Eye mask system

Abstract

An eye mask system for providing respiratory pressure therapy (RPT) for the treatment of sleep-disordered breathing, the eye mask system including: an eye mask configured to cover a user's eyes in use; and one or more transducers configured to affect the user's sleep and / or detect the user or characteristics of the user's sleep. The eye mask system may include a connection port for receiving a pressurized air flow or a flow generator, and the eye mask system may include a plenum chamber, a seal-forming structure for forming a seal with the user's facial area, and a vent for allowing gases exhaled by the user to flow to the environment. The eye mask system may operate in a non-therapy mode that does not provide RPT to the user and a therapy mode that provides RPT to the user.

Description

【Technical Field】 【0001】 1 Cross - reference to related applications This application claims the priority of Australian Patent Application No. 2020902195 and Australian Patent Application No. 2020902196, and the entire contents of each of these are incorporated herein by reference. 【Background Art】 【0002】 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory - related disorders. This technology also relates to medical devices or apparatuses and their use. 2.2 Description of related technologies 2.2.1 The human respiratory system and its disorders 【0003】 The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airways. 【0004】 The airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The main function of the lungs is gas exchange, which enables the transfer of oxygen from the inhaled air into the venous blood and the transfer of carbon dioxide in the opposite direction. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi constitute the conducting airways and are not involved in gas exchange. The airways further divide and connect to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory region. See Non - Patent Document 1. 【0005】 There are various respiratory disorders. Certain disorders may be characterized by specific events (e.g., apnea, hypopnea, and hyperpnea). 【0006】 Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory dysfunction, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disorders (NMD), and chest wall disorders. 【0007】 Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events including obstruction or closure of the upper airway during sleep. This is a result of a combination of an abnormally small upper airway and a normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharynx during sleep. When affected, a patient's breathing typically stops for periods of 30 to 120 seconds, sometimes as many as 200 to 300 times a night. This often results in excessive daytime sleepiness and can contribute to cardiovascular disease and brain injury. This syndrome is a common disorder, particularly prevalent in overweight middle-aged men, although those affected may not be aware of the problem. See Patent Document 1 (Sullivan). 【0008】 Various therapies have been used to treat or improve such diseases. Furthermore, even otherwise healthy individuals can utilize such therapies to prevent the onset of respiratory problems. However, these therapies have numerous shortcomings. 2.2.2 Therapy 【0009】 A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) have been used to treat one or more of the aforementioned respiratory disorders. 2.2.2.1 Respiratory pressure therapy 【0010】 Respiratory pressure therapy (as opposed to negative pressure therapy, such as tank ventilators or positive / negative pressure external ventilators (cuirass)) involves applying a controlled target pressure, nominally positive relative to the atmosphere, to the airway inlet throughout the patient's entire respiratory cycle. 【0011】 Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as an air pressure splint, preventing upper airway obstruction by pushing the soft palate and tongue forward and backward against the posterior oropharyngeal wall. Treatment of OSA with CPAP therapy can be voluntary, and patients may choose not to follow the therapy if they notice one or more of the following about the devices used to deliver such therapy: discomfort, difficulty of use, high cost, and poor aesthetics. 2.2.3 Respiratory Therapy System 【0012】 These respiratory therapies may be provided by respiratory therapy systems or devices. Such systems and devices may also be used for screening, diagnosing, or monitoring diseases without treating them. 【0013】 A respiratory therapy system may include respiratory pressure therapy devices (RPT devices), air circuits, humidifiers, patient interfaces, oxygen sources, and data management. 2.2.3.1 Patient Interface 【0014】 A patient interface may be used to provide the wearer with an interface to a respiratory device, for example, by providing airflow to the entrance to the airway. Airflow may be provided to the nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy applied, the patient interface may, for example, form a seal with the area of ​​the patient's face to facilitate gas delivery at a pressure sufficiently different from the ambient pressure to produce a therapeutic effect, such as a positive pressure of approximately 10 cmH2O relative to the ambient pressure. In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas to the airway at a positive pressure of approximately 10 cmH2O. 【0015】 Certain other mask systems may be functionally unsuitable in this field. For example, masks intended purely for decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to prevent water from entering due to higher external pressures, but not to maintain internal air at a pressure higher than the surroundings. 【0016】 Certain masks, for example, that block airflow through the nose and allow airflow only through the mouth, may be clinically undesirable in this technology. 【0017】 In certain masks, if the patient has to insert a portion of the mask structure into their mouth and create and maintain a seal through their lips, this technology may be uncomfortable or impractical. 【0018】 Certain masks may be impractical for use during sleep, for example, when sleeping on your side in bed with your head resting on a pillow. 【0019】 Numerous challenges exist in designing patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary considerably from person to person. Different areas of the face respond differently to mechanical forces because the head contains bone, cartilage, and soft tissue. The jaw or mandible can move relative to other bones of the skull. The entire head can move during respiratory therapy. 【0020】 Due to these challenges, some masks have one or more of the following problems, especially when worn for extended periods or when the patient is unfamiliar with the system: they are too conspicuous, have undesirable aesthetics, are expensive, have a poor fit, are difficult to use, and are uncomfortable. Using the wrong size mask can lead to decreased compliance, reduced comfort, and a poorer patient outcome. While pilot masks, masks designed as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for administering anesthetics may be tolerable on their first use, they can be undesirably uncomfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient compliance with therapy, especially if the mask needs to be worn during sleep. 【0021】 CPAP therapy is highly effective in treating certain respiratory disorders when patients follow the therapy schedule. Patients may not follow the therapy if the mask is uncomfortable or difficult to use. Patients are often advised to wash their masks regularly, so if cleaning the mask is difficult (e.g., difficult to assemble or disassemble), patients may not wash their masks, which can affect patient compliance. 【0022】 Masks designed for other purposes (e.g., for pilots) may be unsuitable for treating sleep-disordered breathing, while masks designed for treating sleep-disordered breathing may be suitable for other purposes. 【0023】 For these reasons, patient interfaces for CPAP delivery during sleep constitute a separate field. 2.2.3.1.1 Seal-forming structure 【0024】 The patient interface may include a seal-forming structure. Because this structure comes into direct contact with the patient's face, its shape and configuration can directly affect the effectiveness and comfort of the patient interface. 【0025】 The patient interface can be partially characterized according to the design intent of the position where the seal-forming structure engages with the face during use. In one form of the patient interface, the seal-forming structure can include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed to be placed, for example, on the upper lip region and the nasal bridge region of the face. In one form of the patient interface, the seal-forming structure can include an element that surrounds the mouth region during use, for example, by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces include, for the manufacturers thereof, nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks, and may be known by a variety of names. 【0026】 A seal-forming structure that may be effective in one region of a patient's face may be inappropriate in another region, for example, due to different shapes, structures, variabilities, and sensitivity regions of the patient's face. For example, the seal on swimming goggles placed on a patient's forehead may be inappropriate for use on the patient's nose. 【0027】 A particular seal-forming structure can be designed for mass production to fit one design for a wide range of different face shapes and sizes and be comfortable and effective. If there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, it is necessary to adapt one or both to form a seal. 【0028】 One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal the patient's face when force is applied to the patient interface while the seal-forming structure is engaged with the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. In this type of seal-forming structure, if the fit is insufficient, a gap will occur between the seal-forming structure and the face, requiring additional force to press the patient interface against the face and achieve a seal. 【0029】 Another type of seal-forming structure incorporates a thin flap seal positioned around the periphery of the mask to provide a self-sealing effect, making contact with the patient's face when positive pressure is applied inside the mask. Similar to previous styles of seal-forming sections, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage from the mask may occur. Furthermore, if the shape of the seal-forming structure does not conform to the patient's shape, this may result in creases or buckling during use, leading to leakage. 【0030】 Another type of seal-forming structure may include a friction-fitting element for insertion into the nostrils, for example, but some patients find this uncomfortable. 【0031】 Another form of seal-forming structure may achieve a seal using an adhesive. Some patients may find it inconvenient to have adhesive constantly applied to their face or to remove it. 【0032】 The technologies for various patient interface seal formation structures are disclosed in the following patent applications, which have been transferred to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785. 【0033】 One form of nasal pillow can be found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), which was transferred to Puritan-Bennett Corporation. 【0034】 ResMed Limited manufactures the following products incorporating a nasal pillow: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask, and MIRAGE LIBERTY® Full Face Mask. The following patent applications, assigned to ResMed Limited, describe examples of nose pillow masks: International Patent Application WO2004 / 073, 778 (in particular, describing aspects of ResMed Limited's SWIFT® nose pillow); U.S. Patent Application 2009 / 0044808 (in particular, describing aspects of ResMed Limited's SWIFT® LT nose pillow); International Patent Applications WO2005 / 063, 328 and WO2006 / 130, 903 (in particular, describing aspects of ResMed Limited's MIRAGE LIBERTY® full-face mask); and International Patent Application WO2009 / 052, 560 (in particular, describing aspects of ResMed Limited's SWIFT® FX nose pillow). 2.2.3.1.2 Positioning and Stabilization 【0035】 The seal-forming structures of patient interfaces used in positive pressure air therapy are subjected to corresponding forces from air pressure that can hinder the seal. Therefore, various techniques have been employed to position the seal-forming structures and maintain a sealed relationship with the appropriate part of the face. 【0036】 In one technique, adhesives are used. See, for example, U.S. Patent Application Publication US2010 / 0000534. However, the use of adhesives can be unpleasant for some people. 【0037】 In other techniques, one or more straps and / or stabilizing harnesses are used. Many such harnesses have one or more of the following problems: poor fit, bulkiness, discomfort, and unnaturalness when used. 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices 【0038】 Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the numerous therapies mentioned above, for example, by operating the device to generate an airflow for delivery to an interface with the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Therefore, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators. 【0039】 Pneumatic generators are known for a variety of applications, such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that are not met by more general pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may have deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability. 【0040】 One example of a specific requirement for a particular RPT device is acoustic noise. 【0041】 Table of noise output levels for conventional RPT devices (measured for only one sample in CPAP mode at 10 cmH2O using the test method specified in ISO 3744). 【0042】 [Table 1] 【0043】 One known RPT device used to treat sleep-disordered breathing is the S9 sleep therapy system manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can treat numerous diseases (to name few, NMD, OHS, and COPD) by providing invasive and non-invasive, independent ventilation assistance to a variety of patients. 【0044】 The ResMed Elisee® 150 ventilator and the ResMed VSIII® ventilator can treat a wide range of diseases by providing invasive and non-invasive dependent ventilation assistance suitable for adult or pediatric patients. These ventilators offer volumetric and pneumatic ventilation modes using single-branch or double-branch circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface as described above. 【0045】 Device designers may be presented with countless options. Design criteria often conflict, meaning that certain design choices may deviate significantly from convention, or even be unavoidable. Furthermore, the comfort and effectiveness of a particular design may be highly sensitive to even minor changes in one or more parameters. 2.2.3.3 Air Circuit 【0046】 An air circuit is a conduit or tube constructed and positioned to allow airflow to move between two components of a respiratory therapy system (e.g., an RPT device and a patient interface) during use. In some cases, an air circuit may have separate branches for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation. 2.2.3.4 Humidifier 【0047】 Delivering airflow without humidification can lead to airway dryness. When a humidifier is used with the RPT device and patient interface, humidifying gas is produced, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, applying warm air to the facial area within and around the patient interface generally provides greater comfort than cool air. Therefore, humidifiers often have the capability to humidify the airflow as well as heat it. 【0048】 While various artificial humidification devices and systems are known, they may not meet the specific requirements of medical humidifiers. 【0049】 Medical humidifiers are typically used in places where patients may be sleeping or at rest (e.g., hospitals) to increase the humidity and / or temperature of an airflow relative to the ambient air as needed. Medical humidifiers placed by the bedside can be small. They may be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the surrounding environment. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can humidify the air inhaled by the patient through breathing, but these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers. 【0050】 While numerous medical humidifiers are known, they may have one or more shortcomings. Some medical humidifiers may not provide sufficient humidification, while others may be difficult or inconvenient for patients to use. 2.2.3.5 Data Management 【0051】 For clinical reasons, data may be collected to determine whether a patient prescribed respiratory therapy has “complied” (for example, whether the patient has used their RPT device in accordance with one or more “compliance rules”). An example of a compliance rule for CPAP therapy is that a patient must use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period in order to be considered compliant. To determine patient compliance, the provider of the RPT device (e.g., the healthcare provider) may manually collect data describing the patient’s therapy using the RPT device, calculate the usage rate over a given period, and compare it to the compliance rules. If the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, they may notify third parties that the patient is compliant. 【0052】 In patient therapy, there may be other ways in which patients benefit from the transmission of therapeutic data to a third party or external system. 【0053】 Existing processes for transmitting and managing such data may be expensive, time-consuming, and prone to errors. 2.2.3.6 Ventilation Technology 【0054】 Some forms of treatment systems may include vents to flush out exhaled carbon dioxide. These vents may allow gas to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings). 【0055】 The vents may include orifices, through which gas can flow when the mask is in use. Many such vents are noisy. In other cases, they may be blocked during use, resulting in insufficient rinsing. Some vents may disturb the sleep of 1100 people sharing a bed with 1000 patients, for example, due to noise or concentrated airflow. 【0056】 ResMed Limited has developed numerous improved mask ventilation technologies. See International Patent Application Publication WO1998 / 034,665; International Patent Application Publication WO2000 / 078,381; U.S. Patent Nos. 6,581,594; U.S. Patent Application Publication US2009 / 0050156; and U.S. Patent Application Publication 2009 / 0044808. 【0057】 Table of noise levels for conventional masks (ISO 17510-2:2007, 10 cmH2O pressure at 1 m) 【0058】 [Table 2] 【0059】 (*Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744.) 【0060】 The sound pressure values ​​of various objects are listed below. 【0061】 [Table 3] 2.2.4 Screening, diagnostic, and monitoring systems 【0062】 Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary disorders, and typically requires specialized clinical staff to apply the system. PSG typically involves placing 15 to 20 contact sensors on the patient to record a variety of bodily signals, such as electroencephalography (EEG), electrocardiogram (ECG), electrooculography (EOG), and electromyography (EMG). PSG for sleep-disordered breathing has traditionally involved observing the patient in the clinic over two nights (the first night being for pure diagnosis, and the second night for treatment parameter titration by the clinician). Therefore, PSG is expensive and inconvenient. In particular, it is unsuitable for screening / diagnosing / monitoring sleep-disordered breathing at home. 【0063】 Generally, during screening and diagnosis, disease identification is explained by its signs and symptoms. Screening typically yields true / false results indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis can provide clinically actionable information. Screening and diagnosis tend to be one-time processes, whereas monitoring the course of a disease can continue indefinitely. Some screening / diagnostic systems are suitable only for screening / diagnosis, while others can also be used for monitoring. 【0064】 Clinical professionals can adequately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where clinical professionals are unavailable or cannot be paid. Opinions on a patient's illness may differ among clinical professionals. Furthermore, certain clinical professionals may apply different criteria depending on the time period. [Prior art documents] [Patent Documents] 【0065】 [Patent Document 1] U.S. Patent No. 4944310 [Non-patent literature] 【0066】 [Non-Patent Document 1] "Respiratory Physiology" by John B. West, Lippincott Williams & Wilkins (9th edition, published in 2012) [Overview of the Initiative] 【0067】 3. A brief explanation of the technology This technology relates to providing medical devices used for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, and possesses one or more of the following advantages: improved comfort, cost-effectiveness, efficacy, ease of use, and manufacturability. 【0068】 A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders. 【0069】 Another aspect of this technology relates to a method used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders. 【0070】 One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy. 【0071】 One aspect of this technology is an eye mask system configured to be worn on the user's head during sleep, the eye mask system including: An eye mask designed to cover the user's eyes when in use; One or more transducers configured to affect the user's sleep and / or detect the user's sleep characteristics and / or detect the user's characteristics during sleep; and A positioning and stabilizing structure including at least one strap configured to apply force to hold the eye mask in the position where it is used to cover the user's eyes during sleep. 【0072】 In the example: (a) one or more transducers may include one or more sensors configured to detect the characteristics of the user's sleep and / or the characteristics of the user while sleeping; (b) one or more sensors may include an EEG sensor; (c) the eye mask system may include an ECG sensor; (d) the eye mask system may include a heart rate sensor; (e) the eye mask system may include an oxygen saturation sensor; (f) the eye mask system may include a blood pressure sensor; (g) the eye mask system may include an accelerometer; (h) the eye mask system may include a temperature sensor; (i) the eye mask system may include a body temperature sensor and / or an ambient temperature sensor; and / or (j) the eye mask system may include a microphone. 【0073】 In further examples: (a) one or more sensors may be provided on the eye mask; (b) one or more sensors may be provided on peripheral components; (c) the eye mask system may be configured to analyze the output of one or more of the sensors and take action based on the analysis; (d) the eye mask system may be configured to identify sleep characteristics, identify problems, predict outcomes, and / or provide recommendations based on the analysis; (e) the eye mask system may include an artificial intelligence or machine learning module configured to analyze the output of one or more of the sensors; (f) the eye mask system may be configured to detect and / or diagnose disorders; (g) the eye mask system may be configured to detect sleep-disordered breathing; and / or (h) the eye mask system may be configured to detect one or more of apnea, hypopnea, or hyperpnea. 【0074】 In further examples: (a) the eye mask system may be configured to identify when the user is asleep; (b) the eye mask system may be configured to identify a sleep stage; (c) the eye mask system may be configured to identify REM sleep and non-REM sleep; (d) the eye mask system may be configured to identify light sleep and deep sleep; (f) the eye mask system may be configured to wake the user during light sleep; (g) the eye mask system may be configured to change the user's sleep state; and / or (h) the eye mask system may be configured to change the user's sleep state from deep sleep to light sleep without waking the user. 【0075】 In further examples: (a) one or more transducers may include one or more output transducers configured to affect the user's sleep; (b) one or more output transducers may include one or more output transducers configured to help the user fall asleep and / or improve the quality of their sleep; (c) an eye mask system may be configured to activate one or more of the output transducers to achieve one or more of the following: longer sleep, deeper sleep, longer deep sleep, and longer REM sleep; (d) one or more output transducers may include acoustic transducers; (e (f) an acoustic transducer may include an ear pad or over-ear headphones; (g) an acoustic transducer may include a bone conduction transducer; (h) an eye mask system may be configured to provide a noise-canceling effect using an acoustic transducer; (i) one or more output transducers may include a display; (j) a thermal transducer may include a heating element; (k) a thermal transducer may include a thermoelectric cooler; and / or (l) one or more output transducers may include an aroma transducer. 【0076】 In further examples: (a) the eye mask system is configured to optimize the user's sleep; (b) the eye mask system is configured to assist the user in falling asleep, staying asleep for longer periods, achieving deeper sleep, maintaining deep sleep for longer periods, waking up, waking up at an optimal time, and / or waking up gently; (c) the eye mask system is configured to determine, when occurring, any changes that may improve the user's sleep; (d) the eye mask system is configured to receive input from sensors, determine, output, and operate transducers; (e) the eye mask system is configured to assist the user in breathing in a relaxing or sleep-inducing manner; (f) the eye mask system is configured to provide cues for the user's breathing; and / or (g) the cues may be provided via a display or an acoustic transducer. 【0077】 In further examples, an eye mask system further includes any one or more of the following: (a) a connection port configured to receive a pressurized airflow from an air circuit and to fluidly connect to the air circuit; (b) a flow generator configured to generate a pressurized airflow at the therapeutic pressure; (c) a plenum chamber pressurized to the therapeutic pressure, the plenum chamber being sized and constructed to receive an airflow from the connection port at the therapeutic pressure for breathing by the patient; and (d) a plenum chamber constructed to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway. (e) a seal-forming structure having holes inside, wherein the airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use; and (e) a vent allowing gases exhaled by the patient to flow continuously from the inside outwards from the plenum chamber, wherein the vent is sized and shaped to maintain the therapeutic pressure within the plenum chamber during use. 【0078】 In further examples: (a) the eye mask system may include a cushion module, which includes a seal-forming structure and at least partially forms a plenum chamber; (b) the cushion module may be detachably attached to the eye mask. 【0079】 In further examples: (a) an eye mask may include one or more cushion portions positioned on the user-contact side of the eye mask; (b) one or more cushion portions may be formed from any one or more of textiles; woven fabrics; foams; and silicones; (c) one or more cushion portions may include a first cushion portion and a second cushion portion, the first cushion portion having a greater thickness and / or a larger user-contact surface than the second cushion portion, and the first cushion portion being positioned within a portion of the eye mask that applies a greater force to the user's face during use than the second cushion portion; (d) one or more cushion portions may include a first cushion portion and a second cushion portion, the first cushion portion having a greater thickness and / or a larger user-contact surface than the second cushion portion, and the first cushion portion being positioned within a portion of the eye mask that comes into contact with a part of the user's face during use that is more sensitive than the part of the user's face that comes into contact with the second cushion portion during use. 【0080】 Another aspect of one form of this technology is an eye mask system for the treatment of sleep-disordered breathing, and the eye mask system is An eye mask designed to cover the user's eyes when in use; One or more transducers configured to affect the user's sleep and / or detect the user's sleep characteristics and / or detect the user's characteristics during sleep. Includes; The eye mask system is A connection port configured to receive a flow of air pressurized at therapeutic pressure for breathing by the user from an air circuit and to fluidize the air circuit; or A flow generator configured to produce pressurized airflow at the therapeutic pressure described above. It further includes one of the following: The eye mask system is A plenum chamber pressurized to therapeutic pressure, wherein the plenum chamber is sized and constructed to receive airflow at therapeutic pressure through a connection port for patient respiration, A seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, wherein the seal-forming structure has holes inside it so that, as a result, airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle when in use; A vent that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the vent structure further includes a vent that is sized and shaped to maintain therapeutic pressure within the plenum chamber during use. 【0081】 In the example: (a) The eye mask system includes a cushion module, the cushion module includes a seal-forming structure, and at least partially forms a plenum chamber; (b) The cushion module is removablely attachable to the eye mask; (c) The cushion module is movable relative to the eye mask; (d) The cushion module is movable relative to the eye mask; (e) The cushion module is at least partially detached from the eye mask; (f) The cushion module is repositionable relative to the eye mask; (g) The eye mask system includes an actuator for moving the cushion module; (h) The cushion module is forward relative to the eye mask. (i) The cushion module is capable of translational motion along the rear axis; (j) The cushion module is capable of translational motion along the vertical axis relative to the eye mask; (k) The cushion module is capable of changing orientation relative to the eye mask; (l) The cushion module is capable of rotation around the left-right axis relative to the eye mask; (m) The cushion module is capable of rotation around the front-back axis relative to the eye mask; (n) The cushion module is capable of rotation around the vertical axis relative to the eye mask; (o) The cushion module is capable of movement between a non-contact position and a sealed position. 【0082】 In further examples: (a) the eye mask includes a connection port located at the center and front of the eye mask; (b) the connection port is located at the upper position on the patient's head, and the eye mask system includes a pair of headgear tubes that fluidly connect the connection port to the eye mask; (c) the sealing structure is configured to seal around the lower peripheral portion of the patient's nose; (d) the sealing structure includes a pair of nose pillows; (e) the sealing structure includes a nose cushion configured to seal around the patient's nose, including the surface of the patient's nose located above the tip of the patient's nose; (f) the sealing structure includes a full-face cushion configured to seal around the patient's nose and mouth, including the surface of the patient's nose located above the tip of the patient's nose. 【0083】 In further examples: (a) the eye mask system is configured to detect when the user is awake and operate in sleep assistance mode; (b) the eye mask system is configured to detect when the user is asleep and operate in sleep mode; (c) the eye mask system is configured to initiate respiratory pressure therapy when transitioning from sleep assistance mode to sleep mode; and (d) the eye mask system is configured to move the cushion module from a non-contact position to a sealed position when transitioning from sleep assistance mode to sleep mode. 【0084】 Another aspect of one form of this technology is an eye mask system for the treatment of sleep-disordered breathing, the eye mask system including: An eye mask designed to cover the user's eyes when in use; One or more transducers configured to affect the user's sleep and / or detect the user's sleep characteristics and / or detect the user's characteristics during sleep; A flow generator configured to provide a pressurized airflow; A plenum chamber pressurized to therapeutic pressure, wherein the plenum chamber is sized and constructed to receive airflow from a flow generator at therapeutic pressure for patient respiration, A seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, wherein the seal-forming structure has holes inside it so that, as a result, airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle when in use; A ventilation section that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, wherein the ventilation structure is sized and shaped to maintain therapeutic pressure within the plenum chamber during use. 【0085】 In the example: (a) The eye mask system includes a cushion module, the cushion module includes a seal-forming structure, and at least partially forms a plenum chamber; (b) The cushion module is removablely attachable to the eye mask; (c) The cushion module is movable relative to the eye mask; (d) The cushion module is movable relative to the eye mask; (e) The cushion module is at least partially detached from the eye mask; (f) The cushion module is repositionable relative to the eye mask; (g) The eye mask system includes an actuator for moving the cushion module; (h) The cushion module is forward relative to the eye mask. (i) The cushion module is capable of translational motion along the rear axis; (j) The cushion module is capable of translational motion along the vertical axis relative to the eye mask; (k) The cushion module is capable of changing orientation relative to the eye mask; (l) The cushion module is capable of rotation around the left-right axis relative to the eye mask; (m) The cushion module is capable of rotation around the front-back axis relative to the eye mask; (n) The cushion module is capable of rotation around the vertical axis relative to the eye mask; (o) The cushion module is capable of movement between a non-contact position and a sealed position. 【0086】 In further examples: (a) a seal-forming structure configured to seal around the lower peripheral portion of a patient's nose; (b) a seal-forming structure comprising a pair of nose pillows; (c) a seal-forming structure comprising a nose cushion configured to seal around a patient's nose, including the surface of the patient's nose above the tip of the patient's nose; (d) a seal-forming structure comprising a full-face cushion configured to seal around a patient's nose and mouth, including the surface of the patient's nose above the tip of the patient's nose. 