Systems and methods for screening, diagnosing, and monitoring sleep apnea

Abstract

To provide a method and system for use in monitoring / screening / diagnosing a sleep or wake state of a subject or patient.SOLUTION: The method generally includes monitoring activities of a monitored patient during one or more sleep sessions comprising a plurality of intervals known as epochs. The sleep / wake state of the subject is determined during each epoch of the session using actigraphy data obtained during the monitoring session. The actigraphy data provides information about the activities of the patient during the epoch. The sleep or wake state is determined based on a ratio of the activity count during an epoch to the activity count during a preceding epoch. If the ratio is greater than a first activity threshold, then a "wake" indication may be provided by, e.g., the system. Alternatively or additionally, a "wake" indication may be determined if the activity count during the epoch is greater than a threshold.SELECTED DRAWING: Figure 6

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 160,937 (Title: "Systems and Methods for Screening, Diagnosis, an d Monitoring of Sleep - Disordered Breathi ng", filed on May 13, 2015). The entire disclosure of this document is hereby incorporated by reference for all purposes.

[0002] 2 Statement regarding federally - sponsored research or development Not applicable

[0003] 3 Name of the organization for joint research and development Not applicable

[0004] 4 Sequence listing Not applicable

[0005] 5 Background of the technology 5.1 Field of the technology This technology relates to one or more of screening, diagnosis, and monitoring of respiratory - related diseases. In addition, this technology relates to medical devices or systems and their use.

Background Art

[0006] 5.2 Description of related technologies 5.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0007] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, taking oxygen from the air into the venous blood. ​​​ It allows intake and can expel carbon dioxide. The trachea divides into the right and left bronchi, and these bronchi further divide and ultimately divide into terminal bronchioles. The bronchi constitute the conducting airways and are not involved in gas exchange. Further divisions of the airway lead to respiratory bronchioles and ultimately to alveoli. The alveolar region of the lungs is the site where gas exchange takes place and is referred to as the respiratory region. See the following: "Respiratory Physiolog y", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2011.

[0008] A wide range of respiratory diseases exist. Specific diseases can be characterized by specific manifestations (e.g., apnea, hypopnea and hyperpnea).

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) and is characterized by manifestations such as closure or obstruction of the upper airway during sleep, resulting from a normal deficiency in muscle tone in the abnormally small upper airway and tongue regions during sleep, and a combination of the soft palate and the posterior pharyngeal wall. Due to this condition, affected patients typically experience apnea for periods lasting 30 to 120 seconds, and sometimes 200 to 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular disease and brain damage. This syndrome is a common disease, especially common in middle-aged overweight men, but patients may have no awareness of the symptoms. See U.S. Patent No. 4,944,310 (Sull ivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a condition is a disorder of the patient's respiratory regulator, with alternating periods of increasing and decreasing ventilation known as the CSR cycle that occur periodically with each other. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. CSR can be harmful due to repeated episodes of hypoxia. Some patients wake up multiple times from sleep in relation to CSR, leading to worsening insomnia, increased sympathetic activity

[0011] 5.2.2 Diagnostic and Monitoring Systems A clinician can appropriately perform patient screening, diagnosis, or monitoring based on personal observation. However, there are situations where a clinician is not available or payment to a clinician is not possible. Depending on the situation, clinicians may have different opinions on a patient's condition. Some clinicians may apply different criteria depending on the

[0012] time. When clinical practice is busy, it can be difficult for clinicians to keep up with the development of patient management guidelines. A polysomnogram (PSG) is a conventional system for the diagnosis and prognosis of cardiopulmonary diseases and typically involves the application and interpretation by and / or is unpleasant or impractical for a patient attempting to sleep at home There may be cases.

[0013] A more convenient screening / diagnosis / monitoring system for home use includes a nasal cannula, a pressure sensor, a processing device, and recording means. The nasal cannula is a device that includes hollow open-ended protrusions. These protrusions are configured to be inserted into the patient's nostrils with minimal interference with the patient's breathing, being almost non-invasive. These hollow protrusions are in fluid communication with a pressure transducer via a Y-shaped tube. The pressure transducer provides a data signal indicative of the pressure (nasal pressure) at the entrance of the patient's nostrils. Since the nasal pressure signal is similar in shape to the nasal flow signal, nasal pressure is an excellent proxy for nasal flow.

[0014] The processing device can be configured to analyze the nasal pressure signal from the pressure transducer in real time to monitor the patient's breathing. In contrast, diagnosis does not need to be performed in real time . Therefore, the recording means is configured to record the nasal pressure signal from the pressure transducer for later off-line analysis for diagnostic purposes.

[0015] In the analysis of the nasal pressure signal, it may be attempted to identify apnea and hypopnea during a screening / diagnosis / monitoring session. Dividing the total number of apnea and hypopnea by the length of the monitoring session yields an index of SDB severity (known as the apnea-hypopnea index (AHI ). The AHI is a widely used screening and diagnostic tool for sleep disordered breathing. However, in such an analysis, during the session over a long Since the patient may not be asleep, there is a tendency to underestimate the AHI. Thus, when screening patients based on the AHI returned from such an analysis, there is a tendency to miss patients whose sleep is interrupted during the monitoring session, as occurs frequently, for example, in the case of insomnia.

[0016] In the case of a more accurate method for estimating the AHI, the number of apneas and hypopneas is divided by the number of hours the patient was asleep during the session. To calculate the AHI in this way, it is necessary to detect by analysis when the patient has fallen asleep. It has been found that purely detecting the sleep / wake state from nasal pressure ( or actually from a signal indicating nasal flow, of which nasal pressure is a proxy) is a difficult task, and as a result, it affects the accuracy of AHI calculation and thus screening, diagnosis, and monitoring based on the AHI. Therefore, there is a need for an improved SDB screening / monitoring / diagnosis system that more accurately estimates the total sleep time of the patient.

[0017] Therefore, there is a need for an improved SDB screening / monitoring / diagnosis system that more accurately estimates the total sleep time of the patient. SUMMARY OF THE INVENTION

[0018] BRIEF DESCRIPTION OF THE TECHNOLOGY The present technology is directed to providing a medical device for use in the monitoring or diagnosis of respiratory diseases having one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0019] A first aspect of the present technology relates to a system for screening, diagnosing, or monitoring respiratory diseases.

[0020] Another aspect of the present technology is used for screening, diagnosing, or monitoring respiratory diseases. It is related to a method.

[0021] One form of the present technology is a method and system configured to estimate the amount of time a patient has fallen asleep during a monitoring session using actigraphy data collected during the session. This estimation can be used in the calculation of an index of the severity of sleep disordered breathing in the session (e.g., the apnea-hypopnea index (AHI)). Optionally, this estimation can take into account respiratory flow or effort data collected during the session. According to one aspect of the present invention, a method for estimating the total sleep time of a patient including a plurality of epochs during a monitoring session is disclosed. The method includes determining the asleep / awake state of the patient at each epoch of the session using the actigraphy signal of the patient obtained during the monitoring session, and estimating the total sleep time from the sleep / awake state of the patient at each epoch. The determination of the sleep / awake state of the patient at an epoch includes determining the activity count for each epoch from the actigraphy signal, and determining that the ratio of the activity count for the epoch to the activity count for the preceding epoch is higher than a first activity threshold, and determining the sleep / awake state of the patient at the epoch as "awake". According to another aspect of the present invention, a system for estimating the total sleep time of a patient during a monitoring session including a plurality of epochs is disclosed. The system includes an actigraph configured to generate an actigraphy signal indicating the acceleration of the actigraph in each of three orthogonal axes, and a processor. The processor determines each epoch from the actigraphy signal. This estimation can be used in the calculation of an index of the severity of sleep disordered breathing in the session (e.g., the apnea-hypopnea index (AHI)). Optionally, this estimation can take into account respiratory flow or effort data collected during the session.

