Systems and methods for screening, diagnosis, and monitoring of sleep-disordered breathing

Abstract

To provide a method that affects the accuracy of AHI calculation and AHI-based screening, diagnosis and monitoring.SOLUTION: The method primarily involves monitoring patient activity during one or more sleep sessions that include a plurality of intervals known as epochs. The sleep / wake state of the subject is determined at each epoch of the session using the actigraphy data obtained during the monitoring session. The actigraphy data provides information about the patient's activity during the epoch. The sleep or wake state is determined based on a ratio of the activity count during the epoch to the activity count during a previous epoch. If the ratio is higher than the first activity threshold, an "awake" indication may be provided from the system, for example. Alternatively or additionally, if the activity count during the epoch is higher than a threshold, an "awake" indication may be determined.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] 1 Cross-reference to related applications This application is a joint venture of U.S. Provisional Patent Application No. 62 / 160,937, entitled "Systems and Methods for Screening, Diagnosis, an d Monitoring of Sleep-Disordered Breathi ng," filed May 13, 2015. The entire disclosure of which is incorporated by reference.

[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. Technology Background 5.1 Technology Area The present technology relates to one or more of screening, diagnosing and monitoring respiratory-related disorders. The present technology also relates to medical devices or systems and uses thereof. [Background technology]

[0006] 5.2 Description of Related Art 5.2.1 Human respiratory system and its disorders The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways. do.

[0007] These airways contain a series of branching tubes that narrow as they go deeper into the lungs. The lungs' main function is gas exchange, taking oxygen from the air into the venous blood. The trachea divides into a right and left trachea, These tracheae further divide and eventually divide into terminal bronchioles. The respiratory tract is divided into four subdivisions: the respiratory bronchiole, which are the ducts that make up the respiratory tract and do not participate in gas exchange. The alveolar region of the lung is where gas exchange takes place and where breathing takes place. See: Respiratory Physiolog by John B. West, Lippincott Williams & Wilkins, 9th edition published 2011.

[0008] A wide range of respiratory disorders exists. Specific disorders have specific manifestations (e.g., apnea, respiratory failure). may be characterized by shortness of breath (hyperventilation and hyperventilation).

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) that causes breathing problems during sleep. An abnormally small upper airway characterized by episodes of upper airway closure or obstruction during sleep and due to a combination of normal deficits in muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall. This symptom typically causes affected individuals to experience periods of nausea and vomiting lasting between 30 and 120 seconds, sometimes People stop breathing 200 to 300 times a night, resulting in excessive daytime sleepiness and cardiovascular problems. This condition is common, especially among middle-aged adults, and can lead to vascular disease and brain damage. It is common in men with severe glaucoma, but patients do not experience any symptoms. See Ivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. It is a disorder of the respiratory regulator in people with respiratory failure, characterized by alternating waxing and waning of ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. Some people experience frequent awakenings from sleep related to CSR, which can worsen insomnia and lead to decreased sympathetic nervous activity. increases, and afterload increases. nes).

[0011] 5.2.2 Diagnostic and Monitoring Systems Clinical professionals should appropriately screen, diagnose, or monitor patients based on personal observation. However, there may be circumstances where clinical experts are not available or cannot be paid for. In some situations, clinical experts may have different opinions about a patient's condition. Some clinical professionals may apply different standards at different times. Clinicians may find it difficult to keep up with evolving patient management guidelines. There is a match.

[0012] Polysomnography (PSG) is the conventional system for the diagnosis and prognosis of cardiopulmonary diseases. PSG involves a variety of methods, typically applied and interpreted by expert clinical staff. Body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electro-oculography (EO) Typically, 15-20 touch sensors are used to record electromyography (EMG). However, these sensors are not suitable for routine use in clinical settings. While this may be suitable for some applications, such systems can be complex and expensive. and / or is uncomfortable or impractical for patients trying to sleep at home There are cases where this happens.

[0013] A simpler screening / diagnostic / monitoring system for home use is the use of nasal cannulae, pressure sensors, The nasal cannula comprises a hollow, open-ended The device includes protrusions that are designed to minimize interference with the patient's breathing. These hollow protrusions are configured to be inserted into the patient's nostrils in a substantially non-invasive manner. The pressure transducer is in fluid communication with the patient via a Y-shaped tube. The nasal pressure signal is similar in shape to the nasal flow signal. Because of this similarity, nasal pressure is a good proxy for nasal flow.

[0014] The processing device processes the nasal pressure signal from the pressure transducer in real time to monitor the patient's breathing. In contrast, diagnostics do not need to be performed in real time. Therefore, the recording means can record the nasal pressure signal from the pressure transducer offline for later diagnostic purposes. It is configured to record data for use in analysis.

[0015] Analysis of nasal pressure signals may reveal apnea and nasal obstruction during screening / diagnostic / monitoring sessions. The total number of apneas and hypopneas may be calculated over the length of the monitoring session. Dividing by the length of the stool gives an index of SDB severity (Apnea-Hypopnea Index (AHI) The AHI is a widely used screen for sleep-disordered breathing. However, such analysis is not a long-term analysis of the session. Because the patient may not be asleep throughout the entire period, the AHI tends to be underestimated. As a result, if patients are screened based on the AHI returned from such an analysis, ,Sleep during the monitoring session may be interrupted, as is often the case with insomnia. There is a tendency to miss patients who are out of the loop.

