Diagnostic headband

Abstract

In one embodiment, a method includes providing a head-mounted assembly including an electronic module having one or more sensors. The head-mounted assembly may be coupled to a user interface and wearable on a user's head. When in a first configuration, the head-mounted component is wearable on the head and is not coupled to the user interface. The headset assembly is wearable on the head and coupled to the user interface when in a second configuration. The method also includes collecting first sensor data from the one or more sensors while the user wears the head-mounted component in the first configuration while participating in the first sleep session. The method also includes collecting second sensor data from the one or more sensors while the user wears the head-mounted component in the second configuration while the user wears the user interface during a second sleep session.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 433,953, filed on Dec. 20, 2022, which is hereby incorporated by reference in its entirety. Technical field

[0003] The present disclosure generally relates to systems and methods for monitoring sleep, and more particularly, to systems and methods for monitoring sleep before and during the use of a respiratory therapy device. Background art

[0004] Many individuals suffer from sleep - related and / or breathing - related disorders, such as, for example, sleep - disordered breathing (SDB), which can include obstructive sleep apnea (OSA), central sleep apnea (CSA), other types of apnea (such as mixed apnea and hypopnea), respiratory effort - related arousals (RERA), and snoring. In some cases, these disorders manifest or are more pronounced when an individual is in a particular lying / sleeping position. These individuals may also suffer from other health conditions (which can be referred to as comorbidities), such as insomnia (e.g., difficulty falling asleep, frequent or long awakenings after initially falling asleep, and / or waking up early and being unable to fall back asleep), periodic limb movement disorder (PLMD), restless legs syndrome (RLS), Cheyne - Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), rapid eye movement (REM) behavior disorder (also known as RBD), dream enactment behavior (DEB), hypertension, diabetes, stroke, chest wall disorders.

[0005] These disorders are typically treated using a respiratory therapy system (e.g., a continuous positive airway pressure (CPAP) system), which delivers pressurized air to help prevent an individual's airway from narrowing or collapsing during sleep. However, many individuals may go undiagnosed or untreated for a long period of time during which they could have benefited from such treatment. It can be difficult to be aware of having a sleep - related and / or breathing - related disorder, especially when the direct effects occur while the individual is asleep and the secondary effects may be attributed to other problems. In addition, even if an individual suspects that they may have such a disorder, the individual may be discouraged from undergoing official diagnostic techniques, such as a sleep study.

[0006] Ultimately, when a user begins a respiratory therapy, getting the user to continue such therapy can be challenging, especially if the user does not see immediate results. Some users find such systems uncomfortable, difficult to use, expensive, unattractive, and / or do not perceive the benefits associated with using the system. As a result, some users choose not to use a respiratory therapy system or discontinue use if results are not seen quickly enough. The present disclosure aims to address these and other problems. SUMMARY OF THE INVENTION

[0007] According to some embodiments of the present disclosure, a method includes providing a head-mounted component. The head-mounted component includes an electronic module having one or more sensors. The head-mounted component is coupleable to a user interface and wearable on a user's head. When in a first configuration, the head-mounted component is wearable on the head and not coupled to the user interface. When in a second configuration, the head-mounted component is wearable on the head and coupled to the user interface. The method further includes collecting first sensor data from the one or more sensors when the user wears the head-mounted component in the first configuration while participating in a first sleep session. The method further includes collecting second sensor data from the one or more sensors when the user wears the head-mounted component in the second configuration while wearing the user interface during a second sleep session.

[0008] According to some embodiments of the present disclosure, a method includes providing a head-mounted component. The head-mounted component includes an electronic module. The electronic module includes one or more sensors. The method further includes receiving first sensor data associated with a user who participates in a first sleep session while wearing the head-mounted component without receiving respiratory therapy. The method further includes analyzing the first sensor data to generate a respiratory therapy recommendation. The method further includes providing a respiratory therapy system at least in part based on the respiratory therapy recommendation. The respiratory therapy system includes a user interface. The head-mounted component is coupleable to the user interface. The method further includes receiving second sensor data associated with the user who participates in a second sleep session while wearing the electronic module of the head-mounted component coupled to the user interface.

[0009] According to some embodiments of the present disclosure, a system includes a head-mounted component. The head-mounted component includes an electronic module. The electronic module includes one or more sensors. The head-mounted component can be worn in a first configuration to collect first sensor data associated with a user who participates in a first sleep session without receiving respiratory therapy. The system further includes a user interface for supplying air from a respiratory therapy device to the user's airway. When the head-mounted component is in a second configuration, the head-mounted component is reversibly coupleable to the user interface to collect second sensor data associated with the user who participates in a second sleep session while receiving respiratory therapy via the user interface.

[0010] The above invention content is not intended to represent every embodiment or every aspect of the present disclosure. Additional features and advantages of the present disclosure will be apparent from the detailed description and the drawings set forth below. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 is a functional block diagram of a system according to some embodiments of the present disclosure;

[0012] Figure 2 is of at least a portion of a system, a user, and a bed partner according to some embodiments of the present disclosure Figure 1 perspective view;

[0013] Figure 3 is a projected view of a head-mounted assembly according to certain aspects of the present disclosure;

[0014] Figure 4A is a perspective view of a user interface according to some embodiments of the present disclosure;

[0015] Figure 4B is of a user interface according to some embodiments of the present disclosure Figure 4A exploded view;

[0016] Figure 5 is a projected view of a head-mounted assembly having a multi-part separable strap according to certain aspects of the present disclosure;

[0017] Figure 6 is a perspective view of a user interface according to some embodiments of the present disclosure;

[0018] Figure 7 illustrates an exemplary timeline of a sleep session according to some embodiments of the present disclosure;

[0019] Figure 8 illustrates a sleep session according to some embodiments of the present disclosure associated with Figure 7 exemplary hypnogram; and

[0020] Figure 9 is a flowchart depicting a process for using a head-mounted assembly according to certain aspects of the present disclosure.

[0021] Figure 10 is a side view of a head-mounted assembly base according to certain aspects of the present disclosure.

[0022] Figure 11 is an isometric view of a sensor earphone according to certain aspects of the present disclosure.

[0023] Figure 12A side view of a sensor earpiece coupled to a base of a headset assembly in accordance with certain aspects of the present disclosure.

[0024] Figure 13 A side view of a user interface coupled to a base of a headset assembly in accordance with certain aspects of the present disclosure.

[0025] Figure 14 A side view of a sensor earpiece and a user interface in accordance with certain aspects of the present disclosure, both the sensor earpiece and the user interface being coupled to a base of a headset assembly.

[0026] While the present disclosure admits of various modifications and alternative forms, specific embodiments and examples thereof have been shown by way of illustration in the drawings and will be described in detail herein. It should be understood, however, that this is not intended to limit the present disclosure to the particular forms disclosed, but on the contrary, the present disclosure will cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims. Detailed Description

[0027] Certain aspects and features of the present disclosure relate to a headset assembly having an electronic module with one or more sensors. The headset assembly may take various forms (e.g., a headband, an eye pad, an eye mask, a headgear, etc.) and may be worn by a user such as during a sleep session. Then, the acquired sensor data can be utilized to provide information such as whether the user would benefit from a respiratory therapy, what type of therapy equipment is most suitable for the user, etc. For some users, a respiratory therapy may not be needed, or an alternative therapy may be recommended.

[0028] For some users, a respiratory therapy may be recommended. When these users initiate a respiratory therapy, the same electronic module can be used with a respiratory therapy system, such as with a user interface of the respiratory therapy system. The electronic module can be directly attached to the user interface (e.g., attached to a frame or a headgear of the user interface), can be attached to the user interface via a strap such as a headband, or can be otherwise coupled (such as wirelessly coupled) to the respiratory therapy system or an associated electronic device. Then, when the user participates in the respiratory therapy system, the electronic module can be capable of acquiring additional sensor data. This additional sensor data can be used for other purposes, such as to help determine the effectiveness of the respiratory therapy, to generate recommendations for the user (e.g., adding additional pillows and / or sleeping on the side during the next sleep session), to facilitate adjusting parameters of the respiratory therapy system (e.g., adjusting the type of user interface used and / or adjusting the settings of the respiratory therapy device), etc.

[0029] A head-mounted component can be manufactured relatively easily and inexpensively and provided to many users, enabling many users to obtain information about their sleep. When a user begins a respiratory therapy, there is no need to dispose of the head-mounted component; instead, part or all of it can be reused, and it can be coupled to components of a respiratory therapy system, such as a user interface.

[0030] Many individuals suffer from sleep-related and / or respiratory disorders, such as sleep-disordered breathing (SDB), such as obstructive sleep apnea (OSA), central sleep apnea (CSA), and other types of apnea, respiratory effort-related arousals (RERA), snoring, Cheyne-Stokes respiration (CSR), hypoventilation, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), periodic limb movement disorder (PLMD), restless legs syndrome (RLS), neuromuscular disease (NMD), and chest wall disorders.

[0031] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by events of occlusion or obstruction of the upper airway during sleep, which result from a combination of an abnormally small upper airway and loss of normal muscle tone in the regions of the tongue, soft palate, and posterior oropharyngeal wall. More generally, apnea typically refers to a cessation of breathing caused by an air blockage (obstructive sleep apnea) or a halt in respiratory function (commonly referred to as central sleep apnea). CSA occurs when the brain temporarily stops sending signals to the muscles that control breathing. Typically, during an obstructive sleep apnea event, an individual will stop breathing for about 15 seconds to about 30 seconds.

[0032] Other types of apnea include hypopnea, hyperpnea, and hypercapnia. Hypopnea is typically characterized by slow or shallow breathing caused by a narrowed airway, rather than an airway blockage. Hyperpnea is typically characterized by an increase in the depth and / or rate of breathing. Hypercapnia is typically characterized by an elevation or excess of carbon dioxide in the bloodstream, usually caused by inadequate breathing.

[0033] Respiratory effort related arousals (RERAs) are typically characterized by increased respiratory effort lasting ten seconds or longer, resulting in a microarousal from sleep, and which do not meet the criteria for apnea or hypopnea events. An RERA is defined as a respiratory sequence characterized by increased respiratory effort that results in a microarousal from sleep but does not meet the criteria for apnea or hypopnea. These events meet the following criteria: (1) a pattern of gradually more negative esophageal pressure, terminated by a sudden change in pressure to a lower negative level and a microarousal, and (2) the event lasts 10 seconds or longer. In some embodiments, a nasal cannula / pressure transducer system is sufficient and reliable in the detection of RERAs. An RERA detector can be based on an actual flow signal derived from a respiratory therapy device. For example, a flow limitation metric can be determined based on the flow signal. A microarousal metric can then be derived based on the flow limitation metric and a metric of a sudden increase in ventilation volume. One such method is described in WO2008 / 138040 and U.S. Patent No. 9,358,353, both assigned to ResMed Ltd., the disclosures of each of which are hereby incorporated herein by reference in their entirety.

[0034] Cheyne-Stokes respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of the patient's respiratory controller, in which there are rhythmic alternating cycles of waxing and waning ventilation, referred to as CSR cycles. CSR is characterized by repetitive deoxygenation and reoxygenation of arterial blood.

[0035] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia while awake, in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and daytime hypersomnolence.

[0036] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases having certain common characteristics, such as increased resistance to air movement, prolonged expiratory phase of respiration, and loss of normal elasticity of the lungs. COPD encompasses a group of lower airway diseases having certain common characteristics, such as increased resistance to air movement, prolonged expiratory phase of respiration, and loss of normal elasticity of the lungs.

[0037] Neuromuscular diseases (NMDs) encompass many diseases and disorders that directly or indirectly impair muscle function through intrinsic muscle pathology or neuropathology. Thoracic wall disorders are a group of thoracic deformities that result in an inefficient coupling between the respiratory muscles and the thoracic cage.

[0038] These and other disorders are characterized by specific events that occur when an individual is sleeping (e.g., snoring, apnea, hypopnea, restless legs, sleep disturbances, choking, increased heart rate, dyspnea, asthma attacks, seizures, convulsions, or any combination thereof).

[0039] 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 a user during a sleep session by the total number of hours of sleep in the sleep session. The event can be, for example, an apnea that lasts at least 10 seconds. An AHI less than 5 is considered normal. An AHI greater than or equal to 5 but less than 15 is considered an indication of mild sleep apnea. An AHI greater than or equal to 15 but less than 30 is considered an indication of moderate sleep apnea. An AHI greater than or equal to 30 is considered an indication of severe sleep apnea. In children, an AHI greater than 1 is considered abnormal. When the AHI is normal, or when the AHI is normal or mild, sleep apnea can be considered "controlled". The AHI can also be used in combination with the oxygen desaturation level to indicate the severity of obstructive sleep apnea.

[0040] Reference Figure 1 , illustrates a system 10 according to some embodiments of the present disclosure. The system 10 includes a respiratory therapy system 100, a control system 200, one or more sensors 210, a user device 260, an activity tracker 270, and a head-mounted component 290.

[0041] The respiratory therapy system 100 includes a respiratory pressure therapy (RPT) device 110 (referred to herein as the respiratory therapy device 110), a user interface 120 (also referred to as a mask or patient interface), a conduit 140 (also referred to as a tube or air circuit), a display device 150, and a humidifier 160. Respiratory pressure therapy refers to the application of supplying air to the inlet of a user's airway at a controlled target pressure that is nominally positive relative to the atmosphere (e.g., as opposed to negative pressure therapies such as tank ventilators or cuirasses) throughout the user's respiratory cycle. The respiratory therapy system 100 is typically used to treat individuals suffering from one or more sleep-related breathing disorders (e.g., obstructive sleep apnea, central sleep apnea, or mixed sleep apnea).

[0042] The respiratory therapy system 100 can be used as, for example, 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 bilevel 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 changes the air pressure delivered to the user based on, for example, respiratory data associated with the user. The BPAP or VPAP system is configured to deliver a first predetermined pressure (e.g., inspiratory positive airway pressure or IPAP) and a second predetermined pressure lower than the first predetermined pressure (e.g., expiratory positive airway pressure or EPAP).

[0043] As Figure 2 shown, the respiratory therapy system 100 can be used to treat the user 20. In this example, the user 20 of the respiratory therapy system 100 and the bed partner 30 are located on the bed 40 and lying on the mattress 42. The user interface 120 can be worn by the user 20 during a sleep session. The respiratory therapy system 100 generally helps to increase the air pressure in the throat of the user 20 to help prevent the airway from closing and / or narrowing during sleep. The respiratory therapy device 110 can be positioned directly adjacent to the nightstand 44 of the bed 40 as Figure 2 shown, or more generally, positioned on any surface or structure that is generally adjacent to the bed 40 and / or the user 20.