[0022] According to one aspect of the present invention, a method for estimating the total sleep time of a patient including a plurality of epochs during a monitoring session is disclosed. The method includes determining the asleep / awake state of the patient at each epoch of the session using the actigraphy signal of the patient obtained during the monitoring session, and estimating the total sleep time from the sleep / awake state of the patient at each epoch. The determination of the sleep / awake state of the patient at an epoch includes determining the activity count for each epoch from the actigraphy signal, and determining that the ratio of the activity count for the epoch to the activity count for the preceding epoch is higher than a first activity threshold, and determining the sleep / awake state of the patient at the epoch as "awake". This estimation can be used in the calculation of an index of the severity of sleep disordered breathing in the session (e.g., the apnea-hypopnea index (AHI)). Optionally, this estimation can take into account respiratory flow or effort data collected during the session. According to another aspect of the present invention, a system for estimating the total sleep time of a patient during a monitoring session including a plurality of epochs is disclosed. The system includes an actigraph configured to generate an actigraphy signal indicating the acceleration of the actigraph in each of three orthogonal axes, and a processor. The processor determines each epoch from the actigraphy signal. This estimation can be used in the calculation of an index of the severity of sleep disordered breathing in the session (e.g., the apnea-hypopnea index (AHI)). Optionally, this estimation can take into account respiratory flow or effort data collected during the session. According to one aspect of the present invention, a method for estimating the total sleep time of a patient including a plurality of epochs during a monitoring session is disclosed. The method includes determining the asleep / awake state of the patient at each epoch of the session using the actigraphy signal of the patient obtained during the monitoring session, and estimating the total sleep time from the sleep / awake state of the patient at each epoch. The determination of the sleep / awake state of the patient at an epoch includes determining the activity count for each epoch from the actigraphy signal, and determining that the ratio of the activity count for the epoch to the activity count for the preceding epoch is higher than a first activity threshold, and determining the sleep / awake state of the patient at the epoch as "awake". This estimation can be used in the calculation of an index of the severity of sleep disordered breathing in the session (e.g., the apnea-hypopnea index (AHI)). Optionally, this estimation can take into account respiratory flow or effort data collected during the session. According to another aspect of the present invention, a system for estimating the total sleep time of a patient during a monitoring session including a plurality of epochs is disclosed. The system includes an actigraph configured to generate an actigraphy signal indicating the acceleration of the actigraph in each of three orthogonal axes, and a processor. The processor determines each epoch from the actigraphy signal. This estimation can be used in the calculation of an index of the severity of sleep disordered breathing in the session (e.g., the apnea-hypopnea index (AHI)). Optionally, this estimation can take into account respiratory flow or effort data collected during the session.

[0023] According to another aspect of the present invention, a system for estimating the total sleep time of a patient during a monitoring session including a plurality of epochs is disclosed. The system includes an actigraph configured to generate an actigraphy signal indicating the acceleration of the actigraph in each of three orthogonal axes, and a processor. The processor determines each epoch from the actigraphy signal. This estimation can be used in the calculation of an index of the severity of sleep disordered breathing in the session (e.g., the apnea-hypopnea index (AHI)). Optionally, this estimation can take into account respiratory flow or effort data collected during the session. According to one aspect of the present invention, a method for estimating the total sleep time of a patient including a plurality of epochs during a monitoring session is disclosed. The method includes determining the asleep / awake state of the patient at each epoch of the session using the actigraphy signal of the patient obtained during the monitoring session, and estimating the total sleep time from the sleep / awake state of the patient at each epoch. The determination of the sleep / awake state of the patient at an epoch includes determining the activity count for each epoch from the actigraphy signal, and determining that the ratio of the activity count for the epoch to the activity count for the preceding epoch is higher than a first activity threshold, and determining the sleep / awake state of the patient at the epoch as "awake". This estimation can be used in the calculation of an index of the severity of sleep disordered breathing in the session (e.g., the apnea-hypopnea index (AHI)). Optionally, this estimation can take into account respiratory flow or effort data collected during the session. Determining an activity count for a hook, and when a ratio of the activity count for an epoch to a previous activity count for an epoch is higher than a first activity threshold, determining the patient's dozing / awakening state at each hook as "awake", and estimating a total sleep time from the patient's sleep / awakening state at each epoch. When the ratio of the activity count for an epoch to the activity count for an epoch is higher than a first activity threshold, determining the patient's dozing / awakening state at each hook as "awake", and estimating a total sleep time from the patient's sleep / awakening state at each epoch. is programmed to .

[0024] Of course, some of the aspects may form sub - aspects of the present technology. Also, various combinations of sub - aspects and / or aspects may form further aspects or sub - aspects of the present technology. or one of the various aspects may be variously combined to form further aspects or sub - aspects of the present technology. may be formed.

[0025] Other features of the present technology will become apparent in view of the information included in the following detailed description, the drawings, and the claims. will become apparent.

[0026] 7 BRIEF DESCRIPTION OF THE DRAWINGS The present technology is illustrated by way of non - limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements. include the following like elements.

BRIEF DESCRIPTION OF THE DRAWINGS

[0027]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9A

Figure 9B

DETAILED DESCRIPTION OF THE INVENTION

[0028] 8 DETAILED DESCRIPTION OF EXAMPLES OF THE PRESENT TECHNOLOGY Before explaining the present technology in more detail, it should be understood that the present technology is not limited to the specific examples described herein. The terms used in this disclosure are for the purpose of explaining the specific examples described herein and should also be understood not to be limiting.

[0029] The following description is provided in relation to 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 can be combined with one or more features of another example or other examples. In addition, these examples ​​​Any single feature or combination of features in any of the above may constitute further examples. It can be achieved.

[0030] 8.1 Screening, diagnostic and surveillance systems 8.1.1 Polysomnography Systems FIG. 1 shows a patient 1000 undergoing a polysomnogram (PSG). The head box 2000 includes a head box 2000. The head box 2000 receives information from the following sensors: Receive and record signals: EOG electrodes 2015, EEG electrodes 2020, ECG electrodes 20 25, submental EMG electrode 2030, snoring sensor 2035, respiratory inductance on chest girdle Plethysmogram (respiratory effort sensor) 2040, respiratory inductance plethysmogram on abdominal band MogLam (Respiratory Effort Sensor) 2045, Oronasal Cannula and Thermistor 2050, Photoplethysmograph (pulse oximeter) 2055, and body position sensor 20 60. The electrical signal is referred to the ground electrode (ISOG) 2010 positioned at the center of the forehead.

[0031] 8.1.2 Home Use Systems FIG. 3 is a block diagram illustrating a screening / diagnostic / monitoring system 3000 that is particularly suitable for home use. 3 is a block diagram of the system 3000. The system 3000 includes a respiratory sensor 3010. 10 is configured to generate an analog or digital signal indicative of the patient's respiration. In one implementation, the system 3000 includes a nasal cannula 3020. 3020, when connected to the system 3000, acquires a signal indicative of the patient's nasal pressure; The nasal cannula 3020 is configured to deliver the respiratory sensor 3010 to the respiratory sensor 3010. As shown, two prongs or nozzles 302 are configured to be inserted into the patient's nostrils. It includes 5. The prong 3025 of the nasal cannula 3020 is connected to the flexible catheter 3028. The flexible catheter 3028 is configured to convey the pressure at the nostrils to the respiratory sensor 3010 which is the pressure sensor in this implementation. The nasal pressure signal provided by the respiratory sensor 3010 can be taken as indicating the respiratory flow rate Qr of the patient through appropriate unit conversion.

[0032] The system 3000 further includes a processor 3030. The processor 3030 is configured to process and / or analyze the respiratory signal derived from the patient's respiration and generated from the sensor 3020 as described below. The processor 3030 processes and / or analyzes the respiratory signal in cooperation with the memory 3080.

[0033] The respiratory sensor 3010 can be connected to the processor 3030 via an A / D converter 3040. The A / D converter 3040 converts the analog signal generated by the respiratory sensor 3010 into a digital data stream. Alternatively, if the respiratory sensor 3010 is configured to generate a digital signal, the A / D converter 3040 can be omitted.

