Correlating a non-polysomnographic physiological parameter set with sleep states

• US 8,021,299 B2
• Filed: 04/25/2006
• Issued: 09/20/2011
• Est. Priority Date: 06/01/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heruth, Kenneth T., Miesel, Keith A.
• Primary Examiner(s): Yao; Sam
• Assistant Examiner(s): SORIANO, BOBBY GILES
• Application Number:
  US11/410,448
• Publication Number:
  US 20070015976A1
• Time in Patent Office: 1,974 Days
• Field of Search: None
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• 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 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

Abstract

Values of a non-polysomnographic (non-PSG) physiological parameter set may be correlated to polysomnographically (PSG) determined sleep states. The correlated values of the non-PSG parameter set and sleep states may be analyzed, and a relationship between the values and sleep states may be determined. The relationship may allow determination of sleep states for any given patient based on values of the non-PSG physiological parameter set for the patient. The non-PSG physiological parameter set does not include physiological parameters typically required for PSG, such as brain electrical activity (EEG), eye movement (EOG), and jaw or neck muscular activity or tone (EMG). Medical devices, such as implantable medical devices (IMDs) that would generally be unable to monitor such physiological parameters, may apply the relationship to values of the non-PSG physiological parameter set for a patient to identify sleep states of the patient.

Claims

1. A method comprising:

identifying sleep states of a subject during a period of time based on polysomnography;

recording values of a non-polysomnographic physiological parameter set of the subject during the period of time;

subsequent to identifying the sleep states and recording the values of the non-polysomnographic physiological parameter set, correlating the recorded values of the non-polysomnographic physiological parameter set to the identified sleep states using a computing device;

subsequent to correlating the recorded values to the identified sleep states, analyzing the correlated values of the non-polysomnographic physiological parameter set using the computing device;

subsequent to analyzing the correlated values, calculating a relationship between values of the non-polysomnographic physiological parameter set and sleep states based on the analysis using the computing device; and

subsequent to calculating the relationship, storing the relationship between values of the non-polysomnographic physiological parameter set and sleep states in a medical device, wherein the medical device is configured to apply the relationship to a non-polysomnographic physiological parameter to identify sleep states based on the relationship.

2. The method of claim 1, wherein the non-polysomnographic physiological parameter set includes at least one of posture, activity level, heart rate, respiration rate, respiratory volume, blood oxygen saturation, blood pressure, electrocardiogram (ECG) morphology, core temperature, partial pressure of oxygen within blood, partial pressure of oxygen within cerebral spinal fluid, pH of blood or cerebral spinal fluid, glucose level in blood or cerebral spinal fluid, protein marker of pain within cerebral spinal fluid or subcutaneous extracellular fluid, muscular activity, muscular tone, arterial blood flow, or galvanic skin response.

3. The method of claim 1, wherein identifying sleep states of a subject comprises identifying whether the subject is awake or asleep.

4. The method of claim 1, wherein identifying sleep states of a subject comprises identifying whether the subject is in a random eye movement or non-random eye movement state of sleep.

5. The method of claim 1, wherein identifying sleep states of a subject comprises identifying whether the subject is in at least one of the S1, S2, S3 or S4 sleep state.

6. The method of claim 1, wherein identifying sleep states of a subject comprises:

recording values of a polysomnographic physiological parameter set of the subject during the period of time; and

analyzing the values of the polysomnographic physiological parameter set to identify the sleep states.

7. The method of claim 6, wherein recording values of a polysomnographic physiological parameter set and a non-polysomnographic physiological parameter set comprises recording values in a clinic during the period of time.

8. The method of claim 1, wherein recording values of a non-polysomnographic physiological parameter set comprises recording values of the non-polysomnographic physiological parameter set via at least one sensor located proximate to an implantable medical device implant location.

9. The method of claim 1,

further comprising identifying sleep states, recording values of a non-polysomnographic physiological parameter set, and, subsequent to identifying the sleep states and recording the values of the non-polysomnographic physiological parameter set, correlating the recorded values of the non-polysomnographic physiological parameter set to the identified sleep states for each of a plurality of subjects,

wherein analyzing the correlated values comprises, subsequent to correlating the recorded values to the identified sleep states, analyzing the correlated values for the plurality of subjects, and calculating a relationship comprises, subsequent to analyzing the correlated values, calculating the relationship based on the analysis for the plurality of subjects.

10. The method of claim 9, wherein the plurality of subjects comprises a first plurality of subjects, the method further comprising:

for each of a second plurality of subjects, identifying sleep states during a period of time based on polysomnography, recording values of a non-polysomnographic physiological parameter set during the period of time, and, subsequent to recording the values, applying the relationship to the recorded values to identify sleep states during the period of time;

subsequent to applying the relationship, comparing the identification of sleep states based on polysomnography to the identification of sleep states by application of the relationship; and

subsequent to comparing the identifications, modifying the relationship based on the comparison.

