EP4735106A1

EP4735106A1 - Stimulation device

Info

Publication number: EP4735106A1
Application number: EP24829621.2A
Authority: EP
Inventors: Mohankumar Krishnan Valiyambath; Ross William Deas
Original assignee: Resmed Pty Ltd
Current assignee: Resmed Pty Ltd
Priority date: 2023-06-28
Filing date: 2024-06-26
Publication date: 2026-05-06
Also published as: CN121568758A; WO2025000028A1

Abstract

The present invention is concerned with a stimulation device that comprises: an airway opener configured to be positioned around a user's neck and, once positioned, physically impact the user's airway patency; and a stimulator provided on the airway opener, the stimulator configured, once the airway opener is in position around the user's neck, to deliver an electric current to a target area on the user.

Description

STIMULATION DEVICE

TECHNICAL FIELD

[1] The present disclosure relates generally to devices and methods for treating sleep-related respiratory disorders, and more particularly, to devices and methods for treating sleep-related respiratory disorders through electrical stimulation.

BACKGROUND

[2] Many individuals suffer from sleep-related respiratory disorders such as, for example, Sleep-Disordered Breathing (SDB), Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR). These disorders are characterized by events such as apneas, hypopneas, hyperpnea, and hypercapnia where the individual’s breathing stops or is disrupted/restricted during sleep. Various systems exist for aiding users experiencing sleep apnea and related respiratory disorders. Some such systems require the user to wear an interface (e.g., mask) that aids in supplying pressurized air to the airway of the user (e.g., a continuous positive airway pressure (CPAP) system). Some users find such systems to be uncomfortable, with the result that ongoing compliance with CPAP therapy suffers. Other systems rely on a surgically implanted stimulator that stimulates nerves/muscles to open the airway. However, these stimulators must be surgically implanted and thus subject the user to the risks and disadvantages that surgery entails.

[3] The present disclosure is directed to providing an alternative solution to addressing sleep- related respiratory disorders.

SUMMARY

[4] In one aspect, the present disclosure is concerned with a stimulation device comprising: an airway opener configured to be positioned around a user’s neck and, once positioned, physically impact the user’s airway patency; and a stimulator provided on the airway opener, the stimulator configured, once the airway opener is in position around the user’s neck, to deliver an electric current to a target area on the user.

[5] The stimulator may comprise one or more stimulating elements positioned on the airway opener such that once the airway opener is in position around the user’s neck, the one or more stimulating elements, once activated, deliver the electrical current to the target area on the user.

[6] In some embodiments, activation of selected ones of the one or more of the stimulating elements is controllable to deliver an electric current to a selected target area on the user, such as branches of a nerve of the user or one or more muscles of the user. These branches of a nerve of the user may be adjacent to the tongue of the user.

[7] In some embodiments, the stimulating elements comprise one or more pairs of spaced apart electrodes defining an electric current path therebetween. The spaced apart electrodes of at least one pair of spaced apart electrodes may be substantially coplanar in a horizontal plane passing through the user’s neck. The spaced apart electrodes of at least one pair of spaced apart electrodes may also be located on different horizontal planes passing through the user’s neck.

[8] The airway opener may be configured to be placed into an airway patency setting selected from a group of two or more airway patency settings, the airway opener, when in an airway patency setting, maintaining the user’s head and/or neck in a specified position to impact the user’s airway patency.

[9] The activation of selected ones of the one or more of the stimulating elements is in some cases controllable to account for the airway patency setting in which the airway opener is currently placed.

[10] In some embodiments, the airway opener comprises a dimension modifier for changing an axial length of the airway opener along a longitudinal axis, the axial length of the airway opener thereby defining the group of two or more airway patency settings. The dimension modifier may take the form of one or more inflation chambers configured to receive an inflation fluid, the inflation fluid once received in the inflation chamber changing the axial length of the airway opener. Alternatively, the dimension modifier takes the form of a motor drive configured to move a driven member along a linear path to thereby change the axial length of the airway opener. In another embodiment, the dimension modifier takes the form of an axial force applying component composed of a shape memory alloy and an elastic component, the axial force applying component and elastic component combining to change the axial length of the airway opener.

[11] The present disclosure also provides a stimulation system comprising: a stimulation device according to the first aspect of the present disclosure; a sensor configured to generate respiration data associated with respiration of the user when the stimulation device is positioned around the user’s neck; a memory storing machine-readable instructions; and a control system including one or more processors configured to execute the machine-readable instructions to: receive respiration data from the sensor; generate a respiration signal for the user, the respiration signal based at least in part on the received respiration data; process the respiration signal to identify one or more sleep-related respiratory disorders; and responsive to identifying the one or more sleep-related respiratory disorders, causing the stimulation device to apply a corrective action to the user, the corrective action comprising the airway opener physically impacting the user’s airway patency and/or the stimulator delivering an electric current to the target area on the user.

[12] The control system may be further configured to execute the machine readable instructions to: receive subsequent respiration data from the sensor; generate a subsequent respiration signal for the user, the subsequent respiration signal based at least in part on the received subsequent respiration data; process the subsequent respiration signal to determine whether the identified one or more sleep-related respiratory disorders is continuing; and responsive to the determination, causing the stimulation device to either cease, modify or continue the corrective action.

[13] The corrective action may further comprise placing the airway opener into a selected airway patency setting that is suitable for treating the identified one or more sleep-related respiratory disorders.

[14] According to some embodiments, the corrective action further comprises activating selected ones of the one or more stimulating elements to deliver electrical stimulation to a target area of the user associated with the selected airway patency setting. The corrective action may further comprise modifying the electrical characteristics of the electrical current to accord with the selected airway patency setting.