[0034] The system 3000 may further include a respiratory effort sensor 3050 similar to the respiratory inductance plethysmogram (respiratory effort sensor) 2040 in the PSG system of FIG. 2 on the chest or abdominal belt 3055. The respiratory effort sensor 3050 is connected to the processor 3030 directly (in the case of a digital sensor 3050) or via an A / D converter (in the case of an analog sensor 3050) together with a predetermined sampling frequency (for example, 10 Hz). The processor 3030 may be further configured to process and / or analyze the respiratory effort signal generated from the respiratory effort sensor 3050 as follows. And / or analysis may be performed as follows.

[0035] The system 3000 may further include an actigraph 3060. The actigraph is Labeled as X, Y, and Z and configured to generate signals indicating the acceleration of the actigraph along three orthogonal axes defined relative to the axes of the actigraph. These three signals are collectively referred to as actigraphy signals. Actigraphy Is widely used by researchers as an input for sleep / wake decisions in various scenarios, and the most common applications are misinterpretation of insomnia / somnolence states and assessment of circadian rhythm Disorders. Since actigraphy is not obtained using electrophysiology but rather by quantification of movement, there can be situations where the sleep / wake states derived from PSG and actigraphy Do not match when the patient frequently tosses and turns during sleep or has little movement during wakefulness. Several algorithms for the analysis of actigraphy have been developed and applied in different situations as follows; the agreement between the sleep / wake results obtained from these algorithms And those obtained using an optimal reference PSG is generally good. And those obtained using an optimal reference PSG is generally good. And the results obtained from these algorithms and those obtained using an optimal reference PSG generally agree well. Situation where the agreement is generally good.

[0036] The actigraph 3060 is configured to be attached at a convenient location on the patient's body (e.g., the patient's torso). The connection from the actigraph 3060 to the processor 3030 Is made at a predetermined sampling frequency (e.g., 10 Hz) along with, (digital actigraph ​In the case of the rough 3060), it is performed directly or (in the case of the analog actigraph 3060 ), it is performed via an A / D converter. The actigraph 3060 (in the digital case) or either the A / D converter is said to generate actigraphy data or an actigraphy signal containing samples at a specific sampling frequency. The processor 3030 can be further configured to process and / or analyze the actigraphy signal generated by the actigraph 3060 as described below.

[0037] The system 3000 may further include a power supply 3090 (e.g., a battery) configured to generate power for other components of the system 3000. The system may also use other power sources that become available via an A / C outlet.

[0038] As described above, the signal processing / analysis can be performed by the processor 3030. The processor may specifically include a processor programmed to perform any of monitoring / processing / analysis / diagnosis or other methods described herein (e.g., those related to SDB) . In such an execution of the system 3000, the processing can be embodied as a computer program stored in the memory 3080. Such a computer program may include instructions and / or data for executing the algorithms or methods disclosed herein. These programs can be stored in a memory location (e.g., ROM) and then loaded into RAM as needed during execution time. The processor may, ( e.g., be downloaded from a storage location or burned into hardware) contain code e.g., downloaded from a storage location or burned into hardware ​​​​appropriately programmed digital signal processors or application specific integrated circuits may also be included to execute the algorithms and methods described herein by the processor may also form part of a remote computing device (not shown). In one such implementation, processor 3030

[0039] configured as a "local processor" to relay signals generated by various sensors (e.g., respiration sensor 3010) to a processor associated with a remote computing device (a "remote processor") over a wireless or wired connection via communication interface 3070. In such an implementation, system 3 000 may communicate with a remote computing device (e.g., a laptop, mobile phone, tablet or more generally any computing device with sufficient processing power) via Bluetooth or WiFi. In another such implementation, processor 3030 may store various signals in memory 3080. Memory 308 0 may be removable from system 3000 (e.g., a memory card or external hard drive). In such an implementation, the removed memory 3080 may be inserted into an interface of a remote computing device configured to retrieve the stored signals for processing / analysis by its processor (remote processor). Thus, the memory for storing the actigraph data or signals used by the processor when performing the algorithms or methods described herein is for storing instructions relayed to the remote processor over a wireless or wired connection via communication interface 3070. In such an implementation, system 3 000 may communicate with a remote computing device (e.g., a laptop, mobile phone, tablet or more generally any computing device with sufficient processing power) via Bluetooth or WiFi. In another such implementation, processor 3030 may store various signals in memory 3080. Memory 308 0 may be removable from system 3000 (e.g., a memory card or external hard drive). In such an implementation, the removed memory 3080 may be inserted into an interface of a remote computing device configured to retrieve the stored signals for processing / analysis by its processor (remote processor). Thus, the memory for storing the actigraph data or signals used by the processor when performing the algorithms or methods described herein is for storing instructions relayed to the remote processor over a wireless or wired connection via communication interface 3070. In such an implementation, system 3 000 may communicate with a remote computing device (e.g., a laptop, mobile phone, tablet or more generally any computing device with sufficient processing power) via Bluetooth or WiFi. In another such implementation, processor 3030 may store various signals in memory 3080. Memory 308 0 may be removable from system 3000 (e.g., a memory card or external hard drive). In such an implementation, the removed memory 3080 may be inserted into an interface of a remote computing device configured to retrieve the stored signals for processing / analysis by its processor (remote processor). Thus, the memory for storing the actigraph data or signals used by the processor when performing the algorithms or methods described herein is for storing instructions relayed to the remote processor over a wireless or wired connection via communication interface 3070. In such an implementation, system 3 000 may communicate with a remote computing device (e.g., a laptop, mobile phone, tablet or more generally any computing device with sufficient processing power) via Bluetooth or WiFi. In another such implementation, processor 3030 may store various signals in memory 3080. Memory 308 0 may be removable from system 3000 (e.g., a memory card or external hard drive). In such an implementation, the removed memory 3080 may be inserted into an interface of a remote computing device configured to retrieve the stored signals for processing / analysis by its processor (remote processor). Thus, the memory for storing the actigraph data or signals used by the processor when performing the algorithms or methods described herein is for storing instructions May be different from the memory that stores the program used, or may be the same memory in some executions. It may be the same memory.

[0040] Signal processing / analysis can be shared between the local processor 3030 and the processor of the remote computing device such that some signal processing / analysis is performed by the local processor 3030. Subsequently, the local processor 3030 sends the intermediate analysis results to the remote computing device so that the remaining signal processing / analysis can be performed by the processor of the remote computing device. It can be shared between the local processor 3030 and the processor of the remote computing device so that some signal processing / analysis is performed by the local processor 3030. Then, the local processor 3030 sends the intermediate analysis results to the remote computing device so that the remaining signal processing / analysis can be performed by the processor of the remote computing device. It can be done. It can be done.

[0041] System 3000, respiratory sensor 3010, processor 3030, A / D converter 3040 , communication interface 3070 and memory 3080 are housed in the housing 3095. The housing 3095 is preferably of a handheld size or pocket size so that the patient can easily carry and use it. It is preferably of a handheld size or pocket size so that the patient can easily carry and use it. It is preferably of a handheld size or pocket size so that the patient can easily carry and use it.

[0042] 8.1.3 Signal Processing / Analysis In the following, various aspects of signal processing / analysis performed on various signals as part of the screening / diagnosis / monitoring function of the system 3000 will be described. In the following, various aspects of signal processing / analysis performed on various signals as part of the screening / diagnosis / monitoring function of the system 3000 will be described.

[0043] 8.1.3.1 Estimation of Total Sleep Time According to some aspects of the present disclosure, in the method for estimating total sleep time, an activity-based classifier capable of distinguishing between sleep and wakefulness periods when the patient is in bed during a monitoring session can be used. The method for estimating total sleep time is a supervised learning method and can "learn" parameters using a training dataset. In one execution, the total sleep It is possible to distinguish between sleep and wakefulness periods when the patient is in bed during a monitoring session. It can be used. It can be obtained and "learn" parameters using a training dataset. The method for estimating sleep time takes the three-axis acceleration signals that constitute the actigraphy signal generated from the actigraph 3060 during the monitoring session, appropriately filters them, and divides the monitoring session into epochs. For each epoch from the filtered actigraphy signal, the count of physical activity is estimated. Each epoch is classified into a binary state ("sleep" or "awake") based on the activity count. This classification can be optimized through cross-validation against "scored" training data using an activity threshold. This method takes the three-axis acceleration signals that make up the actigraphy signal generated by the actigraph 3060 during the monitoring session, filters them appropriately, and divides the monitoring session into epochs. For each epoch from the filtered actigraphy signal, the count of physical activity is estimated. Each epoch is classified into a binary state ("sleep" or "awake") based on the activity count. This classification can use an activity threshold that is optimized through cross-validation against "scored" training data.

