Systems and methods for monitoring and managing sleep - Patents.com

Abstract

A system and method are disclosed that takes into account a user's hormonal state to promote sleep: receiving sleep-related data for the user from one or more sensors; receiving one or more inputs related to the user's hormonal state; determining one or more recommendations and / or insights to help improve the user's sleep; and presenting the one or more recommendations and / or insights to the user.

Description

[Technical field]

[0001] 1 CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Australian Patent Application No. 2021904232 filed on December 23, 2021 and Australian Patent Application No. 2022901994 filed on July 15, 2022, the contents of which are incorporated herein by reference in their entireties. [Background technology]

[0002] 2 Background technology 2.1 Technical Field The present technology relates to systems and methods for monitoring and managing sleep, and may relate to systems and methods that assist users in improving their sleep health. 2.2 Background technology

[0003] Poor sleep is a significant problem worldwide. Inadequate rest can negatively impact quality of life, mental health, workplace productivity, healthcare utilization, and disease morbidity.

[0004] Sleep disorders in women are known to be more pronounced during times of major changes in the menstrual cycle and hormonal fluctuations, such as pregnancy, menopause, and conditions such as polycystic ovary syndrome (PCOS). However, while a variety of sleep monitoring and sleep improvement products are on the market (or are on the way), including wearable devices such as watches, armbands, head-mounted devices and contactless products, there is still a need for solutions that take into account the specific needs of women. Summary of the Invention [Means for solving the problem]

[0005] 3. Summary of the Invention Aspects of the present technology may aid in promoting sleep. In particular, aspects of the present technology relate to promoting sleep taking into account a user's hormonal status. For example, a user's hormonal status may be affected by one or more of the user's menstrual cycle, pregnancy, menopause, and / or conditions such as polycystic ovarian syndrome (PCOS).

[0006] Some of the included functionality may include one or more of: recording a user's sleep-related data from one or more sensors; recording inputs related to one or more of the user's hormonal status, exercise, diet, medications, and / or supplements; providing personalized recommendations and / or insights to help improve the user's sleep; and presenting information regarding the user's hormonal status along with the sleep data in a user interface.

[0007] According to one aspect of the present technology, a method is provided that includes receiving sleep-related data for a user from one or more sensors, receiving one or more inputs related to the user's hormonal state, determining one or more recommendations and / or insights to assist in improving the user's sleep, and presenting the one or more recommendations and / or insights to the user.

[0008] In an example, the one or more sensors may be configured to monitor one or more characteristics of the user that may determine one or more sleep events. In an example, the one or more sensors may include one or more of a heart rate sensor, an oxygen level sensor, an ECG sensor, a pulse rate sensor, an accelerometer, a gyroscope, a GPS receiver, a sound sensor and / or microphone, and a non-contact sensing device. In an example, the one or more sensors may include an optical sensor of the wearable sensor device configured to measure a blood volume pulse of the user.

[0009] In an example, the one or more inputs related to the user's hormonal status may be user inputs. In an example, the one or more user inputs related to the user's hormonal status may include fatigue / tiredness level (e.g., light, normal, heavy), localized pain occurrence (e.g., headache, stomach pain, breast pain, back pain), menstrual characteristics: flow rate (e.g., light, normal, heavy), pain level (e.g., low, medium, high), associated symptoms (e.g., fatigue, localized pain, cramps, mood), menstrual timing characteristics of the current or previous cycle (e.g., start, end, duration, regularity, irregularity), medications that affect the menstrual cycle (e.g., delaying the start of menstruation), and / or other factors such as hot flashes, nausea, constipation, acne, mood, and / or appetite.

[0010] In an example, the one or more user inputs may be received as responses to a questionnaire. In an example, the one or more user inputs may be received via a questionnaire interface presented to the user. In an example, the one or more user inputs may be entered by another party conducting a sleep assessment of the user.

[0011] In an example, a user may be provided with a means to enter diary notes (eg, an open field or free-form text).

[0012] In an example, one or more inputs related to the hormonal status of the user may be determined using one or more characteristics of the user obtained using one or more sensors. In an example, one or more inputs related to the hormonal status of the user may be obtained through a biological test. For example, the one or more inputs related to the hormonal status of the user obtained through a biological test may include one or more of glucagon, epinephrine (adrenaline), norepinephrine, cortisol, and growth hormone.

[0013] In an example, one or more inputs regarding the user's exercise habits may be received. In an example, one or more inputs regarding the user's exercise habits may be received as responses to a questionnaire. In an example, one or more inputs regarding the user's exercise habits may be received from one or more exercise applications (e.g., Apple® Fitness+, Fitbit®, MyFitnessPal®, or Samsung® Health).

[0014] Generally, the recommendations are focused on helping the user plan and prepare for anticipated sleep disturbances based on their hormonal status and other predictable causes (e.g., daily dairy intake, comorbidities, past sleep data, etc.) by adjusting factors such as sleep environment, nighttime habits / routines, physical preparation, emotions, beliefs, mindset, etc. Recommendations may provide general guidance to improve sleep and achieve the user's desired sleep goals through general best practices, sleep education, and known science.

[0015] In examples, the one or more recommendations include lifestyle changes, sleep hygiene, an automated sleep diary, an ideal bedtime, a sleep program, relaxation exercises, educational articles, consultation with a sleep consultant, consultation with a medical professional, and / or screening for a sleep-related disorder.

[0016] In examples, the one or more insights may include ovulation phase, hormone fluctuations, the impact of hormone fluctuations on sleep, a correlation between menstrual cycle phase (e.g., menstrual phase, follicular phase, ovulation phase, luteal phase) and the user's sleep metrics, a correlation between the sleep metrics and factors inputted by the user, a readiness metric (e.g., how mentally and / or physically prepared the user is to take on the day) and / or guidance regarding factors that may be affecting the user's sleep or readiness.

[0017] In an example, dietary recommendations may be provided in response to user input indicating that diet is affecting the user's sleep. For example, one or more user inputs in response to a questionnaire may include keywords indicative of dietary factors that affect sleep.

[0018] In an example, a recommendation to consult with a professional may be provided in response to user input indicating that a medication or supplement is affecting the user's sleep. For example, one or more user inputs in response to a questionnaire may include keywords indicating that a medication or supplement is affecting the user's sleep.

[0019] In an example, in response to sensors or user input indicating that hormonal status is affecting the user's sleep, insight regarding the impact of hormonal status on sleep may be provided.

[0020] In an example, in response to user input indicating that stress is affecting the user's sleep, recommendations for reducing stress and insights regarding the impact of stress on sleep may be provided.

[0021] In an example, the method includes predicting that a user is having trouble falling asleep or staying asleep by monitoring one or more factors over an extended period of time. In an example, the extended period of time may be at least 7 days. In an example, the extended period of time may be at least 14 days. In an example, the factors may include one or more of caffeine intake, sleep onset time, diet, supplements, medications, symptoms (e.g., headaches, uterine cramps, etc.), and menstrual cycle stage. In an example, the factors may include one or more of average cycle length (e.g., <21 days, 21-35 days, >35 days, no cycle), contraceptive use (e.g., pill, patch, hormonal IUD, implant, vaginal ring, injection, etc.), pregnancy, breastfeeding, polycystic ovary syndrome (PCOS), menstrual-related disorder (e.g., menorrhagia, absent menstruation, premenstrual syndrome, premenstrual dysphoric disorder), menopause, and perimenopause. In examples, the prediction that a user will have trouble falling asleep or staying asleep may be based in part on monitoring other factors, such as improvements in sleep habits, life experiences (e.g., quality of life, or perceived state of relationships), stress relief activities, etc.

[0022] According to one aspect of the present technology, a method is provided that includes receiving sleep-related data for a user from one or more sensors, receiving one or more inputs related to the user's hormonal status, and presenting information regarding the user's hormonal status along with the sleep data in a user interface.

[0023] According to one aspect of the present technology, a virtual sleep clinic is provided that includes one or more of sleep assessment services, on-demand telehealth visits with qualified practitioners familiar with women's sleep issues and who can diagnose sleep disorders, provide behavioral therapy, and / or prescribe treatment, and offering sleep solutions designed to meet women's sleep needs.

[0024] In an example, the virtual sleep clinic may be configured to facilitate execution of a screening phase to determine a sleep assessment pathway for a user. In an example, the screening phase may identify whether a user is likely to be affected by a male or female hormone condition and direct the user to a sleep pathway based at least in part on this identification. In an example, a first sleep assessment pathway may target sleep breathing conditions (e.g., sleep disorders such as obstructive sleep apnea). In an example, a second sleep assessment pathway may target problems falling asleep or staying asleep.

[0025] According to one aspect of the present technology, there is provided a system including one or more processors and at least one memory having machine-readable instructions stored thereon, the processors configured to execute the machine-readable instructions to perform the methods described herein.

[0026] In an example, the system may include an electronic interface configured to receive user input and / or provide user instructions. In an example, the system includes a head-mounted display device (e.g., an augmented reality head-mounted display, or a virtual reality head-mounted display), and at least one component of the electronic interface is provided via the head-mounted display device. In an example, the electronic interface may include a virtual clinic environment.

[0027] According to one aspect of the present disclosure, there is provided a computer program product comprising instructions that, when executed by a computer, cause the computer to perform any of the methods disclosed herein. In an example, the computer program product is a non-transitory computer-readable medium.

[0028] The described methods, systems, devices, and apparatus may be implemented to improve the functionality of a processor, such as a processor of a special purpose computer, a sleep monitor, a respiratory monitor, and / or a respiratory therapy device, and may provide improvements in the art of automated management, monitoring, and / or treatment of sleep-related conditions (e.g., sleep respiratory conditions, including sleep disordered breathing).

[0029] Of course, some of the aspects may form sub-aspects of the present technology, and various one of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology. Other features of the present technology will become apparent in light of the information contained in the following detailed description, summary, drawings, and claims. 4 Brief description of the drawings

[0030] BRIEF DESCRIPTION OF THE DRAWINGS The present technology is illustrated by way of non-limiting example in the accompanying drawings, in which like reference characters include like elements: 4.1 Respiratory Therapy Systems [Brief description of the drawings]

[0031] [Figure 1A] The system is shown including a patient 1000 wearing a patient interface 3000 in the form of nasal pillows and receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is conditioned by a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position. [Figure 1B] The system is shown to include a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives air at positive pressure supplied from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. [Figure 1C]The system is shown to include a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives air at positive pressure supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An overview of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 4.4RPT device [Figure 4A] FIG. 1 illustrates an RPT device in accordance with one form of the present technology. [Figure 4B] FIG. 1 is a schematic diagram of a pneumatic path of an RPT device in accordance with one form of the present technology. The upstream and downstream directions are indicated with reference 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 in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] FIG. 1 is a schematic diagram of electrical components of an RPT device in accordance with one form of the present technology. [Figure 4D] FIG. 1 is a schematic diagram of an algorithm implemented within an RPT device in accordance with one form of the present technology. [Figure 4E] 4D in accordance with one form of the present technology. [Figure 5A] FIG. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B]FIG. 1 shows an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 5C] 4.6 Respiratory Waveforms [Figure 6A] A model of a typical respiratory waveform of a sleeping person is shown. 4.7 Screening, Diagnostic and Monitoring Systems [Figure 7A] A patient 1000 undergoing polysomnography (PSG) is shown. The patient is sleeping in a supine sleep position. [Figure 7B] 1 shows a monitoring device for monitoring the condition of a patient, the patient being asleep in a supine sleeping position; [Figure 7C] FIG. 4 is a schematic diagram of components of a screening / diagnostic / monitoring device that can be used to implement a respiratory polygraphy (RPG) headbox in a RPG screening / diagnostic / monitoring system concentrator, in accordance with one form of the present technology. [Figure 8A] 1 shows an oxygen concentrator in accordance with one form of the present technology. [Figure 8B] FIG. 8B is a schematic diagram of the oxygen concentrator arrangement of FIG. 4.9 Computing Systems and Processes [Figure 9] 1 illustrates an example system for monitoring sleep and providing insights and / or recommendations, which includes a computing device. [Figure 10] FIG. 1 illustrates parts of an exemplary computing device used to monitor sleep and provide insights and / or recommendations. [Figure 11] FIG. 2 illustrates an exemplary subsystem for collecting sleep-related data from a user. [Figure 12A] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12B] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12C] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12D] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12E] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12F] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12G] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12H] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12I] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12J] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12K] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12L] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12M] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12N] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12O] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12P] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 12Q] 1 is a screen image of an interface on an exemplary user device for providing sleep-related insights and / or recommendations to a user. [Figure 13A(A)] A screen image of an interface for managing and accessing user data. [Figure 13A(B)] A screen image of an interface for managing and accessing user data. [Figure 13B(A)] A screen image of an interface for managing and accessing user data. [Figure 13B(B)] A screen image of an interface for managing and accessing user data. [Figure 14] A screen shot of a web portal offering a virtual sleep path for women. [Figure 15] 13 is a flowchart illustrating a virtual sleep pathway in accordance with one form of the present technology. [Figure 16] 1 is a flowchart illustrating a method for providing sleep-related insights and / or recommendations in accordance with one form of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] 5. MODE FOR CARRYING OUT THEINVENTION Before describing the present technology in more detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in the present disclosure is for the purpose of describing the specific examples described herein, and is not intended to be limiting.