[15] In another aspect, the present disclosure provides a method of treating a user for a sleep- related respiratory disorder, comprising: positioning a stimulation device around the user’s neck, the stimulation device comprising: an airway opener configured to be positioned around a user’s neck and, once positioned, physically impact the user’s airway patency; and a stimulator provided on the airway opener, the stimulator configured, once the airway opener is in position around the user’s neck, to deliver an electric current to a target area on the user; monitoring the user for a sleep-related respiratory disorder; and upon detecting a sleep-related respiratory disorder, causing the stimulation device to apply a corrective action to the user, the corrective action comprising the airway opener physically impacting the user’s airway patency and/or the stimulator delivering an electric current to a selected target area on the user.

[16] In another aspect, the present disclosure provides a stimulation device comprising an airway opener configured to be positioned around a user’s neck and, once positioned, to physically impact the user’s airway patency, the airway opener comprising a dimension modifier that is operable to modify one or more dimensions of the airway opener to locate or maintain the user’ s head and/or neck in a specified position to impact the user’s airway patency.

[17] The dimension modifier may be operable to modify an axial length of the airway opener along a longitudinal axis. The dimension modifier may comprise one or more inflation chambers configured to receive an inflation fluid, the inflation fluid once received in the inflation chamber modifying the axial length of the airway opener Alternatively, the dimension modifier may comprise a motor drive configured to move a driven member along a linear path to thereby the axial length of the airway opener. Yet further, the dimension modifier may comprise an axial force applying component composed of a shape memory alloy and an elastic component, the axial force applying component and elastic component combining to modify the axial length of the airway opener.

[18] The airway opener may take the form of a collar.

[19] The above summary is not intended to represent each implementation or every aspect of the present disclosure. Additional features and benefits of the present disclosure are apparent from the detailed description and figures set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

[20] FIG. l is a diagram that illustrates an overview of a respiratory system of a user;

[21] FIG. 2 is a diagram that illustrates an upper airway of the user of FIG. 1A;

[22] FIG 3 is a schematic illustration of a stimulation device according to an embodiment of the present disclosure in place around the neck of a user;

[23] FIG 4 is a further schematic illustration of a stimulation device according to an embodiment of the present disclosure in place around the neck of a user

[24] FIG 5 is a schematic illustration of a first elevation view of a stimulation device according to an embodiment of the present disclosure;

[25] FIG 6 is a schematic illustration of a second elevation view of a stimulation device according to an embodiment of the present disclosure;

[26] FIG 7 is a cross-sectional view of the stimulation device through the plane B-B in FIG 5;

[27] FIG 8 is a cross-sectional view of the stimulation device through the plane C-C in FIG 6;

[28] FIG 9 is a block diagram of a stimulation system according to an embodiment of the present disclosure;

[29] FIG. 10 is a process flow diagram of computing operations performed by a stimulation system according to an embodiment of the present disclosure.

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

DETAILED DESCRIPTION

[31] Referring to FIG 1 and FIG 2, an overview of a respiratory system 12 of a user 10 (e.g., patient) is shown, which generally includes a nasal cavity, an oral cavity, a larynx, vocal folds, an oesophagus, a trachea, a bronchus, lungs, alveolar sacs, a heart, and a diaphragm. More generally, the user 10 has a throat 20, which includes a region(s) of the respiratory system 12 of the user 10 generally in the neck area of the user 10. The diaphragm of the user 10 is a sheet of muscle that extends across the bottom of the rib cage of the user 10. The diaphragm generally separates the thoracic cavity 30 of the user 10, which contains the heart, lungs, and ribs, from the abdominal cavity 40 of the user 10. As the diaphragm contracts, the volume of the thoracic cavity 30 increases and air is drawn into the lungs.

[32] As is described herein and illustrated in FIG 3, the present disclosure provides a stimulation device that incorporates an airway opener to open the user’s 10 airway and one or more stimulators that deliver stimulation (such as electrical and/or magnetic stimulation) to a target area on the user 10. In one embodiment of the present disclosure, the airway opener is a collar 35 that can be positioned around the user’s 10 neck. Owing to the physical structure and other features of the collar 35, once the collar 35 is in place around the user’s neck, the collar 35 holds the user’s head and neck in a position that impacts the patency of the user’s airway.

[33] The collar 35 also includes one or more stimulators that are disposed on the collar and deliver electrical and/or magnetic stimulation to a target area on the user 10, typically in the user’s respiratory system 12. In this way, the collar 35 provides a combination of physical and electrical/magnetic treatment modalities that aid the user 10, for example, in breathing while sleeping.

[34] For example, the stimulators can take the form of discrete stimulation endpoints that are located on diametrically opposed surfaces of collar 35. An electrical current can be caused to flow from one stimulation endpoint to the other, or a magnetic field generated between the two stimulation endpoints and thus deliver electrical or magnetic stimulation to a tongue 16 of the user 10. In another example, the stimulation endpoints can be positioned on opposed surfaces of the collar so that an electrical current flowing from one endpoint to the other, or a magnetic field generated between the two endpoints, delivers electrical or magnetic stimulation to a nerve (e g., hypoglossal nerve 18) and/or nerve branches. The hypoglossal nerve 18 is generally involved in controlling movement of the tongue 16 and includes a plurality of nerve branches distributed to the extrinsic and intrinsic muscles of the tongue 16.

[35] As shown most clearly in Figure 2, a view of an upper airway 14 of the user 10 is shown, which includes the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils (one shown), a lip superior, a lip inferior, the larynx, a hard palate, a soft palate, an oropharynx, a tongue, an epiglottis, the vocal folds, the esophagus, and the trachea.

[36] The respiratory system 12 of the user 10 facilitates gas exchange. The nose 50 and mouth 60 of the user 10 form the entrance to the airways of the user 10. As best shown in FIG. 1, the airways include a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs of the user 10. The prime function of the lungs is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lungs is where the gas exchange takes place, and is referred to as the respiratory zone.