[0016] For a more accurate method to estimate the AHI, the number of apneas and hypopneas should be counted in a set time. To calculate the AHI, the patient must first be asleep at the time of the AHI calculation. It is necessary to detect when the patient falls asleep by analysis. It is difficult to detect this purely from the signal indicating nasal flow (or from the signal indicating nasal flow, of which nasal pressure is actually a proxy). This has proven to be a challenging task, and as a result, the AHI calculation and therefore the This will affect the accuracy of screening, diagnosis and surveillance.

[0017] This allows for improved SDB screening, which more accurately estimates a patient's total sleep time. A monitoring / diagnostic system is needed. Summary of the Invention

[0018] 6. Brief description of this technology The technology offers one of the following benefits: improved comfort, cost, effectiveness, ease of use, and manufacturability. The present invention is directed to providing a medical device for use in monitoring or diagnosing respiratory disorders having can be.

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

[0020] Another aspect of the technology is for use in screening, diagnosing, or monitoring respiratory disorders. Related to method.

[0021] In one form, the technology collects the amount of time the patient falls asleep during a monitoring session. and system configured to estimate using collected actigraphy data - Patent application This estimate includes an index of the severity of sleep-disordered breathing for that session (e.g., Optionally, this estimate may be used to calculate the respiratory hypopnea index (AHI). Respiratory flow or effort data collected during the session may be taken into account.

[0022] According to one aspect of the present invention, a patient's total sleep time over a monitoring session is calculated based on the total sleep time over a plurality of epochs. A method for estimating sleep time is disclosed, the method comprising: estimating a patient's sleep time during each epoch of a session; The concentration / wakefulness state was determined using the patient's actigraphy signals obtained during the monitoring session. and estimating the total sleep time from the patient's sleep / wake state at each epoch. The determination of the patient's sleep / wake state at the epoch is based on each of the data from the actigraphy signal. Determining activity counts for an epoch and calculating activity counts for the epoch. If the ratio of the activity count for the preceding epoch is higher than a first activity threshold, the epoch is considered complete. and determining the patient's sleep / wake state as "awake" during the check.

[0023] According to another aspect of the present invention, the total sleep of the patient during a monitoring session comprising multiple epochs is A system for estimating time is disclosed. The system estimates time in each of three orthogonal axes. an actigraphy device configured to generate an actigraphy signal indicative of an acceleration of the actigraphy device; The actigraphy signal includes a graph and a processor for generating each epoch from the actigraphy signal. determining the activity count for the epoch and comparing the activity count with the preceding If the ratio of the activity count for the epoch is higher than a first activity threshold, each epoch is counted. The patient's sleep / wake state at each epoch is determined as "wake" and the patient's sleep / wake state at each epoch is determined as "wake." and estimating the total sleep time from the sleep / wake state of the person. .

[0024] Of course, some of the aspects may form sub-aspects of the present technology. Various combinations of various aspects may be used to form further aspects or sub-aspects of the present technology. It may be done.

[0025] Other features of the present technology are described in the following detailed description, drawings, and claims. It becomes clear when you consider the following.

[0026] 7 Brief description of the drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference characters refer to: It contains the following similar elements: [Brief explanation of the drawings]

[0027] [Figure 1] FIG. 1 shows a patient undergoing polysomnography (PSG). [Figure 2] Figure 2 shows an overview of the human respiratory system, including the nose and oral cavity, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 3] FIG. 3 is a block diagram of a screening / diagnostic / monitoring system in accordance with one form of the present technology. [Figure 4] FIG. 4 shows a nasal cannula that can be used to implement the nasal cannula of the system of FIG. [Figure 5]FIG. 5 includes a flowchart illustrating a method that may be used in implementing the total sleep time estimation algorithm executed in the system of FIG. 3 in one form of the present technology. [Figure 6] FIG. 6 includes a flowchart illustrating a method that may be used in implementing the total sleep time estimation algorithm executed in the system of FIG. 3 in another form of the present technology. [Figure 7] FIG. 7 includes a flowchart illustrating a method that may be used in performing the sleep / wake determination step of the method of FIG. [Figure 8] FIG. 8 contains a graph of the total sleep time (TST) estimated using the algorithm of FIG. 5 plotted against the TST values ​​scored over approximately 36 monitoring sessions. [Figure 9A] FIG. 9A shows a polysomnogram of a patient during non-REM sleep breathing, typically lasting approximately 90 seconds. [Figure 9B] FIG. 9B shows a polysomnogram of a patient with sleep-disordered breathing over a period of approximately 6 minutes. DETAILED DESCRIPTION OF THE INVENTION

[0028] 8 Detailed description of examples of this technology Before describing the present technology in more detail, it is important to note that the present technology is not limited to the different methods described herein. It should be understood that the present disclosure is not limited to the specific examples that may be used. The terms used herein are for the purpose of describing the specific examples described herein and are not limiting. It should also be understood that this is not a

[0029] The following description relates to various examples that may share one or more common properties and / or characteristics. One or more features of any one example may be used in conjunction with one or more of another example or other examples. It should be understood that features can be combined. 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 polysomnography (PSG). The headbox 2000 includes 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 2045, oral-nasal cannula and thermistor 2050, Photoplethysmograph (pulse oximeter) 2055 and body position sensor 20 60. The electrical signal is transmitted to a 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. Two prongs or nozzles 302 configured to be inserted into the patient's nostrils as shown. 5. Prongs 3025 of nasal cannula 3020 are connected to a flexible catheter 3028. The flexible catheter 3028 measures the pressure at the nostril via a pressure sensor in this implementation. The respiratory sensor 3010 is configured to deliver the respiratory signal to the respiratory sensor 3010. The nasal pressure signal provided by the nasal pressure sensor shall, with appropriate unit conversion, indicate the patient's respiratory flow rate, Qr. It can be taken as such.

