Method and device for in-home sleep and signal analysis

• US 10,426,399 B1
• Filed: 08/05/2016
• Issued: 10/01/2019
• Est. Priority Date: 06/08/2007
• Status: Active Grant

• Current Assignee: Cleveland Medical Devices Inc.
• Original Assignee: Cleveland Medical Devices Inc.
• Inventors: Kayyali, Hani, Frederick, Craig A., Martin, Christian, Schmidt, Robert N., Kolkowski, Brian
• Primary Examiner(s): Downey, John R
• Assistant Examiner(s): Jian, Shirley
• Application Number:
  US15/229,242
• Time in Patent Office: 1,152 Days
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0806 by whole-body plethysmography measuring blood flow using plethysmography A61B5/0295; impedance plethysmography A61B5/053; measuring volume of the body or parts thereof A61B5/1073
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/1114 Tracking parts of the body
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/398 Electrooculography [EOG], e.g. detecting nystagmus; Electroretinography [ERG]
• CPC Class Codes: A61B 5/4812 : Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4815 : Sleep quality
• CPC Class Codes: A61B 5/4818 : Sleep apnoea
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6814 : Head
• CPC Class Codes: A61B 5/6828 : Leg
• CPC Class Codes: A61B 5/7264 : Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

The present invention provides a method of conducting a sleep analysis by collecting physiologic and kinetic data from a subject, preferably via a wireless in-home data acquisition system, while the subject attempts to sleep at home. The sleep analysis, including clinical and research sleep studies and cardiorespiratory studies, can be used in the diagnosis of sleeping disorders and other diseases or conditions with sleep signatures, such as Parkinson'"'"'s, epilepsy, chronic heart failure, chronic obstructive pulmonary disorder, or other neurological, cardiac, pulmonary, or muscular disorders. The method of the present invention can also be used to determine if environmental factors at the subject'"'"'s home are preventing restorative sleep.

Claims

1. A method of conducting home sleep testing comprising the steps of:

providing a subject with a portable patient interface box worn by the subject on its torso and a nasal cannula or a facemask, a respiratory effort belt and a fingertip pulse oximeter, the patient interface box comprising a battery, at least one kinetic sensor, a nonvolatile digital memory, a pressure transducer, an air port for connecting a nasal cannula or a facemask to the pressure transducer within the patient interface box, and releasable connector sensor inputs to electrically connect and disconnect the respiratory effort belt and the fingertip pulse oximeter, the nasal cannula or facemask for measuring airflow of the subject, the respiratory effort belt for measuring respiratory effort of the subject, the kinetic sensor for measuring body position or orientation and the fingertip pulse oximeter for measuring oxygenation of the subject;

applying and connecting the nasal cannula or facemask, the respiratory effort belt and the fingertip pulse oximeter to the subject, and further the patient interface box to the subject'"'"'s torso;

measuring and collecting data through the patient interface box of the airflow, respiratory effort, body position or orientation and oxygenation of the subject while the subject attempts to sleep at home;

digitizing and storing the collected data from the subject in the nonvolatile digital memory of the patient interface box;

transferring the collected data to a location remote from the subject'"'"'s home;

providing a computer or a processor at the remote location for analyzing the transferred collected data to identify and draw attention to physiological or technological events in the data indicative of a sleeping disorder; and

further analyzing at a minimum the transferred collected data and/or the identified physiological and technological events in the data at the remote location or another remote location to determine whether the subject suffers from a sleeping disorder.

2. The method in claim 1, further including a step of providing a computer or processor at the subject'"'"'s location for checking the adequacy of the collected data from the sensors prior to a transmitter transferring the collected data to the remote location.

3. The method in claim 1, wherein the collected data is transferred via cellular systems, internet, satellite, wired-network and/or land lines to a location remote from the subject'"'"'s home.

4. The method in claim 1, further including a step of determining whether the subject being analyzed for a sleep disorder maintained a normal sleeping pattern prior to analysis based on subjective input from the subject or polysomnography data.

5. The method in claim 1, further including a step of the computer or processor performing automatic scoring of the data prior to said further analyzing.

6. The method of claim 1, further comprising a step of at least in part removing or identifying movement artifacts in the collected data prior to the computer or processor analysis of the collected data by an algorithm of the computer or processor comparing signals from the at least one kinetic sensor with at least one other kinetic or physiological signal to identify and/or remove movement artifacts identified from the signals.

7. The method of claim 1, wherein the patient interface box is capable of providing two way communication between the subject or their care provider and a sleep technician at the remote location.