[37] A range of respiratory disorders exist that can impact the user 10. Certain disorders are characterized by particular events (e.g., apneas, hypopneas, hyperpneas, or any combination thereof). Examples of sleep-related and/or respiratory disorders include Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Sleep-Disordered Breathing (SDB), Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and chest wall disorders.

[38] Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB), and is characterized by events including occlusion or obstruction of the upper air passage during sleep resulting from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall. More generally, an apnea generally refers to the cessation of breathing caused by blockage of the air (Obstructive Sleep Apnea) or the stopping of the breathing function (often referred to as central apnea). Other types of apneas include hypopnea, hyperpnea, and hypercapnia. Hypopnea is generally characterized by slow or shallow breathing caused by a narrowed airway, as opposed to a blocked airway. Hyperpnea is generally characterized by an increase depth and/or rate of breathing. Hypercapnia is generally characterized by elevated or excessive carbon dioxide in the bloodstream, typically caused by inadequate respiration.

[39] Cheyne-Stokes Respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive deoxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some users, CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload.

[40] Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inspire sufficient oxygen or exhale sufficient CO2 to meet the user’s needs. Respiratory failure may encompass some or all of the following disorders. A user with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.

[41] Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.

[42] Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common, such as increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposures, air pollution and genetic factors. Symptoms include: dyspnea on exertion, chronic cough and sputum production.

[43] Neuromuscular Disease (NMD) encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Some users suffering from NMD are characterized by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle impairment that worsens over months and results in death within a few years (e.g. amyotrophic lateral sclerosis (ALS) and duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders: characterized by muscle impairment that worsens over years and only mildly reduces life expectancy (e g. limb girdle, Facioscapulohumeral and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalized weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.

[44] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage. The disorders are usually characterized by a restrictive defect and share the potential of long term hypercapnic respiratory failure. Scoliosis and/or kyphoscoliosis may cause severe respiratory failure Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, repeated chest infections, morning headaches, fatigue, poor sleep quality and loss of appetite.

[45] These other disorders are characterized by particular events (e g., snoring, an apnea, a hypopnea, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof) that occur when the individual is sleeping. While these other sleep-related disorders may have similar symptoms as insomnia, distinguishing these other sleep-related disorders from insomnia is useful for tailoring an effective treatment plan distinguishing characteristics that may call for different treatments. For example, fatigue is generally a feature of insomnia, whereas excessive daytime sleepiness is a characteristic feature of other disorders (e g., PLMD) and reflects a physiological propensity to fall asleep unintentionally.

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

[47] One of more of the disorders described herein can be treated using a combination of electrical and/or magnetic stimulation and physical manipulations of the user’s neck and head that impact airway patency. For example, a stimulator located on a collar can provide electrical and/or magnetic stimulation to the user (e.g., a nerve, nerve branch, a muscle, etc.) to aid in preventing an apnea event about to be experienced by the user, while the collar simultaneously manipulates the user’s head and/or neck in a way that assists the stimulation. The assisted electrical stimulation is able to aid in preventing apneas by, for example, causing the one or more muscles to move (e g , contract) and open the airway of the user prior to an apnea occurring. For example, the stimulation device can electrically stimulate the hypoglossal nerve 18 (FIG. 2) to move the tongue 16 to aid in opening the airway to prevent apneas from occurring.

[48] As shown most clearly in FIG 3, a respiratory sensor 36 is also placed in or proximate to the user and measures the respiration of the user. The timing of the stimulation is determined based on respiration data gathered from the respiratory sensor. In other words, the collar 35 forms part of a stimulation system that determines when to stimulate in substantially real-time based on the respiration data. Thus, in these systems, the collar and the respiratory sensor are communicatively coupled via a suitable communication channel so the respiratory sensor can signal the simulator when to stimulate, and for power (e g., to provide power to the respiratory sensor and/or the collar 35).

[49] Referring to FIG 4, one embodiment of collar 35 is illustrated that shows the collar maintain the user’s 10 neck in a first position. Collar 35 is composed of a material (typically foam or plastic) that has the requisite structural properties to rigidly support the user’s 10 neck in a desired position, or apply a force, to impact the patency of the user’s airway, for example when the user is asleep.

[50] In the exemplified embodiment, one or more characteristics of the collar 35 can be modified in order to impart different physical manipulations or forces to the user 10’s head or neck and corresponding impacts on the patency of the user 10’s airway. In addition (and as described below), the modifications to the characteristics of collar 35 can be tailored to assist the stimulation functions of the stimulation device. For example, a characteristic of the collar 35 can be modified so that the stimulators on the collar 35 can more accurately target selected areas on the user 10 with electrical and/or magnetic stimulation.

[51] The various modifiable characteristics of the collar 35 can be accessed by placing the stimulation device into different airway patency settings. For example, in one embodiment, the stimulation device can be placed into a plurality of different airway patency settings, each of which applies a selected force to the user 10’s neck or head, or manipulates the user 10’s head or neck into a selected position that impacts the airway patency in a particular respect. [52] In the exemplified embodiment illustrated in FIG 4, the modifiable characteristic of the collar 35 is the axial length of the collar along the longitudinal axis A-A. As shown in FIG 4, the axial length of the collar 35 is typically modified from the center, with the length of the collar either increasing or decreasing at both ends. In this way, when the axial length of the collar 35 is increased by moving each end of the collar 35, the collar 35 stretches the user 10’s neck In turn, the stretching of the user 10’s neck stretches the airway and applies tension on the airway walls. This tension then reduces or eliminates the airway walls from collapsing, thus addressing sleep-related conditions with etiologies related to collapsing airway walls (for example OSA).

[53] The axial length of the collar 35 can be modified in a variety of ways. In one embodiment, the collar 35 includes one or more inflation chambers that are each configured to receive an inflation fluid, such as air. When the inflation fluid is received or released from the inflation chambers, the axial length of the collar 35 correspondingly increases or decreases.