【0087】 In further examples: (a) the eye mask system is configured to detect when the user is awake and operate in sleep assistance mode; (b) the eye mask system is configured to detect when the user is asleep and operate in sleep mode; (c) the eye mask system is configured to initiate respiratory pressure therapy when transitioning from sleep assistance mode to sleep mode; and (d) the eye mask system is configured to move the cushion module from a non-contact position to a sealed position when transitioning from sleep assistance mode to sleep mode. 【0088】 One aspect of this technology is an eye mask system configured to be worn on the user's head, the eye mask system including: An eye mask designed to cover the user's eyes when in use; One or more transducers configured to interface with the user and / or the surrounding environment; A positioning and stabilization structure including at least one strap configured to apply force to hold the eye mask in the position where it covers the user's eyes during use. 【0089】 In the example: (a) at least one strap is configured to hold the eye mask in a use position that covers the user's eyes while they are sleeping; and / or (b) one or more transducers are configured to affect the user's sleep and / or detect the user's sleep characteristics and / or detect the user's characteristics while they are sleeping. 【0090】 In the example: (a) one or more transducers may include one or more sensors; (b) one or more sensors may include an EEG sensor; (c) the eye mask system may include an ECG sensor; (d) the eye mask system may include a heart rate sensor; (e) the eye mask system may include an oxygen saturation sensor; (f) the eye mask system may include a blood pressure sensor; (g) the eye mask system may include an accelerometer; (h) the eye mask system may include a temperature sensor; (i) the eye mask system may include a body temperature sensor and / or an ambient temperature sensor; and / or (j) the eye mask system may include a microphone. 【0091】 In further examples: (a) one or more sensors may be provided on the eye mask; (b) one or more sensors may be provided on peripheral components; (c) the eye mask system may be configured to analyze the output of one or more of the sensors and take action based on the analysis; (d) the eye mask system may include an artificial intelligence or machine learning module configured to analyze the output of one or more of the sensors. 【0092】 In further examples: (a) one or more transducers may include one or more output transducers; (b) one or more output transducers may include acoustic transducers; (c) an acoustic transducer may include ear pads or over-ear headphones; (d) an acoustic transducer may include a bone conduction transducer; (e) an eye mask system may be configured to provide a noise-canceling effect using acoustic transducers; (f) an eye mask system may include a display; (g) an eye mask system may include a temperature transducer; (h) a temperature transducer may include a heating element; (i) a temperature transducer may include a thermoelectric cooler; and / or (j) an eye mask system may include an aroma transducer. 【0093】 In further examples, an eye mask system may include: A plenum chamber pressurized to therapeutic pressure, wherein the plenum chamber is sized and constructed to receive airflow at therapeutic pressure through a connection port for the patient to breathe; A seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, wherein the seal-forming structure has holes inside it so that the airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle when in use; and A ventilation section that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, wherein the ventilation structure is sized and shaped to maintain therapeutic pressure within the plenum chamber during use. 【0094】 In further examples: (a) the eye mask system is configured to operate in setup mode, in which setup mode, the eye mask system is configured to help the user set up the eye mask system as a patient interface and / or begin using it; (b) the eye mask system is configured to assist the user with setup by presenting a tutorial to the user; (c) the eye mask system is configured to help the user properly fit the eye mask system for use as a patient interface for respiratory pressure therapy for sleep-disordered breathing; and / or (d) the eye mask system is configured to provide instructions for troubleshooting. 【0095】 In a further example: (a) The eye mask system is configured to monitor one or more signals received from one or more sensors during setup and to provide feedback to the user about the setup based on one or more signals; (b) The eye mask system includes a strap tension sensor; and / or (c) The eye mask system is configured to measure the tension in the back strap of the eye mask system using the strap tension sensor and to provide feedback to the user based on the tension. 【0096】 In further examples: (a) the eye mask system is configured to detect leaks during use of the eye mask system for respiratory pressure therapy; (b) the eye mask system is configured to alert the user to the presence of a leak; (c) the eye mask system is configured to determine the location of the leak; (d) the eye mask system is configured to provide the user with indication of the location of the leak; and / or (e) the eye mask system is configured to provide instructions on reducing or eliminating the leak based on the location of the leak. 【0097】 In further examples: (a) the eye mask system is configured to prompt the user to breathe in a manner that contributes to relaxation; (b) the eye mask system is configured to provide cues for the user's breathing; (c) the cues may be provided via a display or an acoustic transducer; (d) the eye mask system is configured to monitor the patient's adherence to breathing cues using one or more sensors; (e) the eye mask system is configured to provide positive airway pressure via a plenum chamber and a seal-forming structure while providing cues; (f) the eye mask system is configured to increase positive airway pressure from a pressure lower than the therapeutic pressure to the therapeutic pressure. 【0098】 In further examples: (a) an eye mask may include one or more cushion portions positioned on the user-contact side of the eye mask; (b) one or more cushion portions may be formed from any one or more of textiles; woven fabrics; foams; and silicones; (c) one or more cushion portions may include a first cushion portion and a second cushion portion, the first cushion portion having a greater thickness and / or a larger user-contact surface than the second cushion portion, and the first cushion portion being positioned within a portion of the eye mask that applies a greater force to the user's face during use than the second cushion portion; (d) one or more cushion portions may include a first cushion portion and a second cushion portion, the first cushion portion having a greater thickness and / or a larger user-contact surface than the second cushion portion, and the first cushion portion being positioned within a portion of the eye mask that comes into contact with a part of the user's face during use that is more sensitive than the part of the user's face that comes into contact with the second cushion portion during use. 【0099】 Another aspect of one form of this technology is an eye mask system that provides respiratory pressure therapy to a user for the treatment of sleep-disordered breathing, wherein the eye mask system is An eye mask designed to cover the user's eyes when in use; One or more transducers configured to affect the user's sleep and / or detect the user's sleep characteristics and / or detect the user's characteristics during sleep. Includes; The eye mask system is A connection port configured to receive a flow of air pressurized at therapeutic pressure for patient respiration from an air circuit and to fluidize the air circuit; or A flow generator configured to produce pressurized airflow at the therapeutic pressure described above. It further includes one of the following: The eye mask system is A plenum chamber capable of pressurizing up to a therapeutic pressure, wherein the plenum chamber is sized and structured to receive airflow at the therapeutic pressure, A seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, wherein the seal-forming structure has holes inside so that, as a result, airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use. A ventilation section that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the ventilation structure further includes a ventilation section that is sized and shaped to maintain therapeutic pressure inside the plenum chamber during use, The eye mask system is configured to operate in at least two modes: a non-therapeutic mode in which respiratory pressure therapy is not provided to the user, and a therapeutic mode in which respiratory pressure therapy is provided to the user for the treatment of sleep-disordered breathing. 【0100】 In the example: (a) one or more transducers may include one or more sensors configured to detect the characteristics of the user's sleep and / or the characteristics of the user while sleeping; (b) one or more sensors may include an EEG sensor; (c) the eye mask system may include an ECG sensor; (d) the eye mask system may include a heart rate sensor; (e) the eye mask system may include an oxygen saturation sensor; (f) the eye mask system may include a blood pressure sensor; (g) the eye mask system may include an accelerometer; (h) the eye mask system may include a temperature sensor; (i) the eye mask system may include a body temperature sensor and / or an ambient temperature sensor; and / or (j) the eye mask system may include a microphone. 【0101】 In further examples: (a) one or more sensors may be provided on the eye mask; (b) one or more sensors may be provided on peripheral components; (c) the eye mask system may be configured to analyze the output of one or more of the sensors; (d) the eye mask system may be configured to take action based on the analysis; (e) the eye mask system may be configured to identify sleep characteristics, identify problems, predict outcomes, and / or provide recommendations based on the analysis; (f) the eye mask system may include an artificial intelligence or machine learning module configured to analyze the output of one or more of the sensors; (g) The eye mask system may be configured to detect and / or diagnose a disorder; (h) the eye mask system may be configured to detect sleep-disordered breathing; (i) the eye mask may be configured to detect sleep-disordered breathing in at least a non-treatment mode; (j) the eye mask system may be configured to detect one or more of apnea, hypopnea, hyperventilation, snoring, or gasping in at least a non-treatment mode; and / or (k) the eye mask system may be configured to detect sleep-disordered breathing in a non-treatment mode and to switch from a non-treatment mode to a treatment mode when sleep-disordered breathing is detected. 【0102】 In further examples: (a) one or more transducers may include one or more output transducers configured to affect the user's sleep; (b) one or more output transducers may include one or more output transducers configured to help the user fall asleep and / or improve the quality of their sleep; (c) an eye mask system may be configured to activate one or more of the output transducers to achieve one or more of the following: longer sleep, deeper sleep, longer deep sleep, and longer REM sleep; (d) one or more output transducers may include acoustic transducers; (e (f) an acoustic transducer may include an ear pad or over-ear headphones; (g) an acoustic transducer may include a bone conduction transducer; (h) an eye mask system may be configured to provide a noise-canceling effect using an acoustic transducer; (i) one or more output transducers may include a display; (j) a thermal transducer may include a heating element; (k) a thermal transducer may include a thermoelectric cooler; and / or (l) one or more output transducers may include an aroma transducer. 【0103】 In further examples: (a) the eye mask system is configured to optimize the user's sleep; (b) the eye mask system is configured to assist the user in falling asleep, staying asleep for longer periods, achieving deeper sleep, maintaining deep sleep for longer periods, waking up, waking up at an optimal time, and / or waking up gently; (c) the eye mask system is configured to determine, when occurring, any changes that may improve the user's sleep; (d) the eye mask system is configured to receive input from sensors, determine, output, and operate transducers; (e) the eye mask system is configured to assist the user in breathing in a relaxing or sleep-inducing manner; (f) the eye mask system is configured to provide cues for the user's breathing; and / or (g) the cues may be provided via a display or an acoustic transducer. 【0104】 In the example: (a) The eye mask system includes a cushion module, the cushion module includes a seal-forming structure, and at least partially forms a plenum chamber; (b) The cushion module is removablely attachable to the eye mask; (c) The cushion module is movable relative to the eye mask; (d) The cushion module is movable relative to the eye mask; (e) The cushion module is at least partially detached from the eye mask; (f) The cushion module is repositionable relative to the eye mask; (g) The eye mask system includes an actuator for moving the cushion module; (h) The cushion module is capable of translational movement along the longitudinal axis relative to the eye mask; (i) The cushion module is capable of translational movement along the lateral axis relative to the eye mask. (j) The cushion module is capable of translational movement along the vertical axis relative to the eye mask; (k) The cushion module is capable of changing orientation relative to the eye mask; (l) The cushion module is capable of rotation around the left-right axis relative to the eye mask; (m) The cushion module is capable of rotation around the front-back axis relative to the eye mask; (n) The cushion module is capable of rotation around the vertical axis relative to the eye mask; (o) The seal-forming structure is movable between a non-contact position in which the seal-forming structure does not come into contact with the user and a sealed position in which the seal-forming structure can form a seal on the user's face; (p) The cushion module is movable between a non-contact position in which the seal-forming structure does not come into contact with the user and a sealed position in which the seal-forming structure can form a seal on the user's face. 【0105】 In further examples: (a) the eye mask includes a connection port located at the center and front of the eye mask; (b) the connection port is located at the upper position on the patient's head, and the eye mask system includes a pair of headgear tubes that fluidly connect the connection port to the eye mask; (c) the sealing structure is configured to seal around the lower peripheral portion of the patient's nose; (d) the sealing structure includes a pair of nose pillows; (e) the sealing structure includes a nose cushion configured to seal around the patient's nose, including the surface of the patient's nose located above the tip of the patient's nose; (f) the sealing structure includes a full-face cushion configured to seal around the patient's nose and mouth, including the surface of the patient's nose located above the tip of the patient's nose. 【0106】 In further examples: (a) the eye mask system is configured to detect when the user is awake and operate in non-therapeutic mode; (b) the eye mask system is configured to detect when the user is asleep and operate in therapeutic mode; (c) the eye mask system is configured to initiate respiratory pressure therapy when changing from non-therapeutic mode to therapeutic mode; (d) the eye mask system is configured to move the seal-forming structure from a non-contact position to a sealed position when changing from non-therapeutic mode to therapeutic mode. 【0107】 In further examples: (a) the eye mask system is configured to prompt the user to breathe in a manner that contributes to relaxation; (b) the eye mask system is configured to provide cues for the user's breathing; (c) the cues may be provided via a display or an acoustic transducer; (d) the eye mask system is configured to monitor the patient's adherence to breathing cues using one or more sensors; (e) the eye mask system is configured to provide positive airway pressure via a plenum chamber and a seal-forming structure while providing cues; (f) the eye mask system is configured to increase positive airway pressure from a pressure lower than the therapeutic pressure to the therapeutic pressure. 【0108】 Another aspect of one form of this technology is an eye mask system that provides respiratory pressure therapy to a user for the treatment of sleep-disordered breathing, wherein the eye mask system is An eye mask designed to cover the user's eyes when in use; One or more transducers configured to affect the user's sleep and / or detect the user's sleep characteristics and / or detect the user's characteristics during sleep. Includes; The eye mask system is A connection port configured to receive a flow of air pressurized at therapeutic pressure for patient respiration from an air circuit and to fluidize the air circuit; or A flow generator configured to produce pressurized airflow at the therapeutic pressure described above. It further includes one of the following: The eye mask system is A plenum chamber capable of pressurizing up to a therapeutic pressure, wherein the plenum chamber is sized and structured to receive airflow at the therapeutic pressure, A seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, wherein the seal-forming structure has holes inside so that, as a result, airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use. A ventilation section that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber to the surrounding area, the ventilation structure further includes a ventilation section that is sized and shaped to maintain therapeutic pressure inside the plenum chamber during use, The eye mask system is configured to help the user fall asleep and / or maintain sleep during respiratory pressure therapy. 【0109】 In the example: (a) one or more transducers may include one or more sensors configured to detect characteristics of the surrounding environment, characteristics of the user's sleep, and / or characteristics of the user while sleeping; (b) one or more sensors may include an EEG sensor; (c) the eye mask system may include an ECG sensor; (d) the eye mask system may include a heart rate sensor; (e) the eye mask system may include an oxygen saturation sensor; (f) the eye mask system may include a blood pressure sensor; (g) the eye mask system may include an accelerometer; (h) the eye mask system may include a temperature sensor; (i) the eye mask system may include a body temperature sensor and / or an ambient temperature sensor; and / or (j) the eye mask system may include a microphone. 【0110】 In further examples: (a) one or more sensors may be provided on the eye mask; (b) one or more sensors may be provided on peripheral components; (c) the eye mask system may be configured to analyze the output of one or more of the sensors and take action based on the analysis; (d) the eye mask system may be configured to identify sleep characteristics, identify problems, predict outcomes, and / or provide recommendations based on the analysis; (e) the eye mask system may include an artificial intelligence or machine learning module configured to analyze the output of one or more of the sensors; (f) the eye mask system may be configured to detect and / or diagnose disorders; (g) the eye mask system may be configured to detect sleep-disordered breathing; and / or (h) the eye mask system may be configured to detect one or more of apnea, hypopnea, or hyperpnea. 【0111】 In further examples: (a) the eye mask system may be configured to identify when the user is asleep; (b) the eye mask system may be configured to identify a sleep stage; (c) the eye mask system may be configured to identify REM sleep and non-REM sleep; (d) the eye mask system may be configured to identify light sleep and deep sleep; (f) the eye mask system may be configured to wake the user during light sleep; (g) the eye mask system may be configured to change the user's sleep state; and / or (h) the eye mask system may be configured to change the user's sleep state from deep sleep to light sleep without waking the user. 【0112】 In further examples: (a) one or more transducers may include one or more output transducers configured to affect the user's sleep; (b) one or more output transducers may include one or more output transducers configured to help the user fall asleep and / or improve the quality of their sleep; (c) an eye mask system may be configured to activate one or more of the output transducers to achieve one or more of the following: longer sleep, deeper sleep, longer deep sleep, and longer REM sleep; (d) one or more output transducers may include acoustic transducers; (e (f) an acoustic transducer may include an ear pad or over-ear headphones; (g) an acoustic transducer may include a bone conduction transducer; (h) an eye mask system may be configured to provide a noise-canceling effect using an acoustic transducer; (i) one or more output transducers may include a display; (j) a thermal transducer may include a heating element; (k) a thermal transducer may include a thermoelectric cooler; and / or (l) one or more output transducers may include an aroma transducer. 【0113】 In further examples: (a) the eye mask system is configured to optimize the user's sleep; (b) the eye mask system is configured to assist the user in falling asleep, staying asleep for longer periods, achieving deeper sleep, maintaining deep sleep for longer periods, waking up, waking up at an optimal time, and / or waking up gently; (c) the eye mask system is configured to determine, when occurring, any changes that may improve the user's sleep; (d) the eye mask system is configured to receive input from sensors, determine, output, and operate transducers; (e) the eye mask system is configured to assist the user in breathing in a relaxing or sleep-inducing manner; (f) the eye mask system is configured to provide cues for the user's breathing; and / or (g) the cues may be provided via a display or an acoustic transducer. 【0114】 In further examples: (a) the eye mask system is configured to detect when the user is awake and operate in sleep assistance mode; (b) the eye mask system is configured to detect when the user is asleep and operate in sleep mode; (c) the eye mask system is configured to initiate respiratory pressure therapy when transitioning from sleep assistance mode to sleep mode; and (d) the eye mask system is configured to move the cushion module from a non-contact position to a sealed position when transitioning from sleep assistance mode to sleep mode. 【0115】 In further examples: (a) one or more transducers include one or more sensors configured to detect characteristics of the surrounding environment, the characteristics of the user's sleep, and / or the user's characteristics; (b) the eye mask system is configured to determine, when any changes occur, that may help the user fall asleep and / or maintain sleep; (c) the eye mask system is configured to adjust the therapeutic pressure of the airflow based on the output of one or more of the sensors; (d) the eye mask system is configured to detect when the user is awake and reduce the therapeutic pressure; (e) the eye mask system is configured to reduce the therapeutic pressure when it is detected that ambient noise has exceeded a predetermined threshold; (f) the eye mask system The stem includes a microphone and an acoustic transducer; (g) the eye mask system is configured to provide a noise-canceling effect using the acoustic transducer when it is detected that ambient noise exceeds a predetermined threshold; (h) the eye mask system is configured to provide a noise-canceling effect using the acoustic transducer when it is detected that the user is awake; (i) one or more transducers include one or more output transducers configured to affect the user's sleep; and / or (j) one or more output transducers are configured to help the user fall asleep, help maintain the user's sleep, and / or improve the quality of sleep. 【0116】 Another aspect of this technology is a patient interface that is molded together with a surrounding shape that is complementary to the shape of the wearer, or constructed in other ways. 【0117】 One embodiment of this technology is a method for manufacturing an apparatus. 【0118】 One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has little experience using this type of medical device. 【0119】 One embodiment of this technology is a portable RPT device that can be carried around by a person, for example, in the vicinity of their home. 【0120】 One embodiment of this technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, and does not require any special cleaning equipment. Another embodiment of this technology is a humidifier tank that can be cleaned at the patient's home, for example with soapy water, and does not require any special cleaning equipment. 【0121】 The methods, systems, devices, and apparatus described may be implemented to improve the functionality of processors (e.g., processors in purpose-specific computers, respiratory monitors, and / or respiratory therapy devices). Furthermore, the methods, systems, devices, and apparatus described may enable improvements in the field of automated management, monitoring, and / or treatment of respiratory diseases, including sleep-disordered breathing, for example. 【0122】 Of course, some embodiments may form subordinate embodiments of this technology. Furthermore, various subordinate embodiments and / or embodiments can be combined in various ways to constitute further embodiments or subordinate embodiments of this technology. 【0123】 Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawing] 【0124】 4. Brief Description of the Drawings 【0125】 This technology is illustrated non-limitingly as an example in the diagrams of the attached drawings, and in the drawings, similar reference numbers refer to similar elements, including: 4.1 Respiratory Therapy System [Figure 1]The system includes a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow that receives positively pressurized air supplied from an RPT device 4000. The air from the RPT device 4000 is regulated in a humidifier 5000 and delivered to patient 1000 along an air circuit 4170. A bedmate 1100 is also shown. The patient is sleeping in a supine sleeping position. 4.2 Anatomical Structures of the Respiratory System and Face [Figure 2A] This diagram outlines the human respiratory system, including the nasal cavity and oral cavity, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] The diagram shows the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of a face with several features of identified surface anatomical structures, including the upper lip, upper lip red, lower lip red, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and corners of the mouth. Superior, inferior, radially medial, and radially lateral directions are also shown. [Figure 2D] This is a lateral view of the head, featuring several characteristics of identified surface anatomical structures, including the glabella, serion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, outermost lateral point of the alae base, superior and inferior base points. Directions to the upper and lower, as well as the anterior and posterior, are also indicated. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankfort horizontal and nasolabial angles are shown. The coronal plane is also shown. [Figure 2F] A pedicle view of the nose is shown, including several identified features such as the nasolabial folds, lower lips, upper lip red, nostrils, subnasal point, columella, nasal tip, and the long axis and midline sagittal plane of the nostrils. [Figure 2G] A lateral view of the superficial features of the nose is shown. [Figure 2H]This shows the subcutaneous structure of the nose, including the lateral nasal cartilages, nasal septal cartilages, greater alar cartilages, lesser alar cartilages, nasal sesamoid cartilages, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibrous adipose tissue. [Figure 2I] This image shows the nose after an incision made approximately a few millimeters medially from the sagittal midline, particularly highlighting the nasal septum cartilage and the medial crura of the greater alar cartilage. [Figure 2J] A frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone, is shown. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K] This is a lateral view of the skull showing the external shape of the head surface, along with several muscles. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is shown. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2L] An anterolateral view of the nose is shown. 4.3 Patient Interface [Figure 3A] This shows a patient interface in the form of a nasal mask, which is one embodiment of this technology. 4.4 RPT Device [Figure 4A] This shows an RPT device based on one form of this technology. [Figure 4B] This is a schematic diagram of the pneumatic passage of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with respect to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the pneumatic passage between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] A schematic diagram of an electrical component of an RPT device based on one embodiment of this technology. [Figure 4D] This is a schematic diagram of an algorithm implemented in an RPT device using one form of this technology. [Figure 4E]This flowchart illustrates a method implemented using the therapy engine module shown in Figure 4D, which is one form of this technology. 4.5 Humidifier [Figure 5A] An isometric view of a humidifier based on one embodiment of this technology is shown. [Figure 5B] This shows an isometric view of a humidifier according to one embodiment of this technology, with the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Respiratory waveform [Figure 6A] This shows a model of a typical respiratory waveform in a person during sleep. 4.7 Eye Mask System [Figure 7] This is a side view showing a patient wearing the Eye Mask System 7000, an example of this technology. [Figure 8] Figure 7 is a block diagram showing the components of the eye mask 7100 of the eye mask system 7000. [Figure 9] This is a side view showing a patient wearing an eye mask system 7000, another example of the technology, which has a seal-forming structure 3100. [Figure 10] This is a side view showing a patient wearing an eye mask system 7000, another example of this technology, which is connected to an air circuit 4170. [Figure 11] This is a side view showing a patient wearing an eye mask system 7000, another example of the technology, which has a connecting portion 3600 located on the upper part of the patient's head. [Figure 12] This is a side view of an eye mask system 7000 according to another example of the technology, which has a short tube 4175. [Figure 13] This is a perspective cross-section of an eye mask system 7000 having a cushion module 3150. [Figure 14] This is a perspective view of the components of the positioning and stabilization structure 3300 for the eye mask system 7000. [Figure 15] This is a side view showing a patient wearing an eye mask system 7000, another example of the technology, which includes a flow generator 7400. [Figure 16]Figure 15 is a block diagram showing the components of the eye mask system 7000. [Figure 17] This is a rear view of the eye mask 7100, another example of this technology. [Figure 18] Another example of this technology is shown: a positioning and stabilization structure 3300 for an eye mask system 7000. [Figure 19] This is a schematic diagram of the front portion of the eye mask 7100, another example of this technology. [Modes for carrying out the invention] 【0126】 5. Detailed explanation of examples of this technology 【0127】 Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, and that these examples are subject to change. It should also be understood that the terminology used in this disclosure is intended solely to illustrate the specific examples discussed herein and is not limiting. 【0128】 The following description is provided in relation to a variety of examples that may share one or more common properties and / or features. It should be understood that one or more features of any example may be combined with one or more features of another example or any other example. In addition, any single feature or combination of features in any of the examples may constitute further examples. 5.1 Therapy 【0129】 In one embodiment, the technology includes a method for treating respiratory distress, which involves applying positive pressure to the airway entrance of patient 1000. 【0130】 In a specific example of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils. 【0131】 In certain applications of this technology, mouth breathing is restricted, limited, or prevented. 5.2 Respiratory Therapy Systems 【0132】 In one embodiment, the technology includes a respiratory therapy system for the treatment of respiratory disorders. The respiratory therapy system may include an RPT device 4000 that supplies airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000. 5.3 Patient Interface 【0133】 A non-invasive patient interface 3000 according to one aspect of this technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a vent 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3700. In some embodiments, the functional aspects may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional aspects. When in use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airway(s) so as to maintain positive pressure at the entrance(s) to the patient's airway(s). Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy. 【0134】 If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy. 【0135】 A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 6 cmH2O relative to the surroundings. 【0136】 A patient interface 3000 in one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 10 cmH2O relative to the surroundings. 【0137】 A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 20 cmH2O relative to the surroundings. 5.3.1 Seal-forming structure 【0138】 In one embodiment of this technology, the seal-forming structure 3100 may provide a target seal-forming region and further provide a buffering function. The target seal-forming region is a region on the seal-forming structure 3100 where sealing can occur. The region where sealing actually occurs (i.e., the actual sealed surface) may vary from patient to patient within a given treatment session depending on various factors (including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face). 【0139】 In one embodiment, the target seal-forming region is located on the outer surface of the seal-forming structure 3100. 【0140】 In a particular form of this technology, the seal-forming structure 3100 is constructed from a biocompatible material (e.g., silicone rubber). 【0141】 The seal-forming structure 3100 produced by this technology can be constructed from a soft, flexible, and elastic material, such as silicone. 