[0032] The system 3000 further includes a processor 3030. The processor 3030 is 3. Processing a respiratory signal derived from the patient's breathing and generated from sensor 3020 as described above. The processor 3030 is configured to store and process the respiratory signal. 3080 to process and / or analyze the data.

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

[0034] The system 3000 is a respiratory inductance plethysmogram (PPE) system in the PSG system of FIG. (Respiratory Effort Sensor) A respiratory effort sensor 3050 similar to the 2040 is attached to the chest or abdominal band 305 The respiratory effort sensor 3050 may further include a predetermined sampling frequency (e.g., 10Hz) and either directly (for the digital sensor 3050) or analog In the case of the signal sensor 3050, the signal is connected to the processor 3030 via an A / D converter. The processor 3030 processes and controls the respiratory effort signal generated by the respiratory effort sensor 3050. and / or may be further configured to perform the analysis as follows:

[0035] The system 3000 may further include an actigraph 3060. The actigraph may include: Three axes labeled as X, Y, and Z and defined relative to the actigraph axes. and configured to generate signals indicative of acceleration of the actigraph in each of the orthogonal axes of These three signals are collectively called actigraphy signals. Raffi has been used by researchers as input for sleep / wake decisions in a variety of scenarios. Widely used, most commonly for insomnia / sleep misinterpretation and circadian rhythm Actigraphy is not obtained using electrophysiology, but rather is an assessment of movement. This is obtained by quantifying the amount of sleep time, so if the patient turns over frequently during sleep or wakes up, When there is little movement, the sleep / wake states derived from PSG and actigraphy There may be discrepancies. Some algorithms for actigraphy analysis These algorithms have been developed and applied in different situations, such as: The agreement between sleep / wake results obtained from this study and those obtained using gold standard PSG was A generally favorable situation.

[0036] The actigraph 3060 is mounted on a convenient location on the patient's body (e.g., on the patient's torso). The actigraph 3060 is configured to be attached to the processor 3030. The connection is made with a given sampling frequency (e.g., 10 Hz) and a (digital active This can be done directly (in the case of the Rough Actigraph 3060) or (in the case of the Analog Actigraph 3060) Actigraph 3060 (digital) or Either the digital or analog-to-digital converter generates an analog signal containing samples at a particular sampling frequency. The processor is said to generate actigraphy data or actigraphy signals. 3030 processes the actigraphy signals generated by the actigraph 3060 and / or may be further configured to perform analysis as described below.

[0037] The system 3000 may be configured to generate power for other components of the system 3000. The system may further include a power source 3090 (e.g., a battery) configured to: Other power sources, such as those available through a power outlet, may also be used.

[0038] As mentioned above, signal processing / analysis may be performed by processor 3030. The processor may be used in the monitoring / processing / analysis / diagnosis or other methods described herein (e.g., in SDB). A processor specifically programmed to execute one of the following: In such an implementation of the system 3000, the process may include Such a computer program may be embodied as a computer program stored in the memory. The RAM contains instructions and / or instructions for executing the algorithms or methods disclosed herein. These programs may contain programs or data stored in memory locations (e.g., ROM). The program can be stored in RAM and then loaded as needed during run time. For example, code downloaded from a storage location or burned into hardware. appropriately programmed digital signal processors or application specific integrated circuits adapted to execute the algorithms and methods described herein may also be included.

[0039] The processor that executes signal processing / analysis may form part of a remote computing device (not shown). In one such implementation, processor 3030 is a "local processor" configured to relay signals generated from various sensors (e.g., respiration sensor 3010) to a processor associated with a remote computing device (the "remote processor") via a wireless or wired connection through communication interface 3070. In such an implementation, system 3 000 can 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 can store various signals in memory 3080. Memory 308 0 can be removable from system 3000 (e.g., a memory card or external hard drive). In such an implementation, the removed memory 3080 can be inserted into the interface of a remote computing device configured to retrieve the stored signals for processing / analysis by its processor (the remote processor). Thus, the memory that stores the actigraph data or signals used when the processor performs the algorithms or methods described herein is for storing instructions [[ID=..]] processor 3030 can store various signals in memory 3080. Memory, 308 0 may be removable from the system 3000 (e.g., a memory card or an external hard drive). In such an implementation, the removed memory 3080 can be inserted into the interface of a remote computing device configured to retrieve the stored signals for processing / analysis by its processor (remote processor) from the memory 3 080. Therefore, the memory that stores the actigraph data or signals used when the processor performs the algorithms or methods described herein is for storing instructions This may be different from the memory that stores the program used in some executions. The memory may be the same.

[0040] Some signal processing / analysis is performed by the local processor 3030. The local processor 3030 and the processor of the remote computing device The local processor 3030 can then share the remaining The signal processing / analysis can be performed by a processor on a remote computing device. The intermediate analysis results are transmitted to a remote computing device so that the results can be used to

[0041] System 3000: Respiration sensor 3010, processor 3030, A / D converter 3040 The communication interface 3070 and the memory 3080 are housed in a housing 3095. The housing 3095 is preferably handheld for easy carrying and use by the patient. It is handheld or pocket-sized.

[0042] 8.1.3 Signal Processing / Analysis As part of the System 3000 screening / diagnostic / monitoring capabilities: Various aspects of signal processing / analysis performed on such signals are described.