[54] In another embodiment, the collar 35 includes a motor drive that moves a driven member along a linear path to either increase or decrease the axial length of the airway opener.

[55] In a further embodiment, the collar 35 includes a force applying component that is formed from a shape memory alloy and an elastic component. The intrinsic shape memory properties of the force applying component apply an axial force to the elastic component to either increase or decrease the axial length of the collar 35.

[56] An embodiment of stimulators that are disposed on the collar 35 is illustrated by reference to FIG 5. and FIG 6. In the exemplified embodiment, the collar 35 is illustrated schematically as being generally cylindrical in shape, with FIG 5 and FIG 6 respectively showing a first and second elevation view of the collar 35, with the two views being diametrically opposed to each other. In use, the collar 35 is shaped to coincide with the shape of the user’s neck.

[57] A first 37 and second 39 electrode arrays are located on the wall of the collar in a similarly diametrically opposed relation. In the illustrated embodiment, each array 35 and 37 includes nine discrete electrodes (respectively labelled A-I and J-R) in a generally square configuration. Those skilled in the art will appreciate that alternative numbers of electrodes and electrode configurations could be used.

[58] Each electrode in the first electrode array 37 serves as a first stimulating contact point. Likewise, each electrode in the second electrode array 39 serves as a corresponding second electrical contact point.

[59] The multi-electrode arrays 37 and 39 allow the collar 35 to direct an electrical current along a multitude of different paths both in the horizontal and vertical planes so as to more accurately target the internal muscle or nerve that is to be electrically stimulated. A representative example of current paths in the horizontal plane that includes electrodes A,B C, J, K, L is shown in FIG. 7. Those skilled in the art will appreciate that horizontal current paths are also defined in the other horizontal planes of the electrode arrays 37 and 39. The horizontal current paths allow the current to flow between circumferentially spaced locations on the wall of the collar 35 and stimulate the targeted muscle or nerve as the current traverses the current path between the origin and destination electrodes.

[60] A representative example of current paths in the vertical plane that includes electrodes A,D G, J, M, P is shown in FIG 8. Those skilled in the art will likewise appreciate that vertical current paths are also defined in the other vertical planes of the electrode arrays 37 and 39. The vertical current paths allow the current to flow between axially spaced locations on the wall of the collar 35 and stimulate the targeted muscle or nerve as the current traverses the current path between the origin and destination electrodes.

[61] The plurality of current paths allows the collar 35 to precisely direct electrical stimulation to a target area on the user 10, and to change the target or incidence angle of the electrical stimulation in response to an external event or signal. For example, the target or incidence angle of the electrical stimulation may need to be changed to account for a change in the physical characteristics of the collar 35, such as the collar 35’s axial length. In addition, (and as described below), the target or incidence angle of the electrical stimulation may need to be changed in response to a change in position of the target area on the user 10 or to a detection of a sleep-related respiratory disorder in the user.

[62] Referring to FIG. 9, a system 100, according to some implementations of the present disclosure, is illustrated. The system 100 includes a control system 110, a memory device 114, a respiration monitoring device 120, a stimulation device 130, one or more transmitters 140 (hereinafter, transmitter 140), one or more receivers 142 (hereinafter, receiver 142), a magnetic field generator 144, a wearable 146, one or more external sensors 150, and an external device 180.

[63] The control system 110 includes one or more processors 112 (hereinafter, processor 112). The control system 110 is generally used to control (e g., actuate) the various components of the system 100 and/or analyze data obtained and/or generated by the components of the system 100. The processor 112 can be a general or special purpose processor or microprocessor. While one processor 112 is shown in FIG. 9, the control system 110 can include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.) that can be in a single housing, or located remotely from each other. The control system 110 can be coupled to and/or positioned within, for example, a housing of the external device 180, within a housing 124 of the respiration monitoring device 120, a housing 136 of the stimulation device 130, or any combination thereof. The control system 110 can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct). In such implementations including two or more housings containing the control system 110, such housings can be located proximately and/or remotely from each other.

[64] The memory device 114 stores machine-readable instructions that are executable by the processor 112 of the control system 110. The memory device 114 can be any suitable computer readable storage device or media, such as, for example, a random or serial access memory device, a hard drive, a solid state drive, a flash memory device, etc. While one memory device 114 is shown in FIG. 1, the system 100 can include any suitable number of memory devices 114 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). The memory device 114 can be coupled to and/or positioned within the housing of the respiration monitoring device 120, within the housing 136 of the stimulation device 130, or any combination thereof. Like the control system 110, the memory device 114 can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct).

[65] In some implementations, the memory device 114 (FIG. 1) stores a user profile associated with the user. The user profile can include, for example, demographic information associated with the user, biometric information associated with the user, medical information associated with the user, self-reported user feedback, sleep parameters associated with the user (e.g., sleep-related parameters recorded from one or more earlier sleep sessions), or any combination thereof. The demographic information can include, for example, information indicative of an age of the user, a gender of the user, a race of the user, a family history of insomnia or sleep apnea, an employment status of the user, an educational status of the user, a socioeconomic status of the user, or any combination thereof. The medical information can include, for example, information indicative of one or more medical conditions associated with the user, medication usage by the user, or both. The medical information data can further include a multiple sleep latency test (MSLT) result or score and/or a Pittsburgh Sleep Quality Index (PSQI) score or value. The self-reported user feedback can include information indicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, a recent life event experienced by the user, or any combination thereof. [66] While the control system 110 and the memory device 114 are described and shown in FIG. 9 as being a separate and distinct component of the system 100, in some implementations, the control system 110 and/or the memory device 114 are integrated in the external device 180, and/or in the respiration monitoring device 120. Alternatively, in some implementations, the control system 110 or a portion thereof (e.g., the processor 112) can be located in a cloud (e.g., integrated in a server, integrated in an Internet of Things (loT) device, connected to the cloud, be subject to edge cloud processing, etc.), located in one or more servers (e.g., remote servers, local servers, etc., or any combination thereof.