[0044] Figure 5 includes a flowchart showing an example or a method 500 for estimating total sleep time according to one form of the present technology. Method 500 may be executed by, for example, the local processor 3030 shown in Figure 3 or by a remote processor, or alternatively, by a combination of the local processor 3030 and the remote processor as described above. Method 500 starts from step 5010. In step 5010, the actigraphy signal is preprocessed. Preprocessing the actigraphy signal may include, for example, removing any drift in the baseline of the accelerometer. In some implementations, preprocessing may include detrending the actigraphy signal. Subsequently, step 5020 filters the preprocessed actigraphy signal. Steps 5010 to 5030 are each executed independently for the three "channels" of the actigraphy signal (i.e., the acceleration values for each of the three axes (X, Y, and Z)).

[0045] Method 5000 starts at step 5010. At step 5010, the actigraphy signal is preprocessed. Preprocessing the actigraphy signal can include, for example, removing any drift in the baseline of the accelerometer. In some implementations, preprocessing can include detrending the actigraphy signal. After that, step 5020 filters the preprocessed actigraphy signal. Steps 5010 to 5030 are each executed independently for the three "channels" of the actigraphy signal (i.e., the acceleration values for each of the three axes (X, Y, and Z)). For example, it may include removing any drift in the baseline of the accelerometer. In some implementations, preprocessing may include detrending the actigraphy signal. According to some implementations, preprocessing may include detrending the actigraphy signal. Subsequently, step 5020 filters the preprocessed actigraphy signal. Steps 5010 to 5030 are each executed independently for the three "channels" of the actigraphy signal (i.e., the acceleration values for each of the three axes (X, Y, and Z)). That is, the acceleration values for each of the three axes (X, Y, and Z).

[0046] After preprocessing, the resulting preprocessed signal can be filtered as shown at 5020. Filtering can include, for example, reducing or removing components of the activity graph signal that are unrelated to overall body movement. In one implementation, step 5020 includes band-pass filtering the detrended activity graph signal within the range 0.5 Hz to 4.5 Hz corresponding to the range of normal overall body movement. Step 5020 can also include magnitude normalization by dividing the filtered activity graph signal by its 95th percentile value.

[0047] In the next step 5030, each channel is divided into epochs of a predetermined duration. In one implementation, the duration of each epoch is 30 seconds, and each epoch overlaps with the preceding consecutive epoch by 10 seconds to minimize edge cases. However, note that other epoch durations and overlap ranges may be selected.

[0048] In the next step 5040, an activity count A n is determined for each epoch n. In one implementation, step 5040 modifies (e.g., takes the absolute value) three filtered activity graph channels, sums the three modified channels to obtain a single activity graph signal, and calculates the activity count A for each epoch as the root mean square (RMS value or also root mean average) of the summed signal for the epoch. n

[0049] Next, method 5000 proceeds to step 5050. Step 5050 determines the dozing / awakening state of each epoch n based on its activity count A n and the activity count of its preceding epoch (A n-1 ). In one implementation, if the ratio of A to A n exceeds the first n-1 activity threshold T1, the sleep / awakening state of epoch n is determined to be "awake" , and otherwise it is determined to be "sleep". In such an implementation, if the activity count has not substantially increased regardless of the absolute level since the preceding epoch, the patient is determined to be dozing . In another implementation, if the activity count A is higher than a second activity threshold T n , the sleep / awakening state of epoch n is determined to be "awake", and otherwise 2 it is determined to be "sleep". In yet another implementation, if none of these criteria are met, the sleep / awakening state of epoch n is determined to be "awake", and otherwise it is determined to be "sleep". If none of these criteria are satisfied, the sleep / awakening state of epoch n is determined to be "awake", and otherwise it is determined to be "sleep".

[0050] The activity thresholds T 1 and T 2 can be determined from "scored" prior actigraphy data (i.e., the determined sleep / awakening state) by some other means (e.g., using the synchronous PSG data manually). In one implementation, the optimization of the activity thresholds can be performed by six-fold cross-validation, which maximizes the correlation coefficient between the output of method 5000 and the scored actigraphy data. In one such implementation for typical scored actigraphy data, the first activity threshold T T1 The optimal value of 1 is found to be 1.7, and the second activity threshold T 2 The optimal value of 2 is the 94th percentile of the activity count for the scored dataset. However, the value of the first activity threshold in the range [1.3, 2.0] and the second activity threshold in the range between the 65th and 98th percentiles can be used with reasonable effectiveness.

[0051] In the final step 5060, the total sleep time (TST) is estimated from the determined sleep / wake states for each epoch. Since these epochs are overlapping, step 5060 does not simply count the number of epochs determined as sleep or multiply by the duration of each epoch. That is, step 5060 counts the number of time points corresponding to actigraphy signal samples determined as part of an epoch where the sleep / wake state is determined as "sleep" and divides by the sampling frequency of the actigraph 3060 or its A / D converter (whichever supplies the actigraphy signal samples to signal processing / analysis). As a result, the TST value is obtained in seconds.

[0052] Another implementation of the total sleep time estimation method uses, in addition to the actigraphy signal from the actigraph 3060, the respiratory flow signal from the respiratory sensor 3010 or the respiratory effort signal from the respiratory effort sensor 3050.

[0053] Figure 6 includes a flowchart showing a method 6000 that can be used for the implementation of the total sleep time estimation method by another implementation. Steps 6010 - 6040 of ​It is the same as the corresponding steps 5010 to 5040 in 0.

[0054] In step 6050, similar to step 5050, the dozing / awakening state of each epoch n is determined. In step 6050, similar to step 5050, the activity count A of the epoch n and the activity count (A n-1 ) of its previous epoch are used. In contrast to step 5050, step 6050 further takes into account either the respiratory flow signal from the respiratory sensor 3010 or the respiratory effort signal from the respiratory effort sensor 3050. From this additional signal, further insights into the patient's state (especially when the patient may be awake but relatively less mobile during the epoch) can be obtained.

[0055] FIG. 7 includes a flowchart showing a method 7000 that can be used to execute the total sleep time estimation step 6050 of the method 6000 for the current epoch n. Regarding the method 7000, it will be described in terms of the aspect of the respiratory flow signal from the respiratory sensor 3010, but it should be understood that the method 7000 can also be executed with the respiratory effort signal from the respiratory effort sensor 3050 used as an alternative to the respiratory flow signal.

[0056] The method 7000 starts from step 7010. In step 7010, similar to step 5050, the ratio (A n of the activity count A of the current epoch to the activity count A n-1 of the previous epoch (A n / A n-1 ) exceeds the first activity threshold T 1 or the activity count A of the current epoch n exceeds the second activity threshold T2 Check whether it exceeds the current epoch activity count A n and the activity count A of the previous epoch n-1 and the ratio of (A n / A n-1 ) is the first activity threshold T 1 is exceeded or the activity count A of the current epoch n is the second activity threshold value T 2 is exceeded (\"Y\"), in step 7020, the sleep / wake state of the current epoch n is determined as \"awake\". The same activity thresholds T 1 and T 2 can be used in step 7010.

[0057] However, if none of these conditions are met (\"N\"), although the patient's movement is relatively small, method 7000 makes a sleep / wake state determination after further checking. Specifically, in step 7030, it is determined whether the quality of the respiratory flow signal at the current epoch is insufficient. If not (\"N\"), in step 7040 the sleep / wake state of the current epoch is determined as \"unknown\". If not ( \"Y\"), in step 7050, it is determined whether the respiratory flow signal at the current epoch is stable . To test for stability, step 7050 tests whether the variability (e.g., standard deviation) of one or more of the following respiration-flow-related variables for one or more epochs is below a threshold: : · Tidal volume; · Inspiratory time; · Respiratory rate; · Inspiratory peak flow; · Expiratory peak flow position; · Elapsed time since the last breath.