[0033] The following description is provided in conjunction with various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another or other example. In addition, any single feature or combination of features in any of these examples may constitute an additional example. 5.1 Therapy

[0034] In one form, the present technology includes a method of treating a respiratory disorder comprising applying positive pressure to an entrance to an airway of a patient 1000.

[0035] In a particular example of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both of the nostrils. In certain instances of the present technology, mouth breathing is restricted, limited or prevented. 5.2 Respiratory Therapy Systems

[0036] In one form, the present technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may be suitable for delivering any type of respiratory therapy, including, but not limited to, continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), high flow therapy (HFT), oxygen concentration and ventilation.

[0037] The respiratory therapy system may include an RPT device 4000 for supplying air flow to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800. 5.3 Patient Interface

[0038] A non-invasive patient interface 3000 according to one aspect of the present technology includes as functional aspects a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a ventilation section 3400, a form of connection port 3600 for connection to an air circuit 4170, and an optional forehead support 3700. In some forms, the functional aspects may be provided by one or more physical placement elements. In some forms, one physical part may provide one or more functional aspects. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's 1000 airway to maintain positive pressure at the entrance to the airway. As such, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0039] The non-sealed patient interface 3800 in the form of a nasal cannula includes nasal prongs 3810a, 3810b capable of delivering air to each nares of the patient 1000 through respective orifices at the tips. Such nasal prongs generally do not form a seal with the skin surface inside or outside the nares. Air to the nasal prongs may be delivered by one or more air supply lumens 3820a, 3820b coupled to the nasal cannula 3800. The lumens 3820a, 3820b lead from the nasal cannula 3800 through an air circuit to a respiratory therapy device. The non-sealed patient interface 3800 is particularly suited for the delivery of flow therapy, where the RPT device generates an air flow at a controlled flow rate rather than a controlled pressure. In a non-sealed patient interface 3800, the "vent" for venting excess airflow to the surrounding environment is a passageway to atmosphere via the patient's nares between the ends of the prongs 3810a and 3810b of the cannula 3800. 5.4 RPT Devices

[0040] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for the treatment of one or more respiratory disorders described elsewhere herein.

[0041] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering 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.

[0042] The RPT device may have an exterior housing 4010 formed in two portions, an upper portion 4012 and a lower portion 4014. Further, the exterior 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.

[0043] The air path of the RPT device 4000 is composed of one or more air path items, such as 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 and a flow sensor 4274). One or more of the air path items may be disposed within a removable, unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0044] The RPT device 4000 may include a power supply 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 the alternative, the RPT device 4000 may include multiple PCBAs 4202. 5.4.1 Mechanical and Pneumatic Components of RPT Devices

[0045] The RPT device may include one or more of the following components in an integral unit: In one alternative, one or more of the following components may be arranged as their own separate units. 5.4.1.1 Air filter(s)

[0046] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110. In one form, an inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140. In one form, an outlet air filter 4114, e.g., an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800. 5.4.1.2 Muffler(s)

[0047] An RPT device in accordance with one form of the present technology may include a muffler 4120, or multiple mufflers 4120. In one form of the present technology, an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140. In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800. 5.4.1.3 Pressure or flow generators

[0048] In certain forms of the present technology, the RPT device 4000 includes a pressure or flow generator 4140. In one form of the present technology, the pressure or flow generator 4140 for generating an air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be disposed in a volute. The blower may be capable of providing an air supply at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O, at a rate of, for example, up to about 120 liters / min, when providing respiratory pressure therapy. The blower is 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 No. WO2013 / 020167, the entire contents of which are incorporated herein by reference.

[0049] The pressure generator 4140 is under the control of the therapy device controller 4240 . In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows. 5.4.1.4 Transducer(s)

[0050] The transducer may be internal to the RPT device or external to the RPT device. An external transducer may be located, for example, on or form part of the air circuit (e.g., the patient interface). An external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or transfers data to the RPT device.

[0051] In one form of the present technology, the one or more sensors 4270 are positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal representative of a characteristic of the airflow, such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0052] In one form of the present technology, the one or more transducers 4270 may be located proximate to the patient interface 3000 or 3800. By way of example, the one or more transducers 4270 may include a flow sensor 4274 (e.g., based on a differential pressure transducer such as a SDP600 series differential pressure transducer from SENSIRION), a pressure sensor 4272 (e.g., an ASDX series transducer from HONEYWELL, or an NPA series transducer from GENERAL ELECTRIC) located in fluid communication with the air pressure path, and / or a motor speed transducer 4276 (e.g., a speed sensor such as a Hall effect sensor) used to determine the rotational speed of the motor 4144 and / or blower 4142. In other examples, the one or more transducers 4270 may comprise an acoustic sensor (e.g., a microphone) and / or an optical sensor (e.g., a camera or barcode reader).

[0053] In one form, the signal from the transducer 4270 may be filtered, such as by low-pass filtering, high-pass filtering, or band-pass filtering. 5.4.2 Electrical Components of RPT Devices 5.4.2.1 Power supply

[0054] The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000. In one form of the present technology, the power supply 4210 powers only the RPT device 4000. In another form of the present technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000. 5.4.2.2 Input Devices

[0055] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials that allow a person (e.g., a patient or clinician) to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessible via a touch screen. The buttons, switches, or dials may, in one form, be physically connected to the external housing 4010. In one form of the present technology, the input device 4220 may take the form of a keypad or keyboard with buttons that allow a user to input a string of characters, for example, a series of alphanumeric characters. The keypad may be formed from physical buttons or areas of a touch screen device that are visually displayed as buttons, or a combination of such buttons.

[0056] In other forms, the input device 4220 may take the form of a remote external device 4286 and / or a local external device 4288 that is separate or separable from the RPT device 4000 and communicates wirelessly with a data communication interface 4280 of the RPT device 4000 that is electrically connected to the central controller 4230. Exemplary types of wireless communication between the remote external device 4286 and / or the local external device 4288 and the data communication interface 4280 are described further below.

[0057] In one form of the present technology, the input device 4220 is a mobile computing device, e.g., a mobile phone. The mobile computing device may be operable to communicate directly or indirectly with the central controller 4230, e.g., via an intermediate communication device and / or a data communication interface 4280. The mobile computing device may be arranged to execute one or more software applications or applications that display one or more graphical user interfaces (GUIs) to a user via a screen of the mobile computing device.

[0058] In one form, the input device 4220 may be configured and set up to allow a person to select values ​​and / or menu options.

[0059] In certain forms of the present technology, one or more transducers 4270 may operate as input devices 4220 and allow for information to be transmitted to the central controller 4230. For example, information may be received acoustically (e.g., via multi-frequency signaling) and the information may be input to the RPT device 4000 by detection of an acoustic signal by an acoustic sensor. In another example, information may be received optically (e.g., via a barcode, QR code, or coded flashing light) and the information may be input to the RPT device 4000 by detection of an optical signal by an optical sensor. It will be appreciated that the data communication interface 4280 may also include one or more transducers 4270 (e.g., antennas) and function as another input device 4220 capable of transmitting information to the central controller 4230.

[0060] The input device 4220 is arranged to generate signals representative of information or data entered by a user and transmit the signals to the central controller 4230. For example, the signals may be electrical signals transmitted along a wired connection to the central controller 4230. Additionally or alternatively, the signals may be wireless communication signals. In one form of the present technology, the keypad generates data representative of a character string entered by a user on the keypad and transmits the data representative of the character string to the central controller 4230. 5.4.2.3 Central Controller

[0061] In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000. Suitable processors may include x86 INTEL processors, processors based on ARM® Cortex®-M processors from ARM Holdings (e.g., the STM32 series of microcontrollers from ST MICROELECTRONIC). In certain alternative forms of the present technology, 32-bit RISC CPUs such as the ST MICROELECTRONICS STR9 series of microcontrollers manufactured by TEXAS INSTRUMENTS, or 16-bit RISC CPUs such as processors from the MSP430 family of microcontrollers may also be suitable.

[0062] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit. In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0063] The central controller 4230 may be configured to receive input signal(s) from the one or more transducers 4270, the one or more input devices 4220, and the humidifier 5000. The central controller 4230 may be configured to provide output signal(s) to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0064] In some forms of the present technology, the central controller 4230 is configured to implement one or more methodologies described herein (e.g., one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer-readable storage medium such as memory 4260). In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some methodologies may be performed by a remotely located device. For example, the remotely located device may determine control settings for a ventilator or detect respiratory related events by analysis of data stored in any of the sensors described herein, etc. 5.4.2.4 Therapy Device Controllers

[0065] In one form of the present technology, the therapy device controller 4240 is a virtual controller in the form of a therapy control module 4330 that forms part of the algorithms 4300 executed by the central controller 4230. In one form of the present technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used. 5.4.2.5 Memory

[0066] In accordance with one form of the present technology, the RPT device 4000 includes memory 4260, e.g., non-volatile memory. In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM. The memory 4260 may be located on the PCBA 4202. The memory 4260 may be in the form of an EEPROM or NAND flash memory.

[0067] Additionally or alternatively, the RPT device 4000 includes a removable form of memory 4260, such as a memory card made in accordance with the Secure Digital (SD) standard.

[0068] In one form of the present technology, the memory 4260 operates as a non-transitory computer-readable storage medium that stores computer program instructions, such as one or more algorithms 4300, that represent one or more methods described herein. 5.4.2.6 Data communication systems

[0069] In one form of the present technology, a data communications interface 4280 is provided and connected to the central controller 4230. The data communications interface 4280 may be connected to a remote external communications network 4282 and / or a local external communications network 4284. The remote external communications network 4282 may be connectable to a remote external device 4286. The local external communications network 4284 may be connectable to a local external device 4288.

[0070] In one form, the data communications interface 4280 is part of the central controller 4230. In another form, the data communications interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0071] In one form, the remote external communications network 4282 is the Internet. The data communications interface 4280 may be connected to the Internet using wired communications (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE). In one form, the local external communications network 4284 utilizes one or more communications standards such as Bluetooth, Near Field Communications (NFC), or consumer infrared protocols.

[0072] In one form, the remote external device 4286 is one or more computers, e.g., a cluster of networked computers. In one form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be available to appropriately authorized personnel, such as a clinician. The local external device 4288 may be a personal computer, a mobile computing device (e.g., a cell phone or tablet), or a remote control.

[0073] Output devices include an optional display and an alarm.

[0074] In accordance with the present form of the technology, the RPT device 4000 includes one or more output devices 4290.

[0075] The output device 4290 according to the present technology may take the form of one or more of a visual, auditory and tactile unit. The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0076] In forms of the present technology, the output device 4290 may be included as part of the remote external device 4286 and / or the local external device 4288. For example, the output device 4290 may be a display on a mobile computing device (e.g., a cell phone or tablet) that communicates wirelessly with the central controller 4230. The mobile computing device may be arranged to execute one or more software applications, or applications that cause information to be output on a screen of the mobile computing device.

[0077] The data communications interface 4280 may allow information to be output from the RPT device 4000 and may thus act as another form of output device 4290 . 5.4.3 RPT Device Algorithm

[0078] As previously mentioned, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer-readable storage medium, such as the memory 4260. The algorithms 4300 are grouped into groups commonly referred to as modules.

[0079] In other forms of the present 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 this form, input signals and / or intermediate algorithm output data required to represent the part of the algorithm 4300 executed on the external device may be transmitted to the external device via a local external communications network 4284 or a remote external communications network 4282. In such forms, the part of the algorithm 4300 executed on the external device may be represented as a computer program stored on a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute the part of the algorithm 4300.

[0080] In such an embodiment, therapy parameters generated by the external device via the therapy engine module 4320 (if such an embodiment forms part of the algorithm 4300 executed by the external device) may be communicated to the central controller 4230 and sent to the therapy control module 4330. 5.4.3.1 Pre-processing module

[0081] A pre-processing module 4310 according to one form of the present technology receives as input a signal from a transducer 4270, e.g., a flow sensor 4274 or a pressure sensor 4272, and performs one or more process steps to calculate one or more output values ​​that are used as input to another module, e.g., a therapy engine module 4320.

[0082] In one form of the present technology, the output values ​​include interface pressure Pm, respiratory flow Qr, and leak flow Ql.

[0083] In various forms of the present technology, the pre-processing module 4310 includes one or more of an interface pressure estimation algorithm 4312 , a ventilation flow estimation algorithm 4314 , a leak flow estimation algorithm 4316 , and a respiratory flow estimation algorithm 4318 . 5.4.3.2 Therapy Engine Module

[0084] In one form of the present technology, the therapy engine module 4320 receives as inputs one or more of the pressure Pm in the patient interface 3000 or 3800 and the respiratory flow rate Qr of air to the patient and provides one or more therapy parameters as outputs.

[0085] In one form of the present technology, the treatment parameter is a treatment pressure, Pt.

[0086] In one form of the present technology, the therapy parameters are one or more of: amplitude of pressure fluctuations, base pressure, and target ventilation.