8. A method of conducting home sleep testing comprising the steps of:

providing a subject with a portable patient interface box worn by the subject on its torso and a nasal cannula or a facemask, a respiratory effort belt and a fingertip pulse oximeter, the patient interface box comprising a battery, at least one kinetic sensor for measuring body position, a nonvolatile digital memory, a pressure transducer, an air port for connecting a nasal cannula or a facemask to the pressure transducer within the patient interface box, and releasable connector sensor inputs to electrically connect and disconnect the respiratory effort belt and the fingertip pulse oximeter, the nasal cannula or facemask for measuring airflow of the subject, the respiratory effort belt for measuring respiratory effort of the subject, the kinetic sensor for measuring body position or orientation and the fingertip pulse oximeter for measuring oxygenation of the subject;

applying and connecting the nasal cannula or facemask, the respiratory effort belt and the fingertip pulse oximeter to the subject and to the patient interface box, and further the patient interface box to the subject'"'"'s torso;

measuring and collecting data of the airflow, respiratory effort, body position or orientation and oxygenation of the subject while the subject attempts to sleep at home;

digitizing and storing the collected data from the subject in the nonvolatile digital memory of the patient interface box;

transferring the collected data via cellular systems, internet, satellite, wired-network and/or land lines to a location remote from the subject'"'"'s home;

providing a computer or a processor at the remote location for analyzing the transferred collected data to identify and draw attention to physiological or technological events in the data indicative of a sleeping disorder; and

further analyzing at a minimum the transferred collected data and/or the identified physiological and technological events in the data at the remote location or another remote location to determine whether the subject suffers from a sleeping disorder.

9. The method in claim 8, further including a step of providing a computer or processor at the subject'"'"'s location for checking the adequacy of the collected data from the sensors prior to a transmitter transferring the collected data to the remote location.

10. The method in claim 8, further including a step of determining whether the subject being analyzed for a sleep disorder maintained a normal sleeping pattern prior to analysis based on subjective input from the subject or polysomnography data.

11. The method in claim 8, further including a step of the computer or processor performing automatic scoring of the data prior to said further analyzing.

12. The method of claim 8, further comprising a step of at least in part removing or identifying movement artifacts in the collected data prior to the computer or processor analysis of the collected data by an algorithm of the computer or processor comparing signals from the at least one kinetic sensor with at least one other kinetic or physiological signal to identify and/or remove movement artifacts identified from the signals.

13. The method of claim 8, wherein the patient interface box is capable of providing two way communication between the subject or their care provider and a sleep technician at the remote location.

14. A method of conducting home sleep testing comprising the steps of:

providing a subject with a portable patient interface box worn by the subject on its torso and a nasal cannula or a facemask, a respiratory effort belt and a fingertip pulse oximeter, the patient interface box comprising a battery, at least one kinetic sensor for measuring body position, a nonvolatile digital memory, a pressure transducer, an air port for connecting a nasal cannula or a facemask to the pressure transducer within the patient interface box, and releasable connector sensor inputs to electrically connect and disconnect the respiratory effort belt and the fingertip pulse oximeter, the nasal cannula or facemask for measuring airflow of the subject, the respiratory effort belt for measuring respiratory effort of the subject, the kinetic sensor for or orientation and the fingertip pulse oximeter for measuring oxygenation of the subject;

applying and connecting the nasal cannula or facemask, the respiratory effort belt and the fingertip pulse oximeter to the subject, and further the patient interface box to the subject'"'"'s torso;

measuring and collecting data of the airflow, respiratory effort, body position or orientation and oxygenation of the subject while the subject attempts to sleep at home;

digitizing and storing the collected data from the subject in the nonvolatile digital memory of the patient interface box;

transferring the collected data wirelessly, at least in part, to a location or database remote from the subject'"'"'s home;

providing a computer or a processor at the remote location for analyzing the transferred collected data to identify and draw attention to physiological or technological events in the data indicative of a sleeping disorder; and

further analyzing at a minimum the transferred collected data and/or the identified physiological and technological events in the data at the remote location or another remote location to determine whether the subject suffers from a sleeping disorder.

15. The method in claim 14, further including a step of providing a computer or processor at the subject'"'"'s location for checking the adequacy of the collected data from the sensors prior to a transmitter transferring the collected data to the remote location.

16. The method in claim 14, wherein the patient interface box is capable of two way communication between the subject or their care provider and a sleep trained individual at the remote location.

17. The method in claim 14, further including a step determining whether the subject being analyzed for a sleep disorder maintained a normal sleeping pattern prior to analysis based on subjective input from the subject or polysomnography data.

18. The method in claim 14, further including a step of the computer or processor performing automatic scoring of the data prior to said further analyzing.

19. The method of claim 14, further comprising a step of at least in part removing or identifying movement artifacts in the collected data prior to the computer or processor analysis of the collected data by an algorithm of the computer or processor comparing signals from the at least one kinetic sensor with at least one other kinetic or physiological signal to identify and/or remove movement artifacts identified from the signals.