[0058] If the respiratory flow signal during the current epoch is stable ("Y"), step 70 At 60, the sleep / wake state of the current epoch is determined as "sleep". If not ("N"), then in step 7070, the respiratory flow signal is determined to be equal to or greater than SD Determine whether the SDB episode includes an indication that a sleep Refers to respiratory episodes related to respiratory disorders, including snoring, flow limitation, arousals related to respiratory effort, and obstruction. These various types of SDB episodes can include apnea, hypopnea, and obstructive apnea. If so ("Y"), then in step 7060 The sleep / wake state of the current epoch is determined as "sleep". If not, In step 7080, the sleep / wake state of the current epoch is determined as "wake."

[0059] In the final step 6060 of method 6000, the same Similarly, we estimate the total sleep time (TST) from the sleep / wake decisions for each epoch.

[0060] 8.1.3.2 Apnea / hypopnea detection The apnea / hypopnea detection algorithm uses a signal indicative of respiratory flow from the respiratory sensor 3010. It receives as input a signal and outputs a flag indicating whether an apnea or hypopnea is detected. and provide it.

[0061] In one form, apnea is defined as a period in which a function of respiratory flow exceeds a flow threshold for a given period of time. This function is used to detect peak flow, a relatively short-term average The flow rate, or the mean flow rate of the average and peak flow rate for a relatively short period of time, may be determined (e.g., RMS flow rate). The flow rate threshold value can be a measurement value of the flow rate over a relatively long period of time.

[0062] In one form, hypopnea is detected when a function of the respiratory flow rate falls below a second flow rate threshold value over a predetermined period of time. This function can determine the peak flow rate, the average flow rate over a relatively short period of time, or the flow rate intermediate value of the average and peak flow rates over a relatively short period of time (e.g., RMS flow rate). The second flow rate threshold value can be a measurement value of the flow rate over a relatively long period of time. The second flow rate threshold value is higher than the flow rate threshold value used for the detection of apnea.

[0063] 8.1.3.3 Detection of snoring In one form, the snoring detection algorithm receives the respiratory flow rate signal from the respiratory sensor 3010 as an input and provides, as an output, the measured values in the range where snoring exists.

[0064] The snoring detection algorithm can include the step of determining the intensity of the flow rate signal within the range of 30 to 300 Hz. Further, the snoring determination algorithm can include the step of filtering the respiratory flow rate signal to reduce background noise (e.g., the airflow sound in the system from the blower).

[0065] If the intensity of the filtered respiratory flow rate signal exceeds the threshold value, snoring can be considered to be present.

[0066] 8.1.3.4 Determination of airway patency Patency refers to the degree to which the airway is open or the range in which the airway is open. Airway patency refers to an opening. The quantification of airway patency can be performed together with a value (1) indicating patency and a value (0) indicating closure (obstruction). When apnea or hypopnea occurs concurrently with a patent airway, the open ​is considered to be apneic or hypopneic, and when apnea or hypopnea is accompanied by airway occlusion , it is considered to be obstructive apnea or hypopnea.

[0067] In one form, the airway patency determination algorithm receives a respiratory flow signal as an input and determines the output of the signal within a frequency range of about 0.75 Hz to about 3 Hz. The presence of a peak within this frequency range is considered to indicate airway opening. The absence of a peak is considered to be an indication of airway occlusion.

[0068] In one form, the airway patency determination algorithm receives a respiratory flow signal as an input and determines the presence or absence of a cardiac generated signal. The absence of a cardiac generated signal is an indication of airway occlusion and is so considered.

[0069] 8.1.3.5 Detection of Flow Limitation Flow limitation can be detected from the respiratory flow signal as described in U.S. Provisional Patent Application No. 62 / 043,079 (filed August 28, 2014 , ResMed Limited, title: "Diagnosis and trea tment of Respiratory Disorders"). It can be detected from the respiratory flow signal.

[0070] 8.1.3.6 Detection of RERA RERA can be detected from the respiratory flow signal as described in PCT Patent Application No. PCT / AU2015 / 050056 (filed February 13, 20 15, ResMed Limited, title: "Diagnosis and treatment of Respiratory Disorders"). It can be detected from the respiratory flow signal.

[0071] 8.1.3.7 Calculation of AHI The apnea / hypopnea index (AHI) can be calculated as follows.

Number

[0072] Therefore, the AHI indicates the number of apnea / hypopnea episodes that occur (or are detected) per hour of sleep. Conventionally, the AHI has been regarded as an indicator of the severity of human sleep disorder. As a result, treatment decisions can be based on the AHI value calculated by the system 3000.

[0073] 8.1.3.8 Screening / Diagnosis / Monitoring The calculated AHI can be used as a screening tool by signaling out patients whose AHI during the screening session exceeds a specific threshold, thereby making them more noticeable. It can be used.

[0074] The AHI can also be used to diagnose a patient (i.e., categorize the patient according to the severity of their SDB by placing the patient into a category according to the AHI value calculated during the diagnostic session). AHI value at that time, categorizing the patient according to the severity of their SDB). It can also be used for this purpose.

[0075] To monitor patients receiving SDB treatment using the AHI, it may be necessary to calculate the AHI at each treatment session and report any worsening of the SDB (i.e., an increase in the AHI). Treatment parameters can also be changed according to the AHI. This may be necessary.

[0076] 8.1.4 Exemplary Results In a sleep study, an Actiwatch attached to the wrist (Actiwatch (登録 商標), "Scored" actigraphy data from (available from Philips Respironics), was recorded in parallel with actigraphy data from actigraph 3060 placed on the torso of each patient from system 3000. The scored data consisted of 36 monitoring sessions from 29 different patients, containing over 9 million epochs in total. Table 1 below contains the confusion matrix between the sleep / wake states (i.e., without respiratory flow or effort data) determined by the above-described algorithm 5000 applied to the actigraphy data recorded by system 3000, and the scored sleep / wake states of the concurrently recorded actigraphy data. The "scored" actigraphy data from (available from Philips Respironics) was recorded in parallel with actigraphy data from actigraph 3060 placed on the torso of each patient from system 3000. The scored data consisted of 36 monitoring sessions from 29 different patients, containing over 9 million epochs in total. Table 1 below contains the confusion matrix between the sleep / wake states (i.e., without respiratory flow or effort data) determined by the above-described algorithm 5000 applied to the actigraphy data recorded by system 3000, and the scored sleep / wake states of the concurrently recorded actigraphy data. The scored data consisted of 36 monitoring sessions from 29 different patients, containing over 9 million epochs in total. Table 1 below contains the confusion matrix between the sleep / wake states (i.e., without respiratory flow or effort data) determined by the above-described algorithm 5000 applied to the actigraphy data recorded by system 3000, and the scored sleep / wake states of the concurrently recorded actigraphy data. Table 1 below contains the confusion matrix between the sleep / wake states (i.e., without respiratory flow or effort data) determined by the above-described algorithm 5000 applied to the actigraphy data recorded by system 3000, and the scored sleep / wake states of the concurrently recorded actigraphy data. Table 1 below contains the confusion matrix between the sleep / wake states (i.e., without respiratory flow or effort data) determined by the above-described algorithm 5000 applied to the actigraphy data recorded by system 3000, and the scored sleep / wake states of the concurrently recorded actigraphy data. Table 1 below contains the confusion matrix between the sleep / wake states (i.e., without respiratory flow or effort data) determined by the above-described algorithm 5000 applied to the actigraphy data recorded by system 3000, and the scored sleep / wake states of the concurrently recorded actigraphy data. Table 1 below contains the confusion matrix between the sleep / wake states (i.e., without respiratory flow or effort data) determined by the above-described algorithm 5000 applied to the actigraphy data recorded by system 3000, and the scored sleep / wake states of the concurrently recorded actigraphy data.

Table 1

[0077] The resulting sensitivity and specificity are shown in Table 2.