[67] The respiration monitoring device 120 includes one or more sensors 122, a housing 124, and a power supply 126. The one or more sensors 122 generate data associated with respiration of the user and encode such data into a respiration signal for the user.

[68] The one or more sensors 122 can include any suitable sensor(s) for generated data from which a respiration signal of the user can be determined (e.g., a signal indicative of inhalation and/or exhalation of the user). In some implementations, the one or more sensors 122 includes an air pressure sensor (e g., barometric pressure sensor, gauge, absolute transducer, etc.) that generates data indicative of the respiration (e.g., inhaling and/or exhaling) of the user. The pressure sensor can be, for example, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain-gauge sensor, an optical sensor, a potentiometric sensor, or any combination thereof. In some implementations, the one or more sensors 122 includes an air flow sensorthat generates data indicative the respiration (e g., inhaling and/or exhaling) of the user. In some implementations, the one or more sensors 122 includes a motion sensor that generates motion data indicative the respiration (e.g., inhaling and/or exhaling) of the user. In some implementations, the one or more sensors 122 includes an acoustic sensor (e.g., including a microphone and/or a speaker) that generates data indicative of the respiration (e.g., inhaling and/or exhaling) of the user. In other implementations, the one or more sensors 122 includes an electromyography (EMG) sensor that generates data indicative of the respiration (e.g., inhaling and/or exhaling) of the user. In some implementations, the one or more sensors 122 includes a photoplethysmograph (PPG) sensor that generates data indicative of the respiration (e.g., inhaling and/or exhaling) of the user. In other implementations, the one or more sensors 122 includes an oxygen sensor that generates data indicative of a blood oxygen level or oxygen saturation (SpCh), which in turn are indicative of respiration (e.g., inhaling and/or exhaling) of the user.

[69] The sensor(s) 122 can be powered by the power supply 126. The power supply 126 can be, for example, a battery (e.g., a rechargeable battery). In some implementations, the power supply 126 can be recharged by the magnetic field generator 144 and/or the external device 180. Alternatively to the respiration monitoring device 120 including the power supply 126, in some implementations, power for the sensor(s) is supplied wirelessly by the magnetic field generator 144 (which can be included in the external device 180) directly to the electrical sensor(s).

[70] In addition to the sensor(s) 122 and power supply 126 being coupled to or integrated in the housing 124, a number of other elements of the system 100 can be coupled to the housing 124 and placed into the user 10. By coupled to the housing 124 it is meant that the element coupled to the housing 124 is completely incased within the housing 124, attached to an exterior surface of the housing 124, partially protruding from one or more openings in the housing 124, directly or indirectly attached to the housing 124, or any combination thereof. For example, in some implementations, one or more of the transmitters 140 and/or one or more of the receivers 142 can be coupled to or integrated in the housing 124.

[71] In such implementations, the transmitter 140 and/or receiver 142 allow the respiration monitoring device 120 to wirelessly communicate (e.g., using a Bluetooth communication protocol, a WiFi communication protocol, or any other suitable RF communication protocol) with the control system 110, the stimulation device 130, the external device 180 or any combination thereof (e.g., to transmit data generated by the sensor(s) 122 for analysis by the control system 110). If Bluetooth is used the wireless communication frequency is in the MHz range, whereas breaching frequency is about 15 Hz. Thus, the data the respiration monitoring device 120 can be wirelessly transmitted (e.g., to the control system 110) before the next inhalation and/or exhalation of the user.

[72] The stimulation device 130 includes a simulator 132, a housing 136, and a power supply 138. As described herein, the stimulation device 130 is in the form of the collar 35 exemplified above that includes electrodes that stimulate one or more branches of a nerve (e.g., a hypoglossal nerve) at a determined stimulation time.

[73] Once the collar 35 is positioned around the user 10’s neck, the electrode arrays 37 and 39 are capable of delivering electrical and/or magnetic stimulation to the user 10 to aid in causing the one or more muscles of the user 10 to contract. The contraction of the one or more muscles of the user 10 can aid in opening an airway of the user 10. The contraction can alternatively or additionally aid in causing the user 10 to have breathing effort (e.g., causing the diaphragm to draw/suck in air). The electrical stimulation can be applied directly to the one or more muscles of the user 10 (e.g., muscles in the tongue of the user 10, muscles surrounding and/or adjacent to the tongue of the user 10, neck muscles, throat muscles, the palate, other soft issue generally in or around the airway of the user, etc.) and/or directly to the one or more nerves that are connected to the one or more muscles. Directing the electrical stimulation to the one or more nerves (as opposed to the one or more muscles directly) allows for a relatively lower intensity (e.g., voltage, amperage, etc. or any combination thereof) of the electrical stimulation to be applied to cause the one or more muscles (connected to the one or more nerves) to contract.

[74] A number of other elements of the system 100 can be coupled to the housing 136. By coupled to the housing 136 it is meant that the element coupled to the housing 136 is completely incased within the housing 136, attached to an exterior surface of the housing 136, partially protruding from one or more openings in the housing 136, directly or indirectly attached to the housing 136, or any combination thereof. For example, in some implementations, one or more of the transmitters 140 and/or one or more of the receivers 142 can be coupled to or integrated in the housing 136. In such implementations, the transmitter 140 and/or receiver 142 allow the respiration monitoring device 120 to wirelessly communicate (e.g., using a Bluetooth communication protocol, a WiFi communication protocol, or any other suitable RF communication protocol) with the control system 110, the respiration monitoring device 120, or any combination thereof (e.g., to transmit a signal to actuate the stimulator 132 to deliver electrical stimulation). In other implementations, the transmitter 140 and the receiver 142 are combined as a transceiver.