【0142】 In certain embodiments of this technology, a system is provided comprising more than one seal-forming structure 3100, each configured to accommodate a range of different sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 suitable for large heads rather than small heads, and another suitable for small heads rather than large heads. 5.3.1.1 Sealing mechanism 【0143】 In one embodiment, the seal-forming structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. During use, the sealing flange can readily respond to the positive system pressure inside the plenum chamber 3200 (acting on its bottom surface) to bias it to form a tight, sealed engagement with the face. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure. 【0144】 In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member (thickness less than about 1 mm, e.g., about 0.25 mm to about 0.45 mm) extending around the periphery of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends at least a portion around the periphery. The support flange is or contains a spring-like element and has the function of supporting the sealing flange so as not to buckle during use. 【0145】 In one embodiment, the seal-forming structure may include a compression seal portion or a gasket seal portion. During use, the compression seal portion or gasket seal portion is constructed and positioned to be in a compressed state, for example, due to elastic tension in the positioning and stabilizing structure. 【0146】 In one embodiment, the seal-forming structure includes a tensioned portion. During use, the tensioned portion is held under tension, for example, by an adjacent region of a sealing flange. 【0147】 In one embodiment, the seal-forming structure includes a region having an adhesive surface or bonding surface. 【0148】 In a particular embodiment of this technology, the seal-forming structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface. 5.3.1.2 Nasal bridge or nasal ridge region 【0149】 In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the nasal bridge region or nasal ridge region of the patient's face when in use. 【0150】 In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the nasal bridge region or nasal ridge region of the patient's face when in use. 5.3.1.3 Upper lip area 【0151】 In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region of the patient's face (i.e., the upper lip) when in use. 【0152】 In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the upper lip area of ​​the patient's face when in use. 5.3.1.4 Chin area 【0153】 In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the chin area of ​​the patient's face when in use. 【0154】 In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the chin area of ​​the patient's face when in use. 5.3.1.5 Forehead area 【0155】 In one embodiment, the seal-forming structure forms a seal on the forehead area of ​​the patient's face when in use. In this embodiment, the plenum chamber may cover the eye when in use. 5.3.1.6 Nasal pillow 【0156】 In one embodiment, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each of which is constructed and positioned to form a seal with each nostril of the patient's nose. 【0157】 A nasal pillow according to one aspect of this technology includes a frustum of a cone (at least a portion of which forms a seal on the bottom surface of the patient's nose), a stalk, and a flexible region (located on the bottom surface of the frustum of the cone and connecting the frustum of the cone to the stalk). In addition, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the stalk. The flexible region works in conjunction to facilitate a universal joint structure that accommodates relative movement (both displacement and angular movement) between the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stalk is connected. 5.3.2 Plenum Chamber 【0158】 The plenum chamber 3200 has a periphery whose shape is complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber 3200 is positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire periphery of the plenum chamber 3200 during use. In some embodiments, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material. 【0159】 In some forms of this technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less conspicuous and / or provide increased wearer comfort, which may improve compliance with therapy. 【0160】 In certain forms of this technology, the plenum chamber 3200 is constructed from a transparent material, such as transparent polycarbonate. The use of transparent materials can help to make the patient interface less conspicuous, which may help improve compliance with therapy. The use of transparent materials may also help clinicians observe how the patient interface is positioned and functioning. 【0161】 In certain forms of this technology, the plenum chamber 3200 is constructed from a translucent material. The use of translucent material can help to make the patient interface less conspicuous and improve compliance with therapy. 5.3.3 Positioning and stabilization structure 【0162】 The seal-forming structure 3100 of the patient interface 3000 of this technology can be held in a sealed position by the positioning and stabilizing structure 3300 during use. 【0163】 In one embodiment, the positioning and stabilizing structure 3300 provides sufficient holding force to overcome at least the effect of positive pressure in the plenum chamber 3200 and lift the face away from it. 【0164】 In one embodiment, the positioning and stabilizing structure 3300 provides a holding force to overcome the effects of gravity on the patient interface 3000. 【0165】 In one embodiment, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential impact of interfering forces on the patient interface 3000 (e.g., due to tube dragging or accidental interference with the patient interface). 【0166】 In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided, configured to harmonize with what a patient wears while sleeping. In one example, the positioning and stabilizing structure 3300 has an inconspicuous shape or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap. 【0167】 In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is not too large or bulky, thereby preventing a patient from lying in a supine sleeping position with the posterior region of their head resting on a pillow. 【0168】 In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is not too large or bulky, thereby preventing a patient from lying in a lateral sleeping position with the side of their head resting on a pillow. 【0169】 In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a release portion located between the front portion and the rear portion of the positioning and stabilizing structure 3300. The release portion does not resist compression and may be, for example, a flexible or flimsy strap. The release portion is constructed and positioned to prevent forces on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and interfering with the seal when the patient lies down with their head on a pillow. 【0170】 In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a woven patient contact layer, a foam inner layer, and a woven outer layer. In one embodiment, the foam is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the woven outer layer includes a loop material that engages with a hook material portion. 【0171】 In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap may be configured to be tensed during use and to direct a force that pulls the seal-forming structure closer to a portion of the patient's face. In one example, the strap may be configured as a tie. 【0172】 In one embodiment of this technology, the positioning and stabilizing structure includes a first tie, which is constructed and positioned such that, when in use, at least a portion of its lower edge passes above the superior base of the patient's head and rests on a portion of the parietal bone without resting on the occipital bone. 【0173】 In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a second tie, which is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the infraauricular point of the patient's head and rests below or above the occipital bone of the patient's head. 【0174】 In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a third tie constructed and positioned to interconnect a first tie and a second tie, thereby reducing the tendency for the first tie and the second tie to move away from each other. 【0175】 In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a bendable (e.g., non-rigid) strap. An advantage of this embodiment is that when the patient is lying down and sleeping, the patient feels greater comfort from the strap. 【0176】 In a particular form of this technology, the positioning and stabilizing structure 3300 includes a strap that is constructed to be breathable and allows water vapor to pass through. 【0177】 In certain embodiments of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300, each configured to provide holding force and accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads rather than small-sized heads, and another form suitable for small-sized heads rather than large-sized heads. 5.3.4 Ventilation 【0178】 In one embodiment, the patient interface 3000 includes a vent 3400 constructed and positioned to allow for the flushing away of exhaled gases, such as carbon dioxide. 【0179】 In a particular configuration, the vent 3400 is configured to allow a continuous airflow from the inside of the plenum chamber 3200 to the surroundings while the pressure inside the plenum chamber is positive relative to the surroundings. The vent 3400 is configured such that the airflow is large enough to reduce rebreathing of CO2 exhaled by the patient, while maintaining the therapeutic pressure inside the plenum chamber during use. 【0180】 One form of the ventilation section 3400 according to this technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes. 【0181】 The ventilation section 3400 may be located within the plenum chamber 3200. Alternatively, the ventilation section 3400 may be located within a decoupling structure, such as a swivel. 5.3.5 Decoupling Structures (Multiple or Single) 【0182】 In one embodiment, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball socket. 5.3.6 Connection Ports 【0183】 Connection port 3600 allows connection to the air circuit 4170. 5.3.7 Forehead support 【0184】 In one embodiment, the patient interface 3000 includes a forehead support portion 3700. 5.3.8 Suffocation prevention valve 【0185】 In one embodiment, the patient interface 3000 includes an asphyxiation prevention valve. 5.3.9 Ports 【0186】 In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the gas properties within the plenum chamber 3200, such as pressure. 5.4 RPT Devices 【0187】 An RPT device 4000 according to one aspect of this technology includes mechanical components, pneumatic components, and / or electrical components, and is configured to perform one or more algorithms (e.g., any of the methods described herein, either whole or in part). The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway to treat one or more of the respiratory diseases described elsewhere in this document. In some examples, the RPT device 4000 may be incorporated into another device, such as an eye mask 7100, as described later. 【0188】 In one embodiment, the RPT device 4000 is constructed and positioned to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O. 【0189】 In the example shown in Figure 4A, the RPT device 4000 has an external housing 4010 formed of two parts (an upper part 4012 and a lower part 4014). Furthermore, the external housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018. 【0190】 The pneumatic passage of the RPT device 4000 may include one or more pneumatic passage items, for example, an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124, and one or more transducers 4270 (e.g., a pressure sensor 4272, a flow sensor 4274, and / or a motor speed sensor 4276). 【0191】 One or more of the air passage items may be located within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be located within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of a chassis 4016. 【0192】 The RPT device 4000 may include a power supply unit 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative configuration, the RPT device 4000 may include more than one PCBA 4202. 【0193】 Figure 15 shows an example of an eye mask system 7000 (described in more detail below) having a flow generator 7400. Unless otherwise clearly required in the context, any features described herein in relation to the RPT device 4000, described with reference to Figures 4A-4C, should be understood to be applicable to the flow generator 7400. As described later, the flow generator 7400 is configured in some examples to provide a pressurized airflow for respiratory therapy, and in other examples to provide an airflow for non-therapeutic purposes. 5.4.1 Mechanical and pneumatic components of RPT devices 【0194】 An RPT device may include one or more of the following components within an integrated unit. In one alternative configuration, one or more of the following components may each be located as separate units. 5.4.1.1 Air filter (single or multiple) 【0195】 An RPT device according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110. 【0196】 In one embodiment, the inlet air filter 4112 is located upstream of the pressure generator 4140 at the beginning of the pneumatic passage. 【0197】 In one embodiment, the outlet air filter 4114, for example, an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000. 5.4.1.2 Muffler (singular or plural) 【0198】 An RPT device according to one embodiment of this technology may include a muffler 4120 or a plurality of mufflers 4120. 【0199】 In one embodiment of this technology, the inlet muffler 4122 is located upstream of the pressure generator 4140 in the pneumatic passage. 【0200】 In one embodiment of this technology, the outlet muffler 4124 is located in the pneumatic passage between the pressure generator 4140 and the patient interface 3000. 5.4.1.3 Pressure Generator 【0201】 In one embodiment of this technology, the pressure generator 4140 for producing an airflow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The blower 4142 may be housed in a blower housing 4100. The impellers may be located within a volute. When delivering respiratory pressure therapy, the blower may deliver the supply of air at a rate of, for example, up to about 120 liters / minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O. A blower may be described in any one of the following patents or patent applications: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO2013 / 020167 (the contents of which are incorporated herein by reference in their entirety). 【0202】 The flow generator 7400 described below may include a pressure generator 4140 as described herein, but does not necessarily have to be configured to provide respiratory pressure therapy, as will be discussed later. Whenever a pressure generator 4140, or any component or function of the RPT device 4000, is described in reference to therapy, whether the airflow is for therapeutic purposes (e.g., respiratory pressure therapy for the treatment of sleep-disordered breathing) or non-therapeutic purposes (e.g., heating, cooling, sensory effects, etc.), this disclosure should be understood to relate to the flow generator 7400. 【0203】 The pressure generator 4140 is under the control of the therapy device controller 4240. 【0204】 In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows. 5.4.1.4 Transducer (singular or plural) 【0205】 The transducer may be located inside or outside the RPT device. The external transducer may be located on, for example, an air circuit (e.g., a patient interface), or may form part of it. The external transducer may take the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device. 【0206】 In one embodiment of this technology, one or more transducers 4270 may be located upstream and / or downstream of the pressure generator 4140. One or more transducers 4270 may be constructed and positioned to generate signals representing the characteristics of the airflow at that point in the pneumatic path, such as flow rate, pressure, or temperature. 【0207】 In one embodiment of this technology, one or more transducers 4270 may be located in close proximity to the patient interface 3000. 5.4.1.5 Anti-spillback valve 【0208】 In one embodiment of this technology, the anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000, for example, to the motor 4144. In cases where there is no humidifier in the system (for example, in the eye mask system 7000 described with reference to Figures 15-16), the flow generator 7400 may not include the anti-spillback valve. 5.4.2 Electrical components of RPT devices 5.4.2.1 Power supply 【0209】 The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000. 【0210】 In one embodiment of this technology, the power supply 4210 provides power only to the RPT device 4000. In another embodiment of this technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000. 5.4.2.2 Input Devices 【0211】 In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials, enabling a person to interact with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. In one embodiment, the buttons, switches, or dials may be physically connected to an external housing 4010, or in another embodiment, they may be wirelessly connected to a receiver electrically connected to a central controller 4230. 【0212】 In one embodiment, the input device 4220 may be constructed and configured to allow a person to select values ​​and / or menu options. 5.4.2.3 Central Controller 【0213】 In one embodiment of this technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000. 【0214】 In one embodiment of this technology, the central controller 4230 is a dedicated electronic circuit. 【0215】 In one embodiment, the central controller 4230 is an application-specific integrated circuit. In another embodiment, the central controller 4230 includes discrete electronic components. 【0216】 The central controller 4230 may be configured to receive input signals (one or more) from one or more transducers 4270, one or more input devices 4220, and humidifiers 5000. 【0217】 The central controller 4230 may be configured to provide output signals (one or more) to one or more of the output devices 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000. 【0218】 In some embodiments of this technology, the central controller 4230 is configured to implement one or more methodologies described herein (e.g., one or more algorithms 4300 expressed as computer programs stored in a non-temporary computer-readable storage medium such as memory 4260). In some embodiments of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some embodiments of this technology, some methodologies may be performed by a remotely located device. For example, a remotely located device may determine ventilator control settings or detect respiratory-related events by analyzing stored data (e.g., from any of the sensors described herein). 5.4.2.4 Memory 【0219】 According to one embodiment of this technology, the RPT device 4000 includes a memory 4260, for example, a non-volatile memory. In some embodiments, the memory 4260 may include a battery-powered static RAM. In some embodiments, the memory 4260 may include a volatile RAM. 【0220】 As an addition or alternative, the RPT device 4000 may include a removable form of memory 4260, such as a memory card manufactured according to the Secure Digital (SD) standard. 【0221】 In one embodiment of this technology, the memory 4260 functions as a non-temporary computer-readable storage medium that stores computer program instructions representing one or more methodologies (e.g., one or more algorithms 4300) described herein. 5.4.2.5 Data Communication System 【0222】 In one embodiment of this technology, a data communication interface 4280 is provided and connected to a central controller 4230. The data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288. 【0223】 In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor. 【0224】 In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may use wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet. 【0225】 In one configuration, the local external communication network 4284 utilizes one or more communication standards (e.g., Bluetooth® or Consumer Infrared Protocol). 【0226】 In one embodiment, the remote external device 4286 is one or more computers, for example, a cluster of networked computers. In another embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, a person with appropriate authorization, such as a clinician, can access such a remote external device 4286. 【0227】 The local external device 4288 may be a personal computer, mobile phone, tablet, or remote control. 5.4.2.6 Output devices including an optional display and alarm 【0228】 The output device 4290 according to the present technology can take one or more forms among visual, auditory, and tactile units. The visual display can be a liquid crystal display (LCD) or a light emitting diode (LED) display. 5.4.2.6.1 Display driver 【0229】 The display driver 4292 receives, as input, characters, symbols, or images to be displayed on the display 4294, and converts them into commands to display these characters, symbols, or images on the display 4294. 5.4.2.6.2 Display 【0230】 The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 can be an 8-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the number "0") into eight logic signals indicating whether each of the eight segments should be activated to display a specific character or symbol. 5.4.2.6.3 Clock 【0231】 The RPT device 4000 can include a clock 4232 connected to the central controller 4230. 5.4.3 RPT device algorithm 【0232】 As described above, in some forms of the present technology, the central controller 4230 can be configured to implement one or more algorithms 4300 represented as a computer program stored in a non-temporary computer-readable storage medium such as the memory 4260. The algorithms 4300 are generally grouped into groups called modules. 【0233】 In other forms of this technology, part or all of the algorithm 4300 may be implemented by a controller of an external device (e.g., a local external device 4288 or a remote external device 4286). In such a form, data representing input signals and / or intermediate algorithm outputs required for part of the algorithm 4300 executed on the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In such a form, part of the algorithm 4300 executed on the external device may be represented as a computer program stored in a non-temporary computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute part of the algorithm 4300. 【0234】 In this configuration, therapeutic parameters generated by an external device via the therapeutic engine module 4320 (when this configuration forms part of an algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 and sent to the therapeutic control module 4330. 5.4.3.1 Preprocessing Module 【0235】 A preprocessing module 4310 in one embodiment of this technology receives signals from a transducer 4270, such as a flow sensor 4274 or a pressure sensor 4272, as input and performs one or more process steps to calculate one or more output values ​​to be used as input to another module, such as a therapy engine module 4320. 【0236】 In one embodiment of this technology, the output values ​​include interface pressure Pm, breathing flow rate Qr, and leakage flow rate Ql. 【0237】 In various forms of this technology, the preprocessing module 4310 includes one or more of the following algorithms: interface pressure estimation 4312, airflow estimation 4314, leak flow estimation 4316, and breathing flow estimation 4318. 5.4.3.1.1 Interface Pressure Estimation 【0238】 In one embodiment of this technology, the interface pressure estimation algorithm 4312 receives as input a signal from a pressure sensor 4272 indicating the pressure in the pneumatic passage adjacent to the outlet of the pneumatic block (device pressure Pd) and a signal from a flow sensor 4274 indicating the flow rate of the airflow leaving the RPT device 4000 (device flow rate Qd). The device flow rate Qd can be used as the total flow rate Qt if there is no replenishment gas 4180 at all. The interface pressure estimation algorithm 4312 estimates the pressure drop ΔP through the air circuit 4170. The dependence of the pressure drop ΔP on the total flow rate Qt can be modeled by the pressure drop characteristic ΔP(Q) for a particular air circuit 4170. Next, the interface pressure estimation algorithm 4312 provides as output the estimated pressure Pm in the patient interface 3000. The pressure Pm in the patient interface 3000 can be estimated as the device pressure Pd minus the air circuit pressure drop ΔP. 5.4.3.1.2 Estimation of airflow rate 【0239】 In one embodiment of this technology, the airflow rate estimation algorithm 4314 receives the estimated pressure Pm within the patient interface 3000 as input from the interface pressure estimation algorithm 4312, and estimates the airflow rate Qv from the ventilation section 3400 within the patient interface 3000. The dependence of the airflow rate Qv on the interface pressure Pm for a particular ventilation section 3400 during use can be modeled by the airflow characteristic Qv(Pm). 5.4.3.1.3 Leakage Flow Rate Estimation 【0240】 In one embodiment of this technology, the leak flow rate estimation algorithm 4316 receives a total flow rate Qt and an aeration flow rate Qv as inputs and provides an estimated value of the leak flow rate Ql as an output. In one embodiment, the leak flow rate estimation algorithm estimates the leak flow rate Ql by calculating the average of the difference between the total flow rate Qt and the aeration flow rate Qv over a sufficiently long period, such as including several breathing cycles, for example, about 10 seconds. 【0241】 In one embodiment, the leak flow rate estimation algorithm 4316 receives the total flow rate Qt, the vent flow rate Qv, and the estimated pressure Pm in the patient interface 3000 as inputs and provides the leak flow rate Ql as an output, by calculating the leak conductance and determining the leak flow rate Ql to be a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of the low-pass filtered non-vent flow rate, which is equal to the difference between the total flow rate Qt and the vent flow rate Qv, and the low-pass filtered square root of the pressure Pm, where the low-pass filter time constant has a value long enough to include several respiratory cycles, e.g., about 10 seconds. The leak flow rate Ql can be estimated as the product of the leak conductance and the pressure Pm. 5.4.3.1.4 Respiratory flow estimation 【0242】 In one embodiment of this technology, the respiratory flow rate estimation algorithm 4318 receives the total flow rate Qt, the inlet flow rate Qv, and the leakage flow rate Ql as inputs, and estimates the respiratory flow rate Qr of air to the patient by subtracting the inlet flow rate Qv and the leakage flow rate Ql from the total flow rate Qt. 5.4.3.2 Therapy Engine Module 【0243】 In one embodiment of this technology, the therapy engine module 4320 receives one or more of the following as inputs: pressure Pm within the patient interface 3000 and the breathing flow rate Qr of air to the patient, and provides one or more therapy parameters as outputs. 【0244】 In one form of this technology, the therapeutic parameter is the therapeutic pressure Pt. 【0245】 In one embodiment of this technology, the therapeutic parameters are one or more of the following: pressure fluctuation amplitude, base pressure, and target ventilation. 【0246】 In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapy parameter determination 4329. 5.4.3.2.1 Phase determination 【0247】 In one embodiment of this technology, the RPT device 4000 does not determine the phase. 【0248】 In one embodiment of this technology, the phase determination algorithm 4321 receives a signal indicating the respiratory flow rate Qr as input and provides the phase Φ of the current respiratory cycle of patient 1000 as output. 【0249】 In some forms, the phase output Φ, known as discrete phase determination, is a discrete variable. One implementation of discrete phase determination provides a binary phase output Φ having inspiratory or expiratory values, which are represented as values ​​of 0 and 0.5 rotations, respectively, when the start of spontaneous inhalation and exhalation are detected. Since the trigger point and cycle point are the moments when the phase changes from exhalation to inhalation and from inhalation to exhalation, respectively, the RPT device 4000 that "triggers" and "cycles" effectively performs discrete phase determination. In one implementation of binary phase determination, the phase output Φ is determined to have a discrete value of 0 when the respiratory flow rate Qr is above a positive threshold (thus "triggering" the RPT device 4000), and a discrete value of 0.5 rotations when the respiratory flow rate Qr is above a negative threshold (thus "cycles" the RPT device 4000). The inspiratory time Ti and expiratory time Te can be estimated as typical values ​​over a number of respiratory cycles, with the time spent together with the phase Φ (equal to 0 (indicating inspiration) and 0.5 (indicating expiration), respectively). 【0250】 Another implementation of discrete phase determination provides a three-valued phase output Φ having one value among inspiration, apnea during inspiration, and expiration. 【0251】 In other forms, the phase output Φ, known as continuous phase determination, is a continuous variable that varies, for example, from 0 revolutions to 1 revolution, or from 0π radians to 2π radians. The RPT device 4000 that performs continuous phase determination can trigger and cycle when the continuous phase reaches 0 and 0.5 revolutions respectively. In one implementation of continuous phase determination, the continuous value of the phase Φ is determined using fuzzy logic analysis of the respiratory flow rate Qr. The continuous value of the phase determined in this implementation is often referred to as "fuzzy phase". In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow rate Qr: 1. When the respiratory flow rate is zero and rapidly increasing, the phase is 0 revolutions. 2. When the respiratory flow rate is a large positive value and stable, the phase is 0.25 revolutions. 3. When the respiratory flow rate is zero and rapidly decreasing, the phase is 0.5 revolutions. 4. When the respiratory flow rate is a large negative value and stable, the phase is 0.75 revolutions. 5. When the respiratory flow rate is zero, stable, and the absolute value of the respiratory flow rate is large after being low-pass filtered for 5 seconds, the phase is 0.9 revolutions. 6. When the respiratory flow rate is positive and the phase is expiration, the phase is 0 revolutions. 7. When the respiratory flow rate is negative and the phase is inspiration, the phase is 0.5 revolutions. 8. When the absolute value of the respiratory flow rate is large after being low-pass filtered for 5 seconds, the phase increases at a steady rate equal to the patient's respiratory rate, which is low-pass filtered with a time constant of 20 seconds. 【0252】 The output of each rule may be represented as a vector, whose phase is the result of the rule and whose magnitude is the fuzzy range in which the rule is true. The fuzzy range in which the respiratory flow is "large" or "stable" is determined by an appropriate membership function. The results of the rules (represented as vectors) are then combined by several functions, such as taking the centroid. In such combinations, the rules may be equally weighted or differently weighted. 【0253】 In another implementation of continuous phase determination, the phase Φ, like the inspiratory time Ti and expiratory time Te, is first discretely estimated from the respiratory flow rate Qr, as described above. At any given instant, the continuous phase Φ can be determined as half the ratio of the inspiratory time Ti elapsed since the preceding trigger moment, or half the ratio of the expiratory time Te elapsed since the preceding cycle moment plus 0.5 cycles (regardless of which moment is more recent). 5.4.3.2.2 Waveform Determination 【0254】 In one embodiment of this technology, the therapy parameter determination algorithm 4329 provides a nearly constant therapeutic pressure throughout the patient's entire respiratory cycle. 【0255】 In another embodiment of this technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapeutic pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle according to a waveform template Π(Φ). 【0256】 In one embodiment of this technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) having a range of values ​​within the range [0,1] for the phase value Φ provided by the phase determination algorithm 4321 and used by the therapy parameter determination algorithm 4329. 【0257】 In one form suitable for discrete or continuously-taking phases, the waveform template Π(Φ) is a square wave template, having a value of 1 for phase values ​​up to 0.5 turns (including 0.5 turns) and a value of 0 for phase values ​​beyond 0.5 turns. In one form suitable for continuously-taking phases, the waveform template Π(Φ) includes two smoothly curved portions (i.e., a smoothly curved (e.g., raised cosine) rise from 0 to 1 for phase values ​​up to 0.5 turns, and a smoothly curved (e.g., exponential) decay from 1 to 0 for phase values ​​beyond 0.5 turns). In one form suitable for continuously-taking phases, the waveform template Π(Φ) is based on a square wave but has a smooth rise from 0 to 1 for phase values ​​up to a “rise time” lower than 0.5 turns, and a smooth fall from 1 to 0 for phase values ​​within a “fall time” after 0.5 turns, where the “fall time” is lower than 0.5 turns. 【0258】 In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates, depending on the settings of the RPT device. Each waveform template Π(Φ) in the library may be provided as a lookup table of values ​​Π for a phase value Φ. In other forms, the waveform determination algorithm 4322 calculates the waveform template Π(Φ) "on the fly" using a predetermined function form, possibly parameterized by one or more parameters (e.g., the time constant of the exponential curve portion). The parameters of the function form may be predetermined or may depend on the current state of patient 1000. 【0259】 In some forms of this technique suitable for discrete binary phases of inhalation (Φ=0 rotations) or exhalation (Φ=0.5 rotations), the waveform determination algorithm 4322 calculates the waveform template Π "on the fly" as a function of both the discrete phase Φ measured from the most recent trigger moment and time t. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ,t) in two parts (inhalation and exhalation) as follows: 【0260】 【number】 【0261】 Here, Πi(t) and Πe(t) are the inspiratory and expiratory portions of the waveform template Π(Φ,t). In one such form, the inspiratory portion Πi(t) of the waveform template is a smooth rise from 0 to 1, parameterized by the rise time, and the expiratory portion Πe(t) of the waveform template is a smooth fall from 1 to 0, parameterized by the fall time. 5.4.3.2.3 Ventilation Decision 【0262】 In one embodiment of this technology, the ventilation determination algorithm 4323 receives the respiratory flow rate Qr as input and determines a measured value that indicates the current patient ventilation Vent. 