[0044] The respiratory therapy device 110 is generally used to generate pressurized air that is delivered to the user (e.g., using one or more motors that drive one or more compressors). In some embodiments, the respiratory therapy device 110 generates a continuous and constant air pressure that is delivered to the user. In other embodiments, the respiratory therapy device 110 generates two or more predetermined pressures (e.g., a first predetermined air pressure and a second predetermined air pressure). In still other embodiments, the respiratory therapy device 110 generates a variety of different air pressures within a predetermined range. For example, the respiratory therapy device 110 can deliver at least about 6 cmH2O, at least about 10 cmH2O, at least about 20 cmH2O, from about 6 cmH2O to about 10 cmH2O, from about 7 cmH2O to about 12 cmH2O, etc. The respiratory therapy device 110 can also deliver pressurized air at a predetermined flow rate, such as from about -20 L / min to about 150 L / min, while maintaining a positive pressure (relative to ambient pressure).

[0045] The respiratory therapy device 110 includes a housing 112, a blower motor 114, an air inlet 116, and an air outlet 118( Figure 1 ). Referring to Figure 3 A and Figure 3 B, the blower motor 114 is at least partially disposed or integrated within the housing 112. The blower motor 114 draws air from outside the housing 112 (e.g., the atmosphere) via the air inlet 116 and causes the pressurized air to flow through the humidifier 160 and through the air outlet 118. In some embodiments, the air inlet 116 and / or the air outlet 118 includes a cover that is movable between a closed position and an open position (e.g., to prevent or inhibit air flow through the air inlet 116 or the air outlet 118). As Figure 3 A and Figure 3 B show, the housing 112 can include a vent 113 to allow air to reach the air inlet 116 through the housing 112. As described below, the conduit 140 is coupled to the air outlet 118 of the respiratory therapy device 110.

[0046] Return reference Figure 1 , the user interface 120 engages a portion of the user's face and delivers pressurized air from the respiratory therapy device 110 to the user's airway to help prevent the airway from narrowing and / or collapsing during sleep. This can also increase the user's oxygen intake during sleep. Generally, the user interface 120 engages the user's face such that the pressurized air is delivered to the user's airway via the user's mouth, the user's nose, or both the user's mouth and nose. The respiratory therapy device 110, the user interface 120, and the conduit 140 together form an air pathway that is fluidly coupled to the user's airway. The pressurized air also increases the user's oxygen intake during sleep. Depending on the therapy to be applied, the user interface 120 can, for example, form a seal with an area or portion of the user's face to facilitate delivery of gas at a pressure that is sufficiently different from ambient pressure (e.g., at a positive pressure of about 10 cm H2O relative to ambient pressure) to effect the therapy. For other forms of therapy, such as the delivery of oxygen, the user interface may not include a seal sufficient to facilitate delivery of the gas supply to the airway at a positive pressure of about 10 cm H2O.

[0047] The user interface 120 can include, for example, a gasket 122, a frame 124, a headgear 126, a connector 128, and one or more vents 130. The gasket 122 and the frame 124 define a volume of space surrounding the user's mouth and / or nose. When the respiratory therapy system 100 is in use, this volume of space receives pressurized air (e.g., via the conduit 140 from the respiratory therapy device 110) to enter the user's airway. The headgear 126 is generally used to help position and / or stabilize the user interface 120 on a portion of the user (e.g., the face) and, together with the gasket 122 (which can include, for example, silicone, plastic, foam, etc.), helps provide a substantially airtight seal between the user interface 120 and the user 20. In some embodiments, the headgear 126 includes one or more straps (e.g., including hook-and-loop fasteners) that can be associated with a head-mounted assembly 290, as further disclosed in detail herein. The connector 128 is generally used to couple (e.g., connect and fluidly couple) the conduit 140 to the gasket 122 and / or the frame 124. Alternatively, the conduit 140 can be directly coupled to the gasket 122 and / or the frame 124 without a connector 128. The vents 130 can be used to allow carbon dioxide and other gases exhaled by the user 20 to escape. The user interface 120 can generally include any suitable number of vents (e.g., one, two, five, ten, etc.).

[0048] As Figure 2As shown, in some embodiments, the user interface 120 is a face mask (e.g., a full-face mask) that covers at least a portion of the nose and mouth of the user 20. Alternatively, the user interface 120 can be a nasal mask that supplies air to the user's nose or a nasal pillow mask that delivers air directly to the user 20's nostrils. In other embodiments, the user interface 120 includes a mouthpiece (e.g., a night guard mouthpiece molded to conform to the user's teeth, a mandibular repositioning device, etc.).

[0049] In some cases, the user 20 or a bed partner 30 can use the head-mounted components 291, 290. The head-mounted component 290 used by the bed partner 30 shows the head-mounted component 290 used when the bed partner 30 is not participating in the respiratory therapy. For example, the bed partner 30 can use the head-mounted component 290 to monitor their sleep to determine if respiratory therapy is beneficial. The user 20 can use the head-mounted component 291 while using the respiratory therapy system 100. Before using the respiratory therapy system 100, the user 20 may have used the head-mounted component 291 to determine that respiratory therapy would be beneficial to the user 20, which may have prompted the user 20 to obtain the respiratory therapy system 100. Now that the user is using the respiratory therapy system 100, the head-mounted component 291 can be physically coupled to the respiratory therapy system 100, such as via the user interface 120; can be electrically coupled to the respiratory therapy system 100, such as via an electrical connection through the conduit 140; and / or can be communicatively coupled to the respiratory therapy system 100 and / or the user device 260, such as via a wired connection or a wireless connection. Sensor data from the head-mounted component 291 can be used to monitor the user 20's sleep, make recommendations to the user 20, and / or facilitate changes to the user's respiratory therapy (e.g., changing the parameters of the respiratory therapy system 100).

[0050] Figure 3 is a projected view of a head-mounted component 390 according to certain aspects of the present disclosure. The head-mounted component 390 can be any suitable head-mounted component, such as Figure 1 the head-mounted component 190 of Figure 2 the head-mounted component 290 of Figure 2 the head-mounted component 291 of

[0051] Figure 3The head-mounted assembly 390 depicted in [description] is in the form of a headband. The head-mounted assembly 390 includes an electronic module 392 that is coupled to the band 394. The electronic module 392 can be detachably coupled to the band 394 in any suitable manner, such as being placed within a pocket of the band 394 or snapped or otherwise secured to the band 394 via fasteners, clips, or other attachment hardware. In some cases, the electronic module 392 is permanently coupled to the band 394. The band 394 can be made of or include an elastic material, or can be otherwise formed to provide sufficient elasticity to comfortably fit on a user's head. In some cases, the band 394 includes or is made of an elastic woven material.

[0052] The electronic module 392 can include one or more sensors. Any suitable sensors can be used, such as Figure 1 one or more of the one or more sensors 210 of [description]. In some cases, the electronic module 392 includes at least: i) one or more motion sensors; ii) one or more acoustic sensors; iii) one or more PPG sensors; iv) one or more temperature sensors; or v) any combination of i through iv.

[0053] Although the head-mounted assembly 390 is depicted as a headband, in some cases it can take other forms, such as an eye pad, an eye mask, a head covering (e.g., a cap, a bonnet, a hood, etc.), or other forms. In some cases, the head-mounted assembly can include or otherwise take the form of: i) a headband; ii) an eye pad; iii) an eye mask; iv) a head covering; v) a nose band; vi) one or more ear plugs; vii) audio headphones (e.g., over-ear headphones); viii) one or more hearing aids; ix) a pair of glasses; x) a scarf; xi) a head-mounted video display (e.g., an augmented reality headset or a virtual reality headset); or xii) any combination of i through xi.

[0054] Additionally, although the band 394 is depicted as a single continuous piece of material, in some cases the band 394 can be made of multiple pieces of material coupled together, or made of a single piece of material coupled together to form a loop (e.g., via a buckle or a hook-and-loop fastener).

[0055] Although not visible in [description], in some cases the head-mounted assembly 390 includes an additional band or an extension of the band 394 that facilitates coupling the head-mounted assembly 390 to a user interface, such as via the band 394. In some other cases, the electronic module 392 of the head-mounted assembly 390 is detached from the remainder of the head-mounted assembly 390 (e.g., detached from the band 394) and then coupled to a user interface, such as Figure 3 depicted in [description] and Figure 4A and Figure 4B depicted in [description].

[0056] Reference Figure 4A and Figure 4B illustrates a user interface 400 that is the same as or similar to the user interface 120( Figure 1 ) in accordance with some embodiments of the present disclosure. The user interface 400 generally includes a gasket 430 and a frame 450 that define a volume of a space surrounding the user's mouth and / or nose. When in use, the volume of the space receives pressurized air to enter the user's airway. In some embodiments, the gasket 430 and the frame 450 of the user interface 400 form an integral part of the user interface. The user interface 400 may further include a headgear 410 that generally includes a strap assembly and optionally includes a connector 470. The headgear 410 is configured to be positioned generally around at least a portion of the user's head when the user wears the user interface 400. The headgear 410 may be coupled to the frame 450 and positioned on the user's head such that the user's head is positioned between the headgear 410 and the frame 450. The gasket 430 is positioned between the user's face and the frame 450 to form a seal on the user's face. The connector 470 is configured to be coupled to the frame 450 and / or the gasket 430 at one end and to a conduit (not shown) of a respiratory therapy device. Pressurized air may flow directly from the conduit of the respiratory therapy system through the connector 470 into the volume of the space defined by the gasket 430 (or the gasket 430 and the frame 450) of the user interface 400. The pressurized air reaches the user's airway from the user interface 400 through the user's mouth, nose, or both. Alternatively, in the case where the user interface 400 does not include the connector 470, the conduit of the respiratory therapy system may be directly connected to the gasket 430 and / or the frame 450.

[0057] In some embodiments, the connector 470 may include one or more vents 472 (e.g., multiple vents) located on the body of the connector 470 itself and / or one or more vents 476 ("diffuser vents") near the frame 450 for allowing carbon dioxide (CO2) and other gases exhaled by the user to escape. In some embodiments, one or more vents (such as vents 472 and / or 476) may be located in the user interface 400 (such as in the frame 450) and / or in the conduit 140. In some embodiments, the frame 450 includes at least one anti-asphyxia valve (AAV) 474 that allows CO2 and other gases exhaled by the user to escape in the event that the vent (e.g., vent 472 or 476) fails when the respiratory therapy device is activated. Typically, an AAV (e.g., AAV 474) is present with full face masks (e.g., as a safety feature); however, both diffuser vents and vents located on the mask or connector (typically an array of holes in the mask material itself or a mesh made of some fabric, which is replaceable in many cases) are not necessarily present at the same time (e.g., some masks may have only diffuser vents, such as multiple vents 476, while other masks may have multiple vents 472 only on the connector itself).

[0058] In some cases, a portion of user interface 400 can be configured to accommodate a head-mounted assembly, such as an electronics module of the head-mounted assembly. Figure 4A and Figure 4B As depicted, the frame 450 includes a receiving location for receiving an electronic module 492 (e.g., Figure 3 The receiving location may include one or more features that mechanically, electrically, and / or communicatively couple to the electronic module 492, such as magnets, clasps, pockets, etc. Thus, once the head mounted assembly (e.g., the electronic module 492 after the rest of the head mounted assembly is removed) is coupled to the user interface 400, its sensors may be used to monitor the user while the user is using the respiratory therapy system.

[0059] Although a particular style of user interface 400 is depicted, other styles of user interfaces may be used.

[0060] Figure 5 5 is a projection diagram of a head mounted assembly 590 having a multi-part detachable band 594 according to certain aspects of the present disclosure. The head mounted assembly 590 may be similar to Figure 3 The electronic module 592 and the band 594 may be similar to Figure 3 of electronic module 392 and belt 394, except that belt 594 is a multi-part belt.

[0061] The multi-part strap 594 can include a front portion 598 coupled to a rear portion 595. The rear portion 595 can have two ends 596, each end having a fitting or opening for receiving a corresponding end 597 of the front portion 598. After passing through the fitting or opening of the end 596, the corresponding end 597 of the front portion can be attached to the remainder of the front portion 598, such as via a hook-and-loop fastener. Thus, the end 597 can be easily adjusted to ensure that the strap 594 fits well on the user's head and allows the front portion 598 to be detached from the rear portion 595, such as allowing the front portion 598 to be coupled to a respiratory therapy system (e.g., a headgear of a user interface of a respiratory therapy system), such as Figure 6 depicted.

[0062] Reference Figure 6 , illustrates a user interface 600 that is the same as or similar to the user interface 120 ( Figure 1 ) according to some embodiments of the present disclosure. The user interface 600 is similar to the user interface 500 in that it is an indirect user interface. The indirect headgear user interface 600 includes a headgear 610, a gasket 630, and a connector 670. The headgear 610 includes a strap 610a and a headgear conduit 610b. Similar to the user interface 400 ( Figures 4A to 4B ) and the user interface 500 ( Figure 5 A to Figure 5 B), the headgear 610 is configured to be positioned generally around at least a portion of the user's head when the user wears the user interface 600. The headgear 610 includes a strap 610a that can be coupled to the headgear conduit 610b and positioned on the user's head such that the user's head is positioned between the strap 610a and the headgear conduit 610b. The gasket 630 is positioned between the user's face and the headgear conduit 610b to form a seal on the user's face.

[0063] The connector 670 is configured to be coupled to the headgear 610 at one end and to a conduit of a respiratory therapy system (e.g., conduit 140) at the other end. In other embodiments, the connector 670 is not included and the headgear 610 can alternatively be directly connected to a conduit of a respiratory therapy system. The headgear conduit 610b can be configured to deliver pressurized air from a conduit of a respiratory therapy system to the gasket 630, or more specifically, to a volume of a space surrounding the user's mouth and / or nose and enclosed by the user gasket. The headgear conduit 610b is hollow to provide a passage for the pressurized air. Both sides of the headgear conduit 610b can be hollow to provide two passages for the pressurized air. Alternatively, only one side of the headgear conduit 610b can be hollow to provide a single passage. In Figure 6 A and Figure 6In the embodiment illustrated in FIG. B, the headgear conduit 610b includes two channels that are positioned on either side of the user's head / face in use. Alternatively, only one channel of the headgear conduit 610b may be hollow to provide a single channel. Pressurized air may flow from the conduit of the respiratory therapy system through the connector 670 and the headgear conduit 610b and into the volume of the space between the gasket 630 and the user's face. The pressurized air reaches the user's airway from the volume of the space between the gasket 630 and the user's face through the user's mouth, nose, or both.

[0064] In some embodiments, the gasket 630 includes a plurality of air vents 672 on the gasket 630 itself. Additionally or alternatively, in some embodiments, the connector 670 includes a plurality of air vents 676 ("diffuser air vents") that are close to the headgear 610 to allow carbon dioxide (CO2) and other gases exhaled by the user to escape when the respiratory therapy device is activated. In some embodiments, the headgear 610 may include at least one additional anti-asphyxiation valve (AAV) 674 that is close to the gasket 630 to allow CO2 and other gases exhaled by the user to escape in the event that the air vents (e.g., air vents 672 or 676) fail when the respiratory therapy device is activated.

[0065] In some cases, the head-mounted assembly 690 may be coupled to the user interface 100. As Figure 6 depicted, the front portion of the strap of the head-mounted assembly 690 is detachably coupled to the user interface 100 by passing through a corresponding opening in the headgear 610. The ends of the front portion of the strap of the head-mounted assembly 690 may be coupled to the remainder of the strap, such as via a hook-and-loop fastener, to allow adjustment when the head-mounted assembly 690 is coupled to the user interface 100.