[75] In some implementations, the stimulation device 130 can be configured to automatically stimulate the user even if the respiration monitoring device 120 has failed (e.g., the respiration monitoring device 120 has ran out of battery or is no longer receiving power from the magnetic field generator 144). In such implementations, the stimulation device 130 can be configured to stimulate at a 50% duty cycle to continue to stimulate the tongue and to aid in keeping the airway clear during inspiration. While the stimulation may not occur at the optimal stimulation time and this may consume more power in the stimulation device 130, the user will receive at least some benefit from the automatic stimulation. The user can be alerted to any failures (e.g., of the respiration monitoring device 120) by the external device 180.

[76] While the system 100 has been described herein as including one respiration monitoring device 120, the system 100 more generally can include any suitable number of respiration monitoring devices that are the same as, or similar to, the respiration monitoring device 120 (e.g., 2, 3, 5, 10, etc.). Having multiple respiration monitoring devices can be advantageous, for example, to provide redundancy in case another respiration monitoring device fails (e.g., runs out of battery or power) and to provide more respiration data for more accurate determinations of the respiration signal.

[77] The wearable(s) 146 can be worn by the user and are generally used to position the magnetic field generator 144 adjacent to the respiration monitoring device 120 and/or the stimulation device 130 to provide power as described herein. The wearable(s) 146 can include a belt, a collar, a patch (e.g., an adhesive patch), clothing, a sleeve, a bracelet, a necklace, a watch, or any combination thereof. The magnetic field generator 144 can be embedded in the wearable 146 and/or removable from the wearable 146.

[78] The one or more external sensors 150 of the system 100 can be used to validate data from the respiration monitoring device 120 and/or to generate or obtain different physiological data associated with the user. In some implementations, the one or more external sensors 150 can be used instead of the respiration monitoring device 120 to generate data associated with respiration of the user. The one or more external sensors 150 can include an oxygen sensor 152, a motion sensor 154, a camera 156, an acoustic sensor 158, a radio-frequency (RF) sensor 164, a PPG sensor 170, a capacitive sensor 172, a force sensor 174, a strain gauge sensor 176, an EMG sensor 178, and an electrocardiogram (ECG) sensor 179, or any combination thereof. Data from the sensor(s) 150 can be received and stored in the memory device 114 or one or more other memory devices.

[79] The oxygen sensor 152 outputs oxygen data indicative of an oxygen concentration of gas (e.g., in the blood of the user). The oxygen sensor 152 can be, for example, a pulse oximeter sensor an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or any combination thereof.

[80] The motion sensor 154 outputs motion data that is indicative of movement of the user. The motion data from the motion sensor 154 can be used by the control system 110 to determine movement of the user (e.g., respiration). The camera 156 outputs image data reproducible as one or more images (e.g., still images, video images, thermal images, or a combination thereof) that can be stored in the memory device 114. The image data from the camera 156 can be used by the control system 110 to determine movement of the user (e.g., respiration).

[81] The microphone 160 outputs sound data that can be stored in the memory device 114 and/or analyzed by the processor 112 of the control system 110. The microphone 160 can be used to record sound(s) to determine (e.g., using the control system 110) a respiration signal for the user. The speaker 162 outputs sound waves that are audible to a user of the system 100. The speaker 162 can be used, for example, as an alarm clock or to play an alert or message to the user. [82] In some implementations, the microphone 160 and the speaker 162 can be combined into an acoustic sensor 158, as described in, for example, WO 2018/050913, which is hereby incorporated by reference herein in its entirety. In such implementations, the speaker 162 generates or emits sound waves at a predetermined interval and the microphone 160 detects the reflections of the emitted sound waves from the speaker 162. The sound waves generated or emitted by the speaker 162 have a frequency that is not audible to the human ear (e.g., below 20 Hz or above around 18 kHz). Based at least in part on the data from the microphone 160 and/or the speaker 162, the control system 110 can determine movement of the user (e.g., respiration).

[83] The RF transmitter 168 generates and/or emits radio waves having a predetermined frequency and/or a predetermined amplitude (e.g., within a high frequency band, within a low frequency band, long wave signals, short wave signals, etc ). The RF receiver 166 detects the reflections of the radio waves emitted from the RF transmitter 168, and this data can be analyzed by the control system 110 to determine movement of the user. While the RF receiver 166 and RF transmitter 168 are shown as being separate and distinct elements in FIG. 2, in some implementations, the RF receiver 166 and RF transmitter 168 are combined as a part of an RF sensor 164. In some such implementations, the RF sensor 164 includes a control circuit. The specific format of the RF communication could be WiFi, Bluetooth, etc.

[84] In some implementations, the RF sensor 164 is a part of a mesh system. One example of a mesh system is a WiFi mesh system, which can include mesh nodes, mesh router(s), and mesh gateway(s), each of which can be mobile/movable or fixed. In such implementations, the WiFi mesh system includes a WiFi router and/or a WiFi controller and one or more satellites (e.g., access points), each of which include an RF sensor that the is the same as, or similar to, the RF sensor 164. The WiFi router and satellites continuously communicate with one another using WiFi signals. The WiFi mesh system can be used to generate motion data based on changes in the WiFi signals (e.g., differences in received signal strength) between the router and the satellite(s) due to an object or person moving partially obstructing the signals. The motion data can be indicative of motion, breathing, heart rate, gait, falls, behavior, etc., or any combination thereof.