【0263】 In some implementations, the ventilation determination algorithm 4323 determines a measured value of ventilation Vent, which is an estimate of the actual patient ventilation. In one such implementation, half the absolute value of the respiratory flow rate Qr is taken and optionally filtered by a low-pass filter (e.g., a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz). 【0264】 In other embodiments, the ventilation determination algorithm 4323 determines a measurement of the ventilation Vent that is generally proportional to the actual patient ventilation. In such an embodiment, the peak respiratory flow rate Qpeak is estimated over the inspiratory portion of the cycle. This procedure, along with many other procedures involving sampling of the respiratory flow rate Qr, produces a measurement that is generally proportional to ventilation when the variation in the flow waveform shape is not too large (where the respiratory flow waveforms, normalized in time and amplitude, are similar and the shapes of two breaths are interpreted as being similar). To give some simple examples, there are the median of the positive respiratory flow rates, the median of the absolute values of the respiratory flow rates, and the standard deviation of the flow rate. Any linear combination of any order statistics of the absolute value of the respiratory flow rate, using positive coefficients, and even using both positive and negative coefficients, is generally proportional to ventilation. Another example is the average of the respiratory flow rate at the mid K ratio (by time) of the inspiratory portion, where 0 < K < 1. When the flow shape is constant, there are any number of measurements that are exactly proportional to ventilation. 5.4.3.2.4 Determination of Inspiratory Flow Limitation 【0265】 In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the degree of inspiratory flow limitation. 【0266】 In one form, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow rate signal Qr as an input and provides, as an output, a measure of the degree to which the inspiratory portion of the breath exhibits an inspiratory flow limitation. 【0267】 In one embodiment of this technology, the inspiratory portion of each breath is identified by a zero-crossing detector. A number of equally spaced points (e.g., 65) represent time points and are interpolated by an interpolator along the inspiratory flow-time curve of each breath. The curve drawn by these points is then scaled by a scalar to have a length (duration / period) of 1 and an area of ​​1 to remove the effects of changes in respiratory rate and depth. Next, the scaled breath is compared in a comparator to a pre-stored template representing normal non-obstructive breathing similar to the inspiratory portion of the breath shown in Figure 6. Breaths that deviate from the template at any time during inspiration by exceeding a identified threshold (typically 1 scale unit) (e.g., due to coughing, sighing, swallowing, and hiccups) are rejected when determined by the test element. For data that are not rejected, the moving average of the first such scaled points is calculated by the central controller 4230 over several preceding inspiratory events. This is repeated for a second such point, and so on, over the same inspiratory event. Therefore, for example, 65 scaled data points are generated by the central controller 4230 and represent a moving average of several preceding inspiratory events, e.g., three events. The moving average of the continuously updated (e.g., 65) point values ​​is hereafter referred to as the "scaled flow rate" and is denoted as Qs(t). Alternatively, a single inspiratory event can be used instead of a moving average. 【0268】 Two shape factors related to the determination of partial blockage may be calculated from the scaled flow rate. 【0269】 The shape factor of 1 is the ratio of the average of an intermediate (e.g., 32) scaled flow points to the average of all scaled flow points (e.g., 65). If this ratio is greater than 1, respiration is interpreted as normal. If this ratio is less than or equal to 1, respiration is interpreted as obstructive. A ratio of approximately 1.17 is interpreted as a threshold between partially obstructive and non-obstructive respiration, and is the same degree of obstruction that allows for the maintenance of adequate oxygenation in a typical patient. 【0270】 The shape factor 2 is calculated as the RMS deviation from the unit-scale flow rate taken over intermediate points (e.g., 32 points). An RMS deviation of approximately 0.2 units is interpreted as normal. An RMS deviation of zero is interpreted as a breath with generally restricted flow. The closer the RMS deviation is to zero, the more restricted the breath's flow is interpreted as. 【0271】 Shape factors 1 and 2 may be used as alternatives or in combination. In other forms of this technique, the number of sampled points, breaths, and midpoints may differ from those described above. Furthermore, the threshold may differ from those described. 5.4.3.2.5 Determination of apnea and hypopnea 【0272】 In one embodiment of this technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 to determine the presence of apnea and / or hypopnea. 【0273】 In one embodiment, the apnea / hypopnea determination algorithm 4325 receives a respiratory flow signal Qr as input and provides a flag as output indicating whether apnea or hypopnea has been detected. 【0274】 In one form, apnea is said to be detected when a function of respiratory flow rate Qr falls below a flow threshold over a predetermined period. This function can determine the peak flow rate, the average flow rate over a relatively short period, or an intermediate flow rate between the average and peak flow rates, such as the RMS flow rate. The flow threshold may be a relatively long-term measurement of the flow rate. 【0275】 In one form, hypopnea is said to be detected when the respiratory flow rate Qr falls below a second flow threshold over a predetermined period. The function can determine the peak flow, the average flow rate over a relatively short period, or an intermediate flow rate between the average and peak flow rates over a relatively short period, such as the RMS flow rate. The second flow threshold may be a relatively long-term measurement of the flow rate. The second flow threshold is greater than the flow threshold used to detect apnea. 5.4.3.2.6 Determining Snoring 【0276】 In one embodiment of this technology, the central controller 4230 executes one or more snoring determination algorithms 4326 to determine the degree of snoring. 【0277】 In one embodiment, the snoring determination algorithm 4326 receives a respiratory flow signal Qr as input and provides an output that measures the degree to which snoring is present. 【0278】 The snoring determination algorithm 4326 may include a step of determining the intensity of a flow signal in the range of 30 to 300 Hz. Furthermore, the snoring determination algorithm 4326 may include a step of filtering the respiratory flow signal Qr to reduce background noise (e.g., the sound of airflow in the system from a blower). 5.4.3.2.7 Determining airway patency 【0279】 In one embodiment of this technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 to determine the degree of airway patency. 【0280】 In one configuration, the airway patency determination algorithm 4327 receives a respiratory flow signal Qr as input and determines the power of the signal within a frequency range of approximately 0.75 Hz to approximately 3 Hz. The presence of a peak within this frequency range is interpreted as indicating airway openness. The absence of a peak is interpreted as an indication of airway obstruction. 【0281】 In one configuration, the frequency range for which the peak is required is the frequency of small forced oscillations at the therapeutic pressure Pt. In one implementation configuration, the forced oscillation has a frequency of 2 Hz (amplitude is approximately 1 cmH2O). 【0282】 In one configuration, the airway patency determination algorithm 4327 receives a respiratory flow signal Qr as input and determines the presence or absence of a cardiogenic signal. The absence of a cardiogenic signal is interpreted as an indication of airway obstruction. 5.4.3.2.8 Determining the Target Ventilation 【0283】 In one embodiment of this technology, the central controller 4230 takes the current ventilation measurement Vent as input and executes one or more target ventilation determination algorithms 4328 to determine a target value Vtgt for ventilation measurement. 【0284】 In some forms of this technology, the target ventilation determination algorithm 4328 is absent, and the target value Vtgt is predetermined and obtained, for example, by hardcoding during the configuration of the RPT device 4000, or by manual input via the input device 4220. 【0285】 In other forms of this technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from a value Vtyp that represents the patient's typical recent ventilation. 【0286】 In some forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a value that accounts for a high percentage of the typical recent ventilation Vtyp, but is lower than that value. High percentages in such forms can fall within the range of (80%, 100%), (85%, 95%), or (87%, 92%). 【0287】 In other forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a value slightly above a multiple of the typical recent ventilation Vtyp. 【0288】 A typical recent ventilation Vtyp is a value that tends to be distributed and clustered around current ventilation Vent measurements over several time points across several predetermined time scales (i.e., a representative value of current ventilation measurements over recent history). In one implementation of the target ventilation determination algorithm 4328, the recent history is approximately several minutes, but in any case must be longer than the time scale of the Cheyne-Stokes increasing and decreasing cycles. The target ventilation determination algorithm 4328 may determine a typical recent ventilation Vtyp from current ventilation Vent measurements using one of a variety of known representative values. One such measurement is the output of a low-pass filter on current ventilation Vent measurements, with a time constant equal to 100 seconds. 5.4.3.2.9 Determination of Therapeutic Parameters 【0289】 In some forms of this technology, the central controller 4230 executes one or more therapy parameter determination algorithms 4329 for determining one or more therapy parameters, using values ​​returned by one or more other algorithms in the therapy engine module 4320. 【0290】 In one embodiment of this technology, the therapeutic parameter is the instantaneous therapeutic pressure Pt. In one implementation of this embodiment, the therapeutic parameter determination algorithm 4329 determines the therapeutic pressure Pt using the following equation: 【0291】 【number】 【0292】 Here: ● A is the amplitude, ● Π(Φ,t) is the current phase value Φ, time t, and waveform template value (in the range of 0 to 1). ● P0 is the base pressure. 【0293】 If the waveform determination algorithm 4322 provides a waveform template Π(Φ,t) as a lookup table of values ​​Π indexed by phase Φ, the therapy parameter determination algorithm 4329 applies equation (1) by locating the position of the lookup table item closest to the current phase value Φ returned by the phase determination algorithm 4321, or by interpolation between two items spanning the current phase value Φ. 【0294】 The values ​​of amplitude A and base pressure P0 can be set by the therapy parameter determination algorithm 4329 according to the respiratory pressure therapy mode selected in the following manner. 5.4.3.3 Therapy Control Module 【0295】 According to one aspect of this technology, the therapy control module 4330 receives therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320 as input, and controls the pressure generator 4140 to deliver airflow according to the therapy parameters. 【0296】 In one embodiment of this technology, the therapeutic parameter is the therapeutic pressure Pt, and the therapeutic control module 4330 controls the pressure generator 4140 to deliver an airflow at the patient interface 3000 where the interface pressure Pm is equal to the therapeutic pressure Pt. 5.4.3.4 Detection of Fault Conditions 【0297】 In one embodiment of this technology, the central controller 4230 performs one or more methods 4340 for detecting a fault condition. The fault conditions detected by one or more methods 4340 may include at least one of the following: ● Power outage (no power or insufficient power) ● Detecting transducer failure ● Failed to detect the presence of the component. ● Operating parameters outside the recommended range (e.g., pressure, flow rate, temperature, PaO2) ● Failure to perform a test alarm to generate a detectable alarm signal. 【0298】 When a fault condition is detected, the corresponding algorithm 4340 signals the presence of the fault by one or more of the following: ● Initiation of audible, visual, and / or dynamic (e.g., vibration) alarms. ● Sending messages to external devices ● Record of events 5.5 Air Circuit 【0299】 An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and arranged to allow airflow to move between two components (e.g., an RPT device 4000 and a patient interface 3000) during use. 【0300】 In particular, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be called an air delivery tube. In some cases, the circuit may have separate branches for inhalation and exhalation. In other cases, a single branch is used. 【0301】 In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air within the air circuit, for example, to maintain or increase the temperature of the air. The heating elements may take the form of a heated wire circuit and may include one or more transducers, such as temperature sensors. In one embodiment, the heated wire circuit may be wound spirally around the axis of the air circuit 4170. The heating elements may communicate with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent No. 8,733,349, which is incorporated herein by reference in its entirety. 5.5.1 Delivery of replenishment gas 【0302】 In one embodiment of this technology, a supplemental gas, such as oxygen 4180, can be delivered to one or more points in the pneumatic path (e.g., upstream of the pneumatic block 4020), the air circuit 4170, and / or the patient interface 3000. 5.6 Humidifier 5.6.1 Overview of Humidifiers 【0303】 In one embodiment of this technology, a humidifier 5000 (for example, as shown in Figure 5A) is provided to change the absolute humidity of the air or gas to be delivered to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and temperature of the airflow (relative to the ambient air) before delivery to the patient's airway. 【0304】 The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some embodiments, as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006 adapted to receive the humidifier reservoir 5110 and which may include a heating element 5240. 5.6.2 Humidifier components 5.6.2.1 Water Reservoir 【0305】 In one configuration, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a certain volume of liquid, such as water, to evaporate for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum volume of water to provide sufficient humidification for at least the duration of a respiratory therapy session (e.g., an overnight sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other configurations, the humidifier 5000 may be configured to receive water from an external water source (e.g., a building's water supply system). 【0306】 In one embodiment, the water reservoir 5110 is configured to humidify the airflow from the RPT device 4000 as the airflow passes through it. In one embodiment, the water reservoir 5110 may be configured to facilitate the airflow's movement within a meandering path that penetrates the reservoir 5110 while in contact with a certain volume of water inside it. 【0307】 In one embodiment, the reservoir 5110 may be removable from the humidifier 5000 in an outward direction, for example, as shown in Figures 5A and 5B. 【0308】 The reservoir 5110 may also be configured to prevent liquid from flowing out when the reservoir 5110 is displaced and / or rotated, for example, through any opening and / or between its subcomponents, from its normal operating orientation. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent leakage and / or loss of air pressure due to flow impedance. 5.6.2.2 Conductive portion 【0309】 In one configuration, the reservoir 5110 includes a conductive portion 5120 configured to enable efficient heat transfer from the heating element 5240 to a fixed volume of liquid within the reservoir 5110. In one embodiment, the conductive portion 5120 may be arranged as a plate, but other shapes may also be appropriate. The conductive portion 5120, in whole or in part, may consist of a thermally conductive material such as aluminum (e.g., with a thickness of approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved by a less conductive material in an appropriate geometry. 5.6.2.3 Humidifier reservoir dock 【0310】 In one embodiment, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in Figure 5B) configured to receive a humidifier reservoir 5110. In some configurations, the humidifier reservoir dock 5130 may include a locking feature (for example, a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130). 5.6.2.4 Water level indicator 【0311】 The humidifier reservoir 5110 may include a water level indicator 5150, as shown in Figures 5A and 5B. In some forms, the water level indicator 5150 may provide a user, such as a patient 1000 or a caregiver, with one or more indications of the volume of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof (e.g., 25%, 50%, or 75%), or a volume (e.g., 200 ml, 300 ml, or 400 ml). 5.6.2.5 Heating elements 【0312】 In some cases, a heating element 5240 may be supplied to a humidifier 5000 to provide heat input to one or more of a certain volume of water and / or airflow in a humidifier reservoir 5110. The heating element 5240 may include heat-generating components such as an electrically resistive heating track. One suitable example of a heating element 5240 is a layered heating element, for example, described in PCT Patent Application Publication WO2012 / 171072, which is incorporated herein by reference in its entirety. 【0313】 In some configurations, the heating element 5240 may be provided within the humidifier base 5006, where heat may be supplied to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 5B. 5.7 Respiratory waveform 【0314】 Figure 6A shows a model of a typical respiratory waveform in a person during sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow rate. While parameter values ​​can vary, typical respiration can approximate the following: tidal volume (Vt, 0.5 L), inspiratory time (Ti, 1.6 sec), peak inspiratory flow rate (Qpeak, 0.4 L / sec), expiratory time (Te, 2.4 sec), and peak expiratory flow rate (Qpeak, -0.5 L / sec). The total duration of respiration, Ttot, is approximately 4 seconds. In a normal person, the respiratory rate (BPM) is approximately 15 breaths per minute, where ventilation (Vent) is approximately 7.5 L / min. The typical duty cycle (ratio of Ti to Ttot) is approximately 40%. 5.8 Respiratory Therapy Mode 【0315】 A variety of respiratory therapy modes can be implemented by the disclosed respiratory therapy system. 5.8.1 CPAP therapy 【0316】 In some implementations of respiratory pressure therapy, the central controller 4230 sets the therapeutic pressure Pt according to therapeutic pressure equation (1) as part of the therapy parameter determination algorithm 4329. In one such implementation, the amplitude A is equal to zero, and therefore the therapeutic pressure Pt (representing the target value achieved by the interface pressure Pm at this point) is exactly equal to the base pressure P0 throughout the entire respiratory cycle. Such implementations are generally grouped under the title of CPAP therapy. In such implementations, the therapy engine module 4320 for determining the phase Φ or waveform template Π(Φ) is not required. 【0317】 In CPAP therapy, the base pressure P0 can be a constant value, either hardcoded or manually entered into the RPT device 4000. Alternatively, the central controller 4230 may repeatedly calculate the base pressure P0 as a function of the sleep-disordered breathing index or measurement returned by each algorithm in the therapy engine module 4320 (e.g., one or more of flow restriction, apnea, hypopnea, patency, and snoring). This alternative is sometimes referred to as APAP therapy. 【0318】 Figure 4E is a flowchart illustrating method 4500 implemented by the central controller 4230 to continuously calculate base pressure P0 as part of the APAP therapy implementation of the therapy parameter determination algorithm 4329 when pressure support A is equal to zero. 【0319】 Method 4500 begins in step 4520, where the central controller 4230 compares a measurement of the presence of apnea / hypopnea to a first threshold and determines whether the measurement of the presence of apnea / hypopnea has exceeded the first threshold for a predetermined period of time (indicating the occurrence of apnea / hypopnea). If so, Method 4500 proceeds to step 4540; otherwise, Method 4500 proceeds to step 4530. In step 4540, the central controller 4230 compares a measurement of airway patency to a second threshold. If the measurement of airway patency exceeds the second threshold (indicating an open airway), the detected apnea / hypopnea is considered central, and Method 4500 proceeds to step 4560; otherwise, the apnea / hypopnea is considered obstructive, and Method 4500 proceeds to step 4550. 【0320】 In step 4530, the central controller 4230 compares the flow limit measurement to a third threshold. If the flow limit measurement exceeds the third threshold (indicating that the intake airflow is being restricted), method 4500 proceeds to step 4550; otherwise, method 4500 proceeds to step 4560. 【0321】 In step 4550, the central controller 4230 increases the base pressure P0 by a predetermined pressure increment ΔP, provided that the resulting treatment pressure Pt does not exceed the maximum treatment pressure Pmax. In one implementation, the predetermined pressure increment ΔP and the maximum treatment pressure Pmax are 1 cmH2O and 25 cmH2O, respectively. In other implementations, the pressure increment ΔP can be as low as 0.1 cmH2O and as high as 3 cmH2O, or as low as 0.5 cmH2O and as high as 2 cmH2O. In other implementations, the maximum treatment pressure Pmax can be as low as 15 cmH2O and as high as 35 cmH2O, or as low as 20 cmH2O and as high as 30 cmH2O. Next, method 4500 returns to step 4520. 【0322】 In step 4560, the central controller 4230 reduces the base pressure P0 by a certain amount. However, the reduced base pressure P0 does not fall below the minimum therapeutic pressure Pmin. Next, method 4500 returns to step 4520. In one implementation, the reduction is proportional to the value of P0-Pmin, and as a result, the decrease of P0 to the minimum therapeutic pressure Pmin when no events are detected is exponential. In one implementation, the proportionality constant is set such that the time constant τ for the exponential decrease of P0 is 60 minutes, and the minimum therapeutic pressure Pmin is 4 cmH2O. In other implementations, the time constant τ may be as low as 1 minute and as high as 300 minutes, or as low as 5 minutes and as high as 180 minutes. In other implementations, the minimum therapeutic pressure Pmin can be as low as 0 cmH2O and as high as 8 cmH2O, or as low as 2 cmH2O and as high as 6 cmH2O. Alternatively, the reduction in P0 may be predetermined, and therefore, the decrease in P0 to the minimum therapeutic pressure Pmin in the absence of any detected events is linear. 5.8.2 Bi-level therapy 【0323】 In other implementations of this form of the technology, the value of amplitude A in equation (1) may be positive. Such implementations are known as bilevel therapy because, when determining the therapeutic pressure Pt using equation (1) (where amplitude A is positive), the therapeutic pressure Pt fluctuates between two values ​​or levels in synchronization with the spontaneous respiratory effort of patient 1000 by the therapy parameter determination algorithm 4329. That is, based on the conventional waveform template Π(Φ,t) described above, the therapy parameter determination algorithm 4329 increases the therapeutic pressure Pt to P0+A (known as IPAP) at the start of inspiration or during inspiration, and decreases the therapeutic pressure Pt to the base pressure P0 (known as EPAP) at the start of expiration or during expiration. 【0324】 In some forms of bilevel therapy, IPAP is the therapeutic pressure for the same purpose as the therapeutic pressure in CPAP therapy mode, and EPAP is the IPAP minus amplitude A, sometimes having a “small” value (a few cmH2O) called expiratory pressure reduction (EPR). Such forms are sometimes called CPAP therapy with EPR and are generally considered more comfortable than straight CPAP therapy. In CPAP therapy with EPR, either or both IPAP and EPAP can be constant values ​​and are hardcoded or manually entered into the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 may iteratively calculate IPAP and / or EPAP during CPAP with EPR. In this alternative example, the therapy parameter determination algorithm 4329 iteratively calculates EPAP and / or IPAP as a function of the sleep-disordered breathing index or measurement returned by each algorithm in the therapy engine module 4320, in a manner similar to the calculation of the base pressure P0 in APAP therapy described above. 【0325】 In other forms of bilevel therapy, the amplitude A is large enough for the RPT device 4000 to perform some or all of the patient's breathing work. In this form known as pressure-supported ventilation, the amplitude A is called pressure support or swing. In pressure-supported ventilation, IPAP is the base pressure P0 plus pressure support A, and EPAP is the base pressure P0. 【0326】 In some forms of pressure-supported ventilation, known as fixed-pressure-supported ventilation, the pressure A is fixed to a predetermined value (e.g., 10 cmH2O). The predetermined pressure value is a setting of the RPT device 4000, which can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input via the input device 4220. 【0327】 In other forms of pressure support ventilation therapy, widely known as servo ventilation, the therapy parameter determination algorithm 4329 takes as input several parameters of the respiratory cycle that are currently measured or estimated (e.g., the current measurement of ventilation, Vent) and a target value for that respiratory parameter (e.g., the target value of ventilation, Vtgt), and iteratively adjusts the parameter of equation (1) to bring the current measurement of the respiratory parameter closer to the target value. In a form of servo ventilation known as adaptive servo ventilation (ASV), which has been used in the treatment of CSR, the respiratory parameter is ventilation, and the target ventilation value Vtgt is calculated by the target ventilation determination algorithm 4328 from a typical recent ventilation Vtyp, as described above. 【0328】 In some forms of servo ventilation, the therapy parameter determination algorithm 4329 applies a control methodology to iteratively calculate pressure support A to bring the current measured values ​​of respiratory parameters closer to target values. One such control methodology is proportional-integral (PI) control. In one implementation of PI control suitable for ASV mode (where the target ventilation Vtgt is set to be slightly lower than a typical recent ventilation Vtyp), pressure support A is iteratively calculated as follows: 【number】 【0329】 Here, G is the gain of PI control. A larger gain G value indicates a more positive feedback in the therapy engine module 4320. A smaller gain G value indicates a possible room for some residual untreated CSR or central sleep apnea. In some implementations, the gain G is fixed at a predetermined value (e.g., -0.4 cmH2O / (L / min) / sec). Alternatively, the gain G may fluctuate between therapy sessions until it reaches a value that substantially eliminates CSR, starting small but increasing with each session. Conventional methods for retrospectively analyzing therapy session parameters to assess the severity of CSR during a therapy session may be employed in such implementations. In yet other implementations, the gain G may fluctuate depending on the difference between the current ventilation measurement Vent and the target ventilation Vtgt. 【0330】 Other servo ventilation control methodologies that can be applied by the therapy parameter determination algorithm 4329 include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID). 【0331】 The pressure support A value calculated via equation (2) may be clipped to a range defined as [Amin, Amax]. In this implementation, by default, pressure support A remains at minimum pressure support Amin until the current ventilation measurement Vent falls below the target ventilation Vtgt. At this point, A begins to increase and returns to Amin only if Vent exceeds Vtgt again. 【0332】 The pressure support limits Amin and Amax are settings of the RPT device 4000, which are set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input via the input device 4220. 【0333】 In pressure-supported ventilation mode, EPAP is the base pressure P0. Similar to the base pressure P0 in CPAP therapy, EPAP can be a constant value and is defined or determined during titration. Such a constant EPAP can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input via the input device 4220. This alternative is sometimes called fixed EPAP pressure-supported ventilation therapy. Titration of the EPAP for a given patient may be performed by a clinician during a titration session using PSG to prevent obstructive apnea, thereby maintaining airway openness for pressure-supported ventilation therapy in a manner similar to the titration of the base pressure P0 in constant CPAP therapy. 【0334】 Alternatively, the therapy parameter determination algorithm 4329 may iteratively calculate the base pressure P0 during pressure-supported ventilation therapy. In this implementation, the therapy parameter determination algorithm 4329 iteratively calculates EPAP as a function of the sleep-disordered breathing index or measure returned by each algorithm in the therapy engine module 4320 (e.g., one or more of flow restriction, apnea, hypopnea, patency, and snoring). Because the continuous calculation of EPAP is similar to the manual adjustment of EPAP by a clinician during EPAP titration, this process is sometimes also called automated titration of EPAP, and the therapy mode is known as automated titrated EPAP pressure-supported ventilation therapy or automated EPAP pressure-supported ventilation therapy. 5.9 Eye Mask System 【0335】 Some embodiments of this technology include an eye mask system 7000. The eye mask system 7000 according to an example of this technology may also be identified as a sleep mask or a headset. Depending on the specific configuration, it may also be identified as a VR headset, an AR headset or a patient interface. The eye mask system 7000 according to an embodiment of this technology may include some or all of the following functional embodiments: an eye mask 7100, a seal-forming structure 3100, a plenum chamber 3200 and a positioning and stabilizing structure 3300, a connection port 3600, and / or a flow generator 7400. In some embodiments, the functional embodiments may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional embodiments. 【0336】 The eye mask system 7000 can be used by a user. The user may be a person with an illness / disability (e.g., a patient) or a person without an illness / disability. 【0337】 Figure 7 shows the eye mask system 7000 worn by the user. As shown in the figure, the eye mask system 7000 includes an eye mask 7100 and a positioning and stabilization structure 3300. The eye mask 7100 can be held in place by the positioning and stabilization structure 3300. 【0338】 In some forms, the eye mask system 7000 may be considered a “smart” eye mask. That is, the eye mask system 7000 may include features that are considered “smart” (e.g., the ability to interact with the user) and may operate partially or fully autonomously to provide specific functions. The eye mask system 7000 may include one or more transducers configured to interface with the user and / or the surrounding environment. A transducer is a device that converts energy from one form to another. In this specification, the term “transducer” is used to mean a device that converts energy between a signal, usually in the form of an electrical signal, and another form of energy (from a signal to a signal, or to a signal), unless the context clearly indicates otherwise. Transducers interface with the user and / or the surrounding environment through such energy conversion. One or more transducers may interface, for example, by sensing or receiving information about the user and / or the surrounding environment. Additionally or alternatively, one or more transducers may interact by providing input to the user and / or the surrounding environment (e.g., one or more physical stimuli). 【0339】 In some cases, the eye mask system 7000 may be used to promote sleep by assisting the user in falling asleep. In some forms, the eye mask system 7000 may improve or promote the quality of the user's sleep by using transducers (e.g., sensors and output transducers). In some forms, the eye mask system 7000 is configured to provide the user with sensory feedback. In other forms, the eye mask system 7000 may monitor the user's sleep and provide feedback to the user in the form of sleep data, a summary of the user's sleep data over a period of time, a summary of the user's sleep behavior over a period of time, and / or suggestions on how to improve sleep. In some forms, the eye mask system 7000 may diagnose and / or assist in the treatment of sleep apnea using components and methods described, for example, with reference to Figures 4D and 4E. 【0340】 In some forms, the eye mask system 7000 may be used while the user is awake. The eye mask system 7000 may have features or functions that make it usable while the user is awake and not trying to sleep. The eye mask system 7000 may be configured to promote relaxation. The eye mask system 7000 may be configured for entertainment, productivity, education, communication, training, etc. In some forms, the eye mask system 7000 may be configured to provide assistance to the user during setup and / or fitting of the eye mask system 7000 for respiratory pressure therapy. 【0341】 Figure 8 shows a block diagram of the eye mask system 7000 shown in Figure 7. As shown, the eye mask system 7000 includes numerous sensors and output transducers, which are described below. Furthermore, the eye mask system 7000 includes a processor 7900, a memory 7910, and a communication module 7920. In various examples of this technology, the processor 7900 may perform any of the functions described above in relation to the central controller 4230 of the RPT device 4000. Similarly, in various examples, the memory 7910 and the communication module 7920 may operate in any one of the ways that enable the operation of the memory 4260 and the data communication interface 4280, respectively. 