[0066] Returning to Figure 1 , the conduit 140 (also referred to as the air circuit or tube) allows air to flow between components of the respiratory therapy system 100, such as between the respiratory therapy device 110 and the user interface 120. In some embodiments, there may be separate branches for the inhalation and exhalation conduits. In other embodiments, a single branch conduit is used for both inhalation and exhalation.

[0067] In one example, the conduit 140 includes a first end coupled to the air outlet 118 of the respiratory therapy device 110. The first end can be coupled to the air outlet 118 of the respiratory therapy device 110 using a variety of techniques (e.g., press-fit connection, snap-fit connection, threaded connection, etc.). In some embodiments, the conduit 140 includes one or more heating elements that heat the pressurized air flowing through the conduit 140 (e.g., heating the air to a predetermined temperature or within a predetermined temperature range). Such heating elements can be coupled to the conduit 140 and / or embedded within the conduit. In such embodiments, the first end can include electrical contacts that are electrically coupled to the respiratory therapy device 110 to power the one or more heating elements of the conduit 140. For example, the electrical contacts can be electrically coupled to the electrical contacts of the air outlet 118 of the respiratory therapy device 110. In this example, the electrical contacts of the conduit 140 can be male connectors, while the electrical contacts of the air outlet 118 can be female connectors, or alternatively, the opposite configuration can be used.

[0068] The display device 150 is generally used to display images including still images, video images, or both and / or information regarding the respiratory therapy device 110. For example, the display device 150 can provide information regarding the status of the respiratory therapy device 110 (e.g., whether the respiratory therapy device 110 is on / off, the pressure of the air delivered by the respiratory therapy device 110, the temperature of the air delivered by the respiratory therapy device 110, etc.) and / or other information (e.g., sleep score and / or therapy score (also referred to as myAir TM Score, such as those described in WO 2016 / 061629 and U.S. Patent Publication No. 2017 / 0311879, which are hereby incorporated by reference in their entirety), current date / time, personal information of the user 20, etc.). In some embodiments, the display device 150 serves as a human-machine interface (HMI) that includes a graphical user interface (GUI) configured to display images as an input interface. The display device 150 can be an LED display, an OLED display, an LCD display, etc. The input interface can be, for example, a touch screen or a touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the respiratory therapy device 110.

[0069] The humidifier 160 is coupled to or integrated in the respiratory therapy device 110 and includes a reservoir 162 for storing water that can be used to humidify the pressurized air delivered from the respiratory therapy device 110. The humidifier 160 includes one or more heating elements 164 to heat the water in the reservoir to generate water vapor. The humidifier 160 can be fluidly coupled to the water vapor inlet of the air passage between the blower motor 114 and the air outlet 118, or can be formed in line with the air passage between the blower motor 114 and the air outlet 118. For example, air flows from the air inlet 116 through the blower motor 114 and then through the humidifier 160 before leaving the respiratory therapy device 110 via the air outlet 118.

[0070] Although the respiratory therapy system 100 is described herein as including each of the respiratory therapy device 110, the user interface 120, the conduit 140, the display device 150, and the humidifier 160, more or fewer components may be included in the respiratory therapy system according to embodiments of the present disclosure. For example, a first alternative respiratory therapy system includes the respiratory therapy device 110, the user interface 120, and the conduit 140. As another example, a second alternative system includes the respiratory therapy device 110, the user interface 120, the conduit 140, and the display device 150. Thus, various respiratory therapy systems can be formed using any one or more portions of the components shown and described herein and / or in combination with one or more other components.

[0071] The control system 200 includes one or more processors 202 (hereinafter referred to as the processor 202). The control system 200 is generally used to control (e.g., actuate) the various components of the system 10 and / or analyze data obtained and / or generated by the components of the system 10. The processor 202 can be a general-purpose processor or a special-purpose processor or a microprocessor. Although in Figure 1A processor 202 is illustrated, but control system 200 can include any number of processors (e.g., one processor, two processors, five processors, ten processors, etc.), which can be located in a single housing or remotely from each other. Control system 200 (or any other control system) or a portion of control system 200, such as processor 202 (or any other processor or one or more portions of any other control system), can be used to perform one or more steps of any of the methods described and / or claimed herein. Control system 200 can be coupled to the housing of user device 260 and / or located, for example, within the housing of the user device, within a portion of respiratory therapy system 100 (e.g., respiratory therapy device 110), and / or within the housing of one or more of sensors 210. Control system 200 can be centralized (within one such housing) or decentralized (within two or more physically distinct such housings). In such embodiments that include two or more housings that include control system 200, the housings can be located near to and / or remotely from each other.

[0072] Memory device 204 stores machine-readable instructions executable by processor 202 of control system 200. Memory device 204 can be any suitable computer-readable storage device or medium, such as, for example, a random or serial access memory device, a hard disk drive, a solid state drive, a flash memory device, etc. Although Figure 1 one memory device 204 is illustrated, system 10 can include any suitable number of memory devices 204 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). Memory device 204 can be coupled to and / or located within the housing of respiratory therapy device 110 of respiratory therapy system 100, within the housing of user device 260, within the housing of one or more of sensors 210, or any combination thereof. Similar to control system 200, memory device 204 can be centralized (within one such housing) or decentralized (within two or more physically distinct such housings).

[0073] In some embodiments, the memory device 204 stores a user profile associated with a user. The user profile may include, for example, demographic information associated with the user, biometric information associated with the user, medical information associated with the user, self-reported user feedback, sleep parameters associated with the user (e.g., sleep-related parameters recorded from one or more earlier sleep sessions), or any combination thereof. Demographic information may include, for example, information indicating the user's age, user's gender, user's race, user's geographical location, relationship status, family history of insomnia or sleep apnea, user's employment status, user's education status, user's socioeconomic status, or any combination thereof. Medical information may include, for example, information indicating one or more medical conditions associated with the user, the user's medication use, or both. Medical information data may also include multiple sleep latency test (MSLT) results or scores and / or Pittsburgh Sleep Quality Index (PSQI) scores or values. Self-reported user feedback may include information indicating self-reported subjective sleep scores (e.g., poor, average, excellent), the user's self-reported subjective stress level, the user's self-reported subjective fatigue level, the user's self-reported subjective health status, life events recently experienced by the user, or any combination thereof.

[0074] As described herein, the processor 202 and / or the memory device 204 may receive data (e.g., physiological data and / or audio data) from one or more sensors 210 such that the data is stored in the memory device 204 and / or analyzed by the processor 202. The processor 202 and / or the memory device 204 may communicate with 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, via a cellular network, etc.). In some embodiments, the system 10 may 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 may be coupled to or integrated into the housing of the control system 200 (e.g., in the same housing as the processor 202 and / or the memory device 204) or the user device 260.

[0075] Reference Figure 1, one or more sensors 210 include a pressure sensor 212, a flow sensor 214, a temperature sensor 216, a motion sensor 218, a microphone 220, a speaker 222, a radio frequency (RF) receiver 226, an RF transmitter 228, a camera 232, an infrared sensor 234, a photoplethysmography (PPG) sensor 236, an electrocardiogram (ECG) sensor 238, an electroencephalogram (EEG) sensor 240, a capacitance sensor 242, a force sensor 244, a strain gauge sensor 246, an electromyogram (EMG) sensor 248, an oxygen sensor 250, an analyte sensor 252, a humidity sensor 254, a LiDAR sensor 256, or any combination thereof. Generally, each sensor in the one or more sensors 210 is configured to output sensor data that is received and stored in the memory device 204 or one or more other memory devices.

[0076] Although the one or more sensors 210 are shown and described as including each of a pressure sensor 212, a flow sensor 214, a temperature sensor 216, a motion sensor 218, a microphone 220, a speaker 222, an RF receiver 226, an RF transmitter 228, a camera 232, an infrared sensor 234, a PPG sensor 236, an ECG sensor 238, an EEG sensor 240, a capacitance sensor 242, a force sensor 244, a strain gauge sensor 246, an EMG sensor 248, an oxygen sensor 250, an analyte sensor 252, a humidity sensor 254, and a 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.

[0077] As described herein, the system 10 can generally be used to generate physiological data associated with a user (e.g., a user of the respiratory therapy system 100) during a sleep session. The physiological data 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. One or more sleep-related parameters that can be determined for the user 20 during a sleep session include, for example, an apnea-hypopnea index (AHI) score, a sleep score, a flow signal, a respiratory signal, a respiratory rate, an inspiratory amplitude, an expiratory amplitude, an inspiratory-expiratory ratio, a number of events per hour, an event pattern, a stage, a pressure setting of the respiratory therapy device 110, a heart rate, a heart rate variability, movement of the user 20, a temperature, EEG activity, EMG activity, a microarousal, snoring, choking, coughing, whistling, wheezing, or any combination thereof.

[0078] One or more sensors 210 can be used to generate, for example, physiological data, audio data, or both. The control system 200 can use the physiological data generated by one or more of the sensors 210 to determine the sleep-wake signal and one or more sleep-related parameters associated with the user 20( Figure 2 ) during a sleep session. The sleep-wake signal can indicate one or more sleep states, including wakefulness, relaxed wakefulness, micro-arousals, or different sleep stages, such as, for example, the rapid eye movement (REM) stage, the first non-REM stage (commonly referred to as "N1"), the second non-REM stage (commonly referred to as "N2"), the third non-REM stage (commonly referred to as "N3"), or any combination thereof. Methods for determining sleep states and / or sleep stages based on physiological data generated by one or more sensors, such as one or more sensors 210, are described, for example, in WO 2014 / 047310, U.S. Patent Publication No. 2014 / 0088373, WO 2017 / 132726, WO 2019 / 122413, WO 2019 / 122414, and U.S. Patent Publication No. 2020 / 0383580, each of which is hereby incorporated by reference in its entirety.

[0079] In some embodiments, the sleep-wake signal described herein can be timestamped to indicate the time the user enters the bed, the time the user leaves the bed, the time the user attempts to fall asleep, etc. The sleep-wake signal can be measured by one or more sensors 210 during a sleep session at a predetermined sampling rate, such as one sample per second, one sample per 30 seconds, one sample per minute, etc. In some embodiments, the sleep-wake signal can also indicate a respiratory signal, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, number of events per hour, event pattern, pressure setting of the respiratory therapy device 110, or any combination thereof during the sleep session. Events can include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, mask leak (e.g., from the user interface 120), restless legs, sleep disorder, choking, increased heart rate, dyspnea, asthma attack, seizure, convulsion, or any combination thereof. One or more sleep-related parameters that can be determined for the user based on the sleep-wake signal during a sleep session include, for example, total time in bed, total sleep time, sleep onset latency, wake after sleep onset parameter, sleep efficiency, fragmentation index, or any combination thereof. As described in further detail herein, the physiological data and / or sleep-related parameters can be analyzed to determine one or more sleep-related scores.

[0080] The physiological data and / or audio data generated by one or more sensors 210 can also be used to determine a respiratory signal associated with the user during a sleep session. The respiratory signal generally indicates the user's respiration / breathing during the sleep session. The respiratory signal can be indicative of and / or analyzed to determine (e.g., using control system 200) one or more sleep-related parameters such as, for example, respiratory rate, respiratory rate variability, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, the occurrence of one or more events, the number of events per hour, event patterns, sleep state, SLEET stage, apnea-hypopnea index (AHI), pressure settings of respiratory therapy device 110, or any combination thereof. One or more events can include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, mask leak (e.g., from user interface 120), coughing, restless legs, sleep disorder, choking, increased heart rate, dyspnea, asthma attack, seizure, convulsion, elevated blood pressure, or any combination thereof. Many of the sleep-related parameters are physiological parameters, although some of the sleep-related parameters can be considered non-physiological parameters. Other types of physiological parameters and / or non-physiological parameters can also be determined based on data from one or more sensors 210 or based on other types of data.

[0081] The pressure sensor 212 outputs pressure data that can be stored in the memory device 204 and / or analyzed by the processor 202 of the control system 200. In some embodiments, the pressure sensor 212 is an air pressure sensor (e.g., an atmospheric pressure sensor) that generates sensor data indicative of the respiration (e.g., inhalation and / or exhalation) of the user of the respiratory therapy system 100 and / or the ambient pressure. In such embodiments, the pressure sensor 212 can be coupled to or integrated in the respiratory therapy device 110. The pressure sensor 212 can be, for example, a capacitance sensor, an electromagnetic sensor, a piezoelectric sensor, a strain gauge sensor, an optical sensor, a potentiometric sensor, or any combination thereof.

[0082] The flow sensor 214 outputs flow data that can be stored in the memory device 204 and / or analyzed by the processor 202 of the control system 200. Examples of flow sensors (such as, for example, flow sensor 214) are described in International Publication No. WO 2012 / 012835 and U.S. Patent No. 10,328,219, which are hereby incorporated by reference in their entirety. In some embodiments, the flow sensor 214 is used to determine the air flow from the respiratory therapy device 110, the air flow through the conduit 140, the air flow through the user interface 120, or any combination thereof. In such embodiments, the flow sensor 214 can be coupled to the respiratory therapy device 110, the user interface 120, or the conduit 140 or integrated in the respiratory therapy device, the user interface, or the conduit. The flow sensor 214 can be a mass flow sensor, such as, for example, a rotary flow meter (e.g., Hall effect flow meter), 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 some embodiments, the flow sensor 214 is configured to measure ventilatory flow (e.g., intentional "leakage"), unintentional leakage (e.g., mouth leakage and / or mask leakage), patient flow (e.g., air entering and / or leaving the lungs), or any combination thereof. In some embodiments, the flow data can be analyzed to determine the user's cardiac oscillations. In some examples, the pressure sensor 212 can be used to determine the user's blood pressure.

[0083] The temperature sensor 216 outputs temperature data that can be stored in the memory device 204 and / or analyzed by the processor 202 of the control system 200. In some embodiments, the temperature sensor 216 generates temperature data indicative of the core body temperature of the user 20( Figure 2 ), the skin temperature of the user 20, the temperature of the air flowing out of the respiratory therapy device 110 and / or through the conduit 140, the temperature in the user interface 120, the ambient temperature, or any combination thereof. The temperature sensor 216 can be, for example, a thermocouple sensor, a thermistor sensor, a silicon bandgap temperature sensor or a semiconductor-based sensor, a resistance temperature detector, or any combination thereof.

[0084] The motion sensor 218 outputs motion data that can be stored in the memory device 204 and / or analyzed by the processor 202 of the control system 200. The motion sensor 218 can be used to detect the movement of the user 20 during a sleep session, and / or to detect the movement of any component in the components of the respiratory therapy system 100, such as the respiratory therapy device 110, the user interface 120, or the conduit 140. The motion sensor 218 can include one or more inertial sensors, such as an accelerometer, a gyroscope, and a magnetometer. In some embodiments, the motion sensor 218 alternatively or additionally generates one or more signals representing the body movement of the user, from which a signal representing the sleep state of the user can be obtained; for example, via the breathing movement of the user. In some embodiments, the motion data from the motion sensor 218 can be used in combination with additional data from another sensor in the sensors 210 to determine the sleep state of the user.

