during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
96. The method of any one of claims 86 to 95, wherein the at least one metric associated with comfort of the individual while using the MRD includes a self-reported comfort score for the individual during the one or more sleep sessions, a self-reported pain score for the individual during the one or more sleep sessions, a metric associated with the MRD being inserted into and removed from a mouth of the individual during the one or more sleep sessions, or any combination thereof.
97. The method of claim 96, wherein the metric associated with the MRD being inserted into and removed from a mouth of the individual during the one or more sleep sessions includes a number of times the MRD was inserted into and removed from the mouth of the individual during the one or more sleep sessions, a number of times per sleep session the MRD was inserted into and removed from the mouth of the individual during the one or more sleep sessions, or both.
98. The method of any one of claims 86 to 97, wherein in response to the at least one metric associated with the comfort of the individual indicating that the comfort of the individual has improved during the period of time or is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
99. The method of any one of claims 86 to 98, wherein in response to the at least one metric associated with the comfort of the individual indicating that the comfort of the individual has worsened during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
100. The method of any one of claims 86 to 99, wherein the at least one metric associated with the jaw of the individual while using the MRD includes an amount of tension in the jaw of the individual while using the MRD, an amount that the jaw of the individual is advanced while using the MRD, or both.
101. The method of claim 100, wherein in response to the at least one metric associated with the j aw of the individual indicating that the amount of tension in the j aw of the individual and / or the amount that the jaw of the individual is advanced is greater than a threshold amount, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
102. The method of claim 100 or claim 101, wherein in response to the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is less than a threshold amount, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD.
103. The method of any one of claims 100 to 102, wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is greater than a threshold amount and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has increased during the period of time or is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD or the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of a different type of MRD configured advance the jaw of the individual farther than the MRD.
104. The method of any one of claims 100 to 103, wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is less than the threshold amount and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has increased during the period of time or is unchanged during the period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
105. The method of any one of claims 100 to 104 wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is greater than a threshold amount and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has decreased during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of the respiratory therapy device.
106. The method of any one of claims 100 to 105, wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is less than the threshold amount and (ii) at least one other of the one or more metrics associated with theefficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has decreased during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of a different type of MRD configured advance the jaw of the individual farther than the MRD.
107. The method of any one of claims 100 to 106, wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is less than both a first threshold amount and a second threshold amount, and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has decreased during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of a first different type of MRD configured advance the jaw of the individual farther than the MRD by a first amount.
108. The method of claim 107, wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is greater than the first threshold amount and less than the second threshold amount, and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has worsened during the period of time, the recommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of a second different type of MRD configured advance the jaw of the individual farther than the MRD by a second amount that is greater than the first amount.
109. The method of claim 107 or claim 108, wherein in response to (i) the at least one metric associated with the jaw of the individual indicating that the amount of tension in the jaw of the individual and / or the amount that the jaw of the individual is advanced is greater than both the first threshold amount and the second threshold amount, and (ii) at least one other of the one or more metrics associated with the efficacy of the MRD in maintaining the airway of the individual indicating that the efficacy of the MRD has worsened during the period of time, therecommendation transmitted to the individual is the recommendation to transition to the alternative therapy and discontinue use of the MRD, wherein the alternative therapy is use of the respiratory therapy device.
110. The method of any one of claims 101 to 108, further comprising determine a baseline amount of jaw tension when the individual is not using the MRD, a baseline amount of jaw advancement when the individual is not using the MRD, or both, wherein the threshold amount of jaw tension is based at least in part on the baseline amount of jaw tension, and wherein the threshold amount of jaw advancement is based at least in part on the baseline amount of jaw advancement.
111. The method of any one of claims 103 to 109, wherein the at least one other of the one or more metrics associated with the efficacy of the MRD includes at least one metric associated with snoring by the individual while using the MRD, at least one metric associated with respiratory events experienced by the individual while using the MRD, at least one metric associated with a blood oxygen level of the individual while using the MRD, at least one metric associated with comfort of the individual while using the MRD.
112. The method of any one of claims 80 to 111, wherein the MRD is configured to advance a jaw of the individual a first amount, and wherein the alternative therapy includes use of a different type of MRD that is configured to advance a jaw of the individual a second amount that is different than the first amount.
113. The method of claim 112, wherein use of the different type of MRD includes (i) discarding the MRD and using a new MRD that is configured to advance the jaw of the individual the second amount, or (ii) adjusting the MRD so that the adjusted MRD is configured to advance the jaw of the individual the second amount.
114. The method of claim 113, further comprising, subsequent to the individual obtaining the new MRD or adjusting the MRD, verifying that the jaw of the individual is advanced the second amount when the new MRD or the adjusted MRD is used by the individual.
115. The method of any one of claims 111 to 114, further comprising determining a baseline position of the jaw of the individual while not using any MRD, wherein the second amount thatthe different type of MRD is configured to advance the jaw of the individual is based at least in part on the baseline position of the jaw of the individual.
116. The method of claim 115, wherein the second amount that the different type of MRD is configured to advance the jaw of the individual is further based at least in part on a position of the jaw of the individual while using the MRD.