【0342】 Actions described herein as steps performed by the eye mask system 7000 (e.g., actions, decisions, identifications, comparisons, optimizations, and operations) should be understood as steps performed entirely or partially by the processor 7900 of the eye mask system 7000. The processor 7900 may interface with the memory 7910 to, for example, store data, access data, and execute stored instructions. The processor 7900 and memory 7910 may also interface with the communication module 7920 to send and receive data with other devices (e.g., among other options, a remote server, a respiratory pressure therapy device 4000, a wristband worn by the patient, sensors, and output transducers). In the block diagram of Figure 8, all sensors are illustrated to be communicating directly with the processor 7900, but some or all of these may interface with the processor 7900 via the communication module 7920. 【0343】 The processor 7900, memory 7910, and communication module 7920 may each include multiple components. For example, the processor 7900 may include multiple processors that jointly provide the processing functions of the eye mask system 7000. Similarly, the memory 7910 may include multiple forms of memory (e.g., volatile and non-volatile memory), and the communication module 7920 may include multiple communication components (e.g., WiFi®, Bluetooth®, NFC®, etc.). 【0344】 In some forms, the processor 7900 may be located away from the eye mask 7100 and may communicate with the eye mask 7100 via a communication module 7920. In other forms, the processor 7900 includes one or more processors 7900 incorporated within the eye mask 7100 and one or more other processors 7900 located away from the eye mask 7100 and configured to communicate with the eye mask 7100 via a communication module 7920. 【0345】 In some examples, the eye mask system 7000 is powered during use by a battery housed, for example, in the eye mask 7100 or in a separate housing supported by the positioning and stabilization structure 3300. In other examples, the eye mask system 7000 may include power leads configured to be plugged into a separate power source (e.g., an auxiliary battery or a wall socket). 【0346】 In certain forms of this technology, the eye mask system 7000 includes or is configured to communicate with one or more external devices (e.g., the remote external device 4286 and / or local external device 4288 as described above). The external devices may be near the user (e.g., the user's telephone, or an RPT device 4000 accessible via Bluetooth®, the Internet, etc.) or far from the user (e.g., a computing device, server, etc. accessible via the Internet). Communication with the external devices may occur via the communication module 7920. To achieve any one or more of the functions described herein, the eye mask system 7000 may be configured to transmit outputs to, receive inputs from, or communicate with such external devices in other ways. For example, the external devices may be used to enable the user to interact with the eye mask system 7000, for example, to configure it. The external devices may also be used for outputting data, reports, analysis results, or any other information products of the eye mask system 7000. 【0347】 Where it is stated that the eye mask system 7000 or its components can perform actions or provide functions, it should be understood that the eye mask system 7000 or its components may, in some cases, be configured to perform actions or provide functions, and may be programmed to perform actions or provide functions. Disclosure of actions or functions of the eye mask system 7000 should be understood as disclosure of the eye mask system 7000 configured (e.g., programmed) to perform actions or provide functions. Furthermore, where actions or functions of the eye mask system 7000 are disclosed, it should be understood that the eye mask system 7000 may be configured to perform a method that includes the action or function as a method step. 5.9.1 Eye mask 【0348】 In the embodiments of this technology, the eye mask 7100 is a component or assembly of components that covers the user's eyes. In different embodiments, the eye mask 7100 may completely cover one or both of the user's eyes, or it may partially cover one or both of the user's eyes. In certain embodiments, the eye mask 7100 is opaque, so that it is impossible for light to pass through the eye mask 7100 and reach the user's eyes. In other embodiments, part or all of the eye mask 7100 is semi-transparent, so that a certain amount of light can pass through the eye mask 7100 and reach the user's eyes. In some embodiments, the eye mask 7100 has an opaque mask portion and a semi-transparent mask portion. The opacity of the mask and the different covering methods described herein may be used in any embodiment of the technology described herein unless otherwise clearly required in the context. The eye mask 7100 may form part of an eye mask system 7000, which includes the eye mask 7100 and other components, such as a positioning and stabilizing structure 3300 for the eye mask 7100. 【0349】 The eye mask 7100 can cover the user's eyes to assist sleep by reducing or eliminating ambient light perceptible to the patient's eyes. The appearance of the eye mask 7100 may resemble an eye mask or a VR / AR headset. Such an appearance makes the eye mask system 7000 appear to the user as a familiar item, clothing, or electronic device, rather than a medical device used to treat a disorder. A more familiar / approachable appearance can avoid or reduce any tendency for the user to feel alienated when using the eye mask system 7000. 【0350】 In some forms of this technology, the eye mask 7100 may also include a display 7131 for displaying visual content to the user, for example, in the form of a virtual reality (VR) or augmented reality (AR) mask. The display 7131 will be described in more detail below. More generally, the eye mask system 7000 may include one or more transducers, such as sensors or output transducers, as described later. The eye mask 7100 may include one or more transducers and / or one or more other components. 5.9.1.1 Housing 【0351】 The eye mask 7100 may include a housing to provide a support structure for components of the eye mask 7100, such as the display 7131 which may be located inside or elsewhere within the eye mask 7100, and any other components, such as transducers, processors 7900, memory 7910, communication modules 7920, and / or flow generators 7400. The housing 7120 may further protect the display 7131 and / or other components of the eye mask 7100. The housing 7120 may be constructed from a material suitable for providing protection from impact forces. In some examples, the housing 7120 may be constructed from a biocompatible material. 【0352】 The housing 7120 may be constructed from a rigid, stiff, or semi-rigid material, such as plastic. In certain forms, the rigid or semi-rigid material may be at least partially covered with a soft and / or flexible material (e.g., textile, silicone, etc.). This may improve biocompatibility and / or user comfort during contact between the user and the housing 7120, for example, when the user touches or grasps the housing 7120 with their hands. 【0353】 In other forms of this technology, the housing 7120 may be constructed from a soft, flexible, and elastic material, such as silicone rubber. 【0354】 In some forms, the housing 7120 may have a substantially rectangular or substantially elliptical external shape. The housing 7120 may have a three-dimensional shape having a substantially rectangular or substantially elliptical external shape. 【0355】 In the example shown in Figure 7, the overall shape of the housing 7120 includes a curve on the outside of the housing 7120 that extends from the outward to the rearward direction. This shape can approximate the curvature of a human face, allowing the housing 7120 to "cuddle" a person's face, resulting in an inconspicuous appearance. An inconspicuous appearance for the eye mask 7100 may be advantageous as it makes relaxation or sleep easier while wearing it. In some embodiments, the front-facing side of the housing 7120 has substantially the same shape as the rear-facing side of the housing 7120. 【0356】 In some configurations, the display 7131 is permanently integrated into the eye mask 7100, for example, in the example shown in Figure 17. The display 7131 may be a component that is only usable as part of the eye mask system 7000. In some configurations, the display 7131 may be enclosed in the housing 7120, thereby protecting the display 7131 and / or limiting user interference (e.g., movement and / or destruction) with the display 7131 or its components. 【0357】 In certain configurations, the display 7131 may be substantially sealed within the housing 7120 to limit the accumulation of dust or other debris on the surface of the display 7131, which could adversely affect the user's ability to view the image output by the display 7131. Since the display 7131 cannot be removed from the housing 7120, the user may not need to break the seal to access the display 7131. 【0358】 In other configurations, the display 7131 may be a device that can be used independently of the eye mask system 7000, as it is detachably integrated into the housing 7120. For example, the display 7131 may be mounted on a smartphone or other portable electronic device. 【0359】 The housing 7120 may also include any one or more features of a housing for a head-mounted display device, such as those described in International (PCT) Patent Application No. PCT / AU2021 / 050277, the entire contents of which are incorporated herein by reference. 5.9.1.2 Interface Structure 【0360】 The eye mask 7100 includes parts that come into contact with the user during use, such as parts that come into contact with the user's face. It is desirable that the eye mask 7100 be comfortable for the user to wear. Making the eye mask comfortable encourages the user to wear it for longer periods compared to when the eye mask is not comfortable. It is also desirable that the eye mask 7100 reduces the amount of marks left on the user's face caused by wearing the eye mask 7100. Making the eye mask 7100 comfortable may also promote relaxation, making it easier for the user to fall asleep. 【0361】 The eye mask 7100 may include an interface structure 7140 as shown in Figure 17. The eye mask 7100 of the eye mask system 7000 shown in Figures 7, 9 to 12 and 15 may include the interface structure 7140 shown in Figure 17, or an interface structure 7140 having an alternative configuration. The interface structure 7140 may be provided on the rear side of the eye mask 7100 (for example, on the rear side of the housing 7120) and may be configured to engage with the user's face when in use. In certain embodiments of the art, the interface structure 7140 may include one or more cushion portions positioned on the user contact side of the eye mask 7100, for example on one or more rear surfaces of the eye mask 7100. 【0362】 In some embodiments, the interface structure 7140 according to this technology may be constructed from biocompatible materials. In some embodiments, the interface structure 7140 according to this technology may be constructed from soft materials, flexible materials, and / or elastic materials. In certain embodiments, the interface structure 7140 may include any one or more of the following materials: textiles, fabrics, foams, and / or silicones. 【0363】 The interface structure 7140 may come into contact with sensitive areas of the user's face that may be prone to discomfort. The interface structure 7140 may be configured to provide a buffering effect in these sensitive areas, thereby advantageously limiting or avoiding user discomfort while wearing the eye mask system 7000. These sensitive areas may include the user's forehead and areas of the user's head close to the frontal bone, such as the cranial surface muscles and / or the space between the eyebrows. This area may be sensitive because it has limited natural buffering from muscles and / or fat between the user's skin and bone. Similarly, the user's nasal bridge may have little or no natural buffering. The interface structure 7140 may be configured to provide a buffering effect in these areas. In some examples, the interface structure 7140 is configured such that compliance in one area is higher than in another. 【0364】 In some forms, the interface structure 7140 may include a single element. In some embodiments, the interface structure 7140 may be designed for mass production. For example, the interface structure 7140 may be designed to comfortably fit a wide range of different face shapes and sizes. 【0365】 In some forms, the interface structure 7140 may include different elements that are placed on different areas of the user's face. Different parts of the interface structure 7140 may be constructed from different materials and may provide the user with different textures and / or buffering effects in different areas. 【0366】 In a particular form, the interface structure 7140 may include a first cushion portion and a second cushion portion, the first cushion portion having a greater thickness and / or a larger user contact surface than the second cushion portion, and the first cushion portion being positioned within a portion of the eye mask 7100 that applies a greater force to the user's face during use than the second cushion portion. Alternatively, the first cushion portion may be positioned within a portion of the eye mask 7100 that is in contact with a part of the user's face during use that is more sensitive than the part of the user's face that comes into contact with the second cushion portion during use (e.g., the nose contact area). 【0367】 In some forms, the interface structure 7140 is connected to the surface of the eye mask 7100. In some examples, the interface structure 7140 may include a compliant portion configured to engage with the user's face and a clip portion which is more rigid than the compliant portion and is configured to secure the interface structure 7140 to the housing 7120 of the eye mask 7100. 【0368】 In some forms, the interface structure 7140 may extend at least partially around the housing 7120 and may form a viewing opening. The viewing opening may at least partially receive the user's face when in use. Specifically, the user's eyes may be received within the viewing opening formed by the interface structure 7140. 【0369】 Alternatively or additionally, interface structure 7140 may include any one or more features of interface structures as described in international patent application PCT / AU2021 / 050277. 5.9.1.2.1 Light-shielding part 【0370】 Some forms of the eye mask system 7000 may include a light-shielding section that can be constructed from an opaque material and configured to block ambient light from reaching the user's eyes. The light-shielding section may be part of the interface structure 7140 or a separate element. In some examples, the interface structure 7140 may form the light-shielding section by shielding the user's eyes from ambient light, in addition to providing a comfortable contact area for contact between the eye mask 7100 and the user's face. In some examples, the light-shielding section may be formed from multiple components that together block ambient light. 【0371】 In certain configurations, the light-shielding portion may prevent ambient light from reaching the eye area (the area of ​​the cranial surface muscles, within the user's sphenoid bone, across the lateral cheek area between the sphenoid bone and the left or right zygomatic arch, across the zygomatic arch, across the medial cheek area from the zygomatic arch to the outermost lateral part of the nasal ala base, and formed on the user's nasal bridge beneath the serion, potentially enveloping a portion of the user's face between them). 【0372】 In one configuration, the light-blocking portion may not come into contact with the user's face or the surrounding area. For example, the light-blocking portion may be positioned at a distance from the user's nasal bridge. The width of this distance may be substantially small, so as to substantially limit the intrusion of ambient light. However, the user's nasal bridge can be sensitive and prone to inflammation. Therefore, avoiding direct contact with the user's nasal bridge can improve user comfort while wearing the eye mask system 7000. 5.9.1.2.2 Seal-forming structure 【0373】 In some forms, the interface structure 7140 is formed as a seal-forming structure and may include a target seal-forming region. The target seal-forming region is a region on the seal-forming structure where sealing can occur. The region where sealing actually occurs (i.e., the actual sealed surface) may change daily within a given session depending on various factors, including, but not limited to, the placement of the eye mask 7100 on the face, the tension in the positioning and stabilizing structure 3300, and / or the shape of the user's face. 【0374】 In one embodiment, the target seal-forming region is located on the outer surface of the interface structure 7140. In a particular embodiment, the entire periphery of the interface structure 7140 may be configured to seal the user's skin and block ambient light from reaching the eye region. The eye region may be formed in the area of ​​the cranial surface muscles, within the user's sphenoid bone, across the lateral cheek region between the sphenoid bone and the left or right zygomatic arch, across the zygomatic arch, across the medial cheek region from the zygomatic arch to the outermost lateral part of the nasal ala base, and on the user's nasal bridge below the selion, enclosing a portion of the user's face between them. 【0375】 In certain configurations, this can create a seal around the user's eyes. The seal generated by the seal-forming structure or interface structure 7140 can create a light seal to limit ambient light from reaching the user's eyes. 【0376】 When a seal-forming structure is provided, the interface structure 7140 may come into contact with sensitive areas on the user's face, such as the user's nasal bridge. This contact can completely prevent the entry of ambient light. Sealing around the entire periphery of the housing 7120 can improve the performance of the eye mask system 7000. Furthermore, biocompatible materials may be selected so that direct contact with the user's nasal bridge does not significantly reduce the user's comfort while wearing the eye mask system 7000. 【0377】 In a particular form of this technology, the eye mask system 7000 includes a plurality of interface structures 7140, each configured to fit a range of different user head sizes and / or shapes. For example, the eye mask system 7000 may include one form of interface structure 7140 suitable for larger heads rather than smaller heads, and another form suitable for smaller heads rather than larger heads. Since the different interface structures 7140 may be removable and interchangeable, various users can use the same eye mask system 7000 even if they have different head sizes. 5.9.1.2.3 Biocompatibility of materials 【0378】 Biocompatible materials are considered materials that undergo a detailed evaluation of their biological responses related to safety during use, in accordance with the ISO 10993-1 standard. This evaluation takes into account the nature and duration of expected contact with human tissue during use. In some forms of this technology, at least some of the following biocompatibility tests may be performed on materials used in positioning and stabilization structures and interface structures: Cytotoxicity-elution test (MeM extraction): ANSI / AAMI / ISO10993-5 Skin sensitization: ISO10993-10 Inflammation: ISO10993-10 Genotoxicity - Bacterial mutagenicity test: ISO 10993-3 Transplantation: ISO10993-6 5.9.1.3 Sensors 【0379】 In some embodiments of this technology, the eye mask system 7000 may include one or more sensors or one or more transducers that take the form of one or more sensors. A sensor can be understood as a transducer that receives input energy, for example, in a physical form (e.g., light, sound, temperature, motion, etc.) and generates electrical energy (e.g., an electrical signal). Each sensor may include multiple components that form a sensor in an assembly, for example. In some examples, a sensor or component of a sensor may be physically separated from other components of the eye mask system 7000. That is, one or more sensors may be provided on the eye mask 7100. Alternatively or additionally, one or more sensors may be provided on peripheral components such as a wristband. For example, the eye mask system 7000 may include an eye mask 7100 worn on the user's head and sensors located elsewhere on the user's body (e.g., the user's wrist, chest, or fingers). In some examples, one or more sensors may be physically separated from the user's body, for example, located on a bedside table. 【0380】 One or more sensors may be configured to detect characteristics of the surrounding environment, the user's sleep characteristics, and / or user characteristics (e.g., while awake or asleep). 5.9.1.3.1 Electroencephalography (EEG) 【0381】 In some examples of this technology, the eye mask system 7000 includes an EEG sensor 7110. 【0382】 The EEG sensor 7110 may include one or more sensor elements (for example, forming one or more channels). In some examples, the EEG sensor 7110 may include multiple sensor elements and may include an assembly. In some examples, the eye mask system 7000 may include a cap configured to be worn on the user's head, and the cap may include multiple sensor elements that together form the EEG sensor 7110. In some examples, the cap may be detachably attached to other parts of the eye mask system 7000. The cap may form, for example, at least part of a positioning and stabilization structure 3300. 【0383】 In some examples, the eye mask system 7000 may include a positioning and stabilization structure 3300 that includes an EEG sensor 7110. The EEG sensor 7110 may include a plurality of sensor elements positioned on the positioning and stabilization structure 3300. The sensor elements may be provided on one or more strap portions of the positioning and stabilization structure 3300 (for example, located on or embedded within the strap portions of the positioning and stabilization structure 3300). 【0384】 It should be understood that the number of sensor elements forming the EEG sensor 7110 may vary depending on the example of this technology. 5.9.1.3.2 Electrocardiogram (ECG) 【0385】 In some examples of this technology, the eye mask system 7000 includes an ECG sensor 7111. 【0386】 The ECG sensor 7111 may include one or more sensor elements that form the ECG sensor 7111. The ECG sensor 7111 may include multiple sensor elements and may include an assembly. In some examples, the eye mask system 7000 may include multiple electrodes configured to be attached to the user's body. The ECG sensor 7111 may include electrodes or may be configured to receive signals from electrodes. The ECG sensor 7111 may generate an ECG signal or generate signals from leads attached to electrodes and transmit these signals to another component or processor that generates an ECG signal. 5.9.1.3.3 Pulse / HR 【0387】 In some examples of this technology, the eye mask system 7000 includes a heart rate sensor 7112 configured to detect the user's heart rate. 【0388】 In some examples, the heart rate sensor 7112 may include, for example, an optical heart rate monitor assembly that includes an LED configured to detect pulses and a sensor element that comes into contact with the user's skin. The heart rate sensor 7112 may come into contact with the patient's forehead during use. The eye mask 7100 may include the heart rate sensor 7112. In another example, the eye mask system 7000 may include one or more ear pads that include the heart rate sensor 7112. In yet another example, the heart rate sensor 7112 may include an electrical heart rate monitor assembly that includes a chest band worn around the user's chest. 【0389】 In some examples, the eye mask system 7000 may include an assembly that provides either a sensor element or both an ECG sensor 7111 and a heart rate sensor 7112. 5.9.1.3.4 Oxygen 【0390】 In some examples of this technology, the eye mask system 7000 includes an oxygen saturation sensor 7113 configured to detect the user's blood oxygen saturation level or to generate a signal (from which the user's blood oxygen saturation level can be determined). 【0391】 In some examples, the oxygen saturation sensor 7113 may include a photoelectric fingertip volume plethysmography (PPG) sensor, such as a pulse oximeter. The oxygen saturation sensor 7113 may include a forehead pulse oximeter configured to detect the user's blood oxygen saturation. In some examples, the eye mask 7100 includes a forehead pulse oximeter. In other examples, the oxygen saturation sensor 7113 may include a fingertip pulse oximeter or any other type of pulse oximeter (e.g., an earlobe or toe pulse oximeter). 【0392】 In some examples, the eye mask system 7000 may include an assembly that provides either a sensor element or both a heart rate sensor 7112 and an oxygen saturation sensor 7113. 5.9.1.3.5 Blood pressure (BP) 【0393】 In some examples of this technology, the eye mask system 7000 includes a blood pressure sensor 7114. The blood pressure sensor 7100 may generate a signal indicating the patient's blood pressure (for example, from which the patient's blood pressure can be determined or estimated). 【0394】 In some examples, the blood pressure sensor 7114 includes a cuffless blood pressure sensor. The cuffless blood pressure sensor may be integrated into the eye mask 7100. Alternatively, the cuffless blood pressure sensor may be separate from the eye mask 7100 and may be configured to transmit a signal indicating the user's blood pressure to the eye mask 7100. In other examples, the blood pressure sensor 7114 includes a blood pressure measurement system that includes a blood pressure measuring cuff and a pump unit for inflating the cuff. In some examples, the pump unit is configured to transmit the user's blood pressure, or a signal indicating it, to the eye mask 7100. 【0395】 In some examples, the eye mask system 7000 includes an assembly that provides a sensor element, or both a heart rate sensor 7112 and a blood pressure sensor 7114. 5.9.1.3.6 Accelerometer 【0396】 In some examples of this technology, the eye mask system 7000 includes an accelerometer 7115. The accelerometer 7115 may be configured to detect and / or capture the user's movement and / or orientation (for example, by detecting acceleration and determining motion). The accelerometer 7115 may be, for example, a 3-axis, 4-axis, 5-axis, or 6-axis accelerometer. In some examples, the accelerometer 7115 is provided in the eye mask 7100. In other examples, the accelerometer 7115 is located in another component of the eye mask system. 5.9.1.3.7 Temperature 【0397】 In some examples of this technology, the eye mask system 7000 includes a body temperature sensor 7116. The body temperature sensor 7116 may include a contact thermometer or a non-contact thermometer. In some examples, the body temperature sensor 7116 may include an infrared thermometer. The body temperature sensor 7116 may be provided on the eye mask 7100. In some examples, the body temperature sensor 7116 may include an infrared thermometer provided on the eye mask 7100 and may be configured to measure the user's temperature via the user's forehead. Alternatively, the body temperature sensor 7116 may be provided on another component of the eye mask system 7100 (e.g., a wristband worn by the user). The body temperature sensor 7116 may measure the user's skin temperature. 【0398】 In some examples of this technology, the eye mask system 7000 includes an ambient temperature sensor 7117. An ambient temperature sensor 7116 may be provided on the eye mask 7100. Alternatively, the ambient temperature sensor 7116 may be provided on another component of the eye mask system 7100. In one embodiment, the ambient temperature sensor 7116 may be provided on a respiratory pressure therapy device 4000 configured to transmit ambient temperature measurements (e.g., signals indicating them) to the eye mask 7100. 5.9.1.3.8 Humidity 【0399】 In some examples of this technology, the eye mask system 7000 includes an ambient humidity sensor. The ambient humidity sensor may be provided on the eye mask 7100. Alternatively, the ambient humidity sensor may be provided on another component of the eye mask system 7100. In one embodiment, the ambient humidity sensor may be provided on a respiratory pressure therapy device 4000 configured to transmit ambient humidity measurements or signals indicating them to the eye mask 7100. 5.9.1.3.9 Microphone 【0400】 In some examples of this technology, the eye mask system 7000 includes a microphone 7118. The microphone 7118 may be provided on the eye mask 7100. Alternatively, another device (e.g., a user's telephone or respiratory pressure therapy device 4000) that can form part of the eye mask system 7000 or communicate with the eye mask system 7000 may include the microphone 7118. The output of the microphone 7118 may be used by the eye mask system 7000 to detect breathing, snoring, apnea and / or ambient noise. In some examples, the microphone 7118 may be used for voice input by the user. 5.9.1.3.10 Camera 【0401】 In some examples of this technology, the eye mask system 7000 includes a camera. The camera may be provided on the eye mask 7100. Alternatively, another device (e.g., the user's telephone or respiratory pressure therapy device 4000) that may form part of the eye mask system 7000 or communicate with the eye mask system 7000 may include a camera. 【0402】 The camera may be capable of capturing individual images or videos (which can be considered as multiple images captured at intervals short enough that they appear as a video when played back sequentially). 【0403】 The camera output can be presented to the user of the eye mask system 7000 on the display 7131, as will be further described below. 【0404】 In some examples, the eye mask system 7000 includes multiple cameras. 5.9.1.4 Example of Analysis 【0405】 In some forms of this technology, the eye mask system 7000 (e.g., processor 7900) is configured to analyze the output of one or more sensors (e.g., one or more of the aforementioned sensors). The eye mask system 7000 may be configured to analyze the sensor outputs and take action based on the analysis. The eye mask system 7000 may be configured to identify sleep characteristics, identify problems, predict outcomes, and / or provide recommendations to the user or public healthcare service providers. 【0406】 In some forms, the eye mask system 7000 may include an artificial intelligence (AI) module configured to perform these functions. In some forms, the eye mask system 7000 may include a machine learning (ML) module configured to perform these functions. The ML module may be partially trained or may be considered fully trained. In other forms, these functions may be performed remotely, for example, via one or more servers (e.g., servers operated by the developers of the eye mask system 7000). In such an example, the eye mask system 7000 may communicate with the servers to transmit data for analysis and receive results. 5.9.1.4.1 Detection and Diagnosis 【0407】 In some cases, the eye mask system 7000 may be configured to detect and / or diagnose disorders. For example, the eye mask system 7000 may be configured to detect apnea or other respiratory events (e.g., hypopnea or hyperpnea or gasping) that the user is experiencing. The eye mask system 7000 may be configured to detect snoring by the user. In some forms, the eye mask system 7000 may be configured to detect apnea, snoring, or gasping from the user's bedmate. In some cases, the eye mask system 7000 may monitor the user's breathing using a microphone 7118. The eye mask system 7000 may detect apnea or snoring by analyzing the output of the microphone 7118. The eye mask system 7000 may be configured to detect low oxygen levels using, for example, an oxygen saturation sensor 7113, or other abnormal phenomena associated with sleep apnea (e.g., high pulse, blood pressure, or heart rate variability). In some examples, the eye mask system 7000 may receive data representing apnea and / or snoring detected by the RPT device 4000 and also by the user during use, and may process that data by, for example, recording it, presenting the data to the user, and / or recommending changes to the user. The eye mask system 7000 may be configured to detect and / or diagnose sleep-disordered breathing by performing the methods or steps described with reference to Figures 4D and 4E. 【0408】 In some cases, the eye mask system 7000 may be configured to diagnose sleep-disordered breathing (SDB), such as OSA, or to provide clinicians with sufficient information for diagnosis. The eye mask system 7000 may diagnose SDB based on the severity or frequency of detected events (e.g., apnea, hypopnea or hyperpnea, excessive nasal breathing, etc.). In some cases, the eye mask system 7000 may be configured to detect teeth grinding, for example, using a microphone 7118. 5.9.1.4.2 Sleep detection and / or wake detection 【0409】 In one example, the eye mask system 7000 is configured to identify that the user is asleep. Alternatively or additionally, the eye mask system 7000 may be configured to identify that the user is awake. 【0410】 The eye mask system 7000 may be configured to determine whether the user is asleep or awake based on signals (one or more) received from any one or more of the sensors of the eye mask system 7000 (including, but not limited to, the EEG sensor 7110, HR sensor 7112, BP sensor 7114, body temperature sensor 7116, and microphone 7118). 【0411】 The eye mask system 7000 (for example, having a processor 7900 and memory 7910) may be configured to determine whether the user is awake or asleep, to record sleep duration / duration and wake duration / duration, and to present the information to the user or clinician. 5.9.1.4.3 Classification of sleep stages 【0412】 In some cases, the eye mask system 7000 may be configured to identify sleep stages; that is, the eye mask system 7000 may be configured to detect the user's sleep stages. In some cases, the eye mask system 7000 may be configured to identify REM sleep and non-REM sleep. In further cases, the eye mask system 7000 may be configured to identify wakefulness, light sleep, deep sleep, and / or REM sleep. The eye mask system 7000 may be configured to record the time and duration of sleep and / or sleep stages. The eye mask system 7000 may be configured to display the sleep stage record to the user or a clinician. 【0413】 The eye mask system 7000 may be configured to determine a sleep state or stage based on signals (one or more) received from any one or more of the sensors of the eye mask system 7000 (including, but not limited to, the EEG sensor 7110, HR sensor 7112, BP sensor 7114, body temperature sensor 7116, and microphone 7118). 5.9.1.5 Output Transducer 【0414】 In some examples of this technology, the eye mask system 7000 includes one or more transducers, which may take the form of one or more output transducers, or include one or more output transducers. The output transducers may provide the output of the eye mask system 7000. An output transducer can be understood as a transducer that receives input in the form of electrical energy and produces energy in another form, such as a physical form (e.g., light, sound, temperature, motion, etc.). 