[0043] 8.1.3.1 Estimating total sleep time According to some aspects of the present disclosure, a method for estimating total sleep time includes: Activities that allow distinguishing between sleep and wakefulness periods when the patient is in bed The method for estimating total sleep time is a supervised learning method. The training dataset is used to "learn" the parameters. The method for estimating sleep duration was based on the activity data generated by the Actigraph 3060 during the monitoring session. The three-axis acceleration signals that make up the imaging signal are taken, appropriately filtered, and monitored. Divide the viewing session into epochs. Filtered actigraphy signal For each epoch from the beginning, estimate the physical activity counts. Each epoch is Based on the state of the brain, the brain is classified into a binary state ("asleep" or "wakefulness"). The activity threshold can be optimized via cross-validation against the "scored" training data. Use.

[0044] FIG. 5 is a flow diagram illustrating an example or total sleep time estimation method 500 according to one aspect of the present technology. The method 500 may be performed, for example, by the local processor 3030 shown in FIG. Alternatively, it may be performed by a remote processor, or may be performed by a local processor as described above. It may also be performed by a combination of local processor 3030 and a remote processor.

[0045] Method 5000 begins at step 5010. In step 5010, Pre-processing the actigraphy signal. Pre-processing the actigraphy signal can be done, for example, For example, this may include removing any drift in the accelerometer baseline. According to the rows, pre-processing may include detrending the actigraphy signal. Then, step 5020 filters the pre-processed actigraphy signal. Steps 5010 to 5030 respectively measure the three "channels" of the actigraphy signal. channel" (i.e., acceleration values ​​for each of the three axes (X, Y, and Z)) is executed.

[0046] After pre-processing, the resulting pre-processed signal is filtered as shown at 5020. Filtering can be used to filter out, for example, activities that are not related to overall body movement. This may include reducing or eliminating components of the cytometry signal. In this line, step 5020 converts the detrended actigraphy signal into a normal Bandpass filtering was performed within the range 0.5Hz to 4.5Hz, which corresponds to the range of overall body movement. Step 5020 includes filtering the filtered actigraph. It may also include magnitude normalization, which divides the image signal by its 95th percentile value.

[0047] In the next step 5030, each channel is divided into epochs of predetermined duration. In one run, each epoch has a duration of 30 seconds, and each epoch consists of To minimize edge cases, there is a 10 second overlap with the preceding continuation epoch. However, it should be noted that other epoch durations and overlap ranges may be chosen.

[0048] In the next step 5040, for each epoch n, the activity count A n Determine. In one implementation, step 5040 calculates (e.g., takes the absolute value) three filter levels. Correct the actigraphy channels (e.g., take the absolute value) and perform three corrections. The corrected channels were summed to obtain a single actigraphy signal for each epoch. Activity count A n is the mean square of the signal summed over the epoch (RMS value or is calculated as the mean square root.

[0049] Next, method 5000 proceeds to step 5050, which nt A n and the activity count of the preceding epoch (A n-1 ) for each epoch n Determines the sleep / wake state of the n A n-1 The ratio to If the activity threshold T1 of 1 is exceeded, the sleep / wake state of epoch n is determined as “wake.” If not, it is determined as "sleep." In such a run, the activity counter If the rate has not increased substantially since the preceding epoch, regardless of absolute level, the patient is asleep. In another run, activity count A n is higher than the second activity threshold T2 If the value is higher than the threshold, the sleep / wake state of epoch n is determined as "wake"; otherwise, In yet another run, if any of these criteria are met, the event is determined to be "sleep." If is not satisfied, the sleep / wake state of epoch n is determined as "wake", otherwise If not, it is determined as "Sleep."

[0050] The activity thresholds T1 and T2 may be determined by some other means (e.g., by using gated PSG data). The actigraphy data (i.e., the time course used to determine the outcome) are "scored" prior to the actigraphy. In one implementation, the activity threshold optimization was performed in a six-fold manner. This can be performed by cross-validation of the output of method 5000 and the scored The cross-correlation coefficient between actigraphy data is maximized. In one such run on the actigraphy data, a first activity threshold The optimal value for T1 was found to be 1.7, and the optimal value for the second activity threshold T2 was scored as 94th percentile of activity counts for the dataset However, the values ​​of the first activation threshold in the range of [1.3, 2.0] and the 65th and 98th A second activity threshold in the range between the 1st and 2nd percentiles can be used with reasonable efficacy. do.

[0051] In the final step 5060, the total sleep is calculated from the determined sleep / wake states for each epoch. Since these epochs overlap, step 5060 is ,We can simply count the number of epochs determined as sleep, or,the duration of each epoch. That is, step 5060 does not multiply the sleep / wake state as "sleep" Corresponding to actigraphy signal samples determined as part of a determined epoch The number of times the Actigraph 3060 is sampled is counted, and the sampling frequency or its A / D ratio is D converters (among these, feed actigraphy signal samples to signal processing / analysis) The result is the TST value in seconds.

[0052] Another implementation of the total sleep time estimation method is the Actigraph from Actigraph 3060. In addition to the respiratory flow signal from the respiratory sensor 3010 or the respiratory effort sensor 3020, Respiratory effort signal from 050 is used.

[0053] FIG. 6 illustrates a method 6000 that may be used to implement the total sleep time estimation method according to another implementation. Steps 6010 to 6040 of method 6000 are the same as those of method 500. These are the same as the corresponding steps 5010 to 5040 in step 0.

[0054] In step 6050, similar to step 5050, the sleep / wake time of each epoch n is calculated. In step 6050, the epoch is determined in the same manner as in step 5050. Activity count A n and the activity count of the preceding epoch (A n-1 ) is used. In contrast to step 5050, step 6050 measures respiratory flow from respiratory sensor 3010. The respiratory effort signal from the respiratory effort sensor 3050 is further taken into account. From this additional signal, it is possible that the patient is awake during the epoch, but relatively This provides further insight into the patient's condition (when there is less movement).

