COLLECTING ACTIVITY AND SLEEP QUALITY INFORMATION VIA A MEDICAL DEVICE

• US 20090118599A1
• Filed: 01/09/2009
• Published: 05/07/2009
• Est. Priority Date: 03/16/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heruth, Kenneth T., Miesel, Keith A.
• Granted Patent: US 8,337,431 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• 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 medical system comprising:

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

a processor that determines when the patient is attempting to sleep, determines when the patient is asleep based on at least one of the physiological parameters, determines 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 determines an activity level of the patient based on the at least one of the physiological parameters indicative of patient physical activity that is monitored by the medical device via the at least one accelerometer, and determines a value of at least one activity metric based on activity levels determined when the patient is not attempting to sleep.

2. The medical system of claim 1, wherein the processor receives an indication from the patient that the patient is attempting to sleep, and determines when the patient is attempting to sleep based on the indication.

3. The medical system of claim 1, wherein the medical device monitors at least one signal that indicates posture of the patient, and the processor determines when the patient is recumbent based on the at least one signal that indicates posture of the patient to determine when the patient is attempting to sleep.