Table 2

[0078] Figure 8 contains graph 8000 of the TST estimated using algorithm 5000 against the actigraphy data plotted against the scored TST values in 36 monitoring sessions. Graph 8000 shows an almost linear correlation between the estimated TST and the scored TST. The overall correlation coefficient was 0.9914. Table 3 shows the statistical comparison data between the estimated and scored TST values over 36 sessions. Figure 8 contains graph 8000 of the TST estimated using algorithm 5000 against the actigraphy data plotted against the scored TST values in 36 monitoring sessions. Graph 8000 shows an almost linear correlation between the estimated TST and the scored TST. The overall correlation coefficient was 0.9914. Table 3 shows the statistical comparison data between the estimated and scored TST values over 36 sessions. Graph 8000 shows an almost linear correlation between the estimated TST and the scored TST. The overall correlation coefficient was 0.9914. Table 3 shows the statistical comparison data between the estimated and scored TST values over 36 sessions. Table 3 shows the statistical comparison data between the estimated and scored TST values over 36 sessions. Table 3 shows the statistical comparison data between the estimated and scored TST values over 36 sessions.

Table 3

[0079] According to Table 3, in the case of TST, compared with the scored data, algorithm 5 The reason for this is that the two actigraphs were worn This may be due to placement on different parts of the body (wrist and torso). For example, when a patient is reading, the patient's torso is almost motionless, while the patient's The user's wrist may have been moved to turn a page, etc.

[0080] 8.2 Respiratory waveform FIG. 9A shows a polysomnogram of a patient during non-REM sleep. During a period of 0 seconds, approximately 34 breaths are taken. The upper channel is for measuring oxygen saturation ( SpO 2 ) with the scale having a saturation range of 90-99% in the vertical direction. Throughout the period shown, the patient maintained approximately 95% saturation. The quantitative respiratory airflow is shown on a vertical scale ranging from -1 to +1 LPS. Qi is positive. Chest and abdominal movements are shown in the 3rd and 4th channels.

[0081] FIG. 9B shows a polysomnogram of an SDB patient over a period of approximately 6 minutes. There are 11 signal channels spaced over a horizontal span of 6 minutes. The two channels are EEG (electroencephalogram) from different scalp locations. Periodic spikes in the EEG indicate cortical arousal and related activity. The third channel in the lower part , submental EMG (electromyogram). Increased activity around the time of wakefulness indicates recruitment of the genioglossus nerve. The fourth and fifth channels are EOG (electrogenic glossus). The sixth channel is Channel 7 is an electrocardiogram. The seventh channel shows the pulse oxygen saturation measurement (SpO ) when the unsaturation is cycled from about 90% to less than 70%. 2 ) when the unsaturation is cycled from about 90% to less than 70%. The eighth channel is the respiratory airflow using a nasal cannula connected to a differential pressure transducer. Repeated apnea for 25 - 35 seconds, along with a 10 - 15 second burst of recovery breathing, results in EEG arousal and increased EMG activity. Channel 8 is the respiratory airflow using a nasal cannula connected to a differential pressure transducer. Repeated apnea for 25 - 35 seconds, along with a 10 - 15 second burst of recovery breathing, results in EEG arousal and increased EMG activity. Channel 9 shows chest movement and channel 10 shows abdominal movement. The abdomen shows increasing movement over the length of the apnea, leading to arousal. Channel 9 shows chest movement and channel 10 shows abdominal movement. The abdomen shows increasing movement over the length of the apnea, leading to arousal. Both are uneven due to overall body movement during recovery hyperventilation during arousal. Therefore, the apnea becomes obstructive and the condition is serious. The bottom - most channel is the posture, which shows no change in this example. Channel 9 shows chest movement and channel 10 shows abdominal movement. The abdomen shows increasing movement over the length of the apnea, leading to arousal. Both are uneven due to overall body movement during recovery hyperventilation during arousal. Therefore, the apnea becomes obstructive and the condition is serious. The bottom - most channel is the posture, which shows no change in this example. Channel 9 shows chest movement and channel 10 shows abdominal movement. The abdomen shows increasing movement over the length of the apnea, leading to arousal. Both are uneven due to overall body movement during recovery hyperventilation during arousal. Therefore, the apnea becomes obstructive and the condition is serious. The bottom - most channel is the posture, which shows no change in this example. Channel 9 shows chest movement and channel 10 shows abdominal movement. The abdomen shows increasing movement over the length of the apnea, leading to arousal. Both are uneven due to overall body movement during recovery hyperventilation during arousal. Therefore, the apnea becomes obstructive and the condition is serious. The bottom - most channel is the posture, which shows no change in this example. Channel 9 shows chest movement and channel 10 shows abdominal movement. The abdomen shows increasing movement over the length of the apnea, leading to arousal. Both are uneven due to overall body movement during recovery hyperventilation during arousal. Therefore, the apnea becomes obstructive and the condition is serious. The bottom - most channel is the posture, which shows no change in this example.

[0082] 8.3 Terms For the purposes of the disclosure of this technology, in certain forms of this technology, one or more of the following definitions may apply. In other forms of this technology, other definitions may apply. For the purposes of the disclosure of this technology, in certain forms of this technology, one or more of the following definitions may apply. In other forms of this technology, other definitions may apply.

[0083] 8.3.1 General Air: In certain forms of this technology, air may mean the atmosphere. In other forms of this technology, air may mean a combination of other breathable gases (e.g., an oxygen - rich atmosphere). Air: In certain forms of this technology, air may mean the atmosphere. In other forms of this technology, air may mean a combination of other breathable gases (e.g., an oxygen - rich atmosphere). Air: In certain forms of this technology, air may mean the atmosphere. In other forms of this technology, air may mean a combination of other breathable gases (e.g., an oxygen - rich atmosphere).

[0084] Atmosphere: In certain forms of this technology, the term "atmosphere" should be taken to mean (i) outside the treatment system or the patient and (ii) the immediate surroundings of the treatment system or the patient. Atmosphere: In certain forms of this technology, the term "atmosphere" should be taken to mean (i) outside the treatment system or the patient and (ii) the immediate surroundings of the treatment system or the patient. Atmosphere: In certain forms of this technology, the term "atmosphere" should be taken to mean (i) outside the treatment system or the patient and (ii) the immediate surroundings of the treatment system or the patient.

[0085] Respiratory Pressure Therapy (RPT): The application of air supply to the airway at a treatment pressure that is typically positive relative to the atmosphere. The application of air supply to the inlet.

[0086] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the treatment pressure is substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different respiratory cycles of the patient (e.g., increased in response to detection of an indication of partial upper airway obstruction and decreased in the absence of an indication of partial upper airway obstruction).

[0087] Patient: A person with or without a respiratory disease.

[0088] Auto Positive Airway Pressure (APAP) Therapy: A CPAP therapy that can automatically adjust the treatment pressure between a minimum limit and a maximum limit, for example, during respiration, according to the presence or absence of an indication of the onset of SDB.

[0089] 8.3.2 Modes of the Respiratory Cycle Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a duration, for example, of 10 seconds. Obstructive apnea is said to occur when, despite the patient's efforts, the flow of air is not permitted due to some airway obstruction. Central apnea refers to a state in which apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to a state in which a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0090] Respiratory Rate: The patient's spontaneous respiratory rate, usually measured as the number of breaths per minute.​​​​​​

[0091] Duty cycle: The ratio of the total inhalation time Ti to the total respiratory time Ttot.

[0092] Effort (breathing): Breathing effort is the movement that is said to be performed by the spontaneous breathing of a person attempting to breathe. is referred to as.

[0093] Exhalation portion of the respiratory cycle: The period from the start of the exhalation flow to the start of the inhalation flow.

[0094] Flow limitation: Flow limitation is a situation in a patient's breathing where an increase in the patient's effort does not cause a corresponding increase in the flow. When a flow limitation occurs in the inhalation portion of the respiratory cycle, the flow limitation can be referred to as an inhalation flow limitation. When a flow limitation occurs in the exhalation portion of the respiratory cycle, the flow limitation can be referred to as an exhalation flow limitation. is interpreted as. In the case where a flow limitation occurs in the inhalation portion of the respiratory cycle, the flow limitation can be referred to as an inhalation flow limitation. In the case where a flow limitation occurs in the exhalation portion of the respiratory cycle, the flow limitation can be referred to as an exhalation flow limitation. occurs, the flow limitation can be referred to as an inhalation flow limitation. In the case where a flow limitation occurs in the exhalation portion of the respiratory cycle, the flow limitation can be referred to as an exhalation flow limitation. can be called. can be called.