【0415】 The eye mask system 7000 can interact with the user by operating one or more output transducers. In some examples, the eye mask system 7000 may be configured to operate one or more output transducers to help the user fall asleep and / or help the user achieve quality sleep. For example, the eye mask system 7000 may operate output transducers to achieve one or more of the following: longer sleep, deeper sleep, longer deep sleep, longer REM sleep, a better experience upon waking after sleep, and a better experience while awake. In further examples, the eye mask system 7000 may operate one or more output transducers to interact with the user (for example, for entertainment, education, relaxation, etc.) or to help the user fit or set up the eye mask system 7000. 5.9.1.5.1 Acoustic Transducers 【0416】 In some examples of this technology, the eye mask system 7000 includes an acoustic transducer 7130. The acoustic transducer 7130 may be configured to produce sound. 【0417】 Sound may be delivered through the user's ear canal or through the bones within the patient's skull. In certain examples, the acoustic transducer 7130 may include a bone conduction transducer, ear pads, over-ear headphones, or speakers. In some examples, the acoustic transducer 7130 is connected to or formed as part of an eye mask 7100. In some examples, the acoustic transducer 7130 is connected to or formed as part of a positioning and stabilization structure 3300, for example, to a back strap 3310 of the positioning and stabilization structure 3300 of the eye mask system 7000. 【0418】 In some examples, sound does not have to be delivered directly to the user's ear or ear canal. Some users may prefer not to cover / block their ears. In the example shown in Figure 17, the eye mask 7100 includes an acoustic transducer 7130 in the form of two speakers (one on each outer surface of the eye mask 7100, configured to direct sound substantially rearward towards the user's ear). The speakers may be connected to or housed within the housing 7120. The housing 7120 or separate speaker housings may optionally include two groups of holes formed within the housing 7120 adjacent to the speakers to propel and / or direct sound rearward. 【0419】 In some forms of this technology, the acoustic transducer 7130 includes an active noise control mechanism (which may be alternatively called a noise-canceling or active noise reduction mechanism configured to reduce specific sounds in the sound output to the user). For example, unwanted ambient noise can be reduced by generating sound waves that are out of phase with respect to the received sound waves and outputting these out-of-phase sound waves to the user. 5.9.1.5.2 Display 【0420】 The eye mask 7100 of the eye mask system 7000 can block virtually all ambient light. This can help the user relax or fall asleep if desired, and can help the user maintain sleep. 【0421】 In some examples of this technology, the eye mask system 7000 includes a display 7131. The display 7131 may be incorporated within the eye mask 7100 and may include a VR or AR display. In some examples, the display may occupy the user's entire field of view. In other examples, one or more light sources, display elements, or screens that may be included in the display 7131 are within the user's field of view but do not occupy the entire field of view. The display 7131 may include a single display screen that occupies the user's entire field of view, or it may include two display components (e.g., two display screens, each corresponding to one of the user's eyes). 5.9.1.5.2.1 Lens and display screen 【0422】 In some examples, the display 7131 includes at least one lens 7134. The user can view the image provided by the display screen through the lens 7134. At least one lens 7134 helps to move the display screen away from the user's face to limit eye strain. At least one lens 7134 also helps to better observe the image displayed by the display. 【0423】 Figure 17 shows an example of a display 7131 provided on an eye mask 7100. The display 7131, or any one or more of its features, may be applied to any of the other eye masks 7100 described herein, as shown in the description with reference to Figure 17 and the illustrations therein. In the example shown in Figure 17, the display 7131 includes two lenses 7134. Generally, in an example where the display 7131 includes two lenses, when a feature of a single lens is described, it should be understood that the feature is applicable to each lens of the pair. Similarly, when a feature of a single display screen is referred to, it should be understood that the feature is applicable to each of the pair of display screens. In some examples, the display 7131 may also include one display screen and two lenses. 【0424】 In some forms, lens 7134 is a Fresnel lens. 【0425】 In some configurations, the shape of each lens 7134 may be substantially frustoconical. The wider end of the lens 7134 may be positioned closer to the display screen 3104, while the narrower end of the lens 7134 may be positioned closer to the user's eye during use. 【0426】 In some forms, the lens 7134 may have a substantially cylindrical shape and may have substantially the same width as the display screen and the user's eye when in use. 【0427】 In some configurations, at least one lens 7134 may also magnify the image on the display screen to help the user view the image. 【0428】 In some forms, the head-mounted display system 7000 includes one lens 7134 (e.g., a binocular display) for each of the user's eyes. In other words, the user can see through separate lenses positioned in front of each pupil in each eye. While each lens 7134 may be identical, in some examples one lens 7134 may differ from the other lens 7134 (for example, they may have different magnifications or different shapes, such as mirror shapes providing left and right lenses). 【0429】 In certain configurations, the display screen can output two images simultaneously. Each user's eye can see only one of the two images. The images can be displayed side-by-side on the display screen. Each lens 7134 allows each eye to observe only the image closest to it. The user can observe these two images together as a single image. 【0430】 In some configurations, the posterior periphery of each lens 7134 may be approximately the size of the user's orbit. The posterior periphery may be slightly larger than the size of the user's orbit to ensure that the user can look into each lens 7134 with their entire eye. For example, the outer edge of each lens 7134 may be aligned superiorly with the user's frontal bone (e.g., close to the user's eyebrow) and inferiorly with the user's maxilla (e.g., close to the lateral buccal region). 【0431】 By positioning and / or sizing the lens 7134, the user can have a nearly 360° peripheral field of view in the virtual environment to meticulously simulate the physical environment. 【0432】 In some forms, the eye mask system 7000 includes a single lens 7134 (e.g., a monocular display). The lens 7134 may be positioned in front of both eyes (e.g., so that images from the display screen are viewed through the lens 7134 with both eyes) or in front of only one eye (e.g., so that images from the display screen can be viewed with only one eye). 5.9.1.5.2.2 Lens mounting 【0433】 The lens 7134 may be connected to a spacer positioned close to the display screen (for example, between the display screen and the interface structure 7140), so that the lens 7134 does not come into direct contact with the display screen (for example, so that the lens 7134 does not scratch the display screen). 【0434】 The lens 7134 may be concave relative to the interface structure 7140, and as a result, the lens 7134 is positioned within the viewing opening. During use, each of the user's eyes is aligned with each lens 7134, while the user's face is received within the viewing opening (e.g., the operating position). 【0435】 In some configurations, the front periphery of each lens 7134 may encompass approximately half of the display screen. A substantially small gap may exist between the two lenses 7134 along the centerline of the display screen. This allows a user looking through both lenses 7134 to see substantially the entire display screen and all the images / videos / light outputs displayed to the user. 【0436】 In certain configurations, the center of the display screen (for example, along the centerline between the two lenses 7134) may not output an image. For example, in a binocular display (for example, where each side of the display screen outputs substantially the same image), the images may be spaced apart on the display screen. This allows the two lenses 7134 to be positioned very close to the display screen, while the user can see the entire image displayed on the display screen. 【0437】 In some configurations, as shown in Figure 17, for example, the protective layer 7135 may be formed around at least a portion of the lens 7134. During use, the protective layer 7135 may be positioned between the user's face and the display screen. 【0438】 In some configurations, a portion of each lens 7134 may protrude rearward through the protective layer 7135. For example, the narrow end of each lens 7134 may protrude beyond the protective layer 7135 when in use. 【0439】 In some configurations, the protective layer 7135 may be opaque, and as a result, light from the display screen cannot pass through. Furthermore, in some cases, the user may not be able to see the display screen without looking through the lens 7134. 【0440】 In some forms, the protective layer 7135 may be non-planar and may include a contour that substantially conforms to the contour of the user's face. For example, a portion of the protective layer 7135 may be concave in the anterior direction to accommodate the user's nose. 【0441】 In certain configurations, the user cannot come into contact with the protective layer 7135 while wearing the eye mask system 7000. This may help reduce inflammation caused by further contact with the user's face (e.g., the sensitive nasal bridge area). 5.9.1.5.3 Temperature Transducer 【0442】 In some examples of this technology, the eye mask system 7000 may include a temperature transducer 7132. The temperature transducer 7132 may be configured to adjust the actual temperature or the temperature perceived by the user. 【0443】 In one embodiment, the eye mask system 7000 may be configured to heat the user using a temperature transducer 7132. In some examples, the temperature transducer 7132 may include a heating element. The heating element may be provided in the eye mask 7100, the positioning and stabilizing structure 3300, or in another component (e.g., a cap, neck warmer, or heat-generating garment). 【0444】 In another embodiment, the eye mask system 7000 may be configured to cool the user using a temperature transducer 7132. In some examples, the temperature transducer 7132 may include a thermoelectric (Peltier) cooler. The thermoelectric cooler may be provided on the eye mask 7100, the positioning and stabilization structure 3300, or another component. In one example, the temperature transducer 7132 that may be included in the eye mask system 7000 may take the form of a thermoelectric cooler provided on the eye mask 7100 and be configured to cool the patient's forehead. 【0445】 In another example, the temperature transducer 7132 may include a fan or air supply configured to cool the user via convection cooling. 【0446】 The temperature transducer 7132 may include an assembly or system having both heating and cooling devices. For example, the temperature transducer 7132 may include both a heating element and a thermoelectric cooler. The temperature transducer 7132 may operate to heat or cool the user as needed. In another example, the eye mask system 7000 may include multiple temperature transducers 7132 (e.g., a first temperature transducer 7132 configured to provide heating, and a second temperature transducer 7132 configured to provide cooling). 5.9.1.5.4 Aroma Transducer 【0447】 In some examples of this technology, the eye mask system 7000 may include a fragrance transducer 7133 configured to provide a fragrance to the user. 【0448】 The fragrance transducer 7133 may include a material impregnated with fragrance and an emitter (e.g., a valve that can be opened to expose the material to ambient air, or a source of air passing through or over the material). The fragrance transducer 7132 may include a material filled with a fragrance that promotes relaxation / sleep. In some examples, the fragrance transducer 7132 may be configured to emit the fragrance of lavender or chamomile. In some examples, the fragrance transducer 7132 may include removable and replaceable material so that the user can replace the material if the fragrance is depleted or a different fragrance is desired. The fragrance transducer 7132 may be provided in the eye mask 7100. To make the fragrance noticeable, the fragrance transducer 7132 may include a diffuser-type element (which may be a porous material impregnated with fragrance through which air can flow in a meandering path). 5.9.1.6 Example of operation of the eye mask system 【0449】 In some cases, the eye mask system 7000 may include a sleep mode or a sleep support mode. The eye mask system 7000 may include one or more features or functions suitable for use by the user while sleeping. In some forms, the eye mask system 7000 is configured to support the user's sleep, and in some cases, to support sleep optimization. The eye mask system 7000 may help the user fall asleep, stay asleep for longer, achieve deeper sleep, maintain deep sleep for longer, wake up, wake up at the optimal time, and / or wake up gently. 【0450】 The eye mask system 7000 can determine, when it occurs, changes that may improve the user's sleep. The eye mask system 7000 can receive input from sensors, determine outputs, and operate output transducers. 【0451】 In some forms of this technology, the eye mask system 7000 includes an awakening mode. The eye mask system 7000 may include one or more features or functions suitable for use when the user is awake. The eye mask system 7000 may operate in awakening mode when the user is awake and not attempting to sleep. In some examples, the system may detect that the user is awake and switch to awakening mode from another mode (e.g., sleep mode or sleep support mode). 【0452】 In some examples of this technology, the eye mask system 7000 may have one or more modes (e.g., wakefulness mode, sleep mode, and / or sleep support mode), but in some forms, the eye mask system 7000 may not have separate operating modes. For example, the eye mask system 7000 may include a variety of features, some of which may be intended for use while awake, and some may be intended for use during sleep or during the transition between wakefulness and sleep, but these are not associated with a specific operating mode. It should be understood that any feature described herein as a feature of sleep mode, wakefulness mode, or another mode is applicable to the eye mask system 7000 that does not operate in separate modes. 5.9.1.6.1 Sound 【0453】 In some examples, the eye mask system 7000 is configured to play sounds to the user via an acoustic transducer 7130 to induce drowsiness or maintain sleep. In certain examples, the eye mask system 7000 is configured to use the acoustic transducer 7130 to play one or more of the following: white noise, pink noise, calming noise (e.g., ocean noise), fireplace noise, fan noise, etc., and / or music (e.g., songs, lullabies, etc.). 【0454】 In some examples, the eye mask system 7000 may be configured to play music. In some specific examples, the eye mask system 7000 may be configured to play sounds accompanying visual content provided by the display 7131. 【0455】 In some cases, the eye mask system 7000 can produce sounds, music, etc., to promote sleep. In other cases, the eye mask system 7000 can produce sounds, music, etc., as part of the user's entertainment or to promote relaxation. 5.9.1.6.1.1 Noise Cancellation 【0456】 In some cases, the eye mask system 7000 is configured to cancel noise. The eye mask system 7000 may be configured to reduce or eliminate ambient noise by operating the acoustic transducer 7130 to provide a noise-canceling effect, which may help the user relax, concentrate, or sleep. For example, the eye mask system 7000 may operate the microphone 7118 to generate a signal representing ambient noise, and operate the acoustic transducer 7130 to generate an audible sound that is out of phase with respect to the ambient noise, thereby canceling the ambient noise. 5.9.1.6.1.2 Wake up 【0457】 In some examples, the eye mask system 7000 is configured to play sounds to the user via an acoustic transducer 7130 to wake the user, preferably gently. The eye mask system 7000 may be configured to wake the user at the end of a sleep cycle, for example, before or around a specific time when the user intends to wake up. In one example, the eye mask system 7000 may be configured to wake the user gently by playing the acoustic transducer 7130, soft sounds such as birdsong, soothing music, or other sounds. The eye mask system 7000 may operate the acoustic transducer 7130 to gently increase the volume of the sound in order to wake the user gently. 5.9.1.6.2 Display 【0458】 The eye mask system 7000 may be configured to operate the display 7131 to provide the user with visual content (for example, to help the user fall asleep, maintain a sleep state, achieve quality sleep, and / or wake up). In some examples, the eye mask system may be configured to provide visual content via the display 7131 for purposes such as entertainment, relaxation, education, or training. The display 7131 may be configured to display images and / or videos. 【0459】 In some examples, the display 7131 may be configured to provide visual content in the form of virtual reality (VR) and / or augmented reality (AR). The visual content displayed as AR may consist of one or more images or videos captured by a camera included as part of an eye mask system 7000 displayed on the display 7131. In one embodiment, real-time video of images captured by the camera is presented on the display 7131. 【0460】 In some examples, the eye mask system 7000 may be configured to provide communication services, such as video calls or video conferencing, to the user via the display 7131. 【0461】 The eye mask system 7000 may be configured to provide visual content via the display 7131 and audio content via the acoustic transducer 7130. That is, the eye mask system 7000 may be configured to allow the user to view audiovisual content, such as movies, television or other videos with sound, or to engage in other activities involving audio and / or visual content, such as games. 5.9.1.6.2.1 Dusk Mode 【0462】 In some examples, the eye mask system 7000 may be configured to assist the user in falling asleep using the display 7131. In some examples, the eye mask system 7000 may be configured to simulate twilight using the display 7131. The eye mask system 7000 may be configured to display light visible to the user (the light having a predominantly red component) on the display 7131 for a period of time to assist the user in falling asleep. That is, the light may be directed towards the red end of the visible light spectrum. The light may have virtually no blue component. Alternatively, the light may be white light with a greater red component than blue component. 【0463】 In some forms, the eye mask system 7000 may alter the spectrum of light displayed to the user on the display 7131. For example, the spectral change may be controlled to occur gradually. In some forms, the red component of the light spectrum may increase gradually compared to the rest of the spectrum. This simulates the spectral changes of a sunset as dusk approaches, thus creating a natural sleep environment. The changes in the light spectrum, as in the case of a sunset, may be controlled to occur over a period of time. 【0464】 As an addition or alternative, the eye mask system 7000 can gradually dim the light over a period of time (e.g., over periods of 15, 20, 30, 45, 60 minutes, etc.) to assist the user in falling asleep. In some forms of the eye mask, the eye mask system 7000 in some examples may display an image of sunset on the display 7131. 5.9.1.6.2.2 Dawn Mode 【0465】 In some examples, the eye mask system 7000 may be configured to wake the user using the display 7131. In some examples, the eye mask system 7000 may be configured to simulate dawn using the display 7131. The eye mask system 7000 may be configured to display light visible to the user (the light having a predominantly blue component) on the display 7131 for a period of time to help the user wake up. That is, the light may be directed towards the blue end of the visible light spectrum. The light may have virtually no red component. Alternatively, the light may be white light with a greater blue component than red component. 【0466】 The changes in the light spectrum displayed to the user on the display 7131 can also occur in dawn mode, and the spectral changes can be controlled to occur gradually. In some forms, the blue component of the light spectrum can gradually increase compared to the rest of the spectrum. This simulates the changes in the sunrise spectrum as dawn approaches, thus creating a natural environment for the user to wake from sleep. The changes in the light spectrum, as in the case of sunrise, can be controlled to occur over a certain period of time. 【0467】 As an addition or alternative, the eye mask system 7000 can increase the light intensity over a period of time (e.g., over periods of 15, 20, 30, 45, 60 minutes, etc.) to help the user wake up. In some examples, the eye mask system 7000 may display an image of sunset on the display 7131. 5.9.1.6.3 Heating and Cooling 【0468】 The eye mask system 7000 may be configured to measure the temperature of the user and / or the surrounding environment, for example, using a body temperature sensor 7116 and / or an ambient temperature sensor 7117. The eye mask system 7000 may determine that heating is needed and operate a temperature transducer 7132 to provide heating. The eye mask system 7000 may determine that cooling is needed and operate a temperature transducer 7132 to provide cooling. 【0469】 In some examples, a user may provide an input to the eye mask system 7000, which may then operate a temperature transducer 7132 to provide heating or cooling based on the input. 【0470】 In some examples, the eye mask system 7000 may be configured to provide heating rather than cooling (and vice versa). Although both heating and cooling features are described herein, it should be understood that the heating features may be applicable to eye mask systems 7000 that do not have the ability to provide cooling. Similarly, it should be understood that the cooling features may be applicable to eye mask systems 7000 that do not have the ability to provide heating. Unless otherwise clearly required by the context, the heating and cooling features disclosed herein should be understood as independent features that are not closely related. 【0471】 In one example, the eye mask system 7000 may determine that the room temperature is not ideal. The eye mask system 7000 may measure the ambient temperature using the ambient temperature sensor 7117. The eye mask system 7000 may determine that the ambient temperature is outside a predetermined range (which may be defined by the user or another party, such as a physician) and may prompt the user to adjust the room temperature. Alternatively, the eye mask system 7000 may activate the temperature transducer 7132 to heat or cool the user. 【0472】 In another example, the eye mask system 7000 may determine that the user's body temperature is outside a predetermined range (which may be set by the user or another party, such as a doctor). The eye mask system 7000 may measure the user's body temperature using a body temperature sensor 7116. The eye mask system 7000 may determine that the body temperature is outside an ideal range and prompt the user to adjust the room temperature or take other measures to warm or cool themselves. In some examples, the eye mask system 7000 may measure the rate of change of body temperature or ambient temperature and prompt the user to take action based on the rate of change. In some examples, the eye mask system 7000 may communicate with an air conditioning unit and operate the air conditioning unit to heat or cool the room as needed to maintain the ambient temperature or the user's body temperature within a predetermined range. The eye mask system 7000 may operate a temperature transducer 7132 to heat or cool the user as needed. In some configurations, the temperature transducer 7132 is controlled to operate in conjunction with content presented to the user on the display 7131. For example, the temperature transducer 7132 may be controlled to provide cooling when the display 7131 displays content associated with cold (e.g., a snowy landscape) and / or to provide heating when the display 7131 displays content associated with heat (e.g., a desert landscape). Metadata may be included in the image data used to generate the display content representing heating / cooling and used to trigger appropriate changes in the operation of the temperature transducer 7132. 【0473】 In other examples, one or more algorithms and / or AI modules or machine learning modules may be used to determine a temperature desirable for the user. The desired temperature may be determined at one or more stages of the user's sleep cycle (e.g., while asleep; during sleep; during REM sleep; and while awake). The algorithm(s) and / or machine learning system may receive one or more parameters, such as ambient temperature, ambient humidity, time of day, information about the user's medical condition, and sleep data, as input to the desired temperature determination process from sensors. These parameters may be provided by sensors included as part of the eye mask system 7000 or by other sensors or systems. The desired temperature determined by the algorithm or machine learning system may be used by the processor 7900 of the eye mask system 7000 to control the temperature transducer 7132 as needed. 5.9.1.6.4 Optimizing Sleep 【0474】 In some examples of this technology, the eye mask system 7000 may monitor or record the length or quality of sleep along with one or more other variables. The eye mask system 7000 may be configured to compare the length or quality of sleep with one or more other variables and to determine the effect of one or more other variables on the length or quality of sleep. For example, the eye mask system 7000 may be configured to optimize one or more other variables or to recommend changes to one or more other variables to the user. Other variables may include background noise, sleep position, sleep duration, CPAP therapy pressure, type of CPAP therapy, and pre-sleep activity. In some examples, the eye mask system 7000 may determine the optimal therapy pressure for a patient receiving respiratory pressure therapy based on the effect of therapy pressure on outcomes (e.g., sleep length, sleep depth, time within a particular sleep stage, AHI, sleep quality reported by the user, etc.). 5.9.1.6.4.1 Noise 【0475】 In some forms, the eye mask system 7000 may determine that a particular background noise level or type of noise is ideal for a particular user's good sleep. The eye mask system 7000 may measure the background noise level and / or type of noise by microphone 7118 during sleep, monitor the quality and / or length of sleep, and provide feedback to the user about the optimal sleep noise level and type of noise. The eye mask system 7000 may prompt the user to play one or more of a particular type of noise, such as white noise, pink noise, ocean sounds, fireplace sounds, etc. The eye mask system 7000 may monitor the length and quality of sleep between each type of noise and determine the noise that is best for the user's good sleep. The eye mask system 7000 may operate acoustic transducer 7130 to cancel noise or provide a specific noise (e.g., white noise) that brings the user to optimal sleep. 5.9.1.6.4.2 Posture 【0476】 In another example, the eye mask system 7000 may determine that a particular sleeping position is optimal for a particular user. In some examples, the eye mask system 7000 may determine that a user is at risk of sleep apnea due to a particular position. The eye mask system 7000 may determine the user's sleeping position using an accelerometer 7115 (or another sensor), monitor the quality and duration of sleep, and determine the position that is optimal for the user's good sleep. While the user is awake, the eye mask system 7000 may provide the user with feedback on the optimal sleeping position based on the amount and / or quality of sleep determined by the eye mask system 7000 and the position corresponding to that amount and / or quality of sleep. In some examples, the eye mask system 7000 may be configured to compare the frequency of sleep-disordered breathing events (e.g., apnea, hyperventilation, hypopnea, snoring, gasping, etc.) in several different sleeping positions, determined using the accelerometer 7115 (e.g., by determining the orientation of the eye mask 7100), and may determine the risk of sleep apnea due to a particular position based on this frequency. 5.9.1.6.4.3 Waking up between sleep cycles 【0477】 In some cases, the eye mask system 7000 may be configured to wake the user during light sleep or between sleep cycles. This may allow the user to feel more rested after waking up. The eye mask system 7000 may be configured to identify when the user is in light sleep and wake the user. Alternatively, if the eye mask system 7000 determines that the user is not in light sleep, the eye mask system 7000 may be configured to gently awaken the user into light sleep before fully waking the user. More generally, the eye mask system 7000 may be configured to change the user's sleep state, for example, without waking the user. 5.9.1.6.5 Reporting Sleep Data 【0478】 In some examples of this technology, the eye mask system 7000 may monitor or record the user's sleep characteristics and store sleep data representing the user's sleep in the memory 7910. The eye mask system 7000 may be further configured to output the sleep data. The sleep data may be output in its raw form or in a summarized form (e.g., measurements of sleep variables / characteristics over a period of time (e.g., mean, maximum / minimum)). The sleep data may be output on one or more external devices, e.g., a remote external device 4286 and a local external device 4288. The sleep data may be provided to the user, a physician, a clinician or other entity (e.g., a health management system, an insurance provider). 【0479】 As an addition or alternative, sleep data may be analyzed and used to generate other forms of feedback to the user. For example, sleep data may be analyzed to obtain a summary of the user's sleep behavior over a period of time (e.g., a qualitative or quantitative representation of the user's sleep habits). In another example, analysis of sleep data may be used to generate suggestions on how the user can improve their sleep, and these suggestions may be output to any one or more of the aforementioned stakeholders via one or more external devices. 5.9.1.6.6 Breathing exercises 【0480】 In some examples of this technology, the eye mask system 7000 may be configured to operate in a breathing training mode. In some examples, the eye mask system 7000 is configured to assist the user in breathing in a manner that promotes relaxation, meditation, sleep, etc. In one embodiment, the eye mask system 7000 may operate an output transducer, such as a display 7131, to provide cues to prompt the user to breathe. The output transducer may provide cues periodically and at a frequency that, if followed by the user, allows the user to achieve a state of relaxation or meditation. Such a state may prepare the user for sleep and / or help the user fall asleep. Alternatively (or additionally), the eye mask system 7000 may provide breathing cues via an acoustic transducer 7132 or via vibration in a manner that promotes relaxation and / or sleep. 【0481】 In some configurations, the eye mask system 7000 may be configured to monitor the user's breathing during breathing exercises. The eye mask system 7000 may receive signals (from which breathing can be detected) from any one of the aforementioned sensors and may analyze and / or record the breathing. 【0482】 In some cases, the eye mask system 7000 may adjust breathing cues based on input from sensors. In one example, the eye mask system 7000 may monitor the user's heart rate using a heat generation rate sensor 7112 and adjust breathing cues based on the user's heart rate. For example, if the user's heart rate 7112 slows down during relaxation, the eye mask system 7000 may reduce the frequency of cues to facilitate further relaxation as the user becomes ready to relax more. 【0483】 In some cases, the eye mask system 7000 may provide the user with feedback on, for example, compliance with breathing cues. In one example, the eye mask system 7000 may operate a display to advise the user to breathe slowly or softly if the user is not breathing slowly or softly enough. The eye mask system 7000 may monitor the user's breathing for compliance with breathing cues using the microphone 7118. Alternatively, if the eye mask system 7000 is configured for respiratory pressure therapy (for example, in the example described below), the eye mask system may monitor the user's breathing based on the flow rate pattern of air flowing from a flow generator (e.g., a blower) to the plenum chamber 3200 of the eye mask system 7000. 【0484】 In some examples, the eye mask system 7000 is configured to be used in breathing training mode to assist / promote sleep. In some examples, the eye mask system 7000 is configured in breathing training mode to be used for relaxation or meditation while the user is awake. In some examples, breathing training mode may be used for anti-anxiety purposes or to provide a sedative effect. 5.9.2 Positioning and stabilization structure of the eye mask system 【0485】 As mentioned above, the eye mask system 7000 includes a positioning and stabilization structure 3300. The positioning and stabilization structure 3300 can hold the eye mask 7100 in the position used. 【0486】 The positioning and stabilization structure 3300, which contacts the user's head, may be configured to be comfortable and adapt to the weight of the eye mask 7100 in a manner that minimizes facial marks and / or pain resulting from prolonged use. In some examples, the positioning and stabilization structure 3300 may provide a one-size-fits-all (universal fit) (or at least nearly one-size-fits-all) while also providing comfort, usability, and manufacturing cost. The positioning and stabilization structure 3300 may be configured to be adjustable over a given range and may be adjustable by a low-touch, easy setup solution with a low skill threshold. Further considerations include providing a dynamic environment in which the eye mask system 7000 can be used. As part of an immersive experience in a virtual environment, the user may communicate, i.e., converse, while using the eye mask system 7000. In this way, the user's jaw or mandible may move relative to other bones of the skull. Furthermore, the entire head may move during the use of the eye mask system 7000. Examples include the movement of the user's upper body, and possibly lower body, and in particular the movement of the head relative to the upper and lower body. 