[0087] In various forms, the therapy engine module 4320 includes one or more of a phase determination algorithm 4321, a waveform determination algorithm 4322, a ventilation determination algorithm 4323, an inspiratory flow limitation determination algorithm 4324, an apnea / hypopnea determination algorithm 4325, a snoring determination algorithm 4326, an airway patency determination algorithm 4327, a target ventilation determination algorithm 4328, and a treatment parameter determination algorithm 4329. 5.4.3.3 Therapy Control Module

[0088] A therapy control module 4330 according to one aspect of the present technology receives therapy parameters as input from a therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver airflow in accordance with the therapy parameters.

[0089] In one form of the present technology, the therapy parameter is a therapy pressure Pt, and the therapy control module 4330 controls the pressure generator 4140 to deliver an airflow such that the interface pressure Pm at the patient interface 3000 or 3800 is equal to the therapy pressure Pt. 5.4.3.4 Other Operating Parameters of Engine and Control Module

[0090] As discussed above, the central controller 4230 may be arranged to implement one or more algorithms 4300 for controlling the delivery of respiratory therapy, which are categorized into a pre-processing module 4310, a therapy engine module 4320, and a therapy control module 4330. The central controller 4230 may additionally or alternatively be arranged to implement one or more algorithms 4300 for controlling other aspects of the operation of the RPT device 4000. The one or more algorithms 4300 for controlling other aspects of the operation of the RPT device 4000 may be categorized into a pre-processing module, an operation engine module, and an operation control module. 5.4.3.5 Detecting Fault Conditions

[0091] In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detection of fault conditions such as, for example, power failure (no power or insufficient power), detection of transducer failure, failure to detect the presence of a placement element, operating parameters (e.g., pressure, flow, temperature, PaO2) outside of recommended ranges, and failure of a test alarm to generate a detectable alarm signal.

[0092] Upon detecting a fault condition, the corresponding algorithm 4340 signals the presence of a fault by one or more of activating an audible, visual and / or kinetic (e.g., vibration) alarm, sending a message to an external device, and logging the incident. 5.5 Air Circuit

[0093] An air circuit according to one aspect of the present technology is a conduit or tube configured and arranged to allow air flow to travel between two arranged elements of a respiratory therapy system (e.g., the RPT device 4000 and the patient interface 3000 or 3800) in use. In particular, the air circuit 4170 may be fluidly connected with the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used. In some forms, the air circuit 4170 may include one or more heating elements arranged to heat the air in the air circuit, for example to maintain or increase the temperature of the air. The heating elements may be in communication with a controller, such as the central controller 4230. 5.5.1 Auxiliary Gas Delivery

[0094] In one form of the present technology, an auxiliary gas, for example oxygen 4180, is delivered to one or more points in the pneumatic pathway, such as upstream of the pneumatic block 4020, the pneumatic circuit 4170, and / or the patient interface 3000 or 3800. 5.6 Humidifier

[0095] In one form of the present technology, a humidifier 5000 (e.g., as shown in FIG. 5A) is provided for modifying the absolute humidity of air or gas for delivery to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the air stream (relative to the ambient air) prior to delivery to the patient's airways.

[0096] 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 forms, such 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 comprise a humidifier base 5006 adapted to receive the humidifier reservoir 5110 and may comprise a heating element 5240. In one form, the humidifier 5000 may comprise a humidifier reservoir dock 5130 (as shown in Figure 5B) arranged to receive the humidifier reservoir 5110.

[0097] The reservoir 5110 may be arranged to hold or maintain a volume of liquid (e.g., water) that evaporates for humidification of the airflow. The reservoir 5110 may be arranged to hold a predetermined maximum volume of water to provide adequate humidification for at least the duration of a respiratory therapy session, such as a night of sleep. Typically, the reservoir 5110 is configured to accommodate several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other forms, the humidifier 5000 may be arranged to receive water supplied from an external water source, such as a building's water system.

[0098] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducer 4270. The humidifier transducer 5210 may include one or more of an air pressure sensor 5212, an airflow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218, as shown in FIG. 5C. The humidifier transducer 5210 may generate one or more output signals that may be communicated to a controller, such as the central controller 4230 and / or the humidifier controller 5250. In some forms, the humidifier transducers send the output signals to the controller and may be located outside the humidifier 5000 (e.g., in the air circuit 4170).

[0099] In some cases, a heating element 5240 may be provided in the humidifier 5000 to provide heat input to at least a portion of the water in the humidifier reservoir 5110 and / or to the airflow.

[0100] According to one arrangement of the present technology, the humidifier 5000 may include a humidifier controller 5250, as shown in FIG. 5C. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller and may be in communication with the central controller 4230.

[0101] In one form, the humidifier controller 5250 may receive as inputs, for example, measurements of the airflow, the water in the reservoir 5110, and / or characteristics of the humidifier 5000 (e.g., temperature, humidity, pressure, and / or flow rate). The humidifier controller 5250 may also be arranged to run or implement a humidifier algorithm and / or deliver one or more output signals.

[0102] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heated air circuit controller 5254 arranged to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 arranged to control the temperature of the heating element 5240. 5.7 Respiratory waveform

[0103] FIG. 6A shows a typical breathing waveform model for a sleeping human. The horizontal axis is time and the vertical axis is respiratory flow. Although parameter values ​​can vary, a typical breath can have approximate values ​​of ventilation Vt 0.5 L, inspiration time Ti 1.6 s, peak inspiratory flow Qpeak 0.4 L / s, expiration time Te 2.4 s, and peak expiratory flow Qpeak-0.5 L / s. The total time of the breath Ttot is about 4 seconds. Typically, a person breathes at a rate of about 15 breaths per minute (BPM) and has a ventilation Vent of about 7.5 L / min. A typical duty cycle, Ti to Ttot ratio, is about 40%. 5.8 Screening, diagnostic and surveillance systems 5.8.1 Polysomnography

[0104] 7A shows a patient 1000 undergoing polysomnography (PSG). The PSG system includes a headbox 2000 that receives and records signals from EOG electrodes 2015, EEG electrodes 2020, ECG electrodes 2025, submental EMG electrodes 2030, a snore sensor 2035, a respiratory inductance plethysmogram (respiratory effort sensor) 2040 on a chest band, a respiratory inductance plethysmogram (respiratory effort sensor) 2045 on an abdominal band, an oral nasal cannula with oral thermistor 2050, a photoplethysmograph (pulse oximeter) 2055, and a body position sensor 2060. The electrical signals are referenced to a ground electrode (ISOG) 2010 placed in the center of the forehead. 5.8.2 Covert Surveillance Systems

[0105] An example of a monitoring device 7100 for monitoring the respiration of a sleeping patient 1000 is shown in Figure 7B. The monitoring device 7100 includes a non-contact motion sensor generally aimed at the patient 1000. The motion sensor is positioned to generate one or more signals indicative of bodily movements of the patient 1000, resulting in a signal indicative of the patient's respiratory movements. 5.8.3 Respiratory polygraphy

[0106] Respiratory polygraphy (RPG) is a generic term for a simplified form of PSG without electrical signals (EOG, EEG, EMG), snoring, or body position sensors. RPG includes at least a chest motion signal from a respiratory inductance plethysmogram (motion sensor) on a chest band, e.g., motion sensor 2040, a nasal pressure signal sensed via a nasal cannula, and an oxygen saturation signal from a pulse oximeter, e.g., pulse oximeter 2055. The three RPG signals or RPG channels are received by the RPG headbox, similar to the PSG headbox 2000.

[0107] In certain arrangements, the nasal pressure signal is a suitable surrogate for the nasal flow signal generated by a flow transducer fitted with a sealed nasal mask, and the nasal pressure signal is comparable in shape to the nasal flow signal. When the patient's mouth remains closed, i.e., there is no mouth leak, the nasal flow is equal to the respiratory flow.

[0108] 7C is a block diagram illustrating a screening / diagnostic / monitoring device 7200 that may be used to implement an RPG head box in an RPG screening / diagnostic / monitoring system. The screening / diagnostic / monitoring device 7200 receives the three RPG channels described above (a signal indicative of chest movement, a signal indicative of nasal flow, and a signal indicative of oxygen saturation) at a data input interface 7260. The screening / diagnostic / monitoring device 7200 also includes a processor 7210 arranged to execute encoded instructions. The screening / diagnostic / monitoring device 7200 also includes a non-transitory computer-readable memory / storage medium 7230.

[0109] The memory 7230 may be an internal memory of the screening / diagnostic / monitoring device 7200, such as a RAM, flash memory, or ROM. In some embodiments, the memory 7230 may be a removable or external memory linked to the screening / diagnostic / monitoring device 7200, such as, for example, an SD card, a server, a USB flash drive, or an optical disk. In other embodiments, the memory 7230 may be a combination of external and internal memory. The memory 7230 includes stored data 7240 and processor control instructions (code) 7250 adapted to configure the processor 7210 to perform a particular task. The stored data 7240 may include RPG channel data received by the data input interface 7260, and other data provided as configuration elements of the application. The processor control instructions 7250 may also be provided as configuration elements of the application program. The processor 7210 is configured to read the code 7250 from the memory 7230 and execute the encoded instructions. In particular, code 7250 may include instructions adapted to configure processor 7210 to execute a method of processing RPG channel data provided by interface 7260. One such method may be to store the RPG channel data in memory 7230 as data 7240. Another such method may be to analyze the stored RPG data to extract features. Processor 7210 may store results of such analysis in memory 7230 as data 7240.

[0110] The screening / diagnostic / monitoring device 7200 may also include a communication interface 7220. The code 7250 may include instructions arranged to enable the processor 7210 to communicate with an external computing device via the communication interface 7220. The communication mode may be wired or wireless. In one such embodiment, the processor 7210 may transmit stored RPG channel data from the data 7240 to a remote computing device. In such an embodiment, the remote computing device may be arranged to analyze the received RPG data to extract features. In another such embodiment, the processor 7210 may transmit the analysis results from the data 7240 to a remote computing device.

[0111] Alternatively, if the memory 7230 is removable from the screening / diagnostic / monitoring device 7200, the remote computing device may be arranged to be connected to the removable memory 7230. In such an embodiment, the remote computing device may be arranged to analyze the RPG data retrieved from the removable memory 7230 to extract features. 5.9 Portable Oxygen Concentrators

[0112] Oxygen concentrators may utilize pressure swing adsorption (PSA). Pressure swing adsorption may involve using a compressor to increase the gas pressure in a canister containing particles of a gas separation sorbent. As the pressure increases, certain molecules in the gas may become adsorbed to the gas separation sorbent. By removing a portion of the gas in the canister under pressurized conditions, the non-adsorbed molecules can be separated from the adsorbed molecules. The gas separation sorbent may be regenerated by reducing the pressure which reverses the adsorption of the molecules from the sorbent. Further details regarding oxygen concentrators are described, for example, in U.S. Patent Publication No. 2009-0065007, published March 12, 2009, entitled "Oxygen Concentrator Apparatus and Method," which is incorporated herein by reference.

[0113] 8A shows a schematic diagram of an oxygen concentrator 8000 according to one embodiment. The oxygen concentrator 8000 can concentrate oxygen from an air stream and provide an oxygen-enriched gas to a user. The oxygen concentrator 8000 can be a portable oxygen concentrator. For example, the oxygen concentrator 8000 can have a weight and size that allows the oxygen concentrator to be transported by hand and / or in a carrying case.

[0114] Oxygen may be collected from ambient air by pressurizing the ambient air in a canister 8100, which includes a first canister 8102 and a second canister 8104, which include a gas separation sorbent. A gas separation sorbent useful in an oxygen concentrator can separate at least nitrogen from an air stream to produce an oxygen enriched gas. As shown in FIG. 8B, air may be drawn into the oxygen concentrator 8000 via an air inlet 8002 by a compression system 8200. The compression system 8200 may draw air from the oxygen concentrator's surroundings, compress the air, and force the compressed air into one or both of the canisters 8102 and 8104. The compression system 8200 may include one or more compressors capable of compressing the air. In one embodiment, an inlet muffler 8004 may be coupled to the air inlet 8002 to reduce sound generated by the air drawn into the oxygen concentrator by the compression system 8200.

[0115] Coupled to each canister 8102 / 8104 is an inlet valve 8020 / 8022 and an outlet valve 8030 / 8032. As shown in FIG. 8B, the inlet valves 8020 / 8022 are used to control the passage of air from the compression system 8200 to the respective canister. The outlet valves 8030 / 8032 are used to release gas from the respective canister during the ventilation process. In one embodiment, pressurized air is directed to one of the canisters 8102 or 8104 while the other canister is being ventilated.

[0116] In one embodiment, the controller 8300 is electrically coupled to the valves 8020, 8022, 8030, and 8032. The controller 8300 includes one or more processors 8310 operable to execute program instructions stored in the memory 8320. The program instructions are operable to execute various predetermined methods used to operate the oxygen concentrator 8000, such as those described in more detail herein. The controller 8300 may include program instructions for operating the inlet valves 8020 and 8022 out of phase with each other, i.e., when one of the inlet valves 8020 or 8022 is opened, the other valve is closed. During pressurization of the canister 8102, the outlet valve 8030 is closed and the outlet valve 8032 is opened. As with the inlet valves, the outlet valves 8030 and 8032 operate out of phase with each other. In some embodiments, the voltage and duration of the voltage for opening the input and output valves may be controlled by the controller 8300.