117. The method of any one of claims 111 to 116, wherein the MRD is configured to advance a jaw of the individual, and wherein the method further comprises: analyzing the data to determine a recommended change to the MRD to modify an amount that the MRD advances the jaw of the individual; and transmitting the recommended change to the individual.
118. The method of claim 117, wherein the recommended change includes (i) using a new MRD configured to advance the jaw of the individual a different amount or (ii) adjusting the MRD so that the adjusted MRD is configured to advance the jaw of the individual a different amount.
119. The method of claim 117 or claim 118, wherein at least a portion of the data is generated by a wearable sensor configured to generate data indicative of a position of the jaw of the individual, movement of the jaw of the individual, or both.
120. The method of claim 119, wherein the wearable sensor is worn by the individual or mounted on the MRD.
121. The method of any one of claims 35 to 120, wherein the data is generated by one or more wearable sensors that include a smart watch, a smart ring, a sensor worn on a jaw of the individual, a sensor mounted on and / or in the MRD, a sensor configured to generate data indicative of a blood oxygen level of the individual, a sensor configured to generate data indicative of a heart rate of the individual, a sensor configured to generate data indicative of snoring by the individual, a sensor configured to generate data indicative of a jaw position of the individual, a sensor configured to generate data indicative of jaw movement of the individual, or any combination thereof.
122. The method of any one of claims 35 to 121, wherein the alternative therapy is use of the respiratory therapy device, wherein the period of time during which the individual used the MRD is a current period of time, and wherein the individual used the respiratory therapy device and did not use the MRD during a first previous period of time that is before the current period of time.
123. The method of claim 122, wherein the data is indicative of a metric associated with a health of the individual, the individual practicing a healthy habit, or both, and wherein the method further comprises: analyzing the data associated with the individual during current period of time to determine a value of the metric during the current period of time; receiving data associated with the individual during the first previous period of time; and analyzing the data associated with the individual during the first previous period of time to determine a value of the metric during the first previous period of time, wherein in response to the value of the metric during the current period of time being equal to the value of the metric during the first previous period of time, the recommendation transmitted to the individual is the recommendation to transition to the use of the respiratory therapy device and discontinue using the MRD, and wherein in response to the value of the metric during the current period of time not being equal to the value of the metric during the first previous period of time, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
124. The method of claim 123, wherein the individual did not use the respiratory therapy device or the MRD during a second previous period of time that is after the first previous period of time and before the current period of time, and wherein the method further comprises: receiving data associated with the individual during the second previous period of time; and analyzing the data associated with the individual during the second previous period of time to determine a value of the metric during the second previous period of time and the current period of time,wherein in response to the value of the metric during the current period of time improving relative to the value of the metric during the second previous period of time, the recommendation transmitted to the individual is the recommendation to transition to the use of the respiratory therapy device and discontinue using the MRD.
125. The method of claim 124, wherein in response to the value of the metric during the current period of time not improving relative to the value of the metric during the second previous period of time after a threshold amount of time has passed since the individual began using the MRD, the recommendation transmitted to the individual is the recommendation to transition to the use of the respiratory therapy device and discontinue using the MRD.
126. The method of claim 125, wherein in response to the value of the metric during the current period of time not improving relative to the value of the metric during the second previous period of time before the threshold amount of time has passed since the individual began using the MRD, the recommendation transmitted to the individual is the recommendation to continue using the MRD.
127. A system comprising: a control system having one or more processors; and a memory device having stored thereon machine-readable instructions, wherein the control system is coupled to the memory device, and the method of any one of claims 1 to 126 is implemented when the machine-readable instructions in the memory device are executed by at least one of the one or more processors of the control system.
128. A system comprising a control system configured to implement the method of any one of claims 1 to 126.
129. 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 126.
130. The computer program product of claim 128, wherein the computer program product is a non-transitory computer readable medium.
131. A system for recommending therapy, the system comprising: a control system having one or more processors; and a memory device having stored thereon machine-readable instructions; wherein the control system is coupled to the memory device, and the one or more processors of the control system are configured to execute the machine-readable instructions to: identify a group of one or more individuals, the group including (i) at least one individual that has stopped using a respiratory therapy device, (ii) at least one individual that has not started to use the respiratory therapy device, or (iii) both (i) and (ii); collect data associated with each of the one or more individuals; and for each respective individual of the one or more individuals, determine whether to recommend an alternative therapy based on the data associated with the respective individual.
132. A system for monitoring an individual who is using a mandibular repositioning device (MRD), the system comprising: a control system having one or more processors; and a memory device having stored thereon machine-readable instructions; wherein the control system is coupled to the memory device, and the one or more processors of the control system are configured to execute the machine-readable instructions to: receive data associated with the individual during a period of time where the individual used the MRD during one or more sleep sessions; analyze the data to determine a readiness of the individual to transition from the use of the MRD to an alternative therapy; and based on the analysis, transmit a recommendation to the individual to (i) transition to the alternative therapy and discontinue using the MRD, or (ii) continue using the MRD.
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