[0055] FIG. 7 illustrates the total sleep time estimation step 6050 of method 6000 for the current epoch n. 7000 includes a flowchart illustrating a method 7000 that can be used to implement the method 7000. , as will be described in terms of the respiratory flow signal from the respiratory sensor 3010, The method 7000 is performed with the respiratory effort signal from the respiratory effort sensor 3050 used as a substitute. It should be understood that this can also be done.

[0056] Method 7000 begins at step 7010. In step 7010, As with step 5050, the activity count for the current epoch is A n and the activity count of the preceding epoch A n-1 Ratio to (A n / A n-1 ) exceeds the first activity threshold T1 or Activity count A n Check whether T exceeds the second activity threshold T2. Activity Count A n and the activity count A of the preceding epoch n-1Ratio to (A n / A n-1 )but The first activity threshold T1 is exceeded or the activity count A of the current epoch n is the second activation threshold If the value T2 is exceeded ("Y"), then in step 7020 the sleep / wake time for the current epoch n is The wakefulness state is determined as "wakeful." The same activity threshold T1 and T2 may be used in step 7010.

[0057] However, if none of these conditions are true ("N"), the patient's movement is relative. Although less, method 7000 determines sleep / wake state after further checks. Specifically, in step 7030, the respiratory flow signal at the current epoch is If not ("N"), then in step 7040 If so, determine the sleep / wake state of the current epoch as "unknown". Otherwise ( "Y"), in step 7050, the respiratory flow signal during the current epoch is stable To test for stability, step 7050 determines whether the following respiration-flow-related variables are present: Test whether the variability (e.g., standard deviation) for one or more epochs of the number is below a threshold. Try: ·Tidal volume; · Inspiratory time; ·Respiration rate; · Inspiratory peak flow; · Expiratory peak flow position; -Time since 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"), step 7070 determines whether the respiratory flow signal is greater than SD at the current epoch. Determine whether an SDB episode has occurred. 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 respiratory hypopnea, respiratory depression, and obstructive apnea. If so ("Y"), then in step 7060 If not, the sleep / wake state of the current epoch is determined as "sleep". 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 as step 5060 of method 5000 Similarly, we estimate total sleep time (TST) from the sleep / wake determination 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, an apnea is defined as a period in which the respiratory flow function exceeds a flow threshold for a predetermined period of time. This function is used to detect peak flow, average flow over a relatively short period of time. 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). The flow threshold can be a relatively long-term measurement of flow.

[0062] In one form, hypopnea is when the respiratory flow function drops below a second flow rate over a predetermined period of time. This function is used to detect peak flow, relatively short duration, and The average flow rate of a given period, or the mean flow rate of average and peak flow rates for a relatively short period, may be determined (e.g. For example, RMS flow). The second flow threshold may be a relatively long-term measurement of flow. The flow threshold is higher than the flow threshold used to detect apnea.

[0063] 8.1.3.3 Snoring Detection In one embodiment, the snore detection algorithm uses the respiratory flow from the respiratory sensor 3010. It receives as input a volume signal and provides as output a measure of the extent to which snoring is present.

[0064] The snore detection algorithm determines the strength of the flow signal in the range of 30-300 Hz. Further, the snoring determination algorithm may include a step of: Filters the respiratory flow signal to reduce noise (e.g., airflow noise in the system from the blower) The method may include a step of ringing.

[0065] If the intensity of the filtered respiratory flow signal exceeds a threshold, snoring is considered to be present. It can be done.

[0066] 8.1.3.4 Determining Airway Patency Patency is the degree to which the airway is open or the extent to which the airway is open. Airway patency is defined as an open airway. Airway patency is quantified by dividing the value into 1, which indicates patency, and 2, which indicates closure (obstruction). If apnea or hypopnea occurs in conjunction with a patent airway, Considered as apnea or hypopnea, when apnea or hypopnea occurs in conjunction with airway closure , considered obstructive apnea or hypopnea.

[0067] In one form, the airway patency determination algorithm receives as input a respiratory flow signal. The signal output is determined within a frequency range of approximately 0.75 Hz to approximately 3 Hz. The presence of a peak within the range is taken as an indication of airway patency. is considered an indication for airway closure.

[0068] In one form, the airway patency determination algorithm receives as input a respiratory flow signal. and determine the presence or absence of a cardiogenic signal. The absence of a cardiogenic signal is an indication of airway closure. is regarded as.

[0069] 8.1.3.5 Flow Limitation Detection The flow restriction is described in U.S. Provisional Patent Application No. 62 / 043079 (filed August 28, 2014). , ResMed Limited, Title: "Diagnosis and treatment As described in the "Comment of Respiratory Disorders" It can be detected from the respiratory flow signal.

[0070] 8.1.3.6 RERA Discovery RERA is the subject of PCT patent application no. PCT / AU2015 / 050056 (filing date: 20 February 13, 2015, ResMed Limited, Title: "Diagnosis and treatment of Respiratory Disorders”) It can be detected from the respiratory flow signal as described in

[0071] 8.1.3.7 Calculating the AHI The apnea / hypopnea index (AHI) may be calculated as follows:

number

[0072] Therefore, the AHI is the number of apneas / hyperactivity disorder episodes that occur (or are detected) per hour of sleep. It indicates the number of hypopnea episodes. Traditionally, AHI has been used to indicate the severity of sleep-disordered breathing in humans. As a result, treatment decisions are based on the AHI calculated by system 3000. It may be based on a value.