[0085] The microphone 220 outputs sound and / or audio data that can be stored in the memory device 204 and / or analyzed by the processor 202 of the control system 200. The audio data generated by the microphone 220 can be reproduced as one or more sounds (e.g., the sound from the user 20) during a sleep session. The audio data from the microphone 220 can also be used to identify (e.g., using the control system 200) events experienced by the user during the sleep session, as described in further detail herein. The microphone 220 can be coupled to or integrated in the respiratory therapy device 110, the user interface 120, the conduit 140, or the user device 260. In some embodiments, the system 10 includes multiple microphones (e.g., two or more microphones and / or a microphone array with beamforming), such that the sound data generated by each of the multiple microphones can be used to distinguish the sound data generated by another of the multiple microphones.

[0086] The speaker 222 outputs sound waves audible to a user of the system 10 (e.g., Figure 2 the user 20). The speaker 222 can be used, for example, as an alarm clock or to play an alert or a message to the user 20 (e.g., in response to an event). In some embodiments, the speaker 222 can be used to convey the audio data generated by the microphone 220 to the user. The speaker 222 can be coupled to or integrated in the respiratory therapy device 110, the user interface 120, the conduit 140, or the user device 260.

[0087] The microphone 220 and the speaker 222 can be used as separate devices. In some embodiments, 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, WO2020 / 104465, U.S. Patent Application Publication No. 2022 / 0007965, each of which is hereby incorporated by reference in its entirety. In such embodiments, the speaker 222 generates or emits sound waves at a predetermined interval, and the microphone 220 detects the reflection of the emitted sound waves from the speaker 222. The sound waves generated or emitted by the speaker 222 have a frequency inaudible to the human ear (e.g., below 20 Hz or above about 18 kHz) so as not to disturb the sleep of the user 20 or the bed partner 30( Figure 2 ). Based at least in part on data from the microphone 220 and / or the speaker 222, the control system 200 can determine the position of the user 20( Figure 2 ) and / or one or more of the sleep-related parameters described herein, such as, for example, a respiratory signal, a respiratory rate, an inspiratory amplitude, an expiratory amplitude, an inspiratory-expiratory ratio, the number of events per hour, an event pattern, a sleep state, a sleep stage, a pressure setting of the respiratory therapy device 110, or any combination thereof. In such a context, a sonar sensor can be understood to involve active acoustic sensing such as generating and / or sending ultrasonic and / or low-frequency ultrasonic sensing signals (e.g., in a frequency range such as about 17 kHz - 23 kHz, 18 kHz - 22 kHz, or 17 kHz - 18 kHz) through air.

[0088] In some embodiments, the sensor 210 includes: (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 different from the first microphone integrated in the acoustic sensor 224.

[0089] 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, a long-wave signal, a short-wave signal, etc.). The RF receiver 226 detects the reflection of the radio waves emitted from the RF transmitter 228, and the data can be analyzed by the control system 200 to determine the position of the user and / or one or more of the sleep-related parameters described herein. The RF receiver (the RF receiver 226 and the RF transmitter 228 or another RF pair) can also be used for wireless communication between the control system 200, the respiratory therapy device 110, one or more sensors 210, the user device 260, or any combination thereof. Although the RF receiver 226 and the RF transmitter 228 are in Figure 1shown as separate and distinct elements in, but in some embodiments, the RF receiver 226 and the RF transmitter 228 are combined as part of an RF sensor 230 (e.g., a RADAR sensor). In some such embodiments, the RF sensor 230 includes control circuitry. The format of the RF communication can be Wi-Fi, Bluetooth, etc.

[0090] In some embodiments, the RF sensor 230 is part of a mesh system. An example of a mesh system is a Wi-Fi mesh system, which can include mesh nodes, mesh routers, and mesh gateways, each of which can be mobile / removable or fixed. In such embodiments, 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 includes an RF sensor that is the same as or similar to the RF sensor 230. The Wi-Fi router and the satellites communicate continuously with each other using Wi-Fi signals. The Wi-Fi mesh system can be used to generate motion data based on changes in the Wi-Fi signals between the router and the satellites (e.g., differences in received signal strength) caused by a moving object or person partially blocking the signal. The motion data can indicate motion, breathing, heart rate, gait, falls, behavior, etc. or any combination thereof.

[0091] The camera 232 outputs image data that can be reproduced 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 204. The image data from the camera 232 can be used by the control system 200 to determine one or more of the sleep-related parameters described herein, such as, for example, one or more events (e.g., periodic limb movements or restless leg syndrome), a respiratory signal, a respiratory rate, an inspiratory amplitude, an expiratory amplitude, an inspiratory-expiratory ratio, the number of events per hour, an event pattern, a sleep state, a sleep stage, or any combination thereof. Additionally, the image data from the camera 232 can be used, for example, to identify the user's location, determine the user's chest movement ( Figure 2 ), determine the airflow at the user's mouth and / or nose, determine the time the user enters the bed ( Figure 2 ) and determine the time the user leaves the bed. In some embodiments, the camera 232 includes a wide-angle lens or a fish-eye lens.

[0092] An infrared (IR) sensor 234 outputs infrared image data that can be reproduced as one or more infrared images (e.g., still images, video images, or both) that can be stored in a memory device 204. The infrared data from the IR sensor 234 can be used to determine one or more sleep-related parameters during a sleep session, including the temperature of user 20 and / or the movement of user 20. The IR sensor 234 can also be used in combination with the camera 232 when measuring the presence, location, and / or movement of user 20. For example, the IR sensor 234 can detect infrared light having wavelengths between approximately 700 nm and approximately 1 mm, while the camera 232 can detect visible light having wavelengths between approximately 380 nm and approximately 740 nm.

[0093] A PPG sensor 236 outputs physiological data associated with user 20 ( Figure 2 ) that can be used to determine one or more sleep-related parameters, such as, for example, heart rate, heart rate variability, cardiac cycle, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, estimated blood pressure parameters, or any combination thereof. The PPG sensor 236 can be worn by user 20, embedded in clothing and / or fabric worn by user 20, embedded in the user interface 120 and / or its associated headgear (e.g., strap, etc.) and / or coupled to the user interface and / or its associated headgear (e.g., strap, etc.), etc.

[0094] The gold standard for diagnosing sleep apnea is polysomnography (PSG). PSG uses multiple sensing channels, including electroencephalogram (EEG), electrooculogram (EOG), electromyogram (EMG), electrocardiogram (ECG), and pulse oximetry, as well as airflow and respiratory effort to evaluate the underlying causes of sleep disorders. However, due to the inconvenience of performing in-laboratory PSG tests and, in part, due to the global COVID pandemic, home sleep apnea tests (HSATs) based on peripheral arterial tone measurement (PAT) have rapidly gained popularity and currently include the most widely deployed HSAT category. HSATs based on peripheral arterial tone measurement obtain most of their sensing modalities from finger photoplethysmography (PPG, which can be the same as or similar to the PPG sensor 236), therefrom obtaining oxygen saturation (SpO2), pulse rate (PR), and peripheral arterial tone measurement. HSATs based on peripheral arterial tone measurement allow minimally invasive multi-night testing and can be provided in a fully disposable form. An example of such a system is called NightOwl TM, which is described by Massie et al. (“An evaluation of the Night Owl home sleep apnea testing system”, Journal of Clinical Sleep Medicine, Vol. 14, No. 10, pp. 1791 - 1796, October 2018, doi:10.5664 / jcsm.7398). It includes a fingertip-sized finger probe that senses peripheral arterial tone, an actigraph, and a pulse oximeter, and works with cloud-based analysis software. The analysis determines respiratory-related information, including the occurrence of respiratory events such as obstructive apnea events and central apnea events. The device and analysis are described in US2020 / 0015737A1, WO2021260190A1, and WO2021260192A1, each of which is incorporated herein by reference in its entirety. Such devices are not only suitable for monitoring, screening, and diagnosing sleep apnea, but the device can also be used to determine or derive, for example, respiratory rate, heart rate, heart rate variability, limb and / or body movement from the peripheral arterial tone signal determined from the PPG signal, and the stress level of the user can be inferred therefrom. Additionally, the peripheral arterial tone signal rises and falls with changes in the sympathetic nervous system and can thus be used to monitor sympathetic nervous system activity as an indication of the user's stress level. NightOwl TM Such functionality in the form of NightOwl or similar devices can be incorporated into the electronic modules described herein.

[0095] The ECG sensor 238 outputs physiological data associated with the electrical activity of the heart of the user 20. In some embodiments, the ECG sensor 238 includes one or more electrodes positioned on or around a portion of the user 20 during a 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.

[0096] The EEG sensor 240 outputs physiological data associated with the electrical activity of the brain of the user 20. In some embodiments, the EEG sensor 240 includes one or more electrodes positioned on or around the scalp of the user 20 during a sleep session. The physiological data from the EEG sensor 240 can be used, for example, to determine the sleep state and / or sleep stage of the user 20 at any given time during the sleep session. In some embodiments, the EEG sensor 240 can be integrated in the user interface 120 and / or an associated headgear (e.g., a band, etc.).

[0097] The outputs of the capacitance sensor 242, the force sensor 244, and the strain gauge sensor 246 can be stored in the memory device 204 and used / analyzed by the control system 200 to determine data for one or more of the sleep-related parameters described herein, for example. The EMG sensor 248 outputs physiological data associated with the electrical activity generated by one or more muscles. The oxygen sensor 250 outputs oxygen data indicative of the oxygen concentration of a gas (e.g., in the conduit 140 or at the user interface 120). The oxygen sensor 250 can be, for example, an ultrasonic oxygen sensor, an electro-chemical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, a pulse oximeter (e.g., an SpO2 sensor), or any combination thereof.

[0098] The analyte sensor 252 can be used to detect the presence of analytes in the exhaled breath of the user 20. The data output by the analyte sensor 252 can be stored in the memory device 204 and used by the control system 200 to determine the identity and concentration of any analytes in the user's breath. In some embodiments, the analyte sensor 174 is positioned near the user's mouth to detect analytes in the breath exhaled from the user's mouth. For example, when the user interface 120 is a mask that covers the user's nose and mouth, the analyte sensor 252 can be positioned within the mask to monitor the user's mouth breath. In other embodiments, for example, when the user interface 120 is a nasal mask or a nasal pillow mask, the analyte sensor 252 can be positioned near the user's nose to detect analytes in the breath exhaled through the user's nose. In yet other embodiments, when the user interface 120 is a nasal mask or a nasal pillow mask, the analyte sensor 252 can be positioned near the user's mouth. In this embodiment, the analyte sensor 252 can be used to detect whether any air is inadvertently leaking from the user's mouth and / or the user interface 120. In some embodiments, the analyte sensor 252 is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds. In some embodiments, the analyte sensor 174 can also be used to detect whether the user is breathing through their nose or mouth. For example, if the presence of an analyte is detected by the data output by the analyte sensor 252 positioned near the user's mouth or positioned within the mask (e.g., in embodiments where the user interface 120 is a mask), the control system 200 can use this data as an indication that the user is breathing through their mouth.

[0099] The humidity sensor 254 outputs data that can be stored in the memory device 204 and used by the control system 200. The humidity sensor 254 can be used to detect humidity in various areas around the user (e.g., inside the conduit 140 or the user interface 120, near the user's face, near the connection between the conduit 140 and the user interface 120, near the connection between the conduit 140 and the respiratory therapy device 110, etc.). Thus, in some embodiments, the humidity sensor 254 can be coupled to or integrated in the user interface 120 or the conduit 140 to monitor the humidity of the pressurized air from the respiratory therapy device 110. In other embodiments, the humidity sensor 254 is placed near any area where the humidity level needs to be monitored. The humidity sensor 254 can also be used to monitor the humidity of the surrounding environment that encloses the user, such as the air in a bedroom.

[0100] A light detection and ranging (LiDAR) sensor 256 can be used for depth sensing. This type of optical sensor (e.g., a laser sensor) can be used to detect objects and construct a three-dimensional (3D) map of the surrounding environment (such as a living space). LiDAR typically uses pulsed lasers for time-of-flight measurements. LiDAR is also known as 3D laser scanning. In an example of using such a sensor, a fixed or mobile device (such as a smartphone) having the LiDAR sensor 256 can measure and map an area extending 5 meters or more away from the sensor. For example, LiDAR data can be fused with the point cloud data estimated by an electromagnetic RADAR sensor. The LiDAR sensor 256 can also use artificial intelligence (AI) to automatically geofence the RADAR system by detecting and classifying features in the space that may cause problems for the RADAR system, such as glass windows (which can be highly reflective to RADAR). For example, LiDAR can also be used to provide an estimate of a person's height and the change in height when the person sits down or falls. LiDAR can be used to form a 3D grid representation of the environment. In a further use, for solid surfaces through which radio waves pass (e.g., radio semi-transparent materials), LiDAR can reflect off such surfaces, allowing for the classification of different types of obstacles.

[0101] In some embodiments, the one or more sensors 210 further include a galvanic skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a sphygmomanometer sensor, a pulse oximeter sensor, a sonar sensor, a RADAR sensor, a blood glucose sensor, a color sensor, a pH sensor, an air quality sensor, an inclinometer sensor, a rain sensor, a soil moisture sensor, a water flow sensor, an alcohol sensor, or any combination thereof.

[0102] Although in Figure 1shown separately, but 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 respiratory therapy device 110, the user interface 120, the conduit 140, the humidifier 160, the control system 200, the user device 260, the activity tracker 270, the head-mounted assembly 290 (e.g., the electronic module of the head-mounted assembly 290), or any combination thereof. For example, the microphone 220 and the speaker 222 can be integrated in and / or coupled to the user device 260, and the pressure sensor 212 and / or the flow sensor 132 are integrated in and / or coupled to the respiratory therapy device 110. In some embodiments, at least one of the one or more sensors 210 is not coupled to the respiratory therapy device 110, the control system 200, or the user device 260, and is generally positioned adjacent to the user 20 during a sleep session (e.g., positioned on a portion of the user 20 or in contact with a portion of the user, worn by the user 20, coupled to or positioned on a bedside table, coupled to a mattress, coupled to a ceiling, etc.).

[0103] One or more of the respiratory therapy device 110, the user interface 120, the conduit 140, the display device 150, and the humidifier 160 can include one or more sensors (e.g., a pressure sensor, a flow sensor, a microphone, or any of the other sensors 210 generally described herein). These one or more sensors can be used, for example, to measure the air pressure and / or flow rate of the pressurized air supplied by the respiratory therapy device 110.