【0487】 In some cases, the positioning and stabilizing structure 3300 provides a holding force to overcome the effects of gravity on the eye mask 7100. 【0488】 In some examples of this technology, a positioning and stabilizing structure 3300 is provided that is configured to harmonize with what the user is comfortably wearing. In some examples, the positioning and stabilizing structure 3300 has an inconspicuous shape or cross-sectional thickness to reduce the perceived or actual bulk of the device. For example, the positioning and stabilizing structure 1300 may include at least one strap having a rectangular cross-section. In particular, the positioning and stabilizing structure 3300 may include at least one flat strap. 【0489】 In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is not too large or bulky, thereby preventing the user from comfortably moving their head from side to side. 【0490】 In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a textile user contact layer, a foam inner layer, and a textile outer layer. In one embodiment, the foam is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the skin contact layer of the strap is formed from a material that helps absorb moisture from the user's face. In one embodiment, the textile outer layer includes a loop material that engages with a hook material portion. 【0491】 In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap may be taut during use and configured to direct a force that pulls the eye mask 7100 toward a portion of the user's face, particularly toward the user's eyes and aligned with their field of vision. 【0492】 In some examples, the positioning and stabilizing structure 3300 includes a tie, which is constructed and positioned such that at least a portion of it lies over a region of the user's head above the upper earlobe point of the patient's head when in use. 【0493】 In the example shown in Figure 7, the positioning and stabilizing structure 3300 includes a back strap 3310. The back strap 3310 forms a tie. The back strap 3310 is fed around the back of the user's head. Each end of the back strap 3310 is connected to each outside of the eye mask 7100. In this example, the back strap 3310 is a wide band. The wide back strap 3310 can distribute the force applied to the user's head over a large surface area, resulting in reduced pressure on the user's head. The user may find lower pressure more comfortable than higher pressure. The length and / or angle of the back strap 3310 may be adjustable. In some examples, the back strap is detachable from the eye mask 7100. 【0494】 The backstrap 3310 may rest on the parietal bone of the user's skull, or on the upper portion of the parietal and occipital bones. When in use, the backstrap 3310 rests on the area of ​​the user's head above the superior base of the ear. 【0495】 Figure 14 shows a positioning and stabilization structure 3300 including a back strap and a face support portion 3320. The face support portion 3320 is configured to lie on the patient's cheeks and forehead without (or with minimal) obstruction of the user's vision when in use. The face support portion 3320 may provide a large surface area that can distribute tension within the back strap to reduce the force applied to the user's face. The eye mask 7100 can be attached to the face support portion 3320 and / or the back strap 3310. 【0496】 In some cases, the positioning and stabilizing structure 3300 pulls the eye mask 7100 toward and onto the user's face. By pulling the eye mask 7100 toward the user's face, a portion of the weight of the eye mask 7100 can be supported by the user's cheeks and forehead, along with the friction between the eye mask 7100 and the user's face. 【0497】 Figure 18 shows another example of a positioning and stabilization structure 3300 that can form part of the eye mask system 7000 together with any eye mask 7100 shown, for example, in Figures 7, 9-13, 15, or 17. In the example in Figure 18, the positioning and stabilization structure 3300 includes a top strap portion 3311 configured to lie over the parietal bone of the user's head. The positioning and stabilization structure 3300 also includes a occipital strap portion 3312 configured to lie over or be beneath the occipital bone of the user's head. Furthermore, in this particular example, the positioning and stabilization structure 3300 includes a pair of outer strap portions 3313 (each configured to lie over the outside of the user's head when in use and to connect the eye mask 7100 to the top strap portion 3311 and the occipital strap portion 3312). 【0498】 The top strap portion 3311 and the occipital strap portion 3312 may be positioned to contact the posterior surface of the user's head. The outer strap portion 3313 may be configured to be taut when in use, pulling the eye mask 7100 backward to engage with the user's face. 【0499】 In some examples, the outer strap portion 3313 may be configured to be attached to the eye mask 7100 by passing it through an opening inside the eye mask 7120 (e.g., inside the housing 7120 or an arm extending from the housing 7120) and wrapping it around the back and securing it to itself using, for example, a hook-and-loop connection, a mechanical fastener, a magnetic connection, a snap button, or another suitable connection. By pulling a sufficient amount of each outer strap portion 3313 through the opening or arm inside the housing 7120 and then securing each outer strap portion 3313 to itself, the user can tighten the outer strap portion 3313 and generate tension to hold the eye mask 7100 over their head. 【0500】 For example, the eye mask 7100 shown in Figure 17 includes a pair of arms 3330 extending from a housing 7120. Each arm 3330 is positioned on each outer side of the housing 7120 and is configured to be attached to each outer strap portion 3313. Each arm 3330 includes an opening at its rear side end through which the outer strap portion 3313 passes and which can be re-secured onto itself after being tightened by the user. As shown in Figure 18, a pair of outer strap portions 3313 that may be included in the positioning and stabilization structure 3300 have each end portion 3314 (each which can be re-secured onto each outer strap portion 3313 after passing through the opening in each arm 3330). In this example, the end portion 3314 includes a hook material configured to be attached to a loop material provided on the outer strap portion 3313. 【0501】 The positioning and stabilization structure 3300 may be flexible and / or elastic so that the eye mask system 7000 can be worn without adjustment of the outer strap portion 3313. That is, when the user adjusts the outer strap portion 3313, the eye mask system 7000 may be configured (for example, with sufficient flexibility and / or elasticity in the positioning and stabilization structure 3300 and the entire system) to allow the eye mask system 7000 to be put on and taken off by further adjustment of the strap portion. In this way, the positioning and stabilization structure 3300 may provide fully automatic adjustment after setup. 【0502】 The positioning and stabilizing structure 3300 may also be described in any example in International Patent Application PCT / AU2021 / 050277, the entirety of which is incorporated herein for reference. 5.9.2.1 Arm 【0503】 The arm 3330 can be any rigid or semi-rigid connector (e.g., rigid enough to support its own shape) and extends from the eye mask 7100 (e.g., from its housing 7100) to the positioning and stabilizing structure 3300 for connection. In some examples, the arm 3330 is formed from a thermoplastic material. In some examples, the arm 3330 is formed from a thermoplastic elastomer (e.g., Hytrel®). The arm 3330 may be substantially non-stretchable. 【0504】 The arms 3330 can generally be aligned in the front-to-back direction. In some examples, the arms 3330 are configured to be aligned substantially parallel to the sagittal plane of the user's head when in use. In some examples, the arms 3330 are configured to be angled with respect to the sagittal plane and extend rearward and outward. 【0505】 The arm 3330 and / or the outer strap portion 3313 may be configured to align with the Frankfort horizontal plane of the user's head and above the cheekbone (e.g., above the user's cheekbone) when in use. In some examples, the arm 3330 may extend posteriorly and superiorly from the housing 7120. In some embodiments, the arm 3330 and / or the outer strap portion 3313 may be configured to align above the antihelix of each of the user's ears when in use. In some examples, the arm 3330 is configured to rotate relative to the housing 7120. The arm 3330 may be pivotably connected to the housing 7120. 【0506】 The arms 3330 may be elongated. The cross-section of each arm 3330 may be substantially flat. For example, the cross-section of each arm 3330 may be larger in the axis aligned with the vertical direction during use than in the axis aligned with the inward-outward direction during use. The cross-sectional shape of each arm may be several times larger (e.g., at least 3 times, at least 5 times, at least 8 times, or at least 10 times) in the vertical axis than in the inward-outward axis. 【0507】 In some configurations, each arm 3330 may have a three-dimensional shape with curvature along all three axes (X, Y, and Z). The thickness of each arm 3330 may be substantially uniform, but its height may vary along its entire length. The purpose of the shape and dimensions of each arm 3330 is to fit snugly to the user's head in order to maintain an unobtrusive and inconspicuous appearance (for example, to avoid appearing excessively bulky). 【0508】 In certain embodiments, a flexible and / or resilient material may be provided around the rigid or semi-rigid material of the arm 3330. The flexible material in contact with the user's head may be more comfortable than the material forming the arm 3330 in order to improve wearability and provide soft contact with the user's face. In one embodiment, the flexible material is a textile sleeve that is permanently or detachably connected to each arm 3330. 【0509】 In one embodiment, the textile may be overmolded onto at least one side of the arm 3330. In one embodiment, the arm 3330 may be formed separately from the resilient components, and a sock of user contact material (e.g., Breath-O-Prene®) may then be wrapped around or slid onto the arm 3330. In an alternative embodiment, the user contact material may be provided to the arm 3330 by adhesive, ultrasonic welding, sewing, hook-and-loop material, and / or stud connectors. 【0510】 In some configurations, the user contact material may be located on both sides of the arm 3330, or alternatively, only on the user contact side of the arm 3330 (e.g., the side that contacts the user or the side facing the user), thereby advantageously reducing the bulk and cost of the material. 【0511】 Arm 3330 may also be described in any example within International Patent Application PCT / AU2021 / 050277, the entirety of which is incorporated herein for reference. 5.9.3 Eye mask systems for respiratory pressure therapy 【0512】 Figure 9 shows the eye mask system 7000 in another embodiment of the present technology. In this embodiment, the eye mask system 7000 is configured to provide respiratory pressure therapy, such as CPAP, to a patient. In this embodiment, the eye mask system 7000 is the patient interface. In the context of the eye mask system 7000 providing respiratory pressure therapy, the user of the eye mask system 7000 may be a patient. More generally, the person using the eye mask system 7000 is a human user, who may or may not be a patient. Where a patient is referred to in this specification regarding features or functions of the eye mask system 7000, it should be understood that the features or functions may be used by any user. Similarly, where a user is referred to, the described features or functions may be used by a patient or during the treatment of a patient. 【0513】 The eye mask system 7000 shown in Figure 9 may include any one or more of the components and features described with reference to Figures 7 and 8. In addition, the eye mask system 7000 includes a plenum chamber 3200, as previously mentioned. The plenum chamber 3200 may be pressurized to a therapeutic pressure of at least 6 cmH2O (and in other examples, at least 2, 4, 10, 20, or 30 cmH2O) above the ambient air pressure. The eye mask system 7000 may include a plenum chamber inlet port that is sized and constructed to receive an airflow into the plenum chamber 3200 at a therapeutic pressure for patient breathing. 【0514】 In the example shown in Figure 9, the eye mask system 7000 is configured to leave the patient's mouth uncovered. In an example where the seal-forming structure 3100 included in the eye mask system 7000 covers the patient's mouth, the eye mask system 7000 may be configured to allow the patient to breathe through their mouth from the surroundings if pressurized air does not flow into the plenum chamber 3200, for example, through an anti-asphyxiation valve (AAV). 5.9.3.1 Seal-forming structure 【0515】 The eye mask system 7000 shown in Figure 9 also includes a seal-forming structure 3100. The seal-forming structure 3100 is constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway. The seal-forming structure 3100 has holes inside it so that the airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils. The seal-forming structure 3100 is constructed and positioned to maintain the therapeutic pressure within the plenum chamber 3200 throughout the patient's entire respiratory cycle during use. 【0516】 In this example, the seal-forming structure 3100 is attached to the eye mask 7100. The seal-forming structure 3100 may be removable from the eye mask 7100 for cleaning and replacement. In some examples of this technology, the eye mask 7100 may be used as an eye mask (for example, a smart eye mask as described above) without the seal-forming structure 3100 attached. 【0517】 In the example in Figure 9, a portion of the seal-forming structure 3100 is visible. The seal-forming structure 3100 defines at least partially the plenum chamber 3200. The seal-forming structure 3100 seals the underside surface of the patient's nose when in use. The seal-forming structure 3100 may seal the underside peripheral area of ​​the patient's nose when in use. The seal-forming structure 3100 may be identified as a “cradle” cushion and may form a seal around the patient’s nostrils. The seal-forming structure 3100 may not enter the patient’s nostrils, but other examples of the art may include a nasal pillow that enters the nostrils and forms a seal around the edges of the nostrils. The seal-forming structure 3100 may seal the underside and / or anterior surface of the patient’s nasal tip and may include a concave portion configured to receive the patient’s nasal tip. The seal-forming structure 3100 may seal below the bridge of the nose. 【0518】 In some examples of this technology, each of the pair of posterior corners that may be included in the seal-forming structure 3100 is configured to seal the patient's face at an external and / or inferior position relative to each of the patient's nostrils. Each of the posterior corners may seal the patient's face at a position adjacent to each of the patient's nasolabial folds, at a position between each of the nasolabial folds and each nostril, and / or at a position where each nostril is joined to the surface facing the front of the patient's face. 【0519】 In other examples, the seal-forming structure 3100 may include a nose cushion configured to seal around the patient's nose, including the nose above the tip of the nose; a full-face cushion configured to seal around the patient's nose and mouth, including the nose above the tip of the nose; a miniature full-face cushion configured to seal around the patient's nose and mouth and the underside and / or front surface of the patient's nose; and / or a nose pillow cushion. 5.9.3.2 Positioning and stabilization structure 【0520】 As previously mentioned with reference to Figure 7, the eye mask system 7000 may include a positioning and stabilization structure 3300 to hold the eye mask 7100 in the use position on the patient's face. An eye mask system 7000 configured for providing respiratory pressure therapy may include any features of the positioning and stabilization structure 3300 as described above with reference to Figures 7 and 8. 【0521】 In the example shown in Figure 9, the positioning and stabilizing structure 3300 of the eye mask system 7000 also provides a force to hold the seal-forming structure 3100 in a therapeutically effective position on the patient's head. The positioning and stabilizing structure 3300 can provide a force large enough to hold the eye mask 7100 and the seal-forming structure 3100 in place, while compensating for the pressure within the plenum chamber 3200 that would impose a force on the patient's face that would tend to separate the seal-forming structure 3100 from the patient's face. 5.9.3.3 Ventilation 【0522】 The example of the eye mask system 7000 in Figure 9 may also include a vent 3400 (not shown). The vent 3400 allows gas exhaled by the patient to flow from inside the plenum chamber 3200 to the surroundings. The gas flow may be a continuous gas flow. The vent 3400 may be sized and shaped to maintain therapeutic pressure within the plenum chamber 3200. Gas can flow from the plenum chamber 3200 to the surroundings through multiple holes that may be included in the vent 3400. 5.9.3.4 Supply of pressurized gas flow 【0523】 An example of the eye mask system 7000 in Figure 9 may include a flow generator (not shown) configured to produce a pressurized gas flow. In this example, the eye mask 7100 includes the flow generator. The flow generator is located inside the eye mask 7100. The flow generator is fluidly connected to the plenum chamber 3200. Thus, a pressurized gas flow is supplied to the plenum chamber 3200 by the flow generator for breathing by the patient. The seal-forming structure 3100 seals around the patient's airway to maintain therapeutic pressure within the plenum chamber 3200 during use. 【0524】 In another example of this technology, the eye mask system 7000 is configured to receive a pressurized gas flow from an air circuit 4170. The air circuit 4170 can transport the gas flow from the RPT device 4000 to the eye mask system 7000 for patient respiration. The eye mask system 7000 may include a connection port 3600 configured to fluidize the air circuit 4170. The air circuit 4170 may include a tube configured to connect to the eye mask system 7000. 【0525】 Figure 10 shows an eye mask system 7000 in which the eye mask 7100 includes a connection port 3600. In this example, the connection port 3600 is located in the center of the front and lower portions of the eye mask 7100. The connection portion 3600 is close to the plenum chamber 3200. The connection port 3600 may pivot around its central axis. In another example, the connection port 3600 may be located in an elbow provided in the eye mask 7100, which is configured to connect to an air circuit 4170. The elbow may have a bend inside (e.g., a 90-degree or 135-degree bend), allowing a tube to extend substantially downward relative to the eye mask 7100. In the example shown in Figure 10, the tube extends partially downward and partially forward. The elbow may pivot. The elbow may include a ball joint or a joint configured to allow the elbow to rotate relative to the eye mask 7100 about multiple axes. The eye mask 7100 may include a "tube down" configuration or a "tube up" configuration. 【0526】 Figure 11 shows an eye mask system 7000 in which the connection port 3600 is located on the top of the patient's head. In this example, the eye mask system 7000 includes a headgear tube 3350 configured to connect between the connection port 3600, located in an upper position on the patient's head, and the eye mask 7100. In this example, the headgear tube 3350 forms a conduit headgear that forms part of the positioning and stabilizing structure 3300. The headgear tube 3350, together with the back strap 3310, can provide force to hold the seal-forming structure 3100 in a sealed position when in use. In other examples, the headgear tube 3350 may not provide force to the seal-forming structure 3100, but may allow the connection port 3600 to be located on the upper surface of the patient's head, and as a result, the air circuit 4170 is not located in front of the patient's face or body when in use. 【0527】 Figure 12 shows another eye mask system 7000 including a connection port 3600. In this example, the eye mask system 7000 includes a short pipe 4175. The connection port 3600 is located at the distal end of the short pipe 4175. The short pipe 4175 is the piping portion of the eye mask system 7000 that is fluidly connected to the plenum chamber 3200. An air circuit 4170 can be connected to the connection port 3600. The short pipe 4175 is configured to carry a pressurized flow of breathable gas to the plenum chamber 3200. The short pipe 4175 can at least partially disconnect the eye mask system 7000 from the air circuit 4170. By connecting the air circuit 4170 to the eye mask system 7000 via the flexible short pipe 4175, tube drag can be advantageously reduced. In the example shown in Figure 12, the short pipe 4175 extends from the outer portion of the eye mask 7100. In other examples, the short tube 4175 may be connected to the eye mask 7100 at a front position, and (for example, in a downward-facing configuration of the tube) extend downward from, for example, the center and front positions on the eye mask 7100. 5.9.3.5 Cushion Module 【0528】 The eye mask systems 7000 shown in Figures 9 to 11 each include a cushion module 3150. The cushion module 3150 includes a seal-forming structure 3100 and may define part or all of the plenum chamber 3200. In some examples, the cushion module includes a seal-forming structure 3100 connected to a chassis portion, and the seal-forming structure 3100 and the chassis portion together form part or all of the plenum chamber. 【0529】 The cushion module 3150 is removable and replaceable, allowing the user to remove it for washing and replace it with a new one at the end of its service life. The cushion module 3150 may be available in multiple shapes and / or sizes to fit a particular eye mask 7100, which allows the eye mask system 7000 to fit a wide range of patients. 【0530】 Figure 19 is a schematic diagram of the front and inner portions of the eye mask 7100 having a removable cushion module 3150. The eye mask 7100 may have any one or more of the features of the eye mask 7100 described elsewhere herein, such as one or more transducers configured to cover the user's eyes when in use and to affect the user's sleep and / or to detect the user's sleep characteristics and / or to detect the user's characteristics during sleep. 【0531】 In the example shown in Figure 19, the cushion module 3150 is formed from a flexible material, such as an elastomer material like silicone or TPE. The cushion module 3150 is removablely attachable to the eye mask 7100. In this example, the cushion module 3150 has a front hole that can stretch to fit into a corresponding portion of the eye mask 7100 in order to remove it from the eye mask 7100. In other examples, the cushion module 3150 may include a substantially rigid clip configured to snap onto the eye mask 7100 to remove the cushion module 3150 from the eye mask 7100. The user can use the eye mask system 7000 without the cushion module 3150 by manually removing the cushion module 3150 before use. The user can also use the eye mask system 7000 with the cushion module 3150 fitted by attaching the cushion module 3150 before use. 【0532】 As shown in the figure, the cushion module 3150 includes a seal-forming structure 3100 and partially defines a plenum chamber 3200 which is fluidly connected to a connecting portion 3600. When in use, the plenum chamber 3200 is filled with air at therapeutic pressure for the user to breathe. The plenum chamber 3200 is attached to the housing 7120 of the eye mask 7100. 【0533】 As shown in Figure 19, the eye mask system 7000 includes a connection port 3600 configured to receive a pressurized airflow from the air circuit 4170 at a therapeutic pressure for the user's breathing and to fluidly connect to the air circuit 4170. In other examples, the eye mask system 7000 includes a flow generator 7400 (e.g., integrated into the eye mask 7100 (e.g., mounted in the housing 7120)) configured to generate a pressurized airflow at the therapeutic pressure. The eye mask system 7000 may also include a vent (not shown in Figure 19) that allows gas exhaled by the patient to flow continuously from the inside of the plenum chamber outwards, and the vent structure is sized and shaped to maintain the therapeutic pressure within the plenum chamber during use. The vent may be formed by a plurality of holes in the housing 7120 and / or the walls of the plenum chamber 3200. 【0534】 The eye mask 7100 may be configured to accept multiple cushion modules 3150 of different sizes. This allows for the accommodation of a wider range of users. The eye mask system 7000 may include the eye mask 7100 and multiple cushion modules 3150, each having a different size from one another. The eye mask 7100 shown in Figure 19 forms part of the eye mask system 7000, which may be configured to operate regardless of whether the cushion modules 3150 are fitted. As will be discussed later, the eye mask system 7000 may be able to operate in a non-therapeutic mode in which the user is not provided with respiratory pressure therapy. The eye mask system 7000 may be able to operate in a non-therapeutic mode regardless of whether the cushion modules 3150 are attached to the eye mask 7100. The eye mask system 7000 may be able to operate in a non-therapeutic mode in the absence of cushion modules 3150, for example, when there are no cushion modules 3150 that fit the eye mask 7100. 【0535】 As described below, in some examples, the seal-forming structure 3100 may be movable between a non-contact position in which the seal-forming structure 3100 does not come into contact with the user and a sealed position in which the seal-forming structure 3100 can form a seal on the user's face. In some examples, the cushion module 3150 is movable relative to the eye mask 7100. The cushion module 3150 may be movable between a non-contact position in which the seal-forming structure 3100 does not come into contact with the user and a sealed position in which the seal-forming structure 3100 can form a seal on the user's face. 【0536】 Figure 19 also shows an interface structure 7140 that connects to a portion of the eye mask 7100 located above the cushion module 3150. A portion of the interface structure 7140 shown in Figure 19 is configured to engage with the user's nasal bridge to create a light seal. 5.9.3.6 Disconnecting the cushion module 【0537】 Figure 13 is a schematic diagram of the eye mask system 7000. In this example, the eye mask system 7000 includes an eye mask 7100 which may have any of the features described above with reference to Figures 7 to 11, and a positioning and stabilizing structure 3300. The eye mask 7100 includes a cushion module 3150 having a seal-forming structure 3100. In this example, the cushion module 3150 at least partially defines the plenum chamber 3200. As described above, the cushion module 3150 may be removablely attached to the eye mask 7100. 5.9.3.6.1 Positional movement and orientation 【0538】 In this example of the technology, the cushion module 3150 is movable relative to the eye mask 7100. Figure 13 shows several ways in which the cushion module 3150 can move relative to the eye mask 7100, indicated by arrows. 【0539】 The cushion module 3150 can be repositioned relative to the eye mask 7100. Furthermore, the cushion module 3150 can be reoriented relative to the eye mask. In other examples of this technology, the cushion module 3150 can be repositioned relative to the eye mask 7100 but cannot be reoriented (or vice versa). In further examples, the cushion module 3150 can be fixed in place relative to the eye mask 7100. 【0540】 To change its position relative to the eye mask 7100, the cushion module 3100 may be able to perform translational motion. The cushion module 3100 may be able to perform translational motion along the front-to-back axis relative to the eye mask 7100, as indicated by arrow B in Figure 13. Additionally or alternatively, the cushion module 3150 may be able to perform translational motion along the left-to-right axis relative to the eye mask 7100, as indicated by arrow A in Figure 13. In some examples, the cushion module 3150 may be able to perform translational motion along the up-to-down axis relative to the eye mask 7100. 【0541】 To change its orientation relative to the eye mask 7100, the cushion module 3100 may be able to rotate. The cushion module 3150 may be able to rotate left-right relative to the eye mask 7100 about an axis oriented vertically, as shown by arrow C in Figure 13. Additionally or alternatively, the cushion module 3150 may be able to rotate up-down relative to the eye mask 7100 about an axis oriented horizontally, as shown by arrow D in Figure 13. In some examples, the cushion module 3150 may be able to rotate front-back relative to the eye mask 7100 about an axis. 5.9.3.6.2 Tunability 【0542】 One way in which the cushion module 3150 can be moved relative to the eye mask 7100 (for example, in the manner described above) is that it can be moved, for example by the patient or clinician, to adjust the cushion module 3150. The cushion module 3150 may be moved to a position and / or orientation that is consistent with a good fit on a particular user or patient. 【0543】 In some examples, the position and / or orientation of the cushion module 3150 relative to the eye mask 7100 may be adjustable. In some examples, the cushion module 3150 may be fixed to the eye mask 7100 and held in place by static friction strong enough to prevent movement of the cushion module 3150 if, for example, movement is not intended during use of the eye mask system 7000. However, the static friction may be weak enough to allow the patient or clinician to push, pull, or rotate the cushion module 3150 to a desired position and / or orientation (if applicable). In another example, the cushion module 3150 may be attached to the eye mask 7100 with a locking mechanism configured to allow the user or clinician to unlock the locking mechanism and move the cushion module 3150 to change its position and / or orientation, while locking the position and / or orientation of the cushion module 3150. 【0544】 An eye mask system 7000 having a movable cushion module 3150 for adjustment may, advantageously, allow the eye mask system 7000 to be used by a wider range of users. Alternatively or as an addition, a movable cushion module 3150 for adjustment may, advantageously, allow individual users to achieve a good fit. 5.9.3.6.3 Decoupling 【0545】 Another way in which the cushion module 3150 can move relative to the eye mask 7100 (in the manner described above) is that it can be at least partially detached from the eye mask 7100. By detaching the cushion module 3150 from the eye mask 7100, a comfortable fit of the eye mask system 7000 to the patient can be obtained. By at least partially detaching the cushion module 3150, it may be possible to move the cushion module 3150 to accommodate the geometric shape of a particular patient's face, resulting in a comfortable and stable fit. 【0546】 The cushion module 3150 may be attached to the eye mask 7100 by a flexible connection, allowing for several movements of the cushion module 3150 relative to the eye mask 7100 (e.g., in any one or more of the directions described above). For example, the cushion module 3150 may be attached to a portion of the eye mask 7100 formed from an elastic material such as silicone. Alternatively or additionally, the cushion module 3150 may be attached to the eye mask 7100 by one or more hinges configured to allow the cushion module 3150 to move to a predetermined position and / or orientation relative to the eye mask 7100. 【0547】 The cushion module 3150, which is detached from the eye mask 7100 and allows at least some movement relative to the eye mask 7100, may also allow the eye mask system 7000 to withstand forces applied to the eye mask 7100, otherwise it could interfere with the seal formed on the patient's face by the seal-forming structure 3100. When the patient turns their head to the side, forces applied to the eye mask 7100 from the patient's pillow or the like may, advantageously, not be transmitted to the seal-forming structure 3100, in cases where the cushion module 3100 is at least partially detached from the eye mask 7100. 【0548】 The cushion module 3150 illustrated in Figure 13 is a cradle cushion, but in other examples, the cushion module 3150 may be of a different type, such as a nose pillow cushion, a full-face cushion, a nose cushion, or an oral-nose cushion. In the case of an oral-nose cushion, the cushion module 3150 may include a nose portion and an oral portion. The nose portion and the oral portion can be disconnected from each other. In other examples, the eye mask system 7000 may include a nose cushion module and an oral cushion module that can be partially or completely disconnected from each other. 5.9.3.6.4 Operation of the cushion module 【0549】 Another way in which the cushion module 3150 can move relative to the eye mask 7100 is by which it can be actuated by the eye mask 7100. The eye mask 7100 may include one or more actuators configured to move the cushion module 3150 to a predetermined position and / or orientation. The actuators may be rotary or linear, or electronically driven (e.g., among other options, small electric motors, servo motors or stepper motors, small linear actuators, electromagnets paired with magnets or ferromagnetic components). Alternatively, one or more actuators may be pneumatically driven and controlled, for example, by the magnitude of the therapeutic pressure and / or the opening and closing of a valve, by a breathable gas delivered through the plenum chamber 3200 during use of the eye mask system 7000 for respiratory pressure therapy. 5.9.3.6.4.1 Operation based on patient input 【0550】 In some cases, the cushion module 3150 may be adjusted, for example, to achieve a better fit, and moved to a predetermined position and / or orientation by an actuator. The patient may provide input to the eye mask system 7000 via a user control interface, activating one or more actuators to change the position and / or orientation of the cushion module 3150 during fitting. 5.9.3.6.4.2 Operation based on therapeutic pressure 【0551】 In some examples, the operation of the cushion module 3150 can be controlled by the eye mask system 7000 (e.g., its processor 7900) without input from the patient. In some examples, the eye mask system 7000 can actuate the cushion module 3150 to bias it to move toward the patient's face for increased sealing force. In this example, the movement of the cushion module 3150 may be slight, but the force holding the seal-forming structure 3100 toward the patient's face may increase. In some examples, the eye mask system 7000 can actuate the cushion module 3100 to provide a sealing force corresponding to a specific therapeutic pressure. That is, the cushion module 3150 may be actuated by a force that is substantially equal to or corresponds to the minimum force required to maintain the seal at a specific therapeutic pressure. 