[0073] 8.1.3.8 Screening / Diagnostic / Monitoring The calculated AHI was calculated for patients whose AHI at the screening session was above a certain threshold. It can be used as a screening tool by signaling out It is possible.

[0074] The AHI is used to diagnose a patient (i.e., to identify a patient as having a condition that is calculated during the diagnostic session). By placing patients in categories according to their AHI values, patients were classified according to the severity of their SDB. It can also be used for categorizing.

[0075] To monitor patients undergoing SDB treatment using the AHI, Calculate the AHI and report worsening of SDB (i.e., increasing AHI). Treatment parameters may also be modified depending on the AHI.

[0076] 8.1.4 Example Results In sleep studies, wrist-mounted actigraphs (Actiwatch (登録 商標) "Scored" from the The actigraphy data from the System 3000 Scoring was performed in parallel with an Actigraph 3060 placed on each patient's torso. The collected data consisted of 36 datasets from 29 different patients, totaling over 9 million epochs. The monitoring session consisted of: As determined by the above algorithm 5000 applied to actigraphy data Sleep / wake states (i.e., without respiratory flow or effort data) were recorded in parallel. Confusion matrix between scored sleep / wake states of actigraphy data include. [Table 1]

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

[0078] Figure 8 shows the TST scores plotted against the TST values ​​scored over the 36 monitoring sessions. TST estimated using Algorithm 5000 on actigraphy data Graph 8000 includes the estimated TST and the scored TST. The overall correlation coefficient was 0.9914. The statistical comparison data between the TST values ​​estimated and scored across the 36 sessions were This indicates the data. [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 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 moving, such as turning a page.

[0080] 8.2 Respiratory waveform FIG. 9A shows a polysomnogram of a patient during non-REM sleep. During a 0 second period, approximately 34 breaths are taken. The upper channel is used for oxygen saturation measurement ( SpO2), with the scale ranging from 90 to 99% saturation in the vertical direction. The patient maintained approximately 95% saturation throughout the period shown. The quantitative respiratory airflow scale ranges from -1 to +1 LPS in the vertical direction. Qi is positive. Chest and abdominal movements are shown in the third and fourth channels.

[0081] Figure 9B shows a polysomnogram of an SDB patient over a period of approximately 6 minutes. There are 11 signal channels spaced at a horizontal span of 6 minutes. The two channels are EEGs (electroencephalograms) from different scalp locations. Periodic spikes in the EEG indicate cortical arousal and related activity. The third channel in the lower , submental EMG (electromyogram). Increased activity around wakefulness is due to recruitment of the genioglossus nerve. The fourth and fifth channels are EOG (electrogenioglossus). The sixth channel is The seventh channel repeats desaturation from about 90% to less than 70%. The eighth channel shows the pulse oximetry (SpO2) when the pressure is changed. Respiratory airflow using a nasal cannula connected to an air ventilator. Repeated apnea for 25-35 seconds. This was followed by a 10-15 second burst of recovery breathing, accompanied by an EEG arousal and increased EMG activity. The ninth channel shows chest movement, and the tenth channel shows abdominal movement. The abdomen exhibits progressively greater movements over the duration of the apnea, resulting in arousal. Both are irregular due to the overall body movements during recovery hyperventilation during wakefulness. Therefore, the apnea becomes obstruction and the condition is serious. The bottom channel posture, which is not shown to change in this example.

[0082] 8.3 Terminology For purposes of this disclosure, in certain forms of this technology, one or more of the following definitions may be used: In other aspects of the technology, other definitions may also apply.

[0083] 8.3.1 General Air: In certain forms of the present technology, air may refer to the atmosphere, and in other forms of the present technology By air, we mean a combination of other breathable gases (e.g., oxygen-rich atmosphere). possible.

[0084] Atmosphere: In certain forms of the present technology, the term "atmosphere" refers to (i) the temperature of the treatment system or external to the patient and (ii) the immediate surroundings of the treatment system or patient. should be taken as such.

[0085] Respiratory Pressure Therapy (RPT): A method of applying pressure to the airways at a treatment pressure that is typically positive relative to the atmosphere. Providing an air supply to the inlet.

[0086] Continuous Positive Airway Pressure (CPAP) Therapy: A therapy in which the treatment pressure remains nearly constant throughout the patient's respiratory cycle. In some forms of respiratory pressure therapy, the pressure at the entrance to the airways is increased during exhalation. In some configurations, the pressure increases slightly during breathing and decreases slightly during inhalation. Varying between different respiratory cycles (e.g., in response to detection of an indication of partial upper airway obstruction) (Increased in response to steroids and decreased in the absence of indications of partial upper airway obstruction).

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

[0088] Automated positive airway pressure (APAP) therapy: depending on the presence or absence of indications for SDB onset, e.g. CPAP capable of automatically adjusting treatment pressure between minimum and maximum limits between breaths Therapy.

[0089] 8.3.2 Aspects of the respiratory cycle Apnea: According to some definitions, an apnea is a period in which flow drops below a certain threshold, e.g., 1 An obstructive apnea is said to have occurred if it continues for a duration of 0 seconds. It occurs when some kind of airway obstruction does not allow air to flow despite the person's efforts. Central apnea is a condition in which respiratory effort is reduced or decreased despite the airway being open. It is said to refer to a state in which apnea is detected due to the absence of respiratory effort. , which refers to a condition in which reduced or absent respiratory effort occurs concurrently with airway obstruction.