[0104] Data from the one or more sensors 210 can be analyzed (e.g., by the control system 200) to determine one or more sleep-related parameters, which can include a respiratory signal, a respiratory rate, a respiratory pattern, an inspiratory amplitude, an expiratory amplitude, an inspiratory-expiratory ratio, the occurrence of one or more events, the number of events per hour, an event pattern, a sleep state, an apnea-hypopnea index (AHI), or any combination thereof. One or more events can include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, mask leak, cough, restless legs, sleep disorder, choking, increased heart rate, dyspnea, asthma attack, seizure, convulsion, elevated 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 non-physiological parameters. Other types of physiological and non-physiological parameters can also be determined based on data from the one or more sensors 210 or based on other types of data.

[0105] The user device 260( Figure 1) includes a display device 262. The user device 260 can be, for example, a mobile device such as a smart phone, a tablet computer, a game console, a smart watch, a laptop computer, etc. Alternatively, the user device 260 can be an external sensing system, a television (e.g., a smart TV), or another smart home device (e.g., a smart speaker such as Google Home, Amazon Echo, Alexa, etc.). In some embodiments, the user device is a wearable device (e.g., a smart watch). The display device 262 is generally used to display images including still images, video images, or both. In some embodiments, the display device 262 serves as a human-machine interface (HMI) that includes a graphical user interface (GUI) configured to display images and an input interface. The display device 262 can be an LED display, an OLED display, an LCD display, etc. The input interface can be, for example, a touch screen or a 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 260. In some embodiments, the system 10 can use and / or include one or more user devices.

[0106] In some embodiments, the system 100 also includes an activity tracker 270. The activity tracker 270 is generally used to help generate physiological data associated with a user. The activity tracker 270 can include one or more of the sensors 210 described herein, such as, for example, a motion sensor 138 (e.g., one or more accelerometers and / or gyroscopes), a PPG sensor 154, and / or an ECG sensor 156. The physiological data from the activity tracker 270 can be used to determine, for example, the number of steps, the distance traveled, the number of steps climbed, the duration of physical activity, the type of physical activity, the intensity of physical activity, the time spent standing, the respiratory rate, the average respiratory rate, the resting respiratory rate, the maximum respiratory rate, the respiratory rate variability, the heart rate, the average heart rate, the resting heart rate, the maximum heart rate, the heart rate variability, the number of calories burned, the blood oxygen saturation, the skin electrical activity (also known as skin conductance or skin electrical response), or any combination thereof. In some embodiments, the activity tracker 270 is (e.g., electronically or physically) coupled to the user device 260.

[0107] In some embodiments, the activity tracker 270 is a wearable device that can be worn by a user, such as a smart watch, a wristband, a ring, or a patch. For example, reference Figure 2, the activity tracker 270 is worn on the wrist of the user 20. The activity tracker 270 can also be coupled to or integrated into clothing or garments worn by the user. Alternatively, the activity tracker 270 can also be coupled to or integrated within the user device 260 (e.g., within the same housing). More generally, the activity tracker 270 can be communicatively coupled to or physically integrated within (e.g., within a housing) the control system 200, the memory device 204, the respiratory therapy system 100, and / or the user device 260.

[0108] In some embodiments, the system 100 further includes a blood pressure device 280. The blood pressure device 280 is generally used to help generate cardiovascular data to determine one or more blood pressure measurements associated with the user 20. The blood pressure device 280 can include at least one of the one or more sensors 210 to measure, for example, a systolic blood pressure component and / or a diastolic blood pressure component.

[0109] In some embodiments, the blood pressure device 280 is a sphygmomanometer that includes an inflatable cuff that can be worn by the user 20 and a pressure sensor (e.g., the pressure sensor 212 described herein). For example, in Figure 2 the example, the blood pressure device 280 can be worn on the upper arm of the user 20. In such embodiments where the blood pressure device 280 is a sphygmomanometer, the blood pressure device 280 further includes a pump (e.g., a manually operated bulb) for inflating the cuff. In some embodiments, the blood pressure device 280 is coupled to the respiratory therapy device 110 of the respiratory therapy system 100, and the respiratory therapy device in turn delivers pressurized air to inflate the cuff. More generally, the blood pressure device 280 can be communicatively coupled to and / or physically integrated within (e.g., within a housing) the control system 200, the memory device 204, the respiratory therapy system 100, the user device 260, and / or the activity tracker 270.

[0110] In other embodiments, the blood pressure device 280 is a mobile blood pressure monitor communicatively coupled to the respiratory therapy system 100. The mobile blood pressure monitor includes a portable recording device attached to a strap or band worn by the user 20 and an inflatable cuff attached to the portable recording device and worn around the arm of the user 20. The mobile blood pressure monitor is configured to measure blood pressure approximately every 15 minutes to about 30 minutes during a 24-hour or 48-hour period. The mobile blood pressure monitor can simultaneously measure the heart rate of the user 20. The multiple readings are averaged over a 24-hour period. The mobile blood pressure monitor determines any changes in the blood pressure and heart rate of the user 20 measured during the user 20's sleep period and wake period, as well as any distribution and / or trend patterns of the blood pressure and heart rate data. Then the measured data and statistics can be communicated to the respiratory therapy system 100.

[0111] The blood pressure device 280 can be positioned external to the respiratory therapy system 100, directly or indirectly coupled to the user interface 120, directly or indirectly coupled to the headgear associated with the user interface 120, or inflatably coupled to a portion of or around the user 20. The blood pressure device 280 is generally used to assist in generating physiological data to determine one or more blood pressure measurements associated with the user, such as a systolic blood pressure component and / or a diastolic blood pressure component. In some embodiments, the blood pressure device 280 is a sphygmomanometer that includes an inflatable cuff wearable by the user and a pressure sensor (e.g., the pressure sensor 212 described herein).

[0112] In some embodiments, the blood pressure device 280 is an invasive device that can continuously monitor the arterial blood pressure of the user 20 and collect arterial blood samples as needed to analyze the gases in the arterial blood. In some other embodiments, the blood pressure device 280 is a continuous blood pressure monitor that uses a radio frequency sensor and is capable of measuring the blood pressure of the user 20 once every few seconds (e.g., every 3 seconds, every 5 seconds, every 7 seconds, etc.). The radio frequency sensor can use continuous wave, frequency modulated continuous wave (FMCW with ramp chirp, triangular wave, sine wave), other schemes such as PSK, FSK, etc., pulsed continuous wave, and / or spread in the ultra-wideband range (which can include spread, PRN code, or pulse system).

[0113] The head-mounted assembly 290 may include an electronic module, which itself may include a processor (e.g., processor 202), a memory device (e.g., memory device 204), and one or more sensors (e.g., one or more sensors 210). In some cases, the processor, memory device, and / or one or more sensors may be located in other parts of the head-mounted assembly 290, such as when the strap of the head-mounted assembly 290 incorporates electrodes of an EEG sensor. In some cases, the head-mounted assembly 290 includes an electronic module that is capable of processing sensor data and outputting physiological parameters and / or a diagnosis or suspected diagnosis (e.g., the user may have OSA). In some cases, the head-mounted assembly 290 includes an electronic module that only collects sensor data and relays the sensor data to another device with minimal or no processing. For example, the electronic module may include one or more sensors, a transmitter, and a battery or energy harvesting power source. The electronic module may be coupled to a strap or other material to allow the head-mounted assembly 290 to be worn on the user's head. The head-mounted assembly 290 may be configured to operate in at least two configurations, the at least two configurations including: a first configuration in which the head-mounted assembly 290 may be worn alone; and a second configuration in which the head-mounted assembly 290 may be (e.g., mechanically, electrically, and / or communicatively) coupled to the respiratory therapy system 100 (e.g., coupled to the user interface 120 of the respiratory therapy system 100). In some cases, at least a portion of the head-mounted assembly 290 is at least mechanically coupled to the user interface 120 (e.g., coupled to the headgear of the user interface 120). At least a portion of the head-mounted assembly 290 may be coupled to the user interface 120 at any suitable location on the user interface 120, such as coupled to the headgear, padding, frame, connector 470, etc. In some cases, at least a portion of the head-mounted assembly 290 may be coupled to another component of the respiratory therapy system 100, such as the conduit 140. In some cases, the head-mounted assembly 290 will be coupled to components of the respiratory therapy system 100 in a manner that allows one or more sensors of the head-mounted assembly 290 to still collect sensor data associated with the user (e.g., motion data, audio data, etc.) while the user is participating in a sleep session.

[0114] In some cases, the head-mounted assembly 290 can include: i) an EEG sensor; ii) an electrooculogram (EOG) sensor; iii) a microphone; iv) a speaker; v) a GSR sensor; vi) a PPG sensor; or vii) any combination of i) to vi). Other sensors can also be used. The head-mounted assembly 290 can be used to detect or determine: i) head position; ii) body position; iii) mouth breathing (e.g., via a microphone sensor); iv) mask comfort (e.g., by determining heart rate variability or respiratory rate, or stress levels detected via peripheral arterial tone signals or self-reported); v) sleep quality (e.g., by determining sleep stages, such as based on EEG, microphone, and / or accelerometer data); vi) sleep apnea (e.g., the presence and / or type of sleep apnea); or vii) any combination of i) to vi). In some cases, the head-mounted assembly 290 can facilitate an understanding of positional OSA (e.g., by detecting head position and / or body position and the correlation with detected apnea events).

[0115] In some cases, coupling the head-mounted assembly 290 to the respiratory therapy system 100 can include electrically coupling the head-mounted assembly 290 to the respiratory therapy system 100 to receive power from the respiratory therapy system 100. The received power can be used to power the electronic module during use, or can be used to charge an internal power source (e.g., an internal battery, capacitor, etc.), so that the electronic module can be powered during use. In one example, when used in a second configuration, the head-mounted assembly 290 can be powered and charged by the respiratory therapy system 100, but when used in a first configuration, the head-mounted assembly can consume battery power. In some cases, such electrical coupling can include transferring power through conductors in the conduit 140 and / or a portion of the user interface 120 (e.g., conductors in the headgear 126 and / or the frame 124 of the user interface 120).

[0116] In some cases, coupling the head-mounted assembly 290 to the respiratory therapy system 100 can include communicatively coupling the head-mounted assembly 290 to the respiratory therapy system 100 to transfer data (e.g., sensor data) between the head-mounted assembly 290 and the respiratory therapy system 100 and / or an associated electronic device such as the user device 260. Such communicative coupling can be wired or wireless. In one example, the head-mounted assembly 290 can be wirelessly coupled to the respiratory therapy system 100 via Bluetooth, NFC, RFID, or a similar communication standard.

[0117] As described above, in some cases, the head-mounted assembly 290 can be communicatively coupled to other components of the system 10 that can utilize the acquired sensor data, such as being coupled to the user device 260 (e.g., the user's smart phone) or a cloud-based server.

[0118] In some cases, coupling the head-mounted assembly 290 to the respiratory therapy system 100 can include mechanically coupling the head-mounted assembly 290 to the respiratory therapy system 100, such as securing the head-mounted assembly 290 in place on the user's head together with components of the respiratory therapy system 100 and / or facilitating securing components of the respiratory therapy system 100 on the user's head. Any suitable mechanical coupling techniques can be used, such as mechanical coupling via mechanical fasteners, snap fittings, hook-and-loop fasteners, magnetic couplings, etc. In some cases, the electronic module of the head-mounted assembly 290 can be directly coupled to the user interface 120 (e.g., by magnetically coupling the electronic module to a corresponding receiving area on the frame 124 of the user interface 120). In some cases, the electronic module of the head-mounted assembly 290 can be indirectly coupled to the user interface 120, such as via a portion of a strap and / or headgear 126 of the head-mounted assembly that can be coupled to the user interface 120. In some cases, mechanically coupling the head-mounted assembly 290 to the user interface 120 can include disassembling components of the user interface 120 (e.g., headgear components, frame components, etc.) and replacing them with one or more components of the head-mounted assembly 290.

[0119] In some cases, the head-mounted component 290 can be used in a first configuration to collect sensor data associated with a user, such as when the user is engaged in a sleep session, which can include the duration of the user's attempt to fall asleep, being asleep, and / or waking up. When the user is not using respiratory therapy, such as: i) because the user has decided not to use respiratory therapy at all during a given sleep session; ii) because the user has temporarily decided to stop using respiratory therapy during the sleep session; or iii) because the user has not yet started using respiratory therapy (e.g., has not yet been diagnosed with a sleep-related disorder), the head-mounted component 290 can be used in the first configuration. In some use cases, when used in the first configuration, the head-mounted component 290 can obtain sensor data associated with the user, which can be used to generate respiratory therapy recommendations. The respiratory therapy recommendations can be: i) a recommendation to use respiratory therapy or that respiratory therapy may be beneficial to the user, such as a notification that the user may have a sleep-related disorder that would benefit from respiratory therapy; ii) a recommendation regarding a particular respiratory therapy system 100 to be used or one or more components of the respiratory therapy system 100 to be used, such as a recommendation to use a particular style, type, or model of user interface; iii) a recommendation regarding one or more parameters of the respiratory therapy system 100 used during respiratory therapy, such as the settings of the respiratory therapy device; or iv) any combination of i to iii. In an example case, if the system 10 determines based on the sensor data obtained when the head-mounted component 290 is used in the first configuration that the user has sleep apnea and typically breathes through the mouth while sleeping, the user may be recommended to consider respiratory therapy and consider using a full-face mask type of user interface. In some cases, the sensor data obtained when the head-mounted component 290 is used in the first configuration can be used to determine various physiological metrics associated with the user (e.g., sleep-related physiological metrics), such as scores associated with SDB, sleep quality, general health, etc. In some cases, as part of, as an alternative to, or in addition to the respiratory therapy recommendations, other warnings or advisories can be conveyed to the user and / or the user's caregiver (e.g., bed partner, doctor, nurse manager, etc.). Such other warnings or advisories can include recommendations to undergo a sleep study (e.g., PSG test), HSAT, and / or seek a doctor's appointment.

[0120] In some cases, the head-mounted assembly 290 can be used in a second configuration to collect sensor data associated with a user while the user is participating in the respiratory therapy system 100 and optionally receiving therapy in the form of pressurized air from the respiratory therapy system. When used in the second configuration to collect sensor data, the sensor data can be used for various purposes, such as monitoring physiological metrics (e.g., the physiological metrics monitored when the head-mounted assembly 290 is used in the first configuration, or other physiological metrics), assisting in titrating or otherwise adjusting the respiratory therapy system 100 during or after initiation, or for other purposes. Additionally, since the head-mounted assembly 290 is capable of obtaining data that cannot be obtained by traditional components of the respiratory therapy system 100, combining this data with sensor data from the respiratory therapy system 100 (e.g., flow data from the respiratory therapy device 110) can enable new types of automation, adjustment, and metrics. For example, data from the head-mounted assembly 290 can be used to identify the user's lying position, which can be utilized in conjunction with flow and / or pressure data to assist in identifying adjustments that can improve the efficacy of respiratory therapy based on the user's lying position. In other examples, physiological metrics can be used to determine whether a user has insomnia (commonly characterized by sleep onset latency, awakenings, sleep efficiency, and / or sleep fragmentation index exceeding acceptable threshold levels), and what information can be utilized to treat the condition (such as via CBTi) before and / or after the user begins using the respiratory therapy system. In some cases, the sensor data collected when the head-mounted assembly 290 is in the second configuration can be used to determine the efficacy of respiratory therapy and / or any recent changes in the parameters of the respiratory therapy system 100. In such or other cases, the sensor data collected when the head-mounted assembly 290 is in the second configuration can be used to inform the automatic adjustment feature of the respiratory therapy system that adjusts the flow of pressurized air to the user's airway based on the number, type, and / or severity of sleep disordered breathing events (e.g., apnea) experienced by the user while participating in respiratory therapy.