11. The method of claim 1, wherein calculating a relationship comprises calculating at least one of a threshold, an equation, a look-up table, or a neural network.

12. The method of claim 1, further comprising:

recording values of the non-polysomnographic physiological parameter set for a patient via the medical device;

subsequent to recording the values, applying the relationship to the values of the non-polysomnographic physiological parameter set; and

subsequent to applying the relationship to the values, identifying sleep states of the patient based on the application of the relationship.

13. The method of claim 1, wherein the medical device is an implantable medical device.

14. The method of claim 12, further comprising:

evaluating quality of sleep of the patient based on the identified sleep states; and

evaluating efficacy of therapy delivered to the patient by the medical device based on the quality of sleep.

15. The method of claim 12, further comprising controlling delivery of therapy by the medical device based on the identified sleep states.

16. A system comprising

a first plurality of sensors that sense a polysomnographic physiological parameter set of a subject;

a second plurality of sensors that sense a non-polysomnographic physiological parameter set of the subject;

a processor that receives signals sensed by the first and second pluralities of sensors during a period of time, determines values of the polysomnographic physiological parameter set and the non-polysomnographic physiological parameter set based on the signals, identifies sleep states based on values of the polysomnographic physiological parameter set, subsequent to determining the values of the non-polysomnographic physiological parameter set and identifying the sleep states, correlates the values of the non-polysomnographic physiological parameter set with sleep states identified based on values of the polysomnographic physiological parameter set, subsequent to correlating the recorded values to the identified sleep states, analyzes the correlated values of the non-polysomnographic physiological parameter set, and, subsequent to analyzing the correlated values, calculates a relationship that relates values of the non-polysomnographic physiological parameter set to sleep states based on the analysis; and

a medical device comprising a memory that, subsequent to the processor calculating the relationship, stores the relationship between values of the non-polysomnographic physiological parameter set and sleep states, wherein the medical device is configured to apply the relationship to a non-polysomnographic physiological parameter to identify sleep states based on the relationship.

17. The system of claim 16, wherein the processor presents the values of the polysomnographic physiological parameter set to a user for identification of sleep states of the subject, subsequent to presenting the values, receives an indication of the sleep states from the user, identifies sleep states based on the indication, and, subsequent to identifying the sleep states, correlates the values of the non-polysomnographic physiological parameter set with the identified sleep states.

18. The system of claim 16, wherein the processor analyzes the values of the polysomnographic physiological parameter set, identifies sleep states of the subject based on the analysis, and, subsequent to identifying the sleep states, correlates the values of the non-polysomnographic physiological parameter set with the identified sleep states.

19. The system of claim 16, wherein the processor, subsequent to correlating the recorded values to the identified sleep states, presents the correlated values of non-polysomnographic physiological parameter set and sleep states to a user.

20. The system of claim 16,

wherein the processor receives signals, determines values of the polysomnographic physiological parameter set and the non-polysomnographic physiological parameter set, identifies sleep states based on values of the polysomnographic physiological parameter set and, subsequent to determining the values of the non-polysomnographic physiological parameter set and identifying the sleep states, correlates the values of non-polysomnographic physiological parameter set with sleep states identified based on the values of the polysomnographic physiological parameter set for each of a plurality of subjects, and

wherein the processor, subsequent to correlating the recorded values to the identified sleep states, analyzes the correlated values for the plurality of subjects, and, subsequent to analyzing the correlated values, calculates the relationship based on the analysis for the plurality of subjects.

21. The system of claim 20, wherein the plurality of subjects comprises a first plurality of subjects, and, for each of a second plurality of subjects, the processor identifies sleep states during a period of time based on polysomnography, records values of a non-polysomnographic physiological parameter set during the period of time, and, subsequent to recording the values of the non-polysomnographic physiological parameter set, applies the relationship to the recorded values to identify sleep states during the period of time, and

wherein the processor, subsequent to applying the relationship, compares the identification of sleep states based on polysomnography to the identification of sleep states by application of the relationship, and, subsequent to comparing the identifications, modifies the relationship based on the comparison.

22. The system of claim 16, wherein the relationship comprises at least one of a threshold, an equation, a look-up table, or a neural network.

23. The system of claim 16, wherein first plurality of sensors include at least one of sensors that sense brain electrical activity, sensors that sense eye motion, or sensors that sense jaw or neck muscle activity or tension.

24. The system of claim 16, wherein the second plurality of sensors includes at least one of sensors that sense posture, sensors that sense activity level, sensors that sense heart rate, sensors that sense respiration rate, sensors that sense respiratory volume, sensors that sense blood oxygen saturation, sensors that sense blood pressure, sensors that sense electrocardiogram (ECG) morphology, sensors that sense core temperature, sensors that sense partial pressure of oxygen within blood, sensors that sense partial pressure of oxygen within cerebral spinal fluid, sensors that sense pH of blood or cerebral spinal fluid, sensors that sense glucose level in blood or cerebral spinal fluid, sensors that sense protein marker of pain within cerebral spinal fluid or subcutaneous extracellular fluid, sensors that sense muscular activity, sensors that sense muscular tone, sensors that sense arterial blood flow, or sensors that sense galvanic skin response.