[0117] Check valves 8040 and 8042 are coupled to canisters 8102 and 8104, respectively. Check valves 8040 and 8042 are one-way valves that are passively operated by a pressure differential created when the canister is pressurized and ventilated. Check valves 8040 and 8042 are coupled to the canisters to allow oxygen generated during canister pressurization to flow out of the canister and to prevent oxygen or any other gas from flowing back into the canister.

[0118] Under pressure, nitrogen molecules in the pressurized ambient air are adsorbed by the gas separation adsorbent in the pressurized canister. As the pressure increases, more nitrogen is adsorbed until the gas in the canister is oxygen-enriched. When the pressure reaches a point sufficient to overcome the resistance of a check valve coupled to the canister, the non-adsorbed gas molecules (mainly oxygen) flow out of the pressurized canister. In an exemplary embodiment, the canister 8102 is pressurized by compressed air generated in the compression system 8200 and passed through the canister 8102, and the canister 8104 is substantially simultaneously vented while the canister 8102 is pressurized. The canister 8102 is pressurized until the pressure in the canister is sufficient to open the check valve 8040. The oxygen-enriched gas generated in the canister 8102 is exhausted through the check valve and, in one embodiment, is collected in the accumulator 8006.

[0119] After a period of time, the gas separation sorbent becomes saturated with nitrogen and is no longer able to separate significant amounts of nitrogen from the incoming air. This point is usually reached after a predetermined time of production of oxygen-enriched gas. In the above embodiment, when the gas separation sorbent in the canister 8102 reaches this saturation point, the flow of compressed air is stopped and the canister 8102 is vented to remove the nitrogen. While the canister 8102 is being vented, the canister 8104 is pressurized to produce oxygen-enriched gas in the same manner as described above. Pressurization of the canister 8104 is achieved by closing the outlet valve 8032 and opening the inlet valve 8022. The oxygen-enriched gas is exhausted from the canister 8104 via the check valve 8042.

[0120] During ventilation of the canister 8102, the outlet valve 8030 is opened, allowing pressurized gas (mainly nitrogen) to exit the canister via the concentrator outlet 8008. In one embodiment, the exited gas may be directed through a muffler 8010 to reduce noise generated by venting the pressurized gas from the canister. As gas is vented from the canister 8102, the pressure within the canister is reduced, allowing the nitrogen to desorb from the gas separation sorbent. The released nitrogen exits the canister via outlet 8008, resetting the canister to a state that allows for re-separation of oxygen from the air stream.

[0121] During ventilation of the canister, it is advantageous for at least a majority of the nitrogen to be removed. In some embodiments, the canister may be further purged with nitrogen using an oxygen enriched stream introduced into the canister from the other canister. In an exemplary embodiment, a portion of the oxygen enriched gas may be transferred from canister 8102 to canister 8104 as nitrogen is being evacuated from canister 8104. In one embodiment, the oxygen enriched gas may be transferred between the two canisters via flow restrictors 8050, 8052, and 8054.

[0122] The flow of oxygen enriched gas is also controlled using valves 8056 and 8058. Valves 8056 and 8058 may be opened for certain periods during the ventilation process (and may be closed otherwise) to prevent excessive oxygen loss from the purged canister. In an exemplary embodiment, when the canister 8102 is being ventilated, it is desirable to purge the canister 8102 by passing a portion of the oxygen enriched gas produced in the canister 8104 through the canister 8102. During ventilation of the canister 8102, a portion of the oxygen enriched gas passes into the canister 8102 through flow restrictor 8050 upon pressurization of the canister 8104. Additional oxygen enriched air passes from the canister 8104 through valve 8058 and flow restrictor 8054 to the canister 8102. Valve 8056 may remain closed during the transfer process or may open if additional oxygen enriched gas is required. Selection of appropriate flow restrictors 8050 and 8054 coupled with a controlled opening in valve 8058 allows a controlled amount of oxygen enriched gas to be sent from canister 8104 to canister 8102. In one embodiment, the controlled amount of oxygen enriched gas is an amount sufficient to purge canister 8102 and minimize loss of oxygen enriched gas through ventilation valve 8030 of canister 8102. While this embodiment describes ventilation of canister 8102, it should be understood that the same process can be used to ventilate canister 8104 using flow restrictor 8050, valve 8056, and flow restrictor 8052.

[0123] The equalization / ventilation valve 8056 / 8058 pair works in conjunction with flow restrictors 8052 and 8054 to optimize the balance of airflow between the two canisters. In some embodiments, the air path may lack a restrictor and instead have a valve with built in resistance, or the air path itself may have a narrow radius to provide the resistance.

[0124] In some cases, the oxygen concentrator may be shut down for a period of time. In one embodiment, by pressurizing both canisters before shutting down, outside air can be prevented from entering the canister after the oxygen concentrator is shut down. In one embodiment, the pressure in the canister at the time of shutdown must be at least greater than ambient pressure. The term "ambient pressure" as used herein refers to the ambient pressure in which the oxygen concentrator is located (e.g., the pressure in a room, outside, on a plane, etc.). In one embodiment, the pressure in the canister at the time of shutdown is at least greater than standard atmospheric pressure (i.e., greater than 760 mmHg (Torr), 1 atm, 101,325 Pa).

[0125] FIG. 8B shows an example of a portable oxygen concentrator 8000. In this embodiment, the oxygen concentrator 8000 includes an outer housing 8500. The outer housing 8500 includes a compression system inlet 8502, a cooling system passive inlet 8502 (not seen in FIG. 8B but indicated with the numeral 8502) and a cooling system passive outlet 8504 at each end of the outer housing 8500. The outer housing 8500 also includes an outlet port 8506, and a control panel 8600. The inlet 8502 and outlet 8504 allow cooling air to enter the housing 8500, flow into the housing, and exit the interior of the housing to help cool the oxygen concentrator 8000. The compression system inlet 8502 allows air to enter the compression system 8200 shown in FIG. 8A. The outlet port 8506 is used to attach a conduit for providing the oxygen enriched gas produced by the oxygen concentrator 8000 to a user. The control panel 8600 serves as an interface between a user and the controller 8300 (shown in FIG. 8A ) and allows the user to initiate predetermined operational modes of the oxygen concentrator 8000 and monitor the status of the system. A charging input port 8602 may be located on the control panel 8600. 5.10 Respiratory Therapy Mode

[0126] Various respiratory therapy modes may be implemented by the disclosed respiratory therapy system. Examples of respiratory therapy modes include CPAP therapy, Bi-level therapy, and high flow therapy. 5.11 Computing Systems and Processes

[0127] In the present form of technology, the RPT device 4000 may be part of or operate in conjunction with the system 9000. The system 9000 may include one or more servers 9010 and one or more computing devices 9040 and may be generally referred to as a computing system 9000. The system 9000 elements may interact with the RPT device 4000, for example, to control and / or monitor the operation of the RPT device 4000. In some examples, the system 9000 may enable a person (e.g., patient, clinician) to control and / or monitor the operation of the RPT device 4000. Controlling and / or monitoring the operation of the RPT device 4000 may enable controlling and / or monitoring the respiratory therapy provided to the patient 1000. 5.11.1 Computing Systems

[0128] 9 illustrates an example of a system 9000 that can be implemented to monitor sleep and provide insights and / or recommendations. The system 9000 may generally include one or more of a server 9010, one or more communication networks 9030, and one or more computing devices 9040. The server 9010 and the computing devices 9040 may also communicate with one or more respiratory therapy devices (e.g., but not limited to, the RPT device 4000 described in connection with FIGS. 4A through 4F) via the one or more communication networks 9030.

[0129] The one or more communications networks 9030 may include, for example, the Internet, a local area network, a wide area network, and / or a personal area network implemented via a wired communications network 9032, a wireless communications network 9034, or a combination thereof (e.g., a wired network with a wireless link). In one form, the local communications network may utilize one or more communications standards such as Bluetooth, Near Field Communication (NFC), or Consumer Infrared Protocol.

[0130] The server 9010 may include processing functionality represented by one or more processors 9012, memory 9014, and other components typically present in such a computing environment. The processing power of the processor 9012 may be provided, for example, by one or more general purpose processors, one or more special purpose processors, or a cloud computing service providing access to a shared pool of computing resources arranged according to desired characteristics, service models, and deployment models. In the illustrated example, the memory 9014 stores information accessible by the processor 9012, including instructions 9016 that may be executed by the processor 9012 and data 9018 that may be retrieved, manipulated, or stored by the processor 9012. The memory 9014 may be any suitable means known in the art capable of storing information in a manner accessible by the processor 9012, including a computer-readable medium or other medium for storing data that may be read using an electronic device. Although the processor 9012 and memory 9014 are illustrated as being within a single unit, this is not intended to be limiting, and it should be understood that each function as described herein may be performed by multiple processors and memories that may or may not be separate from each other and from the rest of the system 9000.

[0131] The instructions 9016 may include any set of instructions suitable for execution by the processor 9012. For example, the instructions 9016 may be stored on a computer readable medium as computer code. The instructions may be stored in any suitable computer language or format. The data 9018 may be retrieved, stored, or modified by the processor 9012 in accordance with the instructions 9016. The data 9018 may also be formatted in any suitable computer readable format. Again, while the data is illustrated as being included in a single location, this is not intended to be limiting, i.e., it should be understood that the data may be stored in multiple memories or locations. The data 9018 may include one or more databases 9020.

[0132] In some examples, the server 9010 can communicate uni-directionally with the computing devices 9040, or vice versa, by providing information to one or more of the computing devices 9040. In other embodiments, the server 9010 and the computing devices 9040 can communicate bi-directionally with each other and share information and / or processing tasks.

[0133] In some examples, the computing device 9040 may include a remote external device 4286 and / or a local external device 4288 described with reference to FIG. 4C. 5.11.2 Computing Devices

[0134] The computing device 9040 may be any suitable processing device, such as, but not limited to, a personal computer, such as a desktop or laptop computer 9042, or a mobile computing device, such as a smartphone 9044 or tablet 9046. Figure 10 shows an exemplary general architecture 9100 of a computing device 9040. The computing device 9040 may include one or more processors 9110. The computing device 9040 may also include memory / data storage 9120, input / output (I / O) devices 9130, and a communication interface 9160.

[0135] The one or more processors 9110 may include functional arrangement elements used to execute instructions, such as functional arrangement elements for fetching control instructions from locations such as memory / data storage 9120, decoding program instructions, executing the program instructions, and writing the results of executed instructions.

[0136] The memory / data storage 9120 may be an internal memory of the computing device, such as RAM, flash memory, or ROM. In some examples, the memory / data storage 9120 may also be an external memory linked to the computing device 130, such as, for example, an SD card, a USB flash drive, an optical disk, or a remotely located memory (e.g., accessed via a server, such as server 9010). In other examples, the memory / data storage 9120 may be a combination of external and internal memory.

[0137] The memory / data storage 9120 includes processor control instructions 9122 that instruct the processor 9110 to perform certain tasks, as described herein, and stored data 9124. As noted above, in examples, the instructions may be executed by, and the data may be stored by and / or accessed from, resources associated with the server 9010 in communication with the computing device 9040.

[0138] In an example, the input / output (I / O) devices 9130 may include one or more displays 9132. In an example, the display 9132 may be a touch-sensitive screen that allows the user to input in addition to outputting visual information to a user of the computing device 9040. In an example, the I / O devices may include other output devices including one or more speakers 9134 and haptic feedback devices 9136. In an example, the input / output (I / O) devices 9130 may include input devices such as physical input devices 9138 (e.g., buttons or switches), optical sensors 9140 (e.g., one or more imaging devices such as cameras), and inertial sensors 9142 (particularly in an example where the computing device 9040 is a mobile computing device). It should be understood that other I / O devices 9130 may be included or accessed through the I / O interface 9150 (e.g., interfacing with peripheral devices connected to the computing device 9130). The communications interface 9160 allows the computing device 9040 to communicate over one or more networks 9030 (shown in FIG. 9). 5.11.3 Computer-Implementable Methods

[0139] The computer-readable instructions may implement the exemplary methods described herein. In an example, the computer-readable instructions include one or more algorithms for execution by one or more processors, e.g., processor 9012 and / or central controller 4230, described herein. The instructions for performing these functions are optionally included in a non-transitory computer-readable storage medium, e.g., memory 9014, or other computer program product arranged to be executed by one or more processors. The computer-readable storage medium may be a tangible device that can hold and store instructions for use by an instruction execution device. The computer-readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the aforementioned storage devices. As used herein, a computer-readable storage medium should not be interpreted as a transitory signal in itself, such as an electric wave or other freely propagating electromagnetic wave, an electromagnetic wave propagating through a wave guide or other transmission medium, or an electric signal transmitted through a wire.