[0095] Flow: The instantaneous amount (or mass) of air delivered per unit time. Flow and ventilation volume have the same scale of amount or mass per unit time, but flow is measured over a fairly short time. In some cases, when referring to flow, it refers to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to flow, it refers to a vector quantity (i.e., a quantity having both magnitude and direction). When referred to as a signed quantity, flow can be nominally positive for the inhalation portion of the patient's respiratory cycle and negative for the exhalation portion of the patient's respiratory cycle. The total flow Qt is the flow of air delivered from the RT device. The flow is given the symbol Q. Flow may be abbreviated as "flow" in some cases. The total flow Qt is the flow of air exiting the RPT device. have the same scale of amount or mass per unit time, but flow is measured over a fairly short time. In some cases, when referring to flow, it refers to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to flow, it refers to a vector quantity (i.e., a quantity having both magnitude and direction). When referred to as a signed quantity, flow can be nominally positive for the inhalation portion of the patient's respiratory cycle and negative for the exhalation portion of the patient's respiratory cycle. The total flow Qt is the flow of air delivered from the RT device. The flow is given the symbol Q. Flow may be abbreviated as "flow" in some cases. The total flow Qt is the flow of air exiting the RPT device. measured. In some cases, when referring to flow, it refers to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to flow, it refers to a vector quantity (i.e., a quantity having both magnitude and direction). When referred to as a signed quantity, flow can be nominally positive for the inhalation portion of the patient's respiratory cycle and negative for the exhalation portion of the patient's respiratory cycle. The total flow Qt is the flow of air delivered from the RT device. The flow is given the symbol Q. Flow may be abbreviated as "flow" in some cases. The total flow Qt is the flow of air exiting the RPT device. quantity (i.e., a quantity having only magnitude). In other cases, when referring to flow, it refers to a vector quantity (i.e., a quantity having both magnitude and direction). When referred to as a signed quantity, flow can be nominally positive for the inhalation portion of the patient's respiratory cycle and negative for the exhalation portion of the patient's respiratory cycle. The total flow Qt is the flow of air delivered from the RT device. The flow is given the symbol Q. Flow may be abbreviated as "flow" in some cases. The total flow Qt is the flow of air exiting the RPT device. quantity (i.e., a quantity having both magnitude and direction). When referred to as a signed quantity, flow can be nominally positive for the inhalation portion of the patient's respiratory cycle and negative for the exhalation portion of the patient's respiratory cycle. The total flow Qt is the flow of air delivered from the RT device. The flow is given the symbol Q. Flow may be abbreviated as "flow" in some cases. The total flow Qt is the flow of air exiting the RPT device. When referred to as a signed quantity, flow can be nominally positive for the inhalation portion of the patient's respiratory cycle and negative for the exhalation portion of the patient's respiratory cycle. The total flow Qt is the flow of air delivered from the RT device. The flow is given the symbol Q. Flow may be abbreviated as "flow" in some cases. The total flow Qt is the flow of air exiting the RPT device. patient's respiratory cycle and negative for the exhalation portion of the patient's respiratory cycle. The total flow Qt is the flow of air delivered from the RT device. The flow is given the symbol Q. Flow may be abbreviated as "flow" in some cases. The total flow Qt is the flow of air exiting the RPT device. device. The flow is given the symbol Q. Flow may be abbreviated as "flow" in some cases. The total flow Qt is the flow of air exiting the RPT device. device. The vent flow rate Qv is the flow rate of air exiting through the vents to allow the outflow of the expelled gas. The leak flow rate Ql is the flow rate of leakage from the patient interface system. The respiratory flow rate Qr is the flow rate of air received in the patient's respiratory system.

[0096] Hypopnea: Preferably, hypopnea means a decrease in flow rather than an interruption of flow. In one condition, hypopnea is said to have occurred when a decrease in flow below a threshold velocity persisted over a period of time. When hypopnea is detected due to a decrease in respiratory effort, it is said that central hypopnea has occurred. In one form in adults, any of the following may be considered hypopnea: (i) A 30% decrease in patient respiration for at least 10 seconds + associated 4% desaturation, or (ii) A decrease (less than 50%) in patient respiration that persists for at least 10 seconds and is associated with desaturation of at least 3% or arousal occurs.

[0097] Hyperventilation: An increase in flow to a level higher than the normal flow rate.

[0098] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the inspiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0099] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. An open airway is open. Airway patency can be quantified by one of the following values: (1) a value of zero (0) when open, when closed (when obstructed).

[0100] Positive end-expiratory pressure (PEEP): A pressure above atmospheric pressure in the lungs

[0101] Peak flow (Qpeak): The maximum flow value in the inspiratory portion of the respiratory flow waveform.

[0102] Respiratory flow, air flow, patient air flow, respiratory air flow (Qr): These synonymous terms can be understood to refer to the estimation of the respiratory air flow of the RPT device and are contrasted with the "true respiratory flow" or "true respiratory airflow", which is the actual respiratory flow of the patient, usually expressed in liters per minute. and is used in contrast to the "true respiratory flow" or "true respiratory airflow", which is the actual respiratory flow of the patient, usually expressed in liters per minute. and is used in contrast to

[0103] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort. and is exhaled.

[0104] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0105] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0106] (Total) time (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the next respiratory flow waveform. and the start of the inspiratory portion of the next respiratory flow waveform.

[0107] Typical recent ventilation: The ventilation value tends to be concentrated in the recent values over a given time scale ( that is, the degree of the tendency of the center of the recent ventilation values).

[0108] Upper airway obstruction (UAO): Includes both partial upper airway obstruction and total upper airway obstruction. It may be associated with a state of flow limitation where the flow level may increase slightly or decrease with an increase in the pressure difference across the upper airway (Starling resistor behavior). and the flow level may increase slightly or decrease with an increase in the pressure difference across the upper airway (Starling resistor behavior). or decrease, and may be associated with a state of flow limitation.

[0109] 8.4 Other considerations Part of the disclosure of this patent document includes content that is protected by copyright. The copyright owner reserves the right to do whatever Even if a person reproduces this patent document or this patent disclosure by fax, there is no objection as long as it is as described in the patent file or the record of the Patent Office, but all copyrights are retained for other purposes. There is no objection as long as it is for the intended purpose as long as it is as described in the patent file or the record, but all copyrights are retained for other purposes. are retained for all other purposes.

[0110] Unless otherwise clear from the context and unless a range of values is provided, one-tenth of the unit of the lower limit, between the upper and lower limits of the range, and any other stated value or intervening value within the stated range is understood to be encompassed by this technology. Even if the upper and lower limits of these intervening ranges that may be independently included within the intervening range particularly exceed the limitations in the stated range they are encompassed by this technology. If the stated range includes one or both of these limitations, ranges that exceed either or both of these stated limitations are also encompassed by this technology. are also encompassed by this technology. Even if the upper and lower limits of these intervening ranges that may be independently included within the intervening range particularly exceed the limitations in the stated range they are encompassed by this technology. If the stated range includes one or both of these limitations, ranges that exceed either or both of these stated limitations are also encompassed by this technology. are also encompassed by this technology.

[0111] Furthermore, when values (singular or plural) are implemented as part of this technology in this specification, unless otherwise specified, such values may be approximated and it is understood that such values can be used to any appropriate significant digits up to the range permitted or required by the actual technical implementation. Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as generally understood by those skilled in the art to which this technology belongs. Any methods and materials similar or equivalent to the methods and materials described in this specification can be used in the practice or testing of this technology, but only a limited number of exemplary methods and materials are described in this specification. are described.

[0112] Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as generally understood by those skilled in the art to which this technology belongs. Any methods and materials similar or equivalent to the methods and materials described in this specification can be used in the practice or testing of this technology, but only a limited number of exemplary methods and materials are described in this specification. but only a limited number of exemplary methods and materials are described in this specification. but only a limited number of exemplary methods and materials are described in this specification. are described.