【0552】 The eye mask system 7000 may also be configured to cause movement of the cushion module 3150 in response to events during use of the eye mask system 7000. For example, if a leak is detected in the seal-forming structure 3100, the actuator may act to move the seal-forming structure 3100 closer to the user's face in an attempt to reduce or prevent the leak. In another example, the cushion module 3150 may slowly move toward the user's face during the intensification phase of the pressurized gas supply so that the force applied to the user's face by the cushion module 3150 corresponds to the therapeutic pressure. As the therapeutic pressure increases, the seal-forming structure 3100 needs to be held in contact with the patient's face with a greater force than at lower therapeutic pressures to counteract the greater force resulting from higher therapeutic pressures that act to move the plenum chamber 3200 away from the patient's face. Since only the minimum necessary force is used, the eye mask system 7000 that acts to actuate the cushion module 3150 to provide a sealing force corresponding to the therapeutic pressure may advantageously minimize the force required to hold the cushion module 3150 toward the patient's face. 5.9.3.6.4.3 Operation between non-contact position and sealed position 【0553】 In a further example, the cushion module 3150 may operate between a non-contact position and a sealed position. The non-contact position may be a position where the cushion module 3150 does not come into contact with the patient's face. The sealed position may be a position where the cushion module 3150 can provide respiratory pressure therapy to the patient. The eye mask system 7000 (or its processor 7900) may be configured to move the cushion module 3150 to a non-contact position when therapy is not being provided, and to move the cushion module 3150 to a sealed position when therapy is being provided to the patient. This allows the patient to wear the eye mask system 7000 advantageously without feeling the cushion module 3150 on their face when they are not receiving therapy. 【0554】 In some examples, the eye mask system 7000 (e.g., having a processor 7900) may be configured to detect whether the user is awake or asleep and to move the cushion module 3150 to a sealed position only if the user is asleep. This allows the user to sleep without feeling the cushion module 3150 on their face, while still receiving respiratory pressure therapy even while asleep. 5.9.3.6.4.4 Operation based on orientation 【0555】 In some examples, the eye mask system 7000 may be configured to detect the orientation of the eye mask 7100, for example, using an accelerometer 7115 or other orientation sensor. The eye mask system 7000 may be configured to actuate a cushion module 3150 to apply force to the eye mask 7100 based on its orientation. 【0556】 In some cases, the eye mask system 7000 may activate the cushion module 3150 to compensate for the movement or weight of the eye mask 7100. For example, if a patient turns their head to the side while sleeping, the eye mask 7100 may move outward relative to the patient's face (e.g., downward relative to gravity) under its own weight. In response to this orientation, the eye mask system 7000 may activate the cushion module 3150 to move outward in the opposite direction relative to the patient's face (e.g., upward relative to gravity) to compensate for the outward pull on the eye mask 7100. In some cases, if the eye mask 7100 is pulled downward by gravity, the eye mask system 7000 may activate the cushion module 3100 to rotate it toward the patient's nose. 5.9.3.7 Setup and Troubleshooting Modes 【0557】 The eye mask system 7000 is configured to operate in, or may include, a setup and troubleshooting mode ("setup mode"). In setup mode, the eye mask system 7000 may be configured to assist a user in setting up and / or beginning to use the eye mask system 7000 as shown in any one of Figures 7, 9-12, 15, and 18. In setup mode, the eye mask system 7000 may be configured to assist a user in setting up the eye mask system 7000 for use as a patient interface, for example, for the treatment of sleep-disordered breathing, if the eye mask system 7000 is configured in that way. 【0558】 The eye mask system 7000 may be configured to present a tutorial to the user to assist with fitting and / or setup. The eye mask system 7000 may operate the display 7131 and / or the acoustic transducer 7130 to provide information and / or instructions about setting up the eye mask system 7000 (e.g., how to fit the eye mask system 7000). The eye mask system 7000 may be configured to provide the user with a video tutorial that includes instructions on setup. The eye mask system 7000 may be configured to assist the user in properly fitting the eye mask system 7000 for use as a patient interface for respiratory pressure therapy for sleep-disordered breathing. 【0559】 In some cases, in setup mode, the eye mask system 7000 may provide troubleshooting. For example, a user has started using the eye mask system 7000 but is experiencing a problem. The eye mask system 7000 may be able to operate in setup mode to repeat setup procedures to troubleshoot a specific problem. For example, the eye mask system 7100 may be configured to provide a set of instructions (e.g., using the display 7131 or the acoustic transducer 7130) to set up the eye mask system 7000 from scratch. Alternatively, the eye mask system 7100 may be able to identify that a problem exists or receive input from the user to identify the problem. The eye mask system 7000 may be configured to provide instructions for troubleshooting and / or resolve the problem. 【0560】 In certain forms, the user may communicate with or receive communications from another party in “remote assistance” mode via the communication module 7920. In remote assistance mode, the user may communicate with human assistance, such as a person who can provide technical assistance when using the eye mask system (e.g., a representative of the manufacturer of the eye mask system 7000) and / or a person who can provide medical assistance (e.g., a doctor or clinician). Alternatively or additionally, the user may communicate with artificial assistance, such as an algorithm- or machine learning-based assistance module. Remote assistance mode may be triggered based on certain events detected by the processor 7900 (e.g., if setup takes longer than a predetermined period, or if a threshold number of operational errors are detected during setup). 5.9.3.7.1 Setup Sensor 【0561】 In some examples, the eye mask system 7000 may be configured to monitor one or more signals received from one or more sensors of the eye mask system 7000 during setup. Based on one or more signals, the eye mask system 7000 may provide feedback to the user about the setup. 【0562】 In one embodiment of this technology, the eye mask system 7000 may include a strap tension sensor. The strap tension sensor may be configured to generate a signal indicating tension in the back strap 3310 of the positioning and stabilizing structure 3300, or in one or more other straps, such as the outer strap portion 3313. The eye mask system 7000 may be configured to measure the tension of the back strap 3310 using the strap tension sensor and provide feedback to the user based on the tension. For example, the eye mask system 7000 may advise the user that the back strap 3310 is too loose, too tight, or properly fastened, for example, by operating a display 7131 or an acoustic transducer 7130. In some examples, the strap tension sensor includes a strain gauge provided on the strap. In some examples, the strap tension sensor includes a stretch sensor having capacitance that changes with stretching of the sensor (or part thereof) from an unstretched length. In other examples, the sensor may have resistance that changes with stretching. 【0563】 In some examples of this technology, the eye mask system 7000 may include a strap angle sensor. The strap angle sensor may be configured to generate a signal indicating the angle of the back strap 3310, the outer strap portion 3313, or one or more other straps of the positioning and stabilizing structure 3300. This angle may be relative to a feature of the eye mask 7100, for example, the back strap connection portion to which the back strap 3310 is connected to the eye mask 7100. The eye mask system 7000 may be configured to measure the angle of the back strap 3310 using the strap angle sensor and provide feedback to the user. For example, the eye mask system 7000 may advise the user that the back strap 3310 is too high, too low, or properly angled by operating, for example, a display 7131 or an acoustic transducer 7130. In some examples, the strap angle sensor includes a strain gauge. In one embodiment, the eye mask system 7000 may include a stretch sensor provided between the back strap 3310 and the strap connection portion of the eye mask 7100 such that the amount of extension of the sensor changes with adjustment of the strap angle. The strap angle sensor may be offset from an axis on which the strap can pivot during strap angle adjustment, so that as the strap angle changes, the extension of the stretch sensor also changes. The sensor may have resistance and / or capacitance that changes with the extension of the sensor (or part thereof) from its unextended length. 【0564】 For example, if the positioning and stabilization structure 3300 shown in Figure 17 includes multiple strap sections, a stretch sensor may be provided between any one strap section and any other strap section to determine the angle between the two strap sections. Alternatively or additionally, each stretch sensor, which may be included in any one or more of the strap sections, is configured to measure the elongation of each strap section. In some examples, the positioning and stabilization structure 3300 includes multiple stretch sensors to detect tension or elongation in the strap sections and the multiple stretch sensors to detect the angle between the strap sections and / or the angle between the strap sections and the eye mask 7000, thereby obtaining complete information about the geometry and forces in the headgear in use. 【0565】 In some forms, the eye mask system 7000 includes an eye mask compression sensor configured to generate a signal indicating the force pulling the eye mask 7100 toward the patient's face. The eye mask compression sensor may be located between the eye mask 7100 and the patient's face, or between a part of the eye mask 7100 configured to contact the patient's face during use (e.g., a foam layer) and another part of the eye mask 7100 (e.g., a frame or housing). The eye mask system 7000 may be configured to measure the force pulling the eye mask 7100 toward the patient's face and to provide the user with feedback on the tension of the back strap 3310. The eye mask compression sensor may include a load cell. In one example, the eye mask compression sensor may have resistance and / or capacitance that changes in relation to the compressive force applied to the eye mask compression sensor. 5.9.3.7.2 Leak detection 【0566】 In some examples, in setup mode, the eye mask system 7000 (e.g., its processor 7900) may be configured to detect leaks during use of the eye mask system 7000 for respiratory pressure therapy. Leaks may occur between the seal-forming structure 3100 of the eye mask system 7000 and the surface of the patient's face. In other examples, leaks may occur between components of the eye mask system 7000, for example, between the cushion module 3150 and the part of the eye mask 7100 to which the cushion module 3150 is fluidly connected. In some examples, the eye mask system 7000 may be configured to detect leaks even when the eye mask system 7000 is not operating in setup mode, for example, when the eye mask system 7000 is operating in therapy mode. 【0567】 In some cases, the eye mask system 7000 may detect leaks and warn the user of their presence, for example, using one or more transducers. For example, the eye mask system 7000 may detect a leak and activate the display 7131 and / or the acoustic transducer 7130 to warn the user or prompt the user to reconfigure the eye mask system 7000 or take other action (e.g., change its position). 【0568】 In some cases, the eye mask system 7000 can determine the magnitude of one or more leaks (e.g., leak flow rates). The eye mask system 7000 can activate a transducer (e.g., a display 7131 or an acoustic transducer 7130) to inform the user of the magnitude of the leak. 【0569】 In some examples, the eye mask system 7000 may operate transducers to provide feedback on the presence and / or magnitude of leaks during the fitting of the eye mask system 7000. The eye mask system 7000 may be configured to identify leaks and provide feedback in real time during the fitting of the eye mask system 7000 so that the user can adjust the eye mask system 7000 to minimize or virtually eliminate leaks during setup. 【0570】 In some examples, the eye mask system 7000 may be configured to determine the location of a leak. Unless otherwise clearly required in the context, reference to determining the location of a leak should not be understood as determining the location with absolute precision. In one example, even if the exact location of a leak on a particular side of the seal-forming structure has not been determined, the location of a leak may be determined to the effect that the leak is located on that particular side of the seal-forming structure. In some examples, the eye mask system 7000 may be configured to detect a leak and provide the patient with indication of the leak's location. 【0571】 In one example, the eye mask system 7000 may be configured to distinguish between a leak on the left side of the seal-forming structure 3100 and a leak on the right side of the seal-forming structure 3100. The eye mask system 7000 may include a pair of microphones 7118 provided on each outside of the eye mask 7100. The eye mask system 7000 may operate the pair of microphones 7118 to determine the leaking side of the seal-forming structure 3100, for example, by comparing noise levels. 【0572】 In another example, the eye mask system 7000 may be configured to distinguish between leaks on the upper side of the seal-forming structure 3100 and leaks on the lower side of the seal-forming structure 3100. In yet another example, the eye mask system 7000 may be configured to distinguish between leaks occurring at three, four, or more locations on the seal-forming structure. 【0573】 The eye mask system 7000 may be configured to provide the user with feedback indicating the location of the leak. The user can then reconfigure the eye mask system 7000 to eliminate or reduce the leak. In some examples, the eye mask system 7000 may be configured to provide instructions on reducing or eliminating the leak based on its location. For example, the eye mask system 7000 may be configured to detect that a leak is occurring on the left side of the seal-forming structure 3100 and prompt the user to rotate the seal-forming structure to the left (if the seal-forming structure 3100 is rotatable for adjustment). Alternatively, the eye mask system 7000 may be configured to detect that a leak is occurring and prompt the user to tighten the back strap 3310. 【0574】 As described above, in some examples of this technology, the eye mask system 7000 may be configured to actuate the cushion module 3150 to move the cushion module to a predetermined position and / or orientation. In some examples, the eye mask system 7000 may be configured to detect leaks and determine at least the approximate location of the leak relative to the seal-forming structure 3100. The eye mask system 7000 may be further configured to actuate the cushion module 3150 based on the leak detection to reduce at least the magnitude of the leak. In some examples, the eye mask system 7000 may move the cushion module 3150 as needed to eliminate the leak. In some situations, further adjustment of the eye mask system 7000 or its positioning and stabilization structure 3300 may be required. However, if only minor adjustments to the cushion module 3150 are required, the eye mask system 7000 configured to automatically detect and resolve leaks may, advantageously, require minimal adjustments by the user, resulting in an eye mask system 7000 / patient interface that is easy to handle and use for the user. 5.9.3.7.3 Onboarding 【0575】 In some examples of this technology, the eye mask system 7000 may be configured to facilitate respiratory pressure therapy for new patients. During operation in setup mode, or in separate onboarding modes, the eye mask system 7000 may be configured to perform the onboarding process. 【0576】 During the onboarding process, after the patient has put on (or otherwise fitted and set up) the eye mask system 7000, the eye mask system 7000 may be configured to operate one or more transducers (e.g., display 7131 and acoustic transducer 7130) to provide breathing cues to facilitate the patient's normal breathing and the resulting relaxation, thereby preventing claustrophobia. The eye mask system 7000 may be configured to monitor the patient's adherence to breathing cues using one or more sensors, such as a microphone 7118, and to monitor the patient's level of relaxation using, for example, a heart rate sensor 7112, a blood pressure sensor 7114, an oxygen sensor 7113, and / or a body temperature sensor 7116. 【0577】 In a further step of the onboarding process, the eye mask system 7000 may be configured to initiate the provision of positive airway pressure (e.g., by activating and controlling a separate RPT device 4000, or by controlling the integrated flow generator 7400 of the eye mask system 7000). In some examples, the eye mask system 7000 may be configured to initially provide a low airway pressure (e.g., 4 cmH2O, or e.g., 2 cmH2O to 6 cmH2O) over a predetermined period. The eye mask system 7000 may also provide breathing cues while providing positive airway pressure, for example, to promote normal breathing and help the patient not experience claustrophobia. The eye mask system 7000 may be configured to increase the positive airway pressure from a pressure lower than the therapeutic pressure up to the therapeutic pressure. In some examples, the eye mask system 7000 may be configured to gradually increase the positive airway pressure up to the therapeutic pressure (e.g., by a stepwise increase in pressure or a continuous increase in pressure). In some cases, the eye mask system 7000 may increase airway pressure based on the patient's level of relaxation, such as that determined by adherence to breathing cues and / or sensor output. 5.9.3.8 Integrated flow generator 【0578】 Figure 15 shows an eye mask system 7000 according to another example of the present technology. In this embodiment, the eye mask system 7100 includes a flow generator 7400. As shown in the figure, the flow generator 7400 is attached to the eye mask 7100. The flow generator 7400 is located on the front and inside of the eye mask 7100. In this example, the eye mask system 7000 forms a head-worn PAP system. 【0579】 The flow generator 7400 is configured to provide a pressurized flow of breathable gas to the plenum chamber 3200 for patient respiration, for example, for the treatment of sleep-disordered breathing. In this example, the flow generator 7400 is fluidly connected to the plenum chamber 3200 through an eye mask 7100. The eye mask system 7000 includes a cushion module 3150 having a seal-forming structure 3100. In this example, the cushion module 3150 defines the plenum chamber 3200 at least partially. 【0580】 Figure 16 shows a block diagram of the components of the eye mask system 7000 shown in Figure 15. In this example, the eye mask system 7000 includes all the sensors and transducers described with reference to Figures 7 and 8, along with the processor 7900, memory 7910, and communication module 7920. In addition, the eye mask system 7000 includes a flow generator 7400 controllable by the processor 7900. In some examples, the flow generator 7400 may include its own processor or controller in addition to the processor 7900. 【0581】 In another example, a flow generator 7400, which may be included in the eye mask system 7000, is supported in an upper position above the patient's head and is fluidly connected to the plenum chamber 3200. The flow generator 7400 may be supported above the patient's head by a positioning and stabilization structure 3300 of the eye mask system 7000. 【0582】 The flow generator 7400 may be as described or may have any one or more of the features described in WO2012 / 113027 or WO2018 / 018074, the entire contents of each of these are incorporated herein by reference. 5.9.3.8.1 Non-therapeutic characteristics 【0583】 In some examples, the eye mask system 7400 may include a flow generator 7400 (for example, the example described above with reference to Figures 15 and 16), which does not have to be configured for respiratory pressure therapy, or may be configured for other uses in addition to providing respiratory pressure therapy. Furthermore, the eye mask system 7400 according to the examples of this technology may be configured to provide both therapeutic and non-therapeutic features simultaneously, such as respiratory pressure therapy. 5.9.3.8.2 Flow generator for sensory effects 【0584】 The eye mask system 7000 does not have to include a seal-forming structure or a plenum chamber (from which the user can breathe a pressurized airflow). Instead, the user can breathe ambient air, and the flow generator 7400 can be used for other purposes. In such embodiments, the eye mask 7100 that may be included in the eye mask system 7000 includes the flow generator 7400 in the manner shown in Figure 15, but does not include the seal-forming structure 3100 shown in Figure 15. 【0585】 The operation of the flow generator 7400 may be controlled by the processor 7900. In some examples, the eye mask system 7000 is configured to operate the flow generator 7400 based on user input. In other examples, the eye mask system 7000 may be configured to operate the flow generator 7400 based on input from one or more sensors of the eye mask system 7000. 【0586】 In some examples, the eye mask system 7000 may be configured to provide sensory effects to the user using a flow generator 7400. 【0587】 In one example, the eye mask system 7000 may be configured to simulate wind or a gentle breeze over the user's head or face. The eye mask system 7000 may be configured to generate airflow using a flow generator 7400. The eye mask system 7000 may be configured so that the airflow overflows and comes into contact with the user's head and / or face. This wind simulation can increase the realism of the simulation provided to the user by the eye mask system 7000. For example, the flow generator 7400 may be configured to work in conjunction with content displayed on the display 7131. In one example, the eye mask system 7000 may be configured to simulate a relaxing outdoor environment using the display 7131 and an acoustic transducer 7132 (and optionally other transducers). The eye mask system 7000 may be configured to simulate a gentle breeze over the patient's head, face and / or body. This allows the user to become more immersed in the simulated environment. In another example, the eye mask system may be configured to simulate an active outdoor environment (e.g., cycling, racing, skiing, etc.). The eye mask system 7000 may be configured to simulate a high-speed environment using a high flow rate of air across the user's face and / or head. The flow generator control data may be incorporated into the media data, for example, as metadata (i.e., processed by the processor 7900 to present the media to the user and also control the operation of the flow generator 7400). 5.9.3.8.3 Heating and / or cooling by flow generators 【0588】 In one embodiment, the flow generator 7400 may be used as a fan. The eye mask system 7000 may be configured to provide heating and / or cooling to the user using the flow generator 7400. As previously mentioned, the eye mask system 7000 may include a temperature transducer 7132. The eye mask system 7000 may be configured to operate both the temperature transducer 7132 and the flow generator 7400 to provide heating and / or cooling. For example, the eye mask system 7000 may be configured to generate an airflow using the flow generator 7400 and to heat and / or cool the airflow using the temperature transducer 7132. 【0589】 In some examples, the temperature transducer 7132 or a portion thereof is located within the airflow generated by the flow generator 7400 (e.g., within a conduit, or otherwise within a flow path in other cases). 5.9.3.9 Provision of Respiratory Pressure Therapy 【0590】 As described above, in some embodiments, the eye mask system 7000 is configured to connect to the RPT device 4000 via an air circuit 4170 connected to a connection port 3600 of the eye mask system. In other embodiments, the eye mask system 7000 may include, for example, an eye mask 7100 or a flow generator 7400 attached to a positioning and stabilizing structure 3300. 【0591】 Regardless of whether the source of the pressurized flow of breathable gas is an RPT device 4000 to which the eye mask system 7000 is connected via an air circuit 4170, or a flow generator 7400 that forms part of the eye mask system 7000, the eye mask system 7000 may be configured to control the respiratory pressure therapy provided to the patient. The eye mask system 7000 may control a separate RPT device 4000 via a communication module 7920 by a processor 7900. Alternatively, the processor 7900 of the eye mask system 7000 may more directly control a head-mounted flow generator 7400. Unless otherwise clearly required in the context, any features or functions relating to the provision, operation, control, etc., of respiratory pressure therapy by the eye mask system 7000 described herein should be understood to be applicable to any of these forms of the Art. 【0592】 In some examples, the eye mask system 7000 is configured to provide respiratory pressure therapy based on parameters set by the patient (e.g., therapy pressure, type of therapy, etc.) (e.g., by the operation of an integrated flow generator 7400 or a separate RPT device 4000). In other examples, the eye mask system 7000 may be configured to provide respiratory pressure therapy based on input from one or more sensors of the eye mask system 7000. 5.9.3.9.1 Sleep stages and therapies 【0593】 In some examples, the eye mask system 7000 is configured to determine whether the user is awake or asleep. For example, the eye mask system 7000 may be configured to detect whether the user is awake, asleep, awake, and / or asleep. The eye mask system 7000 may be configured to provide respiratory pressure therapy only when the user / patient is asleep. For example, the eye mask system 7000 may be configured to switch from a non-therapeutic mode to a therapeutic mode when it is detected that the user is asleep. In some examples, the eye mask system 7000 may be configured to provide respiratory pressure therapy only after a predetermined length of sleep duration or in response to apnea. As mentioned above, respiratory pressure therapy may include providing an airflow at therapeutic pressure for breathing by the user / patient. 【0594】 In some cases, the eye mask system 7000 may be configured to increase the therapeutic pressure when it is detected that the patient is asleep, or to increase it gradually otherwise. The eye mask system 7000 may be configured to adjust the rate at which the therapeutic pressure is increased based on the patient's sleep state or stage. For example, if it is detected that the patient is in deep sleep, but the therapeutic pressure has not yet reached a predetermined (e.g., target) therapeutic pressure, the eye mask system 7000 may increase the rate at which the therapeutic pressure is increased. 【0595】 In some examples, the eye mask system 7000 may operate in either sleep support mode or sleep mode depending on whether the user is trying to fall asleep (sleep support mode) or is asleep (sleep mode). For example, the eye mask system 7000 may be configured to detect that the user is awake and operate in sleep support mode. The eye mask system 7000 may be configured to detect that the user is asleep and operate in sleep mode. In some examples, the eye mask system 7000 may be configured to initiate respiratory pressure therapy when transitioning from sleep support mode to sleep mode. In some examples, airway pressure is slowly increased during sleep support mode and then more rapidly in sleep mode. In some examples, the eye mask system 7000 may operate in REM mode and non-REM mode depending on whether the user is in REM sleep or non-REM sleep. 【0596】 The eye mask system 7000 may be configured to assist the user in falling asleep and / or maintaining sleep during respiratory pressure therapy. The eye mask system 7000 can do so by operating one or more of the transducers described herein. Such transducers may include one or more sensors configured to detect characteristics of the surrounding environment, characteristics of the user's sleep, and / or characteristics of the user. The eye mask system 7000 may be configured to analyze the output of one or more of the sensors and take action based on the...

Claims

[Claim 1] An eye mask system that provides respiratory pressure therapy to the user for the treatment of sleep-disordered breathing, The eye mask system comprises an eye mask configured to cover the user's eyes when in use. The eye mask includes one or more transducers configured to detect the user's sleep characteristics and / or the user's characteristics during sleep, The eye mask further comprises a housing that provides a support structure for one or more of the transducers, The eye mask further comprises an interface structure provided on the rear side of the housing, the interface structure being configured to engage with the user's face, including the user's forehead, sphenoid bone region, and cheeks, when in use. The aforementioned eye mask system is A connection port configured to receive a pressurized airflow from an air circuit at therapeutic pressure for breathing by the user, and to fluidize the air circuit; or, A flow generator configured to generate the pressurized airflow at the therapeutic pressure; It further includes one of the following: The aforementioned eye mask is A plenum chamber capable of pressurizing up to the therapeutic pressure, wherein the plenum chamber is sized and structured to receive the airflow at the therapeutic pressure, A seal-forming structure constructed and positioned to form a seal with the user's facial region surrounding the entrance to the user's airway, wherein the seal-forming structure has holes inside so that the airflow is delivered at least to the entrance to the user's nostrils at the therapeutic pressure, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the user's entire respiratory cycle during use. An eye mask system further comprising: a vent that allows gas exhaled by the user to flow continuously from the inside of the plenum chamber to the surrounding area, the vent being sized and shaped to maintain the therapeutic pressure inside the plenum chamber during use. [Claim 2] The one or more transducers include one or more sensors configured to detect the sleep characteristics of the user and / or the user's characteristics while sleeping, The eye mask system according to claim 1, wherein the eye mask system is configured to analyze the output of one or more of the sensors. [Claim 3] The eye mask system according to claim 2, wherein the one or more sensors include one or more of the following: an EEG sensor, an ECG sensor, a heart rate sensor, an oxygen saturation sensor, a blood pressure sensor, an accelerometer, a microphone, an ambient temperature sensor, and / or a body temperature sensor. [Claim 4] The eye mask system according to claim 2 or 3, wherein the eye mask system is configured to identify sleep characteristics, identify problems, predict outcomes, and / or provide recommendations based on the analysis. [Claim 5] The eye mask system according to any one of claims 2 to 4, wherein the eye mask system is configured to adjust the therapeutic pressure of the airflow based on the output of one or more sensors. [Claim 6] The eye mask system according to claim 5, wherein the eye mask system is configured to detect that the user is awake and to reduce the therapeutic pressure. [Claim 7] The eye mask system according to claim 5 or 6, wherein the eye mask system is configured to reduce the therapeutic pressure when it is detected that ambient noise exceeds a predetermined threshold. [Claim 8] The eye mask system according to any one of claims 1 to 7, configured to detect and / or diagnose sleep-disordered breathing. [Claim 9] The eye mask system according to claim 8, wherein the eye mask system is configured to detect sleep-disordered breathing. [Claim 10] The eye mask system according to any one of claims 1 to 9, wherein the eye mask system is configured to operate in at least two modes: a non-therapeutic mode in which respiratory pressure therapy is not provided to the user, and a therapeutic mode in which respiratory pressure therapy is provided to the user for the treatment of sleep-disordered breathing. [Claim 11] The eye mask system according to claim 10, wherein the eye mask system is configured to detect one or more of apnea, hypopnea, hyperpnea, and gasping in at least the non-treatment mode. [Claim 12] The eye mask system according to claim 11, wherein the eye mask system is configured to detect sleep-disordered breathing in the non-treatment mode and to switch from the non-treatment mode to the treatment mode when sleep-disordered breathing is detected. [Claim 13] The eye mask system includes a seal-forming structure, the seal-forming structure is movable between a non-contact position in which the seal-forming structure does not come into contact with the user and a sealed position in which the seal-forming structure can form a seal on the user's face, and the eye mask system is configured to move the seal-forming structure from the non-contact position to the sealed position during a transition from the non-treatment mode to the treatment mode. The eye mask system further comprises a cushion module, the cushion module including the seal-forming structure, and at least partially forming the plenum chamber, To move the seal-forming structure between the non-contact position and the sealed position: the cushion module is attached to a portion of the eye mask formed of an elastic material; or the cushion module is attached to the eye mask by one or more hinges configured to move the position and / or orientation of the cushion module relative to the eye mask, the eye mask system according to claim 11 or 12. [Claim 14] The eye mask system according to claim 13, wherein the cushion module is detachably attached to the eye mask. [Claim 15] The eye mask system according to claim 14, wherein the eye mask system is capable of operating in the non-therapeutic mode regardless of whether the cushion module is attached to the eye mask. [Claim 16] The eye mask system according to any one of claims 11 to 15, wherein the eye mask system is configured to identify that the user is asleep. [Claim 17] The eye mask system according to claim 16, wherein the eye mask system is configured to switch from the non-treatment mode to the treatment mode when it is determined that the user is asleep.

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