[0090] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

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

[0092] Effort (breathing): Respiratory effort is the movement made by a person's spontaneous breathing as they try to breathe. It is said to refer to.

[0093] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0094] Flow limitation: Flow limitation occurs when an increase in effort by the patient does not cause a corresponding increase in flow. This is interpreted as a condition in the patient's breathing that is flow-limited during the inspiratory portion of the respiratory cycle. When this occurs, the flow limitation can be referred to as inspiratory flow limitation. When flow restriction occurs in the respiratory tract, the flow restriction can be referred to as expiratory flow restriction. Cut.

[0095] Flow: The instantaneous volume (or mass) of air delivered per unit time. Flow and ventilation have the same magnitude of quantity or mass per unit time, but the flow rate is much shorter. In some cases, when referring to flow rate, it is a scalar quantity (i.e., a large In other cases, when referring to flow rate, the vector Refers to a quantity (i.e., a quantity that has both magnitude and direction). Also referred to as a signed quantity In this case, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle, The total flow Qt can be negative for the expiratory portion of the patient's breathing cycle. The flow rate of the air being sent out is given the symbol Q. The total flow rate Qt is the flow rate of air exiting the RPT device. The vent flow Qv is the amount of air exiting the vent to allow the exhaled gas to flow out. The leakage flow rate Ql is the leakage flow rate from the patient interface system. Respiratory flow Qr is the flow of air received into the patient's respiratory system.

[0096] Hypopnea: Preferably, hypopnea refers to a reduction in flow, not an interruption of flow. In this state, if flow reduction below the threshold velocity continues for a sustained period, hypopnea occurs. If hypopnea is detected due to a decrease in respiratory effort, it is said to have occurred. A decline is said to have occurred if any of the following occurs in an adult: May be considered hypopnea: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (ii) A reduction (less than 50%) in patient respiration lasting at least 10 seconds and associated desaturations is at least 3% or awakening occurs.

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

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

[0099] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency can be quantified by one of the following values: (1) Open A value of zero (0) indicates it is closed (occluded).

[0100] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0101] Peak flow (Q peak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0102] Respiratory flow, airflow, patient airflow, respiratory airflow (Qr): these synonymous terms are: May be understood to refer to an estimate of respiratory airflow from an RPT device, usually in liters per minute Contrast this with "true respiratory flow" or "true respiratory airflow," which is the patient's actual respiratory flow expressed as It is used for.

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

[0104] (Inhalation) 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 time between the start of the inspiratory portion of one respiratory flow waveform and the next respiratory flow waveform The total duration between the start of the inspiratory portion of

[0107] Typical recent ventilation: Ventilation values ​​that tend to cluster together over a given time scale ( i.e., the degree of central tendency of the most recent ventilation value).

[0108] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. Flow level increases slightly with increasing pressure difference across the road (Starling resistor behavior) It may be associated with a condition of flow limitation that may be increased or decreased.

[0109] 8.4 Other Notes A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner reserves the right to modify, revise, or otherwise modify this patent document. If any person reproduces this patent document or this patent disclosure by facsimile, the Patent Office's patent file If it is something that is recorded in the mail or record, there is no objection if it is for a specific purpose, but if it is for any other purpose, All rights reserved.

[0110] Unless otherwise clearly indicated by the context and unless a range of values ​​is provided, the lower limit 1 / 10 of a unit, between the upper and lower limits of the range, and any other stated value in the stated range It is understood that each intervention value for the intervention range is included in the present technology. The upper and lower limits of these intervention ranges that may be included in practice may exceed the limits of the stated ranges. If the range described includes one or both of these limitations, it is also encompassed by the present technology. In some cases, ranges beyond either or both of these stated limits are also encompassed by the technology.

[0111] Furthermore, when a value or values ​​are provided herein and implemented as part of the present technology, other Unless otherwise specified, such values ​​may be approximated and may vary as practical engineering practice permits or requires. It is understood that such values ​​may be used to any suitable extent. do.

[0112] Unless otherwise defined, all technical and scientific terms used herein are defined to the extent that this technology belongs to The term "amount" has the same meaning as that generally understood by a person skilled in the art. Any methods and materials similar or equivalent to those described herein may be used in the practice or testing of this technology. Although a limited number of exemplary methods and materials can be used in various ways, they are described herein. will be done.

[0113] Although specific materials are listed as being used in the construction of the components, other materials with similar properties may be used. Obvious alternative materials may be used as substitutes. Further, unless stated to the contrary, Any and all components described herein are understood to be manufacturable. They can be manufactured collectively or separately to achieve the same.

[0114] As used herein, in the appended claims, the singular "a" "an" and "the" include their plural equivalents unless the context clearly indicates otherwise. Please note that

[0115] All publications mentioned herein are incorporated by reference in their entirety for all purposes, including, but not limited to, the methods and / or methods that are the subject of these publications. or incorporated by reference for the disclosure and description of the materials disclosed herein. The references are provided solely for their disclosure prior to the filing date of the present application. that the present technology did not antedate such publications by virtue of prior patents. Further, the dates of publication stated may not be accurate to the best of our knowledge. Dates of publication may differ from those of the original publication and may need to be independently confirmed.

[0116] The words "comprises" and "comprising" mean elements, constituent elements, The elements or steps described should be interpreted in a non-exclusive sense. An element, component, or step may be combined with other elements, components, or steps not specified. Indicates that they can exist, be used, or be combined together.

[0117] The headings used in the detailed description are solely for the convenience of the reader and should be used to limit what appears in the disclosure or claims as a whole. These headings are not intended to aid in the interpretation of the scope of the claims or claim limitations. should not be used in interpretation.