[0140] However, those skilled in the art will readily appreciate that the entire algorithm and / or portions thereof may alternatively be executed by devices other than a processor and / or embodied in firmware or dedicated hardware in a well-known manner, e.g., the entire algorithm and / or portions thereof may be implemented by an application specific integrated circuit (ASIC), a programmable logic device (PLD), a field programmable logic device (FPLD), a field programmable gate array (FPGA), discrete logic, etc. For example, any or all of the components may be implemented by software, hardware, and / or firmware. Also, some or all of the instructions represented by the flow chart may be implemented manually. Furthermore, although the exemplary algorithm is described with reference to the illustrated flow chart, those skilled in the art will readily appreciate that many other ways of implementing the exemplary processor-readable instructions may alternatively be used. For example, the order of execution of the blocks may be changed, and / or some of the described blocks may be modified, eliminated, or combined.

[0141] As used herein, the terms "deployment element," "module," "system," and the like generally refer to any computer-related entity, hardware (e.g., circuitry), a combination of hardware and software, software, or an entity associated with an operating machine having one or more specific functions. For example, a deployment element may be, but is not limited to, a process running on a processor, a processor, an object, an executable module, a thread of execution, a program, and / or a computer. By way of example, both an application running on a controller and the controller may be a deployment element. One or more deployment elements may reside within a process and / or thread of execution, and deployment elements may be localized on one computer and / or distributed among two or more computers. Furthermore, a "device" may be in the form of specially designed hardware, generalized hardware specialized by the execution of software that enables the hardware to perform a specific function, software stored on a processor-readable medium, or a combination thereof. 5.12 Sleep-promoting systems and processes

[0142] An example of the present technology discloses a system for promoting sleep in an individual after considering the influence of female-specific factors, particularly those related to hormonal status. While hormonal fluctuations are common during the menstrual cycle, such fluctuations also occur due to a variety of influences and conditions. The system may receive input from one or more sensors and / or manual input by a user into an interface to determine personalized recommendations and / or insights to help improve the user's sleep.

[0143] As used herein, the term "insomnia" generally refers to a condition in which a person has persistent problems falling asleep or staying asleep. It should be understood that the term is used herein for ease of understanding and is not intended to be exclusively equated with a clinical diagnosis or classification of a condition. 5.12.1 Data Collection and Processing 5.12.1.1 Sensors and Wearable Devices

[0144] In some examples, the system 9000 may include one or more sensors configured to monitor one or more characteristics of a user that can determine one or more sleep events. For example, as shown in FIG. 11, the one or more sensors are optical sensors of a wearable sensor device 9200 configured to measure a blood volume pulse, as described in U.S. Patent Publication No. 2020 / 0015737, published January 16, 2020, entitled "Apparatus, System, and Method for Diagnosing Sleep," which is incorporated herein by reference. The wearable sensor device 9200 is configured to be attached on one side to a patient's tissue, e.g., a fingertip. The wearable sensor device 9200 includes a reflectance-based optical sensor on the side. The sensor is configured to measure a blood volume pulse when attached to a patient. When attached, the sensor emits light into the patient's tissue and measures the reflected light. The measured signal is indicative of the blood volume pulse of the tissue to which the sensor is attached.

[0145] The wearable sensor device 9200 may be configured to measure and wirelessly transmit the patient's blood volume pulse while sleeping to a mobile communication device such as a smartphone 9044. In examples, processing of the blood volume pulse data may be performed by the smartphone 9044, a remote computing system such as the server 9010, or a combination thereof.

[0146] The additional physiological data may be obtained using, for example, a wearable device 9202 having computing capabilities including communication with a smartphone 9044 and / or a network 9030. In this example, the wearable device 9202 is a wrist-worn device (which may include an Apple™ watch or a Fitbit™, etc.). The wearable device 9202 includes one or more physiological sensors that collect the physiological data. In this example, the sensors may include a heart rate sensor, an oxygen level sensor, an ECG sensor, a pulse rate sensor, etc. The wearable device 9202 may include other sensors such as one or more of an accelerometer, a gyroscope, a GPS receiver, a sound sensor, and / or a microphone.

[0147] The sensor(s) may be provided in various forms. For example, the sensor(s) may be provided in a headband 9204, a ring 9206, or a mat 9208 that is placed under the user while sleeping. In further examples, the sensor(s) may be provided in headgear (e.g., eye mask, earrings, nose wearable, nose mask, face mask, etc.), chest gear (e.g., chest patch, chest strap, necklace, bra or bra insert, etc.), and / or other equipment (e.g., wristband, toe ring, glove, etc.).

[0148] In examples, one or more characteristics of the user may be obtained using a non-contact sensing device, such as those described in International Patent Publication Nos. 2018 / 050913 and 2020 / 104465, each of which is incorporated herein by reference in its entirety. Further examples of non-contact sensing devices include ResMedPtyLtd's "S+" sleep tracking system, and Withings' "Aura" sleep system. 5.12.1.2 User Input

[0149] In some forms of the present technology, additional data may be obtained by the system 9000, for example, by a user manually entering information. For example, the user may enter data related to one or more of medications, supplements, current symptoms, co-morbidities (OSA, depression, bipolar disorder, diabetes, hypertension, etc.), foods, beverages, sleep hygiene habits, other physiological experiences (self-reported temperature, menstrual cycle, illness, nocturnal voiding frequency, etc.), environmental factors (noise, light, room temperature, bed partner disturbance, etc.), changes in sleep location (new home, travel, etc.), flight / time zone change, new or unusual activities, medical device use (CPAP device, etc.), social interactions (caregiving for others, adding family / visitors to home, bereavement, loneliness, etc.), and user-perceived characteristics (alertness, fatigue, mood, stress, anxiety, etc.).

[0150] For example, common input data formats may be selectable (e.g., via tags) and free-form text may be used to input unusual or less common factors that the user believes may affect their sleep (e.g., sports activities, dental visits, stressful social interactions, etc.). 5.12.1.3 Menstrual Cycle Events

[0151] The menstrual cycle has four phases: menstrual, follicular, ovulatory, and luteal. Sleep is affected in different ways across the four phases, for example, risk of sleep apnea varies across the cycle. Sleep problems are most pronounced during periods of major menstrual cycle change and hormonal fluctuation. For example, polycystic ovarian syndrome (PCOS) may increase risk of sleep apnea (SDB) and problems falling asleep or staying asleep (especially insomnia) with prolonged or absent cycles. As yet another example, pregnancy without cycles may increase risk of SDB and restless legs syndrome. As yet another example, perimenopause or menopause with its large cycle fluctuations may increase risk of SDB and insomnia.

[0152] Information about a woman's menstrual cycle can aid in the assessment of sleep and the development of recommendations for managing and improving sleep. Rising and falling levels of estrogen and progesterone, the hormones that regulate the menstrual cycle, can affect a woman's ability to fall asleep and stay asleep. Menstrual cycle patterns can reveal a woman's hormonal status and may help provide contextualized sleep recommendations related to her current hormonal status.

[0153] Additionally, no two women are the same, and correlation of personal sleep data with menstrual cycle data reveals insights into how sleep changes during each phase of the menstrual cycle, allowing for better personalization of sleep recommendations across each stage.

[0154] In an example, a user inputs information about her menstrual cycle into the system. For example, the user interface may provide the ability to input actual events experienced by the woman (e.g., menstruation and other symptoms) so that the information can be tracked periodically (e.g., daily). Examples of such information may include menstrual characteristics such as fatigue level (light, normal, heavy, etc.), instances of localized pain (e.g., headache, stomachache, breast pain, back pain), amount of bleeding (light, normal, severe, etc.), pain level (e.g., low, moderate, high, etc.), associated symptoms (e.g., fatigue, localized pain, cramps, mood), timing characteristics of the current or previous menstrual cycle (e.g., start, end, duration, regularity, irregularity, etc.), medications that affect the menstrual cycle (e.g., delaying the start of menstruation), and / or other factors such as pregnancy, breastfeeding, use of contraceptives, menopause, hot flashes, nausea, constipation, acne, mood, appetite, etc.

[0155] In examples, the menstrual cycle information may be determined using one or more characteristics of the user obtained using one or more sensors. Methods of predicting the timing of events associated with a woman's menstrual cycle are described, for example, in U.S. Patent Publication No. 2020 / 0000441 and International Patent Publication No. 2021 / 263209, each of which is incorporated by reference herein in its entirety. 5.12.1.4 Determining Sleep Events, States, and Stages

[0156] The peripheral arterial tone may be derived from the measured blood volume pulse acquired using the wearable sensor device 9200, for example by deriving the envelope of the acquired blood volume pulse measurement, more specifically the upper and lower envelopes of the measured blood volume pulse. Since the measured blood volume pulse is an oscillating signal whose period is determined by the patient's heartbeat, the upper envelope is determined as a smooth curve surrounding the upper edge of the measured blood volume pulse, and the lower envelope is determined by the lower edge of the measured blood volume pulse. The difference between the upper and lower envelopes is indicative of the peripheral arterial tone.

[0157] The one or more sleep events are determined by detecting changes in peripheral arterial tone, for example by detecting a decrease in the amplitude of peripheral arterial tone and / or an increase in the amplitude of peripheral arterial tone, optionally in combination with a measured blood volume pulse. Sleep events may include, for example, apnea events, periods of heavy snoring, limb movements as periodic or isolated events, cortical arousals, autonomic arousals, periods of teeth grinding, sleep disordered breathing events such as sleep spasms, tossing and turning events, and rotational events. For example, apnea events may be determined by considering the temporal proximity of a decrease in peripheral arterial sound amplitude, a decrease in blood oxygen saturation, and a decrease in the beat-to-beat interval of the blood volume pulse. Autonomic arousals may be determined by considering the temporal proximity of a decrease in peripheral arterial sound amplitude and a decrease in the beat-to-beat interval of the blood volume pulse. Bruxism events may be determined by the temporal proximity of a decrease in peripheral arterial sound amplitude and a decrease in the beat-to-beat interval of the blood volume pulse in the absence of limb movements. This may be determined by the temporal proximity of the decrease in peripheral arterial sound amplitude and the decrease in the beat-to-beat interval of the blood volume pulse in the presence of periodic limb movement.

[0158] Methods of determining sleep states and / or sleep stages from physiological data generated by one or more sensors and / or user input and determining a sleep score are described in, for example, International Patent Publication No. WO 2014 / 047310, U.S. Patent Publication No. 2015 / 0230750, U.S. Patent Publication No. 2014 / 0088373, U.S. Patent Publication No. 2016 / 0151603, International Patent Publication No. 2017 / 132726, International Patent Publication No. 2018 / 050913, International Patent Publication No. 2019 / 122413, International Patent Publication No. 2019 / 122414, U.S. Patent Publication No. 2020 / 383580, International Patent Publication No. 2020 / 104465, and International Patent Publication No. 2021 / 214640, each of which is incorporated by reference in its entirety herein. 5.12.2 User Interface

[0159] 12A illustrates an exemplary user interface home interface 9300, for example, as displayed on a smartphone 9044. In this example, the home interface 9300 includes a sleep score indicator 9302 that displays the user's most recent sleep score in numerical form and as a pie chart 9304. In this example, summary recommendations 9306 in text form is displayed above the sleep score indicator 9302 to provide the user with an overview of current recommendations and / or insights.

[0160] In this example, the home interface 9300 includes a temperature button 9308, a menstrual cycle button 9310, a mood button 9312, and a focus button 9314. Each button may include an indicator of a current state or characteristic of the user. For example, the temperature button 9308 may include an indication of a rising / falling temperature trend, the menstrual cycle button 9310 may include an indication of the current phase of the user's menstrual cycle, the mood button 9312 may include a mood icon indicating the user's current mood, and the focus button 9314 may include an indicator of the user's focus percentage (e.g., in numerical form and / or a graphical representation such as a gauge).

[0161] In this example, the home interface 9300 includes a diary section 9316 that displays user-entered data for one or more categories, such as medications / supplements being taken, the user's current symptoms (e.g., headache, stomach ache, back pain), foods and / or drinks, etc. Selecting the diary section 9316 opens a diary interface to allow the user to enter information.

[0162] In this example, the home interface 9300 includes a navigation bar 9318 that includes a home icon 9320, an insights icon 9322, a chat icon 9324, a recommendations icon 9326, and a contact icon 9328. Selecting each icon navigates the user to the respective interface, which is described further below.

[0163] In this example, selecting the sleep score indicator 9302 takes the user to a sleep diagnostic screen 9330, as shown in FIG. 12B. The sleep diagnostic screen 9330 displays a sleep status bar gauge 9332 that visualizes the user's time asleep relative to the time they fell asleep. The sleep diagnostic screen 9330 further displays a sleep stage graph 9334 that displays the user's sleep stages over time, including awake, REM sleep, deep sleep, and light sleep. A sleep stage section 9336 displays the sleep stages as a bar graph with a numeric value for the time (and percentage of total time) in each stage. In this example, the sleep diagnostic screen 9330 also includes a cessation of breathing graph 9338 that displays occurrences of cessation of breathing on the same time scale as the sleep stage graph 9334. In this example, the sleep diagnostic screen 9330 also includes a heart rate line graph 9340 that shows the user's heart rate while sleeping.