[0113] Although a specific material is described as being used for the construction of a component, components with similar properties An obvious alternative material can be used as a substitute. Further, unless stated to the contrary and all components described herein are understood to be manufacturable and thus can be manufactured either collectively or separately.

[0114] As used herein, in the appended claims, the singular forms "a", "an" and "the" include their plural equivalents unless the context clearly dictates otherwise. It should be noted.

[0115] All publications mentioned herein are incorporated by reference for the purpose of disclosing and describing the methods and / or materials for which they are the subject. The publications mentioned herein are provided solely for their disclosure prior to the filing date of the present application. Nothing in this specification should be construed as an admission that the present technology does not antedate such publications by virtue of prior invention. Further, the dates of the publications may be different from the actual dates of the publications and individual verification may be required. dates of the publications and individual verification may be required. dates of the publications and individual verification may be required.

[0116] The terms "comprises" and "comprising" should be construed as referring to elements, components or steps in a non-exclusive sense, indicating that other elements, components or steps not specified may be present, used or combined with the specified elements, components or steps. or steps in a non-exclusive sense, indicating that other elements, components or steps not specified may be present, used or combined with the specified elements, components or steps. or steps in a non-exclusive sense, indicating that other elements, components or steps not specified may be present, used or combined with the specified elements, components or steps.

[0117] The headings used in the detailed description are solely for the convenience of the reader and should not be used to limit the content found throughout the disclosure or the claims. or throughout the disclosure or the claims. They are not. These headings should not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0118] Although the technology in this specification has been described with reference to specific embodiments, it should be understood that these embodiments merely illustrate the principles and applications of this technology. In some cases, terms and symbols may indicate specific details that are unnecessary for the implementation of this technology. For example, the terms "first" and "second" may be used, but unless otherwise specified, these terms are not intended to indicate any order and may be used to distinguish separate elements. Furthermore, when describing or exemplifying the process steps in this method, they may be presented in sequence, but such sequence is not necessary. A person skilled in the art will recognize that such sequence can be changed and / or these aspects can be performed simultaneously or even synchronously. Therefore, it should be understood that numerous variations are possible in the exemplary embodiments without departing from the spirit and scope of this technology, and other arrangements can be devised.

[0119] Thus, it should be understood that without departing from the spirit and scope of this technology, numerous variations are possible in the exemplary embodiments, and other arrangements can be devised.

Description of Reference Signs

[0120] 8.5 List of Reference Signs Patient 1000 Headbox 2000 Ground Electrode 2010 EOG Electrode 2015 EEG Electrode 2020 ECG Electrode 2025 Submental EMG Electrode 2030 Snore Sensor 2035 Respiratory Inductive Plethysmogram 2040 ​Respiratory Inductance Plethysmogram 2045 Oral / Nasal Cannula 2050 Photoplethysmograph 2055 Body Position Sensor 2060 Screening / Diagnosis / Monitoring System 3000 Respiratory Sensor 3010 Nasal Cannula 3020 Probe 3025 Flexible Catheter 3028 Processor 3030 A / D Converter 3040 Respiratory Effort Sensor 3050 Abdominal Belt 3055 Actigraph 3060 Communication Interface 3070 Memory 3080 Energy Source 3090 Housing 3095 Method 5000 Step 5010 Step 5020 Step 5030 Step 5040 Step 5050 Step 5060 Method 6000 Step 6010 Step 6050 Step 6050 Step 6060 Method 7000 Step 7010 Step 7020 Step 7030 Step 7040 Step 7050 Step 7060 Step 7070 Step 7080 Graph 8000

Claims

**Claim 1** A method in a medical screening device for estimating a patient's total sleep time in a monitoring session, comprising: receiving an actigraphy signal from an actigraphy sensor during the monitoring session; receiving a respiratory effort signal during the monitoring session; dividing the actigraphy signal into a plurality of epochs; determining an activity count for each epoch from the actigraphy signal; determining the sleep / wake state of the patient for each of the plurality of epochs based on (a) the activity count and (b) the respiratory effort signal; and estimating the total sleep time from the sleep / wake states of the plurality of epochs. A method comprising the above steps. **Claim 2** Determining the sleep / wake state of the patient for each of the plurality of epochs includes determining that the sleep / wake state of the patient in the epoch is "awake" based on whether a ratio of the activity count of the epoch to the activity count of a preceding epoch is higher than a first activity threshold, according to the method of Claim 1. **Claim 3** Determining the sleep / wake state further includes determining that the sleep / wake state is "awake" if the activity count of the epoch is higher than a second activity threshold, according to the method of Claim 2. **Claim 4** Determining the sleep / wake state is further based on the patient's respiratory flow signal, according to the method of Claim 1. **Claim 5** Determining the sleep / wake state further includes determining that the sleep / wake state is "sleep" if the respiratory flow signal is stable in the epoch, according to the method of Claim 4. **Claim 6** Determining the sleep / wake state further includes determining that the sleep / wake state is "sleep" if the respiratory flow signal includes an indication of the occurrence of SDB in the epoch, according to the method of Claim 4. **Claim 7** Determining the sleep / wake state further includes determining that the sleep / wake state is "sleep" if the respiratory effort signal is stable in the epoch, according to the method of Claim 1. **Claim 8** The method according to claim 1, wherein determining the sleep / wake state further includes determining the sleep / wake state as "sleep" when the respiratory effort signal includes an indication that SDB onset has occurred in the epoch.

9. The method according to claim 6 or 8, wherein the SDB onset includes one of snoring, flow limitation, arousal related to respiratory effort, obstructive hypopnea, and obstructive apnea.

10. The method according to any one of claims 1 to 9, further including calculating an index of the severity of the patient's sleep disordered breathing from the estimated total sleep time.

11. The calculated index is detecting apnea and hypopnea in the monitoring session, and dividing the number of apnea and hypopnea detected in the monitoring session by the estimated total sleep time The method according to claim 10, including.

12. Obtaining an activity count for the epoch includes modifying each channel of the actigraphy signal, summing the modified channels to obtain a single actigraphy signal, and calculating the root mean square value of the single actigraphy signal for the epoch The method according to any one of claims 1 to 11, including.

13. A system using a medical screening device for estimating a patient's total sleep time in a monitoring session including a plurality of epochs, An actigraph that generates an actigraphy signal indicating the acceleration of the actigraph, A respiratory effort sensor that generates a respiratory effort signal related to the patient's respiration, A processor, Obtaining an activity count for each epoch from the actigraphy signal, Determining the sleep / wake state of the patient in each of the plurality of epochs based on (a) the activity count and (b) the respiratory effort signal, and A processor programmed to estimate the total sleep time from the sleep / wake state of the patient in each of the plurality of epochs A system comprising.

14. The system according to claim 13, further including a respiratory sensor that generates a respiratory flow signal related to the patient's respiration, and the determination of the sleep / wake state is further based on the respiratory flow signal generated from the respiratory sensor.

15. The processor forms part of a remote computing device, and the system a communication interface, and a local processor that relays the actigraphy signal and the respiratory effort signal to the processor of the remote computing device via the communication interface The system according to claim 13, further comprising. **Claim 16** The system according to claim 13, further comprising a removable memory for storing the actigraphy signal. **Claim 17** A medical screening device for estimating a patient's total sleep time in a monitoring session including a plurality of epochs, an actigraph that generates an actigraphy signal indicative of the acceleration of the actigraph, a respiratory effort sensor that generates a respiratory effort signal related to the respiration of the patient, a processor connected to the actigraph and the sensor comprising: The processor receives the actigraphy signal in a monitoring session, divides the actigraphy signal into a plurality of epochs, each epoch including a plurality of channels, determines an activity count for each epoch from the actigraphy signal, determines the sleep / wake state of the patient for each epoch of the plurality of epochs based on (a) the activity count and (b) the respiratory effort signal, and estimates the total sleep time from the sleep / wake state of each of the plurality of epochs. A medical screening device that performs the above. **Claim 18** The medical screening device according to claim 17, which is attached to the body of a sleeping patient when in use.

Images