[0118] Although the technology herein has been described with reference to particular embodiments, these embodiments It should be understood that the above embodiments are merely illustrative of the principles and applications of the present technology. In some cases, terms and symbols may indicate specific details that are not necessary for the practice of the present technology. For example, the terms "first" and "second" may be used, unless otherwise specified. These terms are not intended to denote any order, but rather to distinguish between distinct elements. Furthermore, the process steps in the method are described or illustrated in order. Although the descriptions may be presented in order, such order is not required. The order of these aspects may be changed and / or the aspects may be performed simultaneously or even synchronously. Recognize that it is possible.

[0119] Thus, many exemplary embodiments may be implemented without departing from the spirit and scope of the present technology. It should be understood that variations are possible and other arrangements may be devised. [Explanation of symbols]

[0120] 8.5 List of Reference Symbols patient 1000 Headbox 2000 ground electrode 2010 EOG electrode 2015 EEG electrodes 2020 ECG electrode 2025 Subcervical EMG electrode 2030 Snoring Sensor 2035 Respiratory inductance plethysmogram 2040 Respiratory inductance plethysmogram 2045 Oronasal cannula 2050 Photoplethysmograph 2055 Body Position Sensor 2060 Screening / Diagnostic / Monitoring System 3000 Respiration Sensor 3010 Nasal cannula 3020 Prong 3025 Flexible catheter 3028 Processor 3030 A / D converter 3040 Respiratory effort sensor 3050 Belly band 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

1. 1. A method for estimating a patient's total sleep time during a monitoring session comprising multiple epochs, 、 The actigraphy signals obtained during the monitoring session for the patient are used to determining the patient's sleep / wake state at each epoch of the session; estimating the total sleep time from the sleep / wake state of the patient at each epoch; , including Determining the sleep / wake state of the patient at an epoch comprises: determining an activity count for each epoch from the actigraphy signal; 、 The activity count for the epoch preceding the activity count for the epoch If the ratio of the sleep / wake activity of the patient at the epoch is greater than a first activity threshold, Determining the state of awakening as "awakening" A method comprising:

2. Determining the sleep / wake state of the patient at an epoch determines the activity of the epoch. If the activity count is higher than a second activity threshold, the sleep / wake state is determined to be "wake." The method of claim 1 further comprising:

3. determining said sleep / wake state further depends on a respiratory flow signal of said patient; The method of claim 1.

4. Determining the sleep / wake state may be performed by determining whether the respiratory flow signal at the epoch is stable.

4. The method of claim 3, further comprising determining the sleep / wake state as "sleep" if 。

5. Determining the sleep / wake state may involve determining whether the respiratory flow signal indicates an SDB occurrence at the epoch. determining the sleep / wake state as "sleep" if the sleep / wake state includes an indication that a symptom has occurred.

4. The method of claim 3.

6. determining said sleep / wake state further depends on a respiratory effort signal of said patient; The method of claim 1.

7. Determining the sleep / wake state may include determining whether the respiratory effort signal is stable during the epoch.

7. The method of claim 6, further comprising determining the sleep / wake state as "sleep" if 。

8. Determining the sleep / wake state may include determining whether the respiratory effort signal indicates an SDB occurrence at the epoch. determining the sleep / wake state as "sleep" if the sleep / wake state includes an indication that a symptom has occurred. The method of claim 6.

9. The SDB episodes include snoring, flow limitation, arousals associated with respiratory effort, obstructive hypopnea, and 9. The method of claim 5, wherein the method comprises one of: a) atrial fibrillation; b) angioplasty; c) angioplasty; and d) obstructive apnea.

10. calculating an index of severity of sleep disordered breathing for said patient from said estimated total sleep time; The method of any one of claims 1 to 9, further comprising:

11. The computing the index detecting apneas and hypopneas during said session; The number of detected apneas and hypopneas during the session is multiplied by the estimated total sleep time. Dividing between and The method of claim 10, comprising:

12. Determining an activity count for the epoch comprises: modifying each channel of the actigraphy signal; summing the modified channels to obtain a single actigraphy signal; calculating the mean square root value of said single actigraphy signal for said epoch; Toto The method according to any one of claims 1 to 11, comprising:

13. A system for estimating a patient's total sleep time during a monitoring session that includes multiple epochs. So, actigraphy signals indicative of acceleration of the actigraphy in each of three orthogonal axes; an actigraph configured to generate a signal; 1. A processor, comprising: determining an activity count for each epoch from the actigraphy signal; 、 The activity count for the epoch preceding the activity count for the epoch If the ratio of the patient's activity to the activity threshold is greater than a first activity threshold, the patient is asleep / awake at each epoch. determining the state as "Awakened"; estimating the total sleep time from the sleep / wake state of the patient at each epoch; a processor programmed to perform the Including, the system.

14. a respiration sensor configured to generate a signal indicative of the patient's respiration; 14. The method of claim 13, wherein the sleep / wake state determination further depends on the generated signal. system.

15. a respiratory effort sensor configured to generate a signal indicative of the patient's respiratory effort; wherein the sleep / wake state determination further depends on the generated respiratory effort signal. The system of claim 13.

16. 10. The method of claim 1, wherein the processor forms part of a remote computing device.

3. The system described in

17. a communication interface; The actigraphy signal is transmitted to the remote controller via the communication interface. a local processor configured to relay to said processor of a computing device; Sa and The system of claim 16 further comprising:

18. a removable memory configured to store the actigraphy signal; The system of claim 16, comprising:

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