[0164] In this example, selecting the menstrual cycle button 9310 takes the user to a menstrual cycle screen 9350, as shown in FIG. 12C. The menstrual cycle screen 9350 includes a cycle phase indicator 9352 that displays the current phase of the user's menstrual cycle as recorded by the system 9000. The menstrual cycle screen 9350 also includes a predicted cycle timing section 9354 that displays a predicted time until the user reaches the next phase of their menstrual cycle. The menstrual cycle screen 9350 also includes a cycle statistics section 9356 that displays statistics of the user's menstrual cycle during use of the system 9000. For example, the cycle statistics section 9356 may display one or more of an average cycle length, a minimum cycle length, a maximum cycle width, and a cycle length variation.

[0165] In this example, the menstrual cycle screen 9350 includes a menstrual cycle factors tab 9358, which may capture all physiological factors known to the user that may affect the menstrual cycle. Selecting the "Factors" button displays a list of options to select from (e.g., pregnancy, breastfeeding, contraceptive use, PCOS, perimenopause).

[0166] In an example, selection of the contact icon 9328 may display a community page where the user can interact with other users. For example, the community page may provide a forum where questions related to sleep or women's health can be asked and other users can respond.

[0167] In an example, the system 9000 may initiate a dialogue with the user to take an action to promote sleep, such as establishing a program, initiating an established program, or engaging a medical professional. For example, upon determining that the user is in a situation that may cause difficulty in falling asleep or achieving a desired quality of sleep, the system 9000 may issue a notification to the user via the smartphone 9044 (e.g., an alert displayed on the lock screen, alert center, or in an application providing a user interface) and prompt the user to start a program or take another action to improve this. With reference to Figures 12D and 12E, further engagement may be via a chat interface 9370. An initiation message 9372 is presented to the user, alerting the user of the identified problem (e.g., the stage of the menstrual cycle is approaching a stage that typically causes difficulty in falling asleep), identifying a potential action (e.g., setting up a program to prepare the body for sleep), and providing an action from which the user can select (e.g., yes or no). Upon receiving an indication that the user wishes to utilize the solution, the system may present the user with further queries to assist in customizing the solution to the user's needs. In the illustrated example, the first query message 9374 may request the user to input a selection of factors that prevent the user from achieving sleep, such as racing thoughts, anxiety, restless legs, inability to stay asleep, etc. Upon receiving the user input, the second query message 9376 may request user input regarding a preferred time to fall asleep. The responsive user input 9378 may be via any suitable means, such as a drop down menu or text field. Upon receiving the user input, the system 9000 may establish a customized sleep program for the user and present the user with the option to view the program in a program notification message 9380.12F and 12G, the user is presented with a program overview interface 9382, which may be accessed by selecting a program notification message 9380 or by toggling the chat interface 9370 using a feature selector 9384. The program overview interface 9382 displays a current program recommendation 9386 and a previous recommendations section 9388 that displays previously established personalized programs (e.g., a menopause-focused mindfulness program 9388a and a Cognitive Behavioral Therapy (CBT) / Cognitive Behavioral Therapy for Insomnia (CBT-i) program 9388b). Selecting the current program recommendation 9386 displays a program activity stage (in this example, a sleep hygiene practice stage 9390 provides the user with guidance to prepare the user and their sleep environment for sleep, a journaling stage 9392 encourages the user to write down things they need to remember, and a breathing meditation stage 9394 guides the user through breathing exercises) and a program start button 9396.

[0168] In an example, the system 9000 may initiate a dialogue with the user once a potential sleep disorder is detected. For example, referring to FIG. 12H and FIG. 12I, a problem alert message 9400 may be presented to the user, alerting the user to the identified problem (e.g., an abnormally high number of breathing pauses over multiple consecutive nights) and asking if the user would like to view additional information. Upon receiving an indication that the user would like to view additional information, the system may present an initial information message 9402, in this example, providing an explanation of sleep apnea and why the user's breathing pauses may indicate that the user has the condition. Additionally, the system may invite the user to consult with a sleep consultant to discuss further. Upon accepting the invitation, the user is directed to a sleep consultant interface 9410, as shown in FIG. 12J, where selectable call buttons 9412 and book an appointment buttons 9414 are provided to initiate contact with a sleep consultant or sleep medical professional.

[0169] In an example, the sleep consultant interface 9410 may form part of a recommendations portion of the application. In an example, selectable options are provided to navigate between various interfaces of the recommendations portion, such as a relaxation button 9416, a study button 9418, a shop button 9420, and a consult button 9422. Selecting the study button 9418 displays a learning interface 9424 as shown in FIG. 12K, providing selectable links 9426 to information about sleep-related issues. Selecting the relaxation button 9416 displays a relaxation interface 9428 as shown in FIG. 12L, providing a breathing exercises section 9430, a stretching exercises section 9432, and a meditation exercises section 9434. Each section includes multiple selectable exercises in a respective category that the user can use. Selecting the shop button 9420 displays a shopping interface 9436 as shown in FIG. 12M, allowing the user to browse and purchase or order various products and / or services, such as sleep aids for insomnia 9438 and CPAP machines and masks 9440.

[0170] In an example, the system 9000 provides a user with insights regarding sleep-related issues. For example, selecting the sleep score indicator 9302 in the home interface 9300 displays a sleep insights interface 9450, as shown in FIG. 12N and FIG. 12O. The sleep score insights interface 9450 includes a time scale selector 9452 that allows the user to select the time scale on which the insights are displayed. In this example, the sleep score insights interface 9450 includes a diary insights section 9454 showing the impact of the user's entered activities on the sleep score, accompanied by a text summary of the diary insights 9456. Through these insights, the user is informed of the quantified impact of their activities on their sleep. In this example, the sleep score insights interface 9450 further includes a menstrual cycle insights section 9458 showing the impact of the phase of the menstrual cycle on the sleep score, accompanied by a text summary of the menstrual cycle insights 9460.

[0171] In this example, the user can scroll horizontally from the sleep score insight interface 9450 or select the mood button 9312 in the home interface 9300 to display the mood insight interface 9470, as shown in FIG. 12P. The mood insight interface 9470 includes a graphical representation of the impact of the sleep score on the user's mood (in this example, a mood vs. sleep score scatter plot 9472) and a text summary of the mood insights 9474 (e.g., when a user's sleep score exceeds a certain threshold, the user's reported mood is better than average). In this example, the mood insight interface 9470 further includes a menstrual cycle mood insight section 9476, which shows the impact of the phase of the menstrual cycle on the reported mood, accompanied by a text summary of the menstrual cycle mood insights 9478.

[0172] In this example, the user can scroll horizontally from the sleep score insights interface 9450 or the mood insights interface 9470 or select the focus button 9314 in the home interface 9300 to display the focus insights interface 9480 as shown in FIG. 12Q. The focus insights interface 9480 includes a graphical representation of the impact of sleep score on the user's focus (in this example, a focus vs. sleep score scatter plot 9482) and a text summary of the focus insights 9484 (e.g., observing that for a particular increase in sleep score, the user's focus increases by a certain amount). In this example, the focus insights interface 9480 further includes a menstrual cycle focus insights section 9486 with an impact of the phase of the menstrual cycle on the reported mood, accompanied by a text summary of the menstrual cycle focus insights 9488. 5.12.2.1 Cognitive behavioral therapy

[0173] Cognitive behavioral therapy (CBT) is one of the psychological methodologies for treating conditions, based on several principles, including studying mindset, contributing behaviors and emotions, studying patterns, learning better ways to cope, and recapturing the user's symptoms to make their life more efficient.

[0174] Cognitive behavioral therapy (CBT) emphasizes the development of individuals to become their own mentors through in-session exercises and the development of coping skills where individuals learn to change their way of thinking, problematic feelings, and behaviors. CBT provides insight into an individual's current life along with known history and focuses primarily on more effective ways of coping with life.

[0175] Cognitive behavioural therapy for insomnia (CBT-i) is an effective, compact, structured and evidence-based insomnia treatment that helps people with insomnia fall asleep faster, stay asleep and feel better during the day.

[0176] Cognitive behavioral therapy for insomnia (CBT-i) focuses on exploring the connections between how you think, study factors, and how you sleep. CBT-i uses sleep diaries, sleep facilitators, circadian rhythms, stimulus control, sleep hygiene, and sleep restriction to provide insight. 5.12.3 Managing and Accessing User Data

[0177] According to aspects of the present technology, the system 9000 may be configured to make the collected data accessible to other parties (e.g., healthcare providers, research institutions, healthcare companies, etc.) subject to privacy controls. FIG. 13A(A) / 13A(B) illustrates a user management interface 9500 displaying a summary 9502 of user records. Each user record summary may include, for example, user ID, username, menstrual cycle status (e.g., current menstrual cycle status is normal, irregularity detected, etc.), sleep score, recommendation usage metrics (e.g., percentage-based), last date of data sync, last date of contact with the user, etc.

[0178] In an example, selecting the user record summary may display a patient details interface 9510, as shown in FIG. 13B(A) / 13B(B). The patient details interface 9510 serves as a dashboard providing an overview of the user's health data. In this example, it includes a sleep section 9512 (e.g., details of the user's sleep score over time, composition and duration of sleep states, breathing pauses, etc.), a menstrual cycle section 9514 (e.g., providing details on cycle length and variability), a heart rate section 9516, and a recommendation usage section 9518 (e.g., showing a history of the user utilizing personalized recommendations). 5.12.4 Virtual Sleep Care

[0179] According to aspects of the present technology, a virtual sleep pathway for women is provided. In an example, a web portal 9600, as shown in FIG. 14, is provided to enable access to such a virtual sleep pathway. In an example, the virtual sleep pathway may include one or more of sleep assessment / screening services, on-demand telehealth visits with qualified practitioners familiar with women's sleep issues and who can diagnose sleep disorders, provide CBT-i, or prescribe OSA therapy, and a curated selection of sleep solutions (e.g., wellness products and medical devices) designed for women's specific sleep needs.

[0180] 15 illustrates an exemplary virtual sleep path 9700. In a first embodiment, a user directly engages with the virtual sleep path 9700 via a direct entry point 9702 (e.g., a search engine result or advertisement, a social media advertisement, or direct traffic to a website). In this example, the user is directed to a screening stage 9704.

[0181] In a screening step 9704, user input is received in response to a questionnaire. In an example, the user input includes one or more of hormone status, information about diet and eating habits, medications, supplements, menstrual cycle information, fatigue / fatigue levels, and information about exercise and health habits (e.g., meditation, bedtime habits, etc.).

[0182] In an example, the questionnaire may include female-specific questions such as those outlined in the table below.

[0183] [Table 1]

[0184] In examples, the menstrual cycle information may be determined using information obtained by one or more sensors as described above. Additionally or alternatively, the information may be input by a user.

[0185] In an example, one or more inputs related to the user's hormonal status may be obtained by biological testing (such as at-home or lab testing). For example, the inputs may include one or more of glucagon, epinephrine (adrenaline), norepinephrine, cortisol, and growth hormone.

[0186] Upon receiving user input, the collected information is analyzed to provide personalized insights and / or recommendations. In examples, one or more algorithms may be executed to analyze the information. In examples, the information may be processed by an artificial intelligence model to provide personalized insights and / or recommendations.

[0187] In the illustrated example, the screening step 9704 is configured to determine an appropriate pathway for the user based at least in part on whether the user is likely to be affected by a male or female hormonal condition. In another example, the screening step 9704 may assume that the user has a female hormonal issue. A user identified as having a female hormonal condition is directed to a female pathway 9706, for example, via the web portal 9600 of FIG.

[0188] In an example, a user identified as having a male hormone status may be directed to a gender-neutral pathway 9708, such as through communications and landing pages exemplified in ResMed's "Awakenyourbest" campaign. As an example, a user who has a female hormone status but is at high risk for a respiratory condition such as obstructive sleep apnea (OSA) may be directed to a gender-neutral pathway 9708 focused on such respiratory condition.

[0189] Taking into account the insights and recommendations, the user may select a respiratory disorder focused assessment pathway. By way of example, in a sleep respiratory disorder diagnosis step 9710, the user may be evaluated for a sleep respiratory disorder, such as OSA, using, for example, ResMed's onesleeptest® home sleep test or myNight® snoring and sleep quality application. If the user is diagnosed with OSA, a CPAP trial step 9712 may be performed.

[0190] If the sleep disordered breathing diagnosis phase 9710 indicates that the user is OSA negative but has symptoms suggestive of insomnia, the user may be directed to an insomnia treatment phase 9714. Similarly, if the CPAP compliance is poor during the CPAP trial phase 9712 and the user has symptoms suggestive of insomnia, the user may be directed to an insomnia treatment phase 9714. By way of example, objective sleep data (e.g., via sleep and lifestyle diaries) may be collected simultaneously, as well as factors that may affect sleep. An algorithm may analyze and use the data to predict future events of sleep onset and / or sleep maintenance problems. In the insomnia treatment phase 9714, the user may receive cognitive behavioral therapy for insomnia (CBT-i). In an example, the CBT-i may be delivered virtually.