[0121] In some cases, the head-mounted assembly 290 can be used in a second configuration to facilitate the installation of the user interface 120 onto the user's face, such as by serving as part of a headgear for securing the user interface 120 to the user's head. In such cases, the head-mounted assembly 290 can optionally be used with or without collecting sensor data. When not collecting sensor data, the electronic module can simply not be used, or it can be detached from the remainder of the head-mounted assembly 290 and then coupled to the user interface 120.

[0122] The head-mounted assembly 290 can facilitate longitudinal monitoring of the user over a relatively long period of time, which can facilitate understanding the user's needs and patterns, and can facilitate interpretation of other sensor data acquired later, whether or not the head-mounted assembly 290 is used. In addition, by allowing the user to use the head-mounted assembly 290 in a first configuration and then use the head-mounted assembly in a second configuration, the respiratory therapy onboarding process can be improved because the user will already be familiar with the head-mounted assembly 290 (e.g., familiar with the entire components, the sensor data generated by the head-mounted assembly 290, and / or familiar with wearing the head-mounted assembly 290 during sleep). In some cases, one or more components of the respiratory therapy system 100 can be coupled to the head-mounted assembly 290 in stages to allow the user to get accustomed to the feel of the different components, optionally before supplying airflow at a therapeutic pressure.

[0123] In some cases, the head-mounted assembly 290 may be associated with one or more output devices. In some cases, the one or more output devices may be integrated into the head-mounted assembly 290, such as into an electronic module and / or band of the head-mounted assembly 290, although this is not always the case (e.g., other output devices separate from the head-mounted assembly 290 may be controlled by the head-mounted assembly 290 or data from the head-mounted assembly). The one or more output devices (e.g., lights, speakers, scent release modules, electrodes, etc.) may be used to generate stimulation, such as: i) visual stimulation; ii) tactile stimulation; iii) auditory stimulation; iv) electrical stimulation; v) olfactory stimulation; or vi) chemical stimulation; or vi) any combination of i to vi. Such stimulation may be used to improve the user's sleep, improve the user's therapy (e.g., respiratory therapy), promote hair growth, improve skin appearance, etc.

[0124] Although the control system 200 and the memory device 204 are Figure 1 100, but in some embodiments, the control system 200 and / or the memory device 204 are integrated into the user device 260 and / or the respiratory therapy device 110. Alternatively, in some embodiments, the control system 200 or a portion thereof (e.g., the processor 202) can be located in the cloud (e.g., integrated in a server, integrated in an Internet of Things (IoT) device, connected to the cloud, subject to edge cloud processing, etc.), located in one or more servers (e.g., a remote server, a local server, etc.), or any combination thereof.

[0125] Although system 10 is shown as including all of the above components, more or fewer components may be included in a system according to an embodiment of the present invention. For example, a first alternative system includes at least one of control system 200, memory device 204, and one or more sensors 210, and does not include respiratory therapy system 100. As another example, a second alternative system includes at least one of control system 200, memory device 204, one or more sensors 210, and user device 260. As yet another example, a third alternative system includes control system 200, memory device 204, respiratory therapy system 100, at least one of one or more sensors 210, and user device 260. Thus, various systems can be formed using any one or more parts of the components shown and described herein and / or in combination with one or more other components.

[0126] As used herein, a sleep session can be defined in a variety of ways. For example, a sleep session can be defined by an initial start time and an end time. In some embodiments, a sleep session is the duration of time that a user sleeps, i.e., the sleep session has a start time and an end time, and during the sleep session, the user does not awaken until the end time. That is, any period of time during which the user is awake is not included in the sleep session. According to this first definition of a sleep session, if a user wakes up and falls asleep multiple times during the same night, each of the sleep intervals separated by wake intervals is a sleep session.

[0127] Alternatively, in some embodiments, a sleep session has a start time and an end time, and during the sleep session, the user may wake up as long as the duration of continuous wakefulness is below a wakefulness duration threshold, and the sleep session does not end. The wakefulness duration threshold can be defined as a percentage of the sleep session. The wakefulness duration threshold can be, for example, about 20% of the sleep session, about 15% of the sleep session duration, about 10% of the sleep session duration, about 5% of the sleep session duration, about 2% of the sleep session duration, etc. or any other threshold percentage. In some embodiments, the wakefulness 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.

[0128] In some embodiments, a sleep session is defined as the entire time period between the time when the user first gets into bed at night and the time when the user last gets out of bed the next morning. In other words, a sleep session can be defined as a time period that starts at a first time (e.g., 10:00 p.m.) on a first date (e.g., Monday, January 6, 2020) and ends at a second time (e.g., 7:00 a.m.) on a second date (e.g., Tuesday, January 7, 2020). The first time can be referred to as the current night when the user first gets into bed with the intention of falling asleep (e.g., if the user intends to watch TV or play on a smartphone before falling asleep, then no). The second time can be referred to as the next morning when the user first gets out of bed with the intention of not going back to sleep the next morning.

[0129] In some embodiments, the user can manually define the start 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 elements displayed on the display device 262 of the user device 260 ( Figure 1 ) to manually initiate or terminate a sleep session.

[0130] Generally, a sleep session includes any point in time after the user 20 has lain or sat in the bed 40 (or another area or object where they intend to sleep) and has turned on the respiratory therapy device 110 and put on the user interface 120. A sleep session can thus include the following time periods: (i) when the user 20 is using the respiratory therapy system 100 but before the user 20 attempts to fall asleep (e.g., when the user 20 is lying in the bed 40 reading a book); (ii) when the user 20 starts to attempt to fall asleep but is still awake; (iii) when the user 20 is in light sleep (also known as stages 1 and 2 of non-rapid eye movement (NREM) sleep); (iv) when the user 20 is in deep sleep (also known as slow-wave sleep SWS or stage 3 of NREM sleep); (v) when the user 20 is in rapid eye movement (REM) sleep; (vi) when the user 20 is periodically awake between light sleep, deep sleep, or REM sleep; or (vii) when the user 20 wakes up and does not fall back asleep.

[0131] A sleep session is typically defined as ending once the user 20 removes the user interface 120, turns off the respiratory therapy device 110, and gets out of the bed 40. In some embodiments, a sleep session can include additional time periods, or can be restricted to only some of the time periods disclosed above. For example, a sleep session can be defined as a time period that starts when the respiratory therapy device 110 begins supplying pressurized air to the airway or the user 20, ends when the respiratory therapy device 110 stops supplying pressurized air to the user 20's airway, and includes some or all of the time points between when the user 20 falls asleep or wakes up.

[0132] Reference Figure 7 to the timeline 700 in 床 and the time t of entering the bed is associated with the time when the user initially enters the bed (e.g., when the user lies down or sits on the bed) before falling asleep (e.g., Figure 2 the bed 40 in 床 ). The time t of entering the bed can be identified based on a bed threshold duration to distinguish between the time when the user enters the bed for sleeping and the time when the user enters the bed for other reasons (e.g., watching 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. Although the time t of entering the bed is described herein with reference to the bed 床 , more generally, the time t of entering the bed 床 can refer to the time when the user initially enters any position for sleeping (e.g., a chaise longue, a chair, a sleeping bag, etc.).

[0133] The time of going to sleep (GTS) is associated with the time when the user initially attempts to fall asleep after entering the bed (t 床 ). For example, after entering the bed, the user can engage in one or more activities to relax before attempting to sleep (e.g., reading, watching TV, listening to music, using the user device 260, etc.). The initial sleep time (t 睡眠 ) is the time when the user initially falls asleep. For example, the initial sleep time (t 睡眠 ) can be the time when the user initially enters the first non-REM sleep stage.

[0134] The wake-up time t 觉醒 is the time associated with the time when the user wakes up without falling asleep again (e.g., as opposed to the user waking up in the middle of the night and falling asleep again). The user can experience one of multiple unconscious micro-awakenings (e.g., micro-awakenings MA1 and MA2) with short durations (e.g., 5 seconds, 10 seconds, 30 seconds, 1 minute, etc.) after initially falling asleep. In contrast to the wake-up time t 觉醒 , the user falls asleep again after each of the micro-awakenings MA1 and MA2. Similarly, the user may have one or more conscious awakenings (e.g., awakening A) (e.g., getting up to go to the bathroom, taking care of a child or pet, sleepwalking, etc.) after initially falling asleep. However, the user falls asleep again after awakening A. Therefore, the wake-up time t 觉醒 can be defined, for example, based on an awakening 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.).

[0135] Similarly, the getting-up time t 起身Is associated with the time when the user gets out of bed and stays out of bed to end a sleep session (e.g., as opposed to the user getting out of bed during the night to go to the bathroom, take care of a child or pet, sleepwalk, etc.). In other words, the getting-up time t 起身 Is the time when the user finally leaves the bed and does not return to the bed until the next sleep session (e.g., the next night). Thus, the getting-up time t 起身 Can be defined, for example, based on a getting-up threshold duration (e.g., the user has been out of bed for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.). 床 Time.

[0136] As described above, during the night between the initial t 床 And the final t 起身 The user can wake up and get out of bed more than once. In some embodiments, the final wake-up time t 觉醒 And / or the final getting-up time t 起身 Is identified or determined based on a predetermined threshold duration after an event (e.g., falling asleep or getting out of bed). Such threshold durations can be customized for the user. For a standard user who goes to bed at night and then wakes up and gets out of bed in the morning, any time period from about 12 hours to about 18 hours can be used (between the time the user wakes up (t 觉醒 ) or gets out of bed (t 起身 ) and the time the user goes to bed (t 床 ), falls asleep (t GTS ) or drifts off to sleep (t 睡眠 ). For a user who spends a longer period of time in bed, a shorter threshold time period (e.g., about 8 hours to about 14 hours) can be used. The threshold time period can be initially selected and / or later adjusted based on a system that monitors the user's sleep behavior.

[0137] The total time in bed (TIB) is the duration between the time of getting into bed t 床 And the getting-up time t 起身 . 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 in between. Generally, the total sleep time (TST) will be shorter than the total time in bed (TIB) (e.g., shorter by one minute, shorter by ten minutes, shorter by one hour, etc.). For example, referring to Figure 7 The timeline 700, the total sleep time (TST) is between the initial sleep time t 睡眠 And the wake-up time t 觉醒Span between, but not including, the durations of the first micro-arousal MA1, the second micro-arousal MA2, and the arousal A. As shown, in this example, the total sleep time (TST) is shorter than the total in-bed time (TIB).

[0138] In some embodiments, the total sleep time (TST) can be defined as the persistent total sleep time (PTST). In such embodiments, the persistent total sleep time does not include a predetermined initial portion or period of the first non-REM stage (e.g., the 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 the continuous sleep and smooths the sleep-wake sleep graph. For example, when a user initially falls asleep, the user may be in the first non-REM stage for a very short time (e.g., about 30 seconds), then return to the wake stage for a short period (e.g., one minute), and then return to the first non-REM stage. In this example, the persistent total sleep time does not include the first instance of the first non-REM stage (e.g., about 30 seconds).

[0139] In some embodiments, a sleep session is defined as starting at the time of getting into bed (t 床 ) and ending at the time of getting out of bed (t 起身 ), i.e., the sleep session is defined as the total in-bed time (TIB). In some embodiments, a sleep session is defined as starting at the initial sleep time (t 睡 ) and ending at the wake-up time (t 觉醒 ). In some embodiments, a sleep session is defined as the total sleep time (TST). In some embodiments, a sleep session is defined as starting at the time of entering the sleep time (t GTS ) and ending at the wake-up time (t 觉醒 ). In some embodiments, a sleep session is defined as starting at the time of entering the sleep time (t GTS ) and ending at the time of getting out of bed (t 起身 ). In some embodiments, a sleep session is defined as starting at the time of getting into bed (t 床 ) and ending at the wake-up time (t 觉醒 ). In some embodiments, a sleep session is defined as starting at the initial sleep time (t 睡眠 ) and ending at the time of getting out of bed (t 起身 ).

[0140] Reference Figure 8 , illustrates a timeline 700 corresponding to some embodiments ( Figure 7)Exemplary sleep graph 800. As shown, sleep graph 800 includes a sleep-wake signal 801, a wake stage axis 810, a REM stage axis 820, a light sleep stage axis 830, and a deep sleep stage axis 840. The intersection between the sleep-wake signal 801 and one of the axes 810 to 840 indicates the sleep stage at any given time during a sleep session.

[0141] The sleep-wake signal 801 can be generated based on physiological data associated with a user (e.g., generated by one or more of the sensors 210 described herein). The sleep-wake signal can indicate one or more sleep states, including wakefulness, relaxed wakefulness, micro-awakening, REM stage, first non-REM stage, second non-REM stage, third non-REM stage, or any combination thereof. In some embodiments, 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 classified 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. Although sleep graph 800 is shown in Figure 8 as including a light sleep stage axis 830 and a deep sleep stage axis 840, in some embodiments, sleep graph 800 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 embodiments, the sleep-wake signal can also indicate a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, an event pattern, or any combination thereof. Information describing the sleep-wake signal can be stored in the memory device 204.

[0142] Sleep graph 800 can be used to determine one or more sleep-related parameters, such as, for example, sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE), sleep fragmentation index, sleep blocks, or any combination thereof.

[0143] Sleep onset latency (SOL) is defined as the time (t GTS ) to enter the sleep time and the initial sleep time (t 睡眠) The time between. In other words, the sleep onset latency indicates the time it takes for the user to actually fall asleep after initially attempting to fall asleep. In some embodiments, the sleep onset latency is defined as the 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 between the time of entry into sleep and a predetermined amount of persistent sleep. In some embodiments, the predetermined amount of persistent sleep may 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 awakenings not exceeding 2 minutes, the first non-REM stage, and / or the movements therebetween. In other words, the persistent sleep onset latency requires persistent sleep for up to, for example, 8 minutes within the second non-REM stage, the third non-REM stage, and / or the REM stage. In other embodiments, the predetermined amount of persistent sleep may 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 after the initial sleep time. In such embodiments, the predetermined amount of persistent sleep may not include any micro-awakenings (e.g., a ten-second micro-awakening does not restart the 10-minute period).

[0144] Wake after sleep onset (WASO) is associated with the total duration of wakefulness of the user between the initial sleep time and the wake-up time. Thus, wake after sleep onset includes brief awakenings and micro-awakenings (e.g., Figure 7 the micro-awakenings MA1 and MA2 shown), whether conscious or unconscious. In some embodiments, wake after sleep onset (WASO) is defined as persistent wake after sleep onset (PWASO) that includes only the total duration 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.).