[85] The PPG sensor 170 outputs physiological data associated with the user that can be used to determine, for example, a heart rate, a heart rate variability, a cardiac cycle, respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, estimated blood pressure parameter(s), or any combination thereof. [86] The capacitive sensor 172, the force sensor 174, and the strain gauge sensor 176 output data that can be stored in the memory device 114 and used by the control system 110 to determine movement of the user (e.g., respiration). The EMG sensor 178 outputs physiological data associated with electrical activity produced by one or more muscles. The ECG sensor 179 outputs physiological data associated with electrical activity of the heart of the user. In some implementations, the ECG sensor 179 includes one or more electrodes that are positioned on or around a portion of the user.

[87] While shown separately in FIG. 8, any combination of the one or more sensors 130 can be integrated in and/or coupled to any one or more of the components of the system 100, including the respiration monitoring device 120, the stimulation device 130, the control system 110, the external device 180, or any combination thereof.

[88] In some implementations, the one or more external sensors 150 also include one or more of a temperature sensor, an EEG sensor, an analyte sensor, a moisture sensor, and a Light Detection and Ranging (LiDAR) sensor. The LiDAR sensor can be used for depth sensing. This type of optical sensor (e.g., laser sensor) can be used to detect objects and build three dimensional (3D) maps of the surroundings, such as of a living space. LiDAR can generally utilize a pulsed laser to make time of flight measurements. LiDAR is also referred to as 3D laser scanning. In an example of use of such a sensor, a fixed or mobile device (such as a smartphone) having a LiDAR sensor can measure and map an area extending 5 meters or more away from the sensor. The LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor, for example. The LiDAR sensor(s) can also use artificial intelligence (Al) to automatically geofence RADAR systems by detecting and classifying features in a space that might cause issues for RADAR systems, such a glass windows (which can be highly reflective to RADAR). LiDAR can also be used to provide an estimate of the height of a person, as well as changes in height when the person sits down, or falls down, for example. LiDAR may be used to form a 3D mesh representation of an environment. In a further use, for solid surfaces through which radio waves pass (e.g., radio-translucent materials), the LiDAR may reflect off such surfaces, thus allowing a classification of different type of obstacles.

[89] The external device 180 includes a display device 182. The external device 180 can be, for example, a mobile device such as a smart phone, a tablet, a laptop, or the like. Alternatively, the external device 180 can be an external sensing system, a television (e.g., a smart television) or another smart home device (e g., a smart speaker(s) such as Google Home, Amazon Echo, Alexa etc ). In some implementations, the external device 180 is a wearable device (e.g., a smart watch). The display device 182 is generally used to display image(s) including still images, video images, or both. In some implementations, the display device 182 acts as a human-machine interface (HMI) that includes a graphical user interface (GUI) configured to display the image(s) and an input interface. The display device 182 can be an LED display, an OLED display, an LCD display, or the like. The input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the external device 180. In some implementations, one or more external devices can be used by and/or included in the system 100.

[90] While system 100 is shown as including all of the components described above, more or fewer components can be included in a system for aiding a user (e.g., in breathing) according to implementations of the present disclosure. For example, a first alternative system includes the control system 110, the memory device 114, the respiration monitoring device, and the stimulation device. As another example, a second alternative system includes the control system 110, the memory device 114, the respiration monitoring device 120, the stimulation device 130, and the external device 180. As yet another example, a third alternative system includes the respiration monitoring device 120 and the stimulation device 130. Thus, various systems can be formed using any portion or portions of the components shown and described herein and/or in combination with one or more other components.

[91] Referring to FIG. 10, the computing operations 200 performed by the processor 112 according to some implementations of the present disclosure is illustrated.

[92] Step 201 of the operations 200 includes receiving data associated with respiration of the user. For example, step 201 can include receiving data from the respiration monitoring device 120 (FIG. 8). In some implementations, the respiration data can be transmitted from the respiration monitoring device 120 and received by the memory device 114 for analysis by the processor 112 of control system 110. In other implementations, the respiration data can be transmitted from the respiration monitoring device 120 and received by the external device 180.

[93] Step 202 includes generating a respiration signal for the user based at least in part on the data associated with respiration of the user. The respiration signal is indicative of respiration (e.g., inhalation and exhalation) of the user and can be determined by, for example, the control system 110.

[94] Step 203 includes processing the respiration signal to identify one or more sleep-related respiratory disorders therein. The processor 112 can apply any suitable signal processing routines (that are typically stored in memory 114) to the respiration signal to identify the one or more sleep-related respiratory disorders. For example, the signal processing routine may involve comparing the respiration signal to a stored signal, decomposing the respiration signal into characteristic frequencies associated with sleep-related respiratory disorders, or machine learning techniques.

[95] Step 204 includes the processor determining whether the processing step 203 indicated the presence of a sleep-related respiratory disorder in the respiration signal. In the event that no disorder is identified, the operations return to step 202 where the processor 112 awaits the receipt of further respiration data.

[96] In the event that a sleep-related respiratory disorder is identified in the respiration signal, the operations proceed to step 204, at which the processor causes the collar 35 to apply a corrective action to the user 10. The corrective actions that are applied to the user include one or more of the physical and/or electrical modalities that the collar 35 is capable of applying to the user.

[97] For example, the corrective action may include placing the collar 35 into one of the selected airway patency setting that is suitable for treating the identified one or more sleep- related respiratory disorders. The corrective action may also include activating selected ones of the plurality of electrodes to deliver electrical stimulation to a target area of the user that has a clinical effect in treating the identified one or more sleep-related respiratory disorders. For example, when OSA is identified in the respiratory signal, the corrective action may involve activating selected electrodes to target the hypoglossal nerve of the user.

[98] The corrective actions applied to the user can also be continued, ceased or modified in response to receiving and processing subsequent respiration data. For example, if a subsequent respiration signal indicates that the sleep-related respiratory disorder is no longer occurring, the corrective action will typically be continued. Conversely, if a subsequent respiration signal indicates that the sleep-related respiratory disorder is continuing, the corrective action will typically be ceased or modified.