[0191] In an example, the user may choose to bypass the sleep disordered breathing diagnosis stage 9710 and proceed directly to the insomnia treatment stage 9714. In an example, the user may engage with a healthcare provider (such as a general practitioner) to discuss the insomnia and develop a mental health care plan (MHCP) in the MHCP stage 9716. In an example, the MHCP stage 9716 may be the user's entry point into the virtual sleep pathway 9700. Alternatively, the user may be directed to the MHCP stage 9716 from the women's pathway 9706 (e.g., to gain access to public health funding for subsequent treatment). After developing the MHCP, the referral stage 9718 refers the user to a specialist for participation in the insomnia treatment stage 9714.

[0192] FIG. 16 illustrates an exemplary method 9800 for predicting sleep-related problems and providing insights and recommendations accordingly. In a first step 9802, user input is received in response to a data collection stage (e.g., screening stage 9704). In a second step 9804, the data is evaluated for factors indicative of diet affecting the user's sleep. For example, the one or more user inputs in response to a questionnaire may include keywords indicative of dietary factors affecting sleep. For example, the one or more user inputs may indicate the consumption of foods and beverages that contain substances such as alcohol and caffeine. As another example, the one or more user inputs in response to a questionnaire may indicate the consumption of substances (e.g., nicotine) that may affect sleep. If such problems are identified, dietary recommendations to improve sleep may be provided in a third step 9806.

[0193] In a fourth step 9808, the data is evaluated for indications of medications or supplements that affect the user's sleep. For example, the one or more user inputs in response to the questionnaire may include keywords indicative of medications or supplements that affect sleep. For example, the one or more user inputs may indicate one or more of: feeling tired, sluggish, or lethargic during the day, feeling like they are not getting enough sleep because of dreams, having headaches, not having much energy, etc. In an example, a recommendation to consult with a professional to evaluate the medication or supplements may be provided in a fifth step 9810.

[0194] In a sixth step 9812, the data is evaluated for indications of hormonal conditions, particularly the menstrual cycle, that may affect the user's sleep. For example, the data may indicate one or more of contraceptive use, pregnancy, breastfeeding, polycystic ovarian syndrome (PCOS), menopause, and perimenopause. If this is determined to be the case, insights regarding the menstrual cycle, hormonal fluctuations, menopause, and their impact on sleep health are delivered to the user in a seventh step 9814.

[0195] In an eighth step 9816, the data is evaluated for indicators of stress impacting the user's sleep. Such indicators may include, for example, one or more of daytime fatigue / lethargy, daytime headaches, reduced total sleep time, anxiety and / or depression. In an example, in a ninth step 9818, in response to user input indicating stress, recommendations for reducing stress and / or insights regarding the impact of stress on sleep may be provided.

[0196] In examples, certain data may be used in one or more of the above evaluations.

[0197] In a tenth step 9820, the user inputs are analyzed in a comprehensive manner to predict the user's sleep-related problems, and insights and recommendations are provided to the user in an eleventh step 9822. For example, such recommendations may include guidance on adjusting sleep time, adopting relaxation activities (such as yoga or meditation), avoiding alcohol or foods that affect sleep after a certain time, etc. 5.13 Glossary

[0198] For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, other definitions may apply. 5.13.1 General

[0199] Air: In certain forms of the present technology, air is understood to mean atmospheric air, while in other forms of the present technology, air may be understood to mean other combinations of breathable gases, such as oxygen-rich atmospheric air.

[0200] Surrounding: In certain forms of the present technology, the term surroundings is understood as (i) outside the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0201] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier, such as the humidity of the room the patient is sleeping in. Such ambient humidity may be different from the humidity outside the room in which the patient is sleeping.

[0202] In another example, ambient pressure can be the pressure immediately surrounding or external to the body.

[0203] In certain embodiments, ambient (e.g., acoustic) noise is considered to be the background noise level in the room the patient is in, as opposed to, for example, noise generated by the RPT device or noise emanating from a mask or patient interface. Ambient noise may originate from outdoor sources.

[0204] Automatic Positive Airway Pressure Ventilation (APAP) Therapy: CPAP therapy in which the treatment pressure is automatically adjusted, for example, between a minimum and maximum value on a breath-by-breath basis, depending on the presence or absence of indications of an SDB (sleep disordered breathing) event.

[0205] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is somewhat higher during exhalation and somewhat lower during inhalation. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increasing in response to detection of an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction).

[0206] Flow Rate: The amount (or mass) of air expelled per unit time. Flow rate can refer to an instantaneous quantity. In some cases, a reference to flow rate is a scalar, that is, a quantity with size only. In other cases, a reference to flow rate is a vector quantity, that is, a quantity with both magnitude and direction. Flow rate may be given the symbol Q. "Flow rate" is sometimes written simply as "flow" or "airflow."

[0207] In the patient breathing example, the flow rate may be nominally positive for the inhalation portion of the patient breathing cycle and therefore negative for the exhalation portion of the patient breathing cycle. The device flow rate, Qd, is the flow rate of air leaving the RPT device. The total flow rate, Qt, is the flow rate of air reaching the patient interface via the air circuit, plus any supplemental gases. The exhaust flow rate, Qv, is the rate at which air leaves the exhaust port to expel exhaled gases. The leakage flow rate, Ql, is the flow rate that leaks from the patient interface system or elsewhere. The respiratory flow rate, Qr, is the flow rate of air admitted into the patient's respiratory system.

[0208] Flow Therapy: A respiratory therapy that involves delivering airflow to the entrance of the airways at a controlled flow rate, called the therapeutic flow rate, that is typically positive throughout the patient's respiratory cycle.

[0209] Humidifier: A humidifier is understood as a humidification device constructed, arranged or configured to have a physical structure capable of delivering a therapeutically beneficial amount of water (H2O) vapor to an air stream to improve a medical respiratory condition of a patient.

[0210] Leak: The word leak refers to unintended airflow. In one example, a leak can occur as a result of an imperfect seal between the mask and the patient's face. In another example, a leak can occur at the swivel elbow to the perimeter.

[0211] Conducted (acoustic) noise: Conducted noise, as used herein, refers to noise that is carried to the patient by pneumatic pathways, such as the air circuit and the patient interface, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0212] Radiated (acoustic) noise: Radiated noise herein refers to noise that is carried to the patient by the surrounding air. In one form, radiated noise may be quantified by measuring the volume / pressure level of the object in question according to ISO 3744.

[0213] Ventilation (acoustic) noise: Ventilation noise in this specification refers to noise generated by airflow through any ventilation, such as the ventilation holes of the patient interface.

[0214] Patient: A human being, whether or not suffering from a respiratory condition.

[0215] Pressure: force per unit area. Pressure is measured in cmH2O, gf / cm 2 1 cmH2O can be expressed in a variety of units, including 1 g-f / cm 2 which is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m 2 = 1 mbar to 0.001 atm). In this specification, pressures are given in units of cmH2O unless otherwise stated.

[0216] The pressure at the patient interface is labeled Pm, and the treatment pressure is labeled Pt, which indicates the target value that the current interface pressure should reach, also labeled Pm.

[0217] Respiratory Pressure Therapy (RPT): Delivery of air to the airway entrance, usually at a positive therapeutic pressure relative to the atmosphere. Ventilator: a mechanical device that provides pressure support to a patient to complete some or all of the work of breathing. 5.13.2 Breathing cycle

[0218] Apnea: According to some definitions, apnea is said to occur when flow falls below a predefined threshold for a period of time, e.g., 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0219] Respiratory rate: the patient's spontaneous breathing rate, usually measured in breaths per minute.

[0220] Duty Cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0221] Effort (breathing): The effort required by a spontaneous breather to breathe.

[0222] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow. Flow limitation: Flow limitation is considered to be a condition in a patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. If the flow limitation occurs during the inspiratory portion of the respiratory cycle, it can be referred to as inspiratory flow limitation. If the flow limitation occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow limitation. Flow-limited inspiration waveform types:

[0223] (i) Flattening: There is an upswing followed by a relatively flat section, then a downswing.

[0224] (ii) M-shape: It has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat area between the two peaks.

[0225] (iii) Chair Shape: Has a single local peak at the leading edge followed by a relatively flat section.

[0226] (iv) Reverse chair shape: A relatively flat section followed by a single local peak, this peak being at the trailing edge. Hypopnea: According to some definitions, hypopnea is considered to be a reduction in flow but not a cessation of flow. In one form, hypopnea is said to occur when there is a sustained period of reduction in flow below a threshold rate. When hypopnea is detected due to a reduction in respiratory effort, central hypopnea is said to occur. In one form in adults, hypopnea may be considered to occur when any of the following occur: (i) A 30% decrease in patient breathing for at least 10 seconds and an associated 4% desaturation; or

[0227] (ii) A reduction in patient respiration (but less than 50%) for at least 10 seconds and associated desaturation or agitation of at least 3%.

[0228] Hyperventilation: An increase in airflow to a higher than normal level.

[0229] Inspiration portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiration portion of the respiratory cycle.

[0230] Patency (Airway): The degree to which the airway is open, or the extent to which the airway is open. A patent airway is open. Airway patency may be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).

[0231] Positive end-expiratory pressure (PEEP): The pressure in the lungs above atmosphere that exists at the end of expiration.

[0232] Peak flow (Q peak): The maximum flow value in the inspiratory portion of the respiratory flow waveform.

[0233] Respiratory flow, Patient airflow rate, Respiratory flow rate (Qr): These terms can be understood to refer to the estimation of respiratory flow by an RPT device. In contrast to "actual respiratory flow" or "actual respiratory flow", actual respiratory flow is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0234] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume Vi (volume of air inhaled) is equal to the exhaled volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination, e.g., the average, of the inhaled volume Vi and the exhaled volume Ve.

[0235] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0236] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0237] (Total) Time (Ttot): The total time from the start of one inspiratory portion of the respiratory flow waveform to the start of the inspiratory portion of the next respiratory flow waveform.

[0238] Typical Recent Ventilation: The ventilation value around which recent ventilation valuesVent over a given timescale tend to cluster, i.e., a measure of the central tendency of recent ventilation values.

[0239] Upper Airway Obstruction (UAO): Includes partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase slightly or decrease with increasing pressure differential over the upper airway (Starling resistor behavior). Vent: A measure of the rate at which gas is exchanged by a patient's respiratory system. Measurements of ventilation may include either or both inspiratory and expiratory flows per unit of time. When expressed as volume per minute, this amount is often referred to as "minute ventilation." Minute ventilation is sometimes given simply as volume and is understood as volume per minute. 5.13.3 Ventilation

[0240] Adaptive servo ventilator (ASV): A servo ventilator that has a variable, rather than fixed, target ventilation that can be learned from some characteristics of the patient, for example the patient's breathing characteristics.

[0241] Backup Rate: A ventilator parameter that sets the minimum number of breaths (typically breaths per minute) that the ventilator will deliver to the patient unless triggered by spontaneous breathing effort.

[0242] Cycled: The end of the inspiratory phase of the ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop delivering breaths.

[0243] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are applied within a breath to produce the desired interface pressure the ventilator attempts to achieve at a given time.

[0244] End-Expiratory Pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory portion of an exhalation. If the pressure waveform template Π(Φ) is zeroed at the end of exhalation when Φ=1, i.e., Π(Φ)=0, then EEP is equal to EPAP.

[0245] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0246] Pressure Support: A measure of the pressure the ventilator is increasing above the pressure the ventilator is increasing above, typically referring to the difference between the maximum and base pressures during inspiration (e.g., PS=IPAP-EPAP). In some situations, pressure support refers to the difference the ventilator attempts to achieve, rather than the difference it actually achieves.

[0247] Servo-ventilator: a ventilator that measures patient ventilation, has a target ventilation, and adjusts the level of pressure support to move patient ventilation toward the target ventilation.

[0248] Spontaneous / Timed (S / T): A pattern in which a ventilator or other device attempts to detect the onset of a breath in a spontaneously breathing patient. If the device does not detect a breath within a predetermined period of time, the device automatically begins delivering a breath.

[0249] Swing: A term equivalent to pressure support. Triggered: When a ventilator delivers breathing air to a spontaneously breathing patient, it is said to do so by being triggered at the start of the respiratory portion of the breathing cycle by the patient's effort. 5.14 Other Remarks

[0250] A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the reproduction by any person of this patent document or the patent disclosure by fax, for purposes of disclosure as set forth in the Patent and Trademark Office patent file or records, but reserves all copyright rights thereto for all other purposes.

[0251] Unless the context clearly dictates otherwise, when a range of values ​​is provided, it is understood that each intervening value between the upper and lower limits of the range, to the tenth of the unit of the lower limit, and any other stated or intervening value within the range, is encompassed within the technology. If the upper and lower limits of these intervening ranges, which are independently included in the intervening range, are specifically exceeded in the stated range limit, they are also encompassed within the technology. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed within the technology.

[0252] Additionally, when one or more values ​​are described herein as being implemented as part of the technology, it should be understood that these values ​​may be approximated unless otherwise noted and may be utilized to any suitable significant figures to the extent that the actual technical implementation may permit or require.