[0145] Sleep efficiency (SE) is determined as the ratio of total in-bed time (TIB) to total sleep time (TST). For example, if the total in-bed time is 8 hours and the total sleep time is 7.5 hours, the sleep efficiency for that sleep session is 93.75%. Sleep efficiency indicates the user's sleep hygiene. For example, if the user enters the bed before sleeping and spends time engaging in other activities (e.g., watching TV), the sleep efficiency will decrease (e.g., the user is penalized). In some embodiments, the sleep efficiency (SE) can be calculated based on the total in-bed time (TIB) and the total time the user attempts to sleep. In such embodiments, the total time the user attempts to sleep is defined as the duration between the time of going to sleep (GTS) and the time of getting up as described herein. For example, if the total sleep time is 8 hours (e.g., from 11 p.m. to 7 a.m.), the time of going to sleep is 10:45 p.m., and the time of getting up is 7:15 a.m., then in such embodiments, the sleep efficiency parameter is calculated to be approximately 94%.

[0146] The fragmentation index is determined at least in part based on the number of awakenings during a sleep session. For example, if the user has two micro-awakenings (e.g., Figure 7 the micro-awakenings MA1 and MA2 as shown), the fragmentation index can be represented as 2. In some embodiments, the fragmentation index is scaled between a predetermined range of integers (e.g., between 0 and 10).

[0147] Sleep blocks are associated with transitions between any sleep stage (e.g., the first non-REM stage, the second non-REM stage, the third non-REM stage, and / or REM) and the wake stage. Sleep blocks can be calculated at a resolution of, for example, 30 seconds.

[0148] In some embodiments, the systems and methods described herein can include generating or analyzing a sleep chart including a sleep-wake signal to determine or identify the time of entering the bed (t 床 ), the time of going to sleep (t GTS ), the initial sleep time (t 睡眠 ), one or more first micro-awakenings (e.g., MA1 and MA2), the waking time (t 觉醒 ), the time of getting up (t 起身 ) or any combination thereof, at least in part based on the sleep-wake signal of the sleep chart.

[0149] In other embodiments, one or more of the sensors 210 can be used to determine or identify the time of entering the bed (t 床 ), the time of going to sleep (t GTS ), the initial sleep time (t 睡眠 ), one or more first micro-awakenings (e.g., MA1 and MA2), the waking time (t 觉醒)、wake-up time (t 起身 ) or any combination thereof. For example, the time t of getting into bed can be determined based on data generated by, for example, the motion sensor 218, the microphone 220, the camera 232, or any combination thereof. 床 . The time of falling asleep can be determined based on, for example, data from the motion sensor 218 (e.g., data indicating that the user is not moving), data from the camera 232 (e.g., data indicating that the user is not moving and / or the user has turned off the light), data from the microphone 220 (e.g., data indicating that the user has turned off the TV), data from the user device 260 (e.g., data indicating that the user is no longer using the user device 260), data from the pressure sensor 212 and / or the flow sensor 214 (e.g., data indicating that the user has turned on the respiratory therapy device 110, data indicating that the user has put on the user interface 120, etc.), or any combination thereof.

[0150] Figure 9 is a flowchart depicting a process 900 for using a head-mounted component according to certain aspects of the present disclosure.

[0151] At block 902, a head-mounted component can be provided. Any suitable head-mounted component can be used, such as Figure 1 the head-mounted component 290. The head-mounted component can be provided in a first configuration, or the head-mounted component can be adjusted to a first configuration in which the head-mounted component can be worn alone on the user's head. Various forms of head-mounted components can be used, such as headbands, eye pads, eye masks, hoods, etc. Providing the head-mounted component can include placing the head-mounted component on the user's head and starting data collection.

[0152] At block 904, first sensor data can be collected. The first sensor data can be sensor data obtained from one or more sensors of the head-mounted component. In some cases, the first sensor data can additionally include additional sensor data from one or more additional sensors associated with another device, such as sensors of a user device (e.g., a smartphone). For example, the head-mounted component can obtain motion data, and the user's smartphone can obtain microphone data. However, in some cases, the first sensor data only includes sensor data from the sensors of the head-mounted component. The collected sensor data can be transferred from the head-mounted component to another device for further processing, such as transferred to a smartphone or a cloud computer, although this is not always the case. In some cases, additional processing may occur on the head-mounted component itself.

[0153] At block 906, a sleep therapy recommendation can be generated. Generating the sleep therapy recommendation can include analyzing first sensor data. In some cases, analyzing the first sensor data can include determining physiological data associated with the user, as further disclosed in detail herein. For example, the first sensor data can be used to generate an AHI score, a sleep score, and an indication of mouth breathing (e.g., a mouth breathing signal) associated with the user's sleep session. In some cases, analyzing the sensor data (e.g., the first sensor data) can include determining other types of physiological data, such as: i) identifying one or more sleep disordered breathing events; ii) determining a sleep quality score; iii) determining a general health status score; iv) detecting head position information; v) detecting body position information; vi) identifying mouth breathing; vii) determining stress level information; viii) determining heart rate information; ix) determining respiratory rate information; x) determining sympathetic nervous system activation; xi) determining apnea hypopnea index information; xii) determining sleep state information; xiii) determining sleep stage information; xiv) determining microarousals; xv) detecting insomnia; xvi) determining excessive arousal; xvii) determining hypoxia burden; xviii) differentiating central sleep apnea events from obstructive sleep apnea events; xix) detecting restless legs syndrome; xx) detecting periodic limb movement disorder; xxi) detecting rapid eye movement-dominant obstructive sleep apnea; xxii) detecting positional obstructive sleep apnea; xxiii) detecting arrhythmia; xxiv) determining blood pressure; xxv) determining blood glucose level; xxvi) determining core body temperature; or xxvii) any combination of i through xxvi.

[0154] Based on the physiological data or other information from the first sensor data, a sleep therapy recommendation can be generated. The sleep therapy recommendation can be any recommendation associated with a possible sleep therapy for the user. In some cases, the sleep therapy recommendation can include a recommendation to: i) not participate in any sleep therapy; ii) generally participate in sleep therapy; iii) participate in respiratory therapy; or iv) participate in an alternative sleep therapy other than respiratory therapy. In some cases, the sleep therapy recommendation can include a recommendation for equipment for respiratory therapy or parameters of a respiratory therapy system for respiratory therapy. In some cases, the sleep therapy recommendation can include recommendations regarding when to start sleep therapy, what actions to take before participating in sleep therapy (e.g., recommendations regarding good sleep hygiene, such as not using devices like TVs or smartphones before starting a sleep session), what actions to take after a sleep therapy session, etc. In some cases, the sleep therapy recommendation can include a recommendation to continue using the head-mounted component in a first configuration for additional iterations of blocks 904, 906.

[0155] After generating a sleep therapy recommendation, it can be presented to the user or others (e.g., a caregiver associated with the user) in any suitable manner, such as by displaying it on a display device. In some cases, the sleep therapy recommendation can include parameters or settings that can be sent to the necessary recipient for automatic execution, such as settings on a respiratory therapy device being automatically transmitted to the respiratory therapy device for implementation.

[0156] In some cases, as a supplement to or an alternative to generating a sleep therapy recommendation at block 906, one or more physiological metrics (e.g., a sleep score) can be generated and presented to the user. In some cases, the sleep therapy recommendation can be direct (e.g., a notification instructing the user to start respiratory therapy or seek a diagnosis for a sleep-related disorder) or indirect (e.g., a notification showing a sleep score below a threshold, which can indicate to the user that a certain sleep therapy would be beneficial).

[0157] In some cases, such as if the sleep therapy recommendation generated at block 906 is a recommendation that no sleep therapy is needed, process 900 can end at block 908. The user can continue to wear the head-mounted component for future sleep sessions (e.g., to continue tracking sleep-related data, such as a sleep score), and / or can otherwise dispose of the head-mounted component.

[0158] In some cases, such as if the sleep therapy recommendation generated at block 906 is a recommendation to participate in an alternative sleep therapy other than respiratory therapy, process 900 can continue by facilitating the alternative sleep therapy at block 910. Facilitating the alternative sleep therapy can include presenting information about the alternative sleep therapy to the user, providing information to the user or caregiver to facilitate the diagnosis of a sleep-related condition or the development of an alternative sleep therapy, or taking any other suitable action to help facilitate the user's participation in the alternative sleep therapy.

[0159] However, in some cases, the sleep therapy recommendation generated at block 906 can indicate or otherwise include a recommendation for the user to participate in respiratory therapy. If a respiratory therapy system has not been purchased, the user can purchase a respiratory therapy system. In some cases, the sleep therapy recommendation can include information that can be used to help diagnose the user's sleep-related condition and / or help determine which respiratory therapy system or which components of a respiratory therapy system should be used for the user's respiratory therapy.

[0160] At block 912, the head-mounted assembly can be coupled to the respiratory therapy system. In some cases, coupling the head-mounted assembly to the respiratory therapy system can include coupling the entire head-mounted assembly, although this is not always the case. In some cases, coupling the head-mounted assembly to the respiratory therapy system can include first disassembling one or more components. In a first example, the head-mounted assembly, which is a headband, can be integrally coupled to the user interface. In a second example, the electronic module of the head-mounted assembly can be separated from the remainder of the head-mounted assembly, and subsequently the electronic module can be coupled to the user interface. In a third example, the electronic module of the head-mounted assembly can be separated from the strap of the head-mounted assembly, and subsequently the strap can be coupled to the user interface. In some cases, coupling the head-mounted assembly to the respiratory therapy system can include coupling the head-mounted assembly to the user interface of the respiratory therapy system, although this is not always the case.

[0161] Coupling the head-mounted assembly to the respiratory therapy system can result in the head-mounted assembly being used in a second configuration.

[0162] At block 914, second sensor data can be collected. Collecting the second sensor data can be similar to collecting the first sensor data at block 904, except that the head-mounted assembly is in the second configuration. In some cases, collecting the second sensor data occurs when the user is engaged in respiratory therapy (e.g., receiving pressurized air from a respiratory therapy device), although this is not always the case. In some cases, the second sensor data can be collected when the user is wearing the user interface but has not yet received respiratory therapy. In such cases, the user can become familiar with and accustomed to wearing the respiratory therapy system or its components during a sleep session before starting the therapy.

[0163] In some cases, the second sensor data can additionally include additional sensor data from one or more additional sensors associated with another device, such as sensors of a user device (e.g., a smartphone) and / or sensors of the respiratory therapy system. In one example, sensors of the respiratory therapy system can provide flow and / or pressure data associated with the pressurized air supplied to a user participating in a sleep session, while the head-mounted assembly provides movement data indicating the user's lying position. The flow and / or pressure data and the movement data together can be used to automatically adjust the operation of the respiratory therapy device. For example, if it is determined that the user has positional sleep apnea, the flow and / or pressure settings can be adjusted (such as increased) when the user is in the lying position associated with a greater likelihood of apnea events. Similarly, the flow and / or pressure data and EEG data (or other sleep staging data) can be used to automatically adjust the operation of the respiratory therapy device. For example, if it is determined that the user has REM-dominant sleep apnea, the flow and / or pressure settings can be adjusted (such as increased) when the user is in or about to enter the REM sleep stage.

[0164] In some cases, the second sensor data may initially be collected by the head-mounted component and transmitted to the user interface and / or the respiratory therapy device via a wired or wireless technology. In some cases, an antenna in the user interface or the respiratory therapy device may be used to wirelessly receive the second sensor data from the electronic module when the head-mounted component is worn in the second configuration. In some cases, an electrical connector on the user interface or the respiratory therapy device may be used to receive the second sensor data via a wire (e.g., via an electrical connection between the electronic module and the electrical connector).

[0165] At block 916, an action may be taken based on the second sensor data and optionally further based on the first sensor data (e.g., a comparison between the first sensor data and the second sensor data). Taking an action at block 916 may include analyzing the second sensor data, such as determining physiological data associated with the user's participation in a sleep session while wearing the user interface and / or while receiving respiratory therapy.

[0166] In some cases, taking an action at block 916 may include generating an assessment at block 918. Generating an assessment may include determining a score (e.g., a sleep score and / or a therapy score (such as a myAir TM score) or other metrics that can be used to determine whether the user is responding positively to the respiratory therapy. In some cases, a modification to a parameter of the respiratory therapy system may be associated with the assessment such that the assessment indicates whether the modification to the parameter is beneficial and / or whether it should be maintained or reversed.

[0167] In some cases, taking an action at block 916 may include generating a recommendation at block 920. Generating a recommendation at block 920 may be similar to generating a sleep therapy recommendation at block 906, although other recommendations may be generated. The recommendations generated at block 920 may include a recommendation to continue using the respiratory therapy system, a recommendation to take certain actions before the next sleep session (e.g., change the respiratory therapy system, change the user's sleep environment, perform or avoid certain actions immediately before going to sleep, etc.), and so on.

[0168] In some cases, taking an action at block 916 may include facilitating a modification to a parameter of the respiratory therapy system. The parameters of the respiratory therapy system may include any modifiable aspects of the respiratory therapy system, such as the style of the user interface being used, the type of tubing being used, one or more settings of the respiratory therapy device, etc. Facilitating a modification to the parameter may include automatically modifying the parameter (e.g., automatically adjusting the settings on the respiratory therapy device during a sleep session or before the next sleep session), recommending a modification (e.g., generating a notification recommending that the user switch to a different user interface), or otherwise helping the modification to occur (e.g., automatically sending a different user interface to the user for them to try on their own).

[0169] In some cases, taking an action based on the second sensor data at block 916 can include taking additional actions. Taking an action at block 916 can occur dynamically (e.g., during a sleep session in response to real-time sensor data collected during the sleep session), or occur at a later time (e.g., after the sleep session ends based on sensor data from the entire sleep session).

[0170] Although process 900 is described with specific blocks in a specific order, in some cases, process 900 can occur with fewer blocks, more blocks, one or more blocks replacing one or more existing blocks, blocks being executed in a different order, etc. For example, in some cases, instead of generating a sleep therapy recommendation at block 906, only a sleep score can be generated.

[0171] Figure 10 is a side view of a head-mounted component base 1002 according to certain aspects of the present disclosure. The head-mounted component base 1002 is shown being worn by a user 1000. The head-mounted component base 1002 includes mounting points 1004 located on both sides of the user's head. Here, the mounting points 1004 are located directly above the user's ears, although in some cases the mounting points 1004 can be positioned otherwise.

[0172] The mounting points 1004 can include a mounting mechanism that is designed to interact with or otherwise removably couple to a sensor earpiece and / or a user interface. As Figure 10 depicted, the mounting points 1004 include hook-and-loop surfaces that are designed to removably couple to corresponding hook-and-loop surfaces on the sensor earpiece and / or the user interface. However, as described herein, any suitable coupling mechanism can be used, such as a mechanical coupling via mechanical fasteners, snap fittings, hook-and-loop fasteners, magnetic couplings, etc.