25. The system of claim 16, wherein at least one of the second plurality of sensors is located proximate to an implantable medical device implant location.

26. The system of claim 16, further comprising an external data recorder that receives signals from the second plurality of sensors, and provides the received signals to the processor.

27. The system of claim 26, wherein the period of time is a first period of time, the external data recorder receives signals from the sensors during the first period of time, stores the signals in a memory, and provides the stored signals to the processor during a second period of time.

28. The system of claim 27, further comprising a device that includes the processor, wherein the memory is a removable memory that is receivable by the device that includes the processor for provision of the stored signals to the processor.

29. The system of claim 26, wherein the external data recorder is configured to be worn by the subject, includes a housing, and includes at least one of the second plurality of sensors within the housing.

30. The system of claim 29, wherein the external data recorder includes a three-axis accelerometer.

31. The system of claim 26, wherein the external data recorder comprises first external data recorder, the system further comprising a second external data recorder that receives signals from the first plurality of sensors, and provides the received signals to the processor.

32. The system of claim 16, further comprising a computer that includes the processor.

33. A system comprising:

means for identifying sleep states of a subject during a period of time based on polysomnography;

means for recording values of a non-polysomnographic physiological parameter set of the subject during the period of time;

means for correlating the recorded values of the non-polysomnographic physiological parameter set to the sleep states identified by polysomnography during the period of time subsequent to identifying the sleep states and recording the values of the non-polysomnographic physiological parameter set;

means for analyzing the correlated values of the non-polysomnographic physiological parameter set subsequent to correlating the recorded values to the identified sleep states;

means for calculating a relationship between values of the non-polysomnographic physiological parameter set and sleep states based on the analysis subsequent to analyzing the correlated values; and

means for storing the relationship between values of the non-polysomnographic physiological parameter set and sleep states in a medical device to determining the relationship wherein the medical device is configured to apply the relationship to a non-polysomnographic physiological parameter to identify sleep states based on the relationship.

34. The system of claim 33, wherein the means for identifying sleep states comprises means for identifying sleep states for each of a plurality of subjects during respective periods of time, the means for recording comprises means for recording values of the non-polysomnographic physiological parameter set for each of the plurality of subjects during the respective periods of time, the means for correlating comprises means for correlating the values of the non-polysomnographic physiological parameter set recorded during the respective periods of time for each of the subjects to the sleep states identified by polysomnography during the respective periods of time for each of the subjects subsequent to identifying the sleep states and recording the values of the non-polysomnographic physiological parameter set during the respective periods of time for each of the subjects, the means for analyzing comprises means for analyzing the correlated values for each of the plurality of subjects subsequent to correlating the recorded values to the identified sleep states for each of the subjects, and the means for calculating a relationship comprises means for calculating the relationship based on the analysis for the plurality of subjects subsequent to analyzing the correlated values for each of the subjects.

35. A non-transitory computer-readable medium comprising instructions that cause a programmable processor to:

identify sleep states of a subject during a period of time based on polysomnography;

record values of a non-polysomnographic physiological parameter set of the subject during a period of time;

subsequent to identifying the sleep states and recording the values of the non-polysomnographic physiological parameter set, correlate the recorded values of the non-polysomnographic physiological parameter set to the sleep states identified by polysomnography during the period of time;

subsequent to correlating the recorded values to the identified sleep states, analyze the correlated values of the non-polysomnographic physiological parameter set;

subsequent to analyzing the correlated values, calculate a relationship that relates values of the non-polysomnographic physiological parameter set to sleep states based on the analysis; and

subsequent to calculating the relationship, store the relationship between values of the non-polysomnographic physiological parameter set and sleep states in a medical device, wherein the medical device is configured to apply the relationship to a non polysomnographic physiological parameter to identify sleep states based on the relationship.

36. The non-transitory computer-readable medium of claim 35,

wherein the instructions that cause a programmable processor to identify sleep states, record values of a non-polysomnographic physiological parameter set, and correlate the recorded values to the sleep states comprise instructions that cause a programmable processor to identify sleep states, record values of the non-polysomnographic physiological parameter set, and, subsequent to identifying the sleep states and recording the values of the non-polysomnographic physiological parameter set, correlate the recorded values to the sleep states for each of a plurality of subjects, and

wherein the instructions that cause a programmable processor to analyze the correlated values and calculate a relationship based on the analysis comprise instructions that cause a programmable processor to, subsequent to correlating the recorded values to the identified sleep states, analyze the correlated values for the plurality of subjects and calculate the relationship based on the analysis.