[0253] Unless otherwise defined, all technical and scientific terms used herein shall have the same meaning as commonly understood by those skilled in the art. Any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, but a limited number of exemplary methods and materials are described herein.

[0254] Although particular materials are described as being preferred for use in the construction of a component, obvious alternative materials having similar properties may be substituted. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable, and therefore may be manufactured collectively or separately.

[0255] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0256] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. Publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology does not antedate such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0257] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps that are not specifically described.

[0258] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the limitations of the claims.

[0259] Although the technology herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are not necessary for the practice of the technology. For example, the terms "first" and "second" (and the like) are used, but unless otherwise specified, these terms are not intended to indicate any order, but are used to distinguish separate elements. Furthermore, although the description or illustration of process steps in the method may be described in an order, such order is not required. Those skilled in the art will recognize that such order can be changed and / or aspects can be performed simultaneously or even synchronously.

[0260] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0261] 1000 patients 1100 Bedmate 2000 Headbox 2010 Grounding Electrode (ISOG) 2015 EOG electrode 2020 EEG Electrodes 2025 ECG electrode 2030 Submental EMG electrode 2035 Snoring Sensor 2040 Respiratory Inductance Plethysmogram (Respiratory Effort Sensor) 2045 Respiratory inductance plethysmogram (respiratory effort sensor) 2050 Oral and Nasal Cannula 2055 Photoplethysmography (pulse oximeter) 2055 Pulse Oximeter 2060 Posture Sensor 3000 Patient Interface 3100 Seal forming structure 3200 Plenum Chamber 3300 Positioning and Stabilizing Structures 3400 Ventilation section 3600 Connection Port 3700 Forehead support 3800 Patient Interface 3810a, 3810b Nasal prongs 3820a, 3820b Lumens 4000 RPT Devices 4010 Outer Housing 4012 Upper 4014 Lower 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet Air Filter 4120 Muffler 4122 Inlet muffler 4124 Exit muffler 4140 Pressure Generator, Flow Generator 4142 Blower 4144 Motor 4170 Air Circuit 4171 Heated Air Circuit 4180 Oxygen 4200 Electrical Components 4202 Printed Circuit Board Assembly (PCBA) 4210 Power supply 4220 Input Device 4230 Central Controller 4240 Therapy Device Controller 4250 protection circuit 4260 Memory 4270 Transducer (Sensor) 4272 Pressure Sensor 4274 Flow Sensor 4276 Motor Speed ​​Transducer 4280 Data Communication Interface 4282 Remote External Communications Network 4284 local external communications network 4286 Remote External Device 4288 local foreign device 4290 output device 4300 Algorithm 4310 Pretreatment Module 4312 Interface Pressure Estimation Algorithm 4314 Ventilation Flow Estimation Algorithm 4316 Leakage flow rate estimation algorithm 4318 Respiratory flow estimation algorithm 4320 Therapy Engine Module 4321 Phase Determination Algorithm 4322 Waveform Determination Algorithm 4323 Ventilation Decision Algorithm 4324 Inspiratory Flow Limitation Decision Algorithm 4325 Apnea / Hypopnea Decision Algorithm 4326 Snoring Determination Algorithm 4327 Airway Patency Determination Algorithm 4328 Target ventilation decision algorithm 4329 Treatment Parameter Decision Algorithm 4330 Therapy Control Module 4340 Algorithm 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Humidifier Reservoir 5130 Humidifier Reservoir Dock 5210 Humidifier transducer (sensor) 5212 Air pressure sensor 5214 Air Flow Transducer 5216 Temperature Sensor 5218 Humidity Sensor 5240 Heating Element 5250 Humidifier Controller 5251 Central Humidifier Controller 5252 Heating Element Controller 5254 Heated Air Circuit Controller 7100 Monitoring equipment 7200 Screening / Diagnostic / Monitoring Devices 7210 Processor 7220 Communication Interface 7230 Storage media, memory 7240 Data 7250 Processor Control Instructions (Code) 7260 Data Entry Interface 8000 Oxygen Concentrator 8002 Air inlet 8004 Inlet muffler 8006 Accumulator 8008 Exit 8010 Muffler 8020 Inlet valve 8022 Inlet valve 8030 Outlet valve, ventilation valve 8032 Outlet valve 8040 Check valve 8042 Check valve 8050 Flow Restrictor 8052 Flow Restrictor 8054 Flow Restrictor 8056 Valve 8058 Valve 8100 Canister 8102 1st Canister 8104 1st Canister 8200 Compression System 8300 Controller 8310 Processor 8320 Memory 8500 Outer Housing 8506 Exit Port 8600 Control Panel 8602 Charging input port 9000 System 9010 Server 9012 Processor 9014 Memory 9016 Instructions 9018 Data 9020 Database 9030 Network 9032 Wired communication networks 9034 Wireless communication network 9040 Computing Devices 9042 Desktop computers, laptop computers 9044 Smartphone 9046 Tablet 9100 General Architecture 9110 Processor 9120 Memory / Data Storage 9122 Processor Control Instructions 9124 Memory Data 9130 Output (I / O) Device 9132 Display 9134 Speaker 9136 Haptic Feedback Device 9138 Physical Input Device 9140 Optical Sensor 9150 I / O Interface 9160 Communication Interface 9200 Wearable Sensor Device 9202 Wearable Devices 9204 Headband 9206 Ring 9208 Matte 9300 Home Interface 9302 Sleep Score Indicator 9304 Pie Chart 9308 Temperature Button 9310 Menstrual Cycle Button 9312 Mood Button 9314 Concentration Button 9316 Diary Section 9318 Navigation Bar 9320 Home Icon 9322 Insight Icon 9324 Chat Icon 9326 Recommendation Icon 9328 Contact Icon 9330 Sleep diagnosis screen 9332 Sleeping State Bargain 9334 Sleep Stage Graph 9336 Sleep Stages Section 9338 Breathing arrest graph 9340 Heart Rate Line Graph 9350 Menstrual Cycle Screen 9352 Cycle Phase Indicator 9354 Predicted Period Timing Section 9356 Periodic Statistics Section 9358 Menstrual Cycle Factors Tab 9370 Chat Interface 9372 Start message 9374 First query message 9376 Second query message 9378 User Input 9380 Program Notification Message 9382 Program Overview Interface 9384 Feature Selector 9386 Program Recommendations 9388 Recommendations Section 9388a Mindfulness Program 9388b Cognitive Behavioral Therapy (CBT) / Cognitive Behavioral Therapy for Insomnia (CBT-i) Program 9390 Sleep Hygiene Practice Stage 9392 Journaling Stage 9394 Breathing Meditation Stage 9396 Program Start Button 9400 Problem Warning Message 9402 Informational Message 9410 Sleep Consultant Interface 9412 Call button 9414 Reservation button 9416 Relaxation Button 9418 Study button 9420 Shopping Button 9422 Consultation button 9424 Learning Interface 9426 Link 9428 Relaxation Interface 9430 Breathing Exercises Section 9432 Stretching Exercise Section 9434 Meditation Exercises Section 9436 Shopping Interface 9438 Sleep aids 9440 CPAP Machines and Masks 9450 Sleep Insights Interface, Sleep Score Insights Interface 9452 Time Scale Selector 9454 Diary Insights Section 9456 Diary Insights 9458 Menstrual Cycle Insights Section 9460 Menstrual Cycle Insights 9470 Mood Insight Interface 9472 Mood vs. sleep score scatter plot 9474 Mood Insights 9476 Menstrual Cycle Mood Insights Section 9478 Menstrual Cycle Mood Insights 9480 Concentration Insights Interface 9482 Concentration vs. Sleep Score Scatter Plot 9484 Concentration Insight 9486 Concentration Insights Section 9488 Concentration Insight 9500 User Management Interface 9502 Overview 9510 Advanced Interface 9512 Sleep Section 9514 Menstrual Cycle Section 9516 Heart Rate Section 9518 Recommendation Usage Section 9600 Web Portal 9700 Virtual Sleep Path 9702 Direct Entry Point 9704 Screening stage 9706 Women's Route 9708 Gender-neutral routes 9710 Sleep-related respiratory disease diagnosis stage, sleep-related breathing disorder diagnosis stage 9712 CPAP trial stage 9714 Insomnia treatment stage 9716 MHCP stage 9718 Introduction stage 9800 method 9802 First Step 9804 2nd Step 9806 3rd Step 9808 4th step 9810 5th step 9812 6th step 9814 7th step 9816 8th Step 9818 9th Step 9820 10th step 9822 11th step Pm Interface Pressure Pt Treatment Pressure Qd Device Flow Rate Ql Leakage flow rate Qpeak Peak inspiratory flow Qr respiratory flow rate Qt Total flow rate Te Exhalation Time Ti Inhalation Time Ttot Total Time Ve Exhaled volume, expiratory volume Vent ventilation volume Vi Intake volume, intake volume Vt Tidal volume Π Pressure Waveform Template

Claims

1. 1. A method comprising: receiving sleep-related data of a user from one or more sensors; receiving one or more inputs related to a hormonal status of the user; determining one or more recommendations and / or insights to assist the user in improving their sleep; and presenting one or more recommendations and / or insights to the user.

2. 2. The method of claim 1, wherein the one or more sensors include one or more of a heart rate sensor, an oxygen level sensor, an ECG sensor, a pulse rate sensor, an accelerometer, a gyroscope, a GPS receiver, a sound sensor and / or microphone, a non-contact sensing device, and an optical sensor of a wearable sensor device configured to measure a blood volume pulse of a user.

3. The method of claim 1 or 2, wherein the one or more inputs related to the hormonal status of the user are user inputs.

4. 4. The method of claim 3, wherein the one or more user inputs related to the user's hormonal status include one or more of the following: level of fatigue / tiredness, occurrence of localized pain, menstrual characteristics, menstrual timing characteristics of the current or previous menstrual cycle, medications that affect the menstrual cycle, and / or other factors including occurrence of hot flashes, nausea, constipation, acne, mood, appetite, etc.

5. The method of claim 3 or 4, wherein the one or more user inputs are received as responses to a survey.

6. The method of any one of claims 1 to 5, wherein one or more of the inputs relating to the hormonal status of the user are determined using one or more characteristics of the user obtained using one or more sensors.

7. 7. The method of claim 1, wherein the one or more inputs related to the hormonal status of the user include one or more of glucagon, epinephrine (adrenaline), norepinephrine, cortisol, growth hormone.

8. The method of any one of claims 1 to 7, comprising receiving one or more inputs related to the user's exercise habits.

9. The method of claim 8 , wherein the one or more inputs related to the user's exercise habits may be received via one or more of: responses to a survey, and one or more exercise applications.

10. 10. The method of any one of claims 1 to 9, wherein the one or more recommendations comprise one or more of lifestyle changes, sleep hygiene, an automated sleep diary, an ideal bedtime, a sleep program, relaxation exercises, educational articles, consultation with a sleep consultant, consultation with a medical professional, and / or screening for sleep related disorders.

11. 10. The method of claim 1, wherein the one or more insights include ovulation, hormone fluctuations, the impact of hormone fluctuations on sleep, correlation between menstrual cycle stage and the user's sleep metrics, correlation between sleep metrics and user inputted factors, readiness metrics, and / or guidance regarding factors likely to affect the user's sleep and / or readiness.

12. 12. A method according to any preceding claim, comprising predicting that a user will have problems falling asleep or staying asleep by monitoring one or more factors over an extended period of time.

13. 13. The method of claim 12, wherein the extended period is one of at least 7 days, or at least 14 days.

14. 13. The method of claim 11 or 12, wherein the one or more factors include one or more of caffeine intake, sleep onset time, diet, supplements, medications, symptoms, menstrual cycle stage, average cycle length, contraceptive use, pregnancy, lactation, polycystic ovary syndrome (PCOS), menstrual related disorders, menopause, perimenopause, improved sleep habits, life experiences, and stress relief activities.

15. 1. A method comprising: receiving sleep-related data of a user from one or more sensors; receiving one or more inputs related to a hormonal status of the user; presenting information regarding the user's hormonal status and sleep data in a user interface.

16. A virtual sleep clinic including one or more of the following: sleep assessment services, on-demand telemedicine visits with qualified practitioners familiar with women's sleep issues and able to diagnose sleep disorders, provide behavioral therapy, and / or prescribe treatment, and providing sleep solutions designed for women's sleep needs, the virtual sleep clinic configured to facilitate performance of the method of any one of claims 1 to 15.

17. 17. The virtual sleep clinic of claim 16, wherein the virtual sleep clinic is configured to facilitate performance of a screening phase to determine a user's sleep assessment pathway.

18. 20. The virtual sleep clinic of claim 17, wherein the screening phase identifies whether the user is likely to be affected by a male or female hormonal condition and directs the user to a sleep pathway based at least in part on the identification.

19. 19. The virtual sleep clinic of claim 17 or claim 18, wherein a first sleep assessment pathway is directed to sleep breathing status and a second sleep assessment pathway is directed to problems falling asleep and staying asleep.

20. A computer program product comprising instructions which, when executed by a computer, cause the computer to carry out the method according to any one of claims 1 to 15.

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