[0173] Figure 11 is an axonometric view of a sensor earpiece 1106 according to certain aspects of the present disclosure. The sensor earpiece 1106 can include a body having one or more sensors 1108 (e.g., EEG sensors and PPG sensors). The body of the sensor earpiece 1106 can include a plurality of attachment points 1104. The attachment points 1104 of the sensor earpiece 1106 can be designed to removably couple to the mounting points of the head-mounted component base (e.g., Figure 10 the mounting points 1004). For example, the attachment points 1104 can include hook-and-loop surfaces that are designed to couple to corresponding hook-and-loop surfaces of the mounting points of the head-mounted component base.

[0174] Figure 12is a side view of a sensor earpiece 1206 coupled to a headset component base 1202 according to certain aspects of the present disclosure. The headset component base 1202 can be Figure 10 the headset component base 1002 of

[0175] The sensor earpiece 1206 coupled to the headset component base 1202 can effectively create a version of the headset component described further herein in detail, such as Figure 3 the headset component 390 of Figure 12 As depicted, the sensor earpiece 1206 is detachably coupled to the headset component base 1202 at the mounting point 1204. When the user 1200 wears in this way, the sensor earpiece 1206 can be positioned to make appropriate measurements on the user 1200 to generate sensor data associated with the user 1200.

[0176] As Figure 12 depicted, the user 1200 can use the sensor earpiece 1206 to collect sensor data without having to utilize a respiratory therapy such as described herein (e.g., with reference to Figure 2 the headset component 290 of

[0177] Figure 13 is a side view of a user interface 1312 coupled to a headset component base 1302 according to certain aspects of the present disclosure. The headset component base 1302 can be Figure 10 the headset component base 1002 of

[0178] The user interface 1312 can be coupled to the headset component base 1302 via one or more straps 1310, which are detachably coupled to corresponding mounting points 1304 of the headset component base 1302. For example, the strap 1310 can include a hook-and-loop surface that is detachably coupled to a corresponding hook-and-loop surface of the corresponding mounting point 1304.

[0179] As Figure 13 depicted, the user 1300 is participating (or preparing to participate) in a respiratory therapy, although not necessarily while using the sensor earpiece.

[0180] Figure 14 is a side view of a sensor earpiece 1406 and a user interface 1412 according to certain aspects of the present disclosure, both the sensor earpiece and the user interface being coupled to a headset component base 1402. The headset component base 1402 can be Figure 10 the headset component base 1002 of Figure 11 the sensor earpiece 1106 of

[0181] The sensor earpiece 1406 can be in a manner as referenced to Figures 11 to 12coupled to the head-mounted component base 1402 in a manner similar to the described manner. The user interface 1412 can be coupled to the ear-mounted component base 1402 in a manner similar to the manner described in reference Figure 13 However, in some cases, one of the sensor earpiece 1406 and the user interface 1412 can be coupled to the head-mounted component base 1402 via the other of the sensor earpiece 1406 and the user interface 1412. For example, the attachment point of the sensor earpiece 1406 can be detachably coupled to the corresponding mounting point of the strap 1410 of the user interface 1412, and the strap 1410 of the user interface 1412 itself can be detachably coupled to the mounting point of the head-mounted component base 1402.

[0182] As Figure 14 depicted, the user 1400 may be participating in (or preparing to participate in) a breathing therapy while also using the sensor earpiece to collect sensor data, such as described herein (e.g., the head-mounted component 291 of reference Figure 2 ).

[0183] One or more elements or aspects or steps or any part thereof from one or more of the following claims can be combined with one or more elements or aspects or steps or any part thereof from one or more of the following other claims or a combination thereof to form one or more additional embodiments and / or claims of the present disclosure.

[0184] Although the present disclosure has been described with reference to one or more specific embodiments or implementations, those skilled in the art will recognize that many changes can be made thereto without departing from the spirit and scope of the present disclosure. Each of these embodiments and their obvious variations are considered to fall within the spirit and scope of the present disclosure. It is also contemplated that additional embodiments in accordance with aspects of the present disclosure can combine any number of features from any of the embodiments described herein.

Claims

1. A method, the method comprising: providing a head-mounted assembly having an electronic module including one or more sensors, the head-mounted assembly being couplable to a user interface and wearable on a user's head, wherein the head-mounted assembly is wearable on the head and not coupled to the user interface when in a first configuration, and wherein the head-mounted assembly is wearable on the head and coupled to the user interface when in a second configuration; collecting first sensor data from the one or more sensors when the user wears the head-mounted assembly in the first configuration while participating in a first sleep session; and collecting second sensor data from the one or more sensors when the user wears the head-mounted assembly in the second configuration coupled to the user interface during a second sleep session.

2. The method according to claim 1, wherein performing a respiratory therapy using the user interface is at least partially based on the first sensor data.

3. The method according to claim 1 or 2, wherein determining to receive the respiratory therapy during the second sleep session is at least partially based on the first sensor data.

4. The method according to any one of claims 1 to 3, wherein the user interface is selected from a plurality of potential user interfaces at least partially based on the first sensor data.

5. The method according to any one of claims 1 to 4, wherein at least one setting of a respiratory therapy device is at least partially based on the first sensor data.

6. The method according to any one of claims 1 to 5, wherein the head-mounted assembly comprises: i) a headband; ii) an eye pad; iii) an eye mask; iv) a headgear; v) a nasal strap; vi) earplugs; or vii) any combination of i to vi.

7. The method according to any one of claims 1 to 6, wherein the electronic module: i) is detachably coupled to a coupling member of the head-mounted assembly; or ii) is detachably positioned within a pocket of the head-mounted assembly.

8. The method according to any one of claims 1 to 7, wherein when the head-mounted assembly is in the second configuration, the electronic module is detachable from the remainder of the head-mounted assembly and couplable to the user interface.

9. The method according to any one of claims 1 to 8, wherein when the head-mounted assembly is in the second configuration, the electronic module is coupled to the user interface via a strap.

10. The method according to any one of claims 1 to 9, wherein collecting the second sensor data comprises: Transmitting the second sensor data to the respiratory therapy device via a wired connection or a wireless connection between the electronic module and the user interface.

11. The method according to any one of claims 1 to 10, wherein collecting the second sensor data comprises: Powering the electronic module via an electrical connection between the electronic module and the respiratory therapy device.

12. The method according to any one of claims 1 to 11, wherein when in the second configuration, the head-mounted assembly facilitates fixing the user interface to the user.

13. The method according to any one of claims 1 to 12, the method further comprising: Collecting third sensor data from the one or more sensors when the user wears the head-mounted assembly in the first configuration after the user stops wearing the user interface during the second sleep session.

14. The method according to any one of claims 1 to 13, the method further comprising: Presenting stimuli to the user via one or more output devices associated with the head-mounted assembly, the stimuli including: i) visual stimuli; ii) tactile stimuli; iii) auditory stimuli; iv) electrical stimuli; v) olfactory stimuli; or vi) chemical stimuli; or any combination of i) to vi).

15. The method according to claim 14, wherein the head-mounted assembly includes the one or more output devices.

16. A method for monitoring a sleeper, the method comprising: Providing a head-mounted assembly having an electronic module including one or more sensors; Receiving first sensor data associated with a user who participates in a first sleep session while wearing the head-mounted assembly and not receiving respiratory therapy; Analyzing the first sensor data to generate a respiratory therapy recommendation; Providing the respiratory therapy recommendation, wherein the respiratory therapy includes using a user interface, and wherein the head-mounted assembly is coupleable to the user interface; And Receiving second sensor data associated with the user who participates in a second sleep session while wearing the head-mounted assembly coupled to the user interface.

17. The method according to claim 16, wherein providing the respiratory therapy system comprises: Determining an adjustment to at least one setting of a respiratory therapy device based at least in part on the second sensor data.

18. The method according to claim 16 or 17, wherein the respiratory therapy recommendation includes a recommendation to participate in respiratory therapy, and wherein the respiratory therapy system is provided in response to the recommendation to participate in respiratory therapy.

19. The method according to any one of claims 16 to 18, wherein the respiratory therapy recommendation includes a recommendation to modify the user's participation in the respiratory therapy system.

20. The method according to any one of claims 16 to 19, wherein the respiratory therapy recommendation includes selecting the user interface from a plurality of possible user interfaces.

21. The method according to any one of claims 16 to 20, wherein analyzing the first sensor data to generate the respiratory therapy recommendation comprises: i) Identifying one or more sleep disordered breathing events; ii) Determining a sleep quality score; iii) Determining a general health status score; iv) Detecting head position information; v) Detecting body position information; vi) Identifying mouth breathing; vii) Determining pressure level information; viii) Determining heart rate information; ix) Determining respiratory rate information; x) Determining sympathetic nervous system activation; xi) Determining apnea hypopnea index information; xii) Determining sleep state information; xiii) Determining sleep stage information; xiv) Determining microarousals; xv) Detecting insomnia; xvi) Determining excessive arousal; xvii) Determining hypoxia burden; xviii) Distinguishing central sleep apnea events from obstructive sleep apnea events; xix) Detecting restless legs syndrome; xx) Detecting periodic limb movement disorder; xxi) Detecting rapid eye movement predominant obstructive sleep apnea; xxii) Detecting positional obstructive sleep apnea; xxiii) Detecting arrhythmia; xxiv) Determining blood pressure; xxv) Determining blood glucose level; xxvi) Determining core body temperature; or any combination of i) to xxvi).

22. The method according to any one of claims 16 to 21, the method further comprising: Present the respiratory therapy recommendation to the user or a caregiver associated with the user.

23. The method according to claim 22, the method further comprising: Receive a respiratory therapy prescription from the caregiver in response to presenting the respiratory therapy recommendation to the caregiver.

24. The method according to any one of claims 16 to 23, the method further comprising: Determine physiological data based at least in part on the second sensor data, the physiological data including: i) sleep disordered breathing event information; ii) sleep quality score information; iii) general health status score information; iv) head position information; v) body position information; vi) mouth breathing detection information; vii) pressure level information; viii) heart rate information; ix) respiratory rate information; x) sympathetic nervous system activation information; xi) apnea hypopnea index information; xii) sleep state information; xiii) sleep stage information; or xiv) any combination of i to xiii.

25. The method according to any one of claims 16 to 24, the method further comprising: Provide an additional head-mounted component to an additional user, the additional head-mounted component having an additional electronic module that includes one or more additional sensors; Receive additional first sensor data associated with an additional user who participates in an additional first sleep session while wearing the additional head-mounted component and not receiving respiratory therapy; Analyze the additional first sensor data to generate an additional respiratory therapy recommendation, wherein the additional respiratory therapy recommendation includes a recommendation not to participate in respiratory therapy; And Present the additional respiratory therapy recommendation to the additional user.

26. The method according to claim 25, wherein the recommendation not to participate in respiratory therapy includes a recommendation to participate in an alternative sleep therapy.

27. A system, the system comprising: A control system that includes one or more processors; And A memory having machine-readable instructions stored thereon; Wherein the control system is coupled to the memory, and when the machine-executable instructions in the memory are executed by at least one of the one or more processors of the control system, the method according to any one of claims 1 to 26 is implemented.

28. A system for monitoring sleep, the system comprising a control system configured to implement the method according to any one of claims 1 to 26.

29. A computer program product comprising instructions that, when executed by a computer, cause the computer to execute the method according to any one of claims 1 to 26.

30. The computer program product according to claim 29, wherein the computer program product is a non-transitory computer-readable medium.

31. A system, the system comprising: A head-mounted component having an electronic module that includes one or more sensors, the head-mounted component being wearable in a first configuration to collect first sensor data associated with a user who participates in a first sleep session without receiving respiratory therapy; And A user interface for supplying air from a respiratory therapy device to a user's airway, wherein the head-mounted component is reversibly coupled to the user interface when in a second configuration to collect second sensor data associated with the user's participation in a second sleep session while receiving respiratory therapy via the user interface.

32. The system according to claim 31, wherein the electronic module: i) is detachably coupled to a coupling member of the head-mounted component; or ii) is detachably positioned within a pocket of the head-mounted component.

33. The system according to claim 31 or 32, wherein the head-mounted assembly comprises: i) A headband; ii) An eye pad; iii) An eye mask; iv) A head cap; v) A nose band; vi) Ear plugs; or vii) Any combination of i to vi.

34. The system according to any one of claims 31 to 33, wherein when the head-mounted component is in the second configuration, the electronic module is detachable from the remainder of the head-mounted component and couplable to the user interface.

35. The system according to any one of claims 31 to 33, wherein when the head-mounted component is in the second configuration, the electronic module is coupled to the user interface via a strap.

36. The system according to any one of claims 31 to 35, wherein the user interface or the respiratory therapy device includes an antenna for wirelessly receiving the second sensor data from the electronic module when the head-mounted component is worn in the second configuration.

37. The system according to any one of claims 31 to 36, wherein the user interface or the respiratory therapy device includes an electrical connector shaped to mate with an electrical connector of the head-mounted component.

38. The system according to any one of claims 31 to 37, wherein when in the second configuration, the head-mounted component facilitates fixing the user interface to the user.

39. The system according to claim 38, wherein the user interface includes a detachable strap that facilitates fixing the user interface to the user, and wherein when in the second configuration, at least a portion of the head-mounted component replaces the detachable strap.

40. A head-mounted component comprising: An electronic module including one or more sensors and a coupling member for coupling to a user interface of a respiratory therapy system, wherein the head-mounted component is configured to be worn in a first configuration to collect first sensor data associated with a user participating in a first sleep session without receiving respiratory therapy; and wherein the head-mounted component is configured to be worn in a second configuration and reversibly coupled to the user interface to collect second sensor data associated with the user's participation in a second sleep session while receiving respiratory therapy via the user interface.

41. The head-mounted component according to claim 40, wherein the electronic module: i) is detachably coupled to a coupling member of the head-mounted component; or ii) is detachably positioned within a pocket of the head-mounted component.

42. The head-mounted assembly according to claim 40 or 41, wherein the head-mounted assembly comprises: i) A headband; ii) An eye pad; iii) An eye mask; iv) a headgear; v) a nasal strap; vi) earplugs; or vii) any combination of i to vi.

43. The head-mounted assembly according to any one of claims 40 to 42, wherein when the head-mounted assembly is in the second configuration, the electronic module is detachable from the remainder of the head-mounted assembly and couplable to the user interface.

44. The head-mounted assembly according to any one of claims 40 to 42, wherein when the head-mounted assembly is in the second configuration, the electronic module is coupled to the user interface via a strap.

45. The head-mounted assembly according to any one of claims 40 to 44, wherein the user interface or the respiratory therapy device includes an antenna for wirelessly receiving the second sensor data from the electronic module when the head-mounted assembly is worn in the second configuration.

46. The head-mounted assembly according to any one of claims 40 to 45, wherein the user interface or the respiratory therapy device includes an electrical connector shaped to mate with an electrical connector of the head-mounted assembly.

47. The head-mounted assembly according to any one of claims 40 to 46, wherein when in the second configuration, the head-mounted assembly facilitates securing the user interface to the user.

48. The head-mounted assembly according to claim 47, wherein the user interface includes a detachable strap that facilitates securing the user interface to the user, and wherein when in the second configuration, at least a portion of the head-mounted assembly replaces the detachable strap.

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