[99] Modifying the corrective action can involve applying the electrical and physical modalities sequentially. For example, the neck extension can be applied first. If a sleep-related respiratory disorder is detected as continuing, then extension can be increased and/or electrical stimulation can be applied. The treatment modalities can also be titrated to find the minimal effective stimulation that ceases the sleep-related respiratory order.

[100] One or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of claims 1-24 below can be combined with one or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of the other claims 1-24 or combinations thereof, to form one or more additional implementations and/or claims of the present disclosure.

[101] While the present disclosure has been described with reference to one or more particular embodiments or implementations, those skilled in the art will recognize that many changes may be made thereto without departing from the spirit and scope of the present disclosure. Each of these implementations and obvious variations thereof is contemplated as falling within the spirit and scope of the present disclosure. It is also contemplated that additional implementations according to aspects of the present disclosure may combine any number of features from any of the implementations described herein.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A stimulation device comprising: an airway opener configured to be positioned around a user’ s neck and, once positioned, physically impact the user’s airway patency; and a stimulator provided on the airway opener, the stimulator configured, once the airway opener is in position around the user’s neck, to deliver an electric current to a target area on the user.

2. A stimulation device according to claim 1, wherein the stimulator comprises one or more stimulating elements positioned on the airway opener such that once the airway opener is in position around the user’s neck, the one or more stimulating elements, once activated, deliver the electric current to the target area on the user.

3. A stimulation device according to claim 2, wherein activation of selected ones of the one or more of the stimulating elements is controllable to deliver the electric current to a selected target area on the user.

4. A stimulation device according to claim 3, wherein the selected target area comprises branches of a nerve or one or more muscles of the user.

5. A stimulation device according to claim 4, wherein the branches of a nerve of the user are adjacent to the tongue of the user.

6. A stimulation device according to claim 2, wherein the stimulating elements comprise one or more pairs of spaced apart electrodes defining an electric current path therebetween.

7. A stimulation device according to claim 6, wherein the spaced apart electrodes of at least one pair of spaced apart electrodes are substantially coplanar in a horizontal plane passing through the user’s neck.

8. A stimulation device according to claim 6, wherein the spaced apart electrodes of at least one pair of spaced apart electrodes are located on different horizontal planes passing through the user’s neck.

9. A stimulation device according to claim 3, wherein the airway opener is configured to be placed into an airway patency setting selected from a group of two or more airway patency settings, the airway opener, when in an airway patency setting, maintaining the user’s head and/or neck in a specified position to impact the user’s airway patency.

10. A stimulation device according to claim 9, wherein the activation of selected ones of the one or more of the stimulating elements is controllable to account for the airway patency setting in which the airway opener is currently placed.

11. A stimulation device according to claim 9, wherein the airway opener comprises a dimension modifier for changing an axial length of the airway opener along a longitudinal axis, the axial length of the airway opener thereby defining the group of two or more airway patency settings.

12. A stimulation device according to claim 11, wherein the dimension modifier comprises one or more inflation chambers configured to receive an inflation fluid, the inflation fluid once received in the inflation chamber changing the axial length of the airway opener.

13. A stimulation device according to claim 11, wherein the dimension modifier comprises a motor drive configured to move a driven member along a linear path to thereby change the axial length of the airway opener.

14. A stimulation device according to claim 11, wherein the dimension modifier comprises an axial force applying component composed of a shape memory alloy and an elastic component, the axial force applying component and elastic component combining to change the axial length of the airway opener.

15. A stimulation system comprising: a stimulation device according to any one of the preceding claims; a sensor configured to generate respiration data associated with respiration of the user when the stimulation device is positioned around the user’s neck; a memory storing machine-readable instructions; and a control system including one or more processors configured to execute the machine- readable instructions to: receive respiration data from the sensor; generate a respiration signal for the user, the respiration signal based at least in part on the received respiration data; process the respiration signal to identify one or more sleep-related respiratory disorders; and responsive to identifying the one or more sleep-related respiratory disorders, causing the stimulation device to apply a corrective action to the user, the corrective action comprising the airway opener physically impacting the user’s airway patency and/or the stimulator delivering or modifying a characteristic of the electric current delivered to the target area on the user.

16. A stimulation system according to claim 15, wherein the control system is further configured to execute the machine readable instructions to: receive subsequent respiration data from the sensor; generate a subsequent respiration signal for the user, the subsequent respiration signal based at least in part on the received subsequent respiration data; process the subsequent respiration signal to determine whether the identified one or more sleep-related respiratory disorders is continuing; and responsive to the determination, causing the stimulation device to either cease, modify or continue the corrective action.

17. A stimulation device according to claim 15, wherein the corrective action further comprises placing the airway opener into a selected airway patency setting that is suitable for treating the identified one or more sleep-related respiratory disorders.

18. A stimulation device according to claim 17, wherein the corrective action further comprises activating selected ones of the one or more stimulating elements to deliver an electric current to a target area of the user associated with the selected airway patency setting.

19. A stimulation device according to claim 17, wherein the corrective action further comprises modifying the electrical characteristics of the electrical current to accord with the selected airway patency setting.

20. A method of treating a user for a sleep-related respiratory disorder, comprising: positioning a stimulation device around the user’s neck, the stimulation device comprising: an airway opener configured to be positioned around a user’s neck and, once positioned, physically impact the user’s airway patency; and a stimulator provided on the airway opener, the stimulator configured, once the airway opener is in position around the user’s neck, to deliver an electric current to a target area on the user; monitoring the user for a sleep-related respiratory disorder; and upon detecting a sleep-related respiratory disorder, causing the stimulation device to apply a corrective action to the user, the corrective action comprising the airway opener physically impacting the user’s airway patency and/or the stimulator delivering the electric current to a selected target area on the user.