Collecting activity and sleep quality information via a medical device

• US 7,491,181 B2
• Filed: 04/15/2004
• Issued: 02/17/2009
• Est. Priority Date: 03/16/2004
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heruth, Kenneth T., Miesel, Keith A.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US10/825,955
• Publication Number:
  US 20050209511A1
• Time in Patent Office: 1,769 Days
• Field of Search: 600/595, 600/594, 600/587, 607/19
• US Class Current: 600/595
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

A device, such as an implantable medical device (IMD) or a programming device, determines when a patient is attempting to sleep. When the device determines that the patient is attempting to sleep, the device determines values for one or more metrics that indicate the quality of a patient'"'"'s sleep based on at least one physiological parameter of the patient. When the device determines that the patient is not attempting to sleep, the device periodically determines activity levels of the patient. Activity metric values may be determined based on the determined activity levels. A clinician may use sleep quality information and patient activity information presented by a programming device to, for example, evaluate the effectiveness of therapy delivered to the patient by the medical device.

Claims

1. A method comprising:

monitoring a plurality of physiological parameters of a patient via a medical device, wherein the plurality of physiological parameters includes at least one parameter indicative of patient physical activity monitored via at least one accelerometer;

determining when the patient is attempting to sleep;

determining when the patient is asleep based on at least one of the physiological parameters;

determining values of at least one sleep quality metric that is indicative of sleep quality based on at least one of when the patient is attempting to sleep, when the patient is asleep, or values of at least one of the physiological parameters when the patient is asleep;

periodically determining an activity level of the patient based on the at least one of the physiological parameters indicative of patient physical activity that is monitored via the at least one accelerometer; and

determining a value of at least one activity metric based on activity levels determined when the patient is not attempting to sleep.

2. The method of claim 1, wherein determining when the patient is attempting to sleep comprises receiving an indication from the patient that the patient is attempting to sleep.

3. The method of claim 1, wherein monitoring a plurality of physiological parameters comprises monitoring at least one signal that indicates posture of the patient, and determining when the patient is attempting to sleep comprises determining when the patient is recumbent.

4. The method of claim 3,

wherein the at least one accelerometer comprises a plurality of orthogonally aligned accelerometers, and

wherein monitoring at least one signal comprises monitoring a signal from each of the plurality of orthogonally aligned accelerometers, and determining when the patient is recumbent comprises determining when the patient is recumbent based on a DC component of each of the signals.

5. The method of claim 1, wherein determining when the patient is attempting to sleep comprises determining when the patient is attempting to sleep based on the activity levels of the patient.

6. The method of claim 5, wherein determining when the patient is attempting to sleep based on the activity levels comprises:

comparing the activity levels to an activity level threshold; and

comparing an amount of time that the activity levels remains substantially below the activity level threshold to a time threshold.

7. The method of claim 1, wherein monitoring a plurality of physiological parameters comprising monitoring a level of melatonin within a bodily fluid, and determining when the patient is attempting to sleep comprises determining when the patient is attempting to sleep based on the melatonin level.

8. The method of claim 1, wherein monitoring a plurality of physiological parameters comprises monitoring at least one of posture, heart rate, respiration rate, respiratory volume, or core temperature.

9. The method of claim 1, wherein monitoring a plurality of physiological parameters comprises monitoring at least one of blood pressure, blood oxygen saturation, partial pressure of oxygen within blood, partial pressure of oxygen within cerebrospinal fluid, muscular activity, arterial blood flow, or galvanic skin response.

10. The method of claim 1, wherein the sleep quality metric comprises sleep efficiency, and determining values of the sleep quality metric comprises

determining a percentage of time that the patient is asleep while the patient is attempting to sleep.

11. The method of claim 1, wherein the sleep quality metric comprises sleep latency, and determining values of the sleep quality metric comprises:

identifying a first time when the patient is attempting to fall asleep;

identifying a second time when the patient falls asleep; and

determining an amount of time between the first and second times.

12. The method of claim 1, wherein determining values of the sleep quality metric comprises

determining an amount of time that the patient is asleep during a period.

13. The method of claim 1, wherein determining values of the sleep quality metric comprises

identifying at least one of a number of arousal events and a number of apnea events during a period of sleep.

14. The method of claim 1, wherein determining values of the sleep quality metric comprises:

identifying when the patient is within a sleep state based on at least one of the physiological parameters; and

determining an amount of time that the patient was within the sleep state.

15. The method of claim 14, wherein the sleep state comprises at least one of an S3 sleep state and an S4 sleep state.

16. The method of claim 1, wherein determining a value of an activity metric comprises determining at least one of a mean and a median of determined activity levels.

17. The method of claim 16, wherein determining a value of an activity metric comprises:

comparing the at least one of the mean and the median activity level to at least one threshold; and

selecting the activity metric value from a plurality of predetermined possible activity metric values based on the comparison.

18. The method of claim 1, wherein determining a value of an activity metric comprises:

comparing each of the activity levels to a threshold value; and

determining at least one of a percentage of time above the threshold and a percentage of time below the threshold.

19. The method of claim 1, wherein determining a value of an activity metric comprises:

comparing each of the activity levels to a threshold value; and

determining an average length of time that consecutively determined activity levels were above the threshold.

20. The method of claim 1, wherein periodically determining an activity level comprises periodically determining a number of activity counts.

21. The method of claim 1, wherein the medical device delivers a therapy to the patient according to a plurality of therapy parameter sets, the method further comprising:

associating each of the determined sleep quality metric values and each of the determined activity levels with one or more of the plurality of therapy parameter sets that was used by the medical device to deliver therapy when that value or level was determined;

for each of the plurality of therapy parameter sets, determining a representative value of each of the at least one sleep quality metric based on the sleep quality metric values associated with the therapy parameter set; and

for each of the plurality of therapy parameter sets, determining at least one activity metric value based on the activity levels associated with the therapy parameter set.

22. The method of claim 21, further comprising presenting a list of the therapy parameter sets, associated representative sleep quality metric values, and associated activity metric values.

23. The method of claim 22, further comprising ordering the list of therapy parameter sets according to values of a user selected one of the sleep quality metrics and activity metrics.

24. The method of claim 1, wherein the medical device comprises an implantable medical device.

25. The method of claim 24, wherein the implantable medical device comprises at least one of an implantable neurostimulator and an implantable drug pump.

26. The method of claim 1, wherein the medical device comprises at least one of a trial neurostimulator and a trial pump.

27. The method of claim 1, further comprising indicating efficacy of a pain therapy based on the values of the at least one sleep quality metric and the value of the at least one activity metric.

28. The method of claim 1, further comprising indicating efficacy of spinal cord stimulation based on the values of the at least one sleep quality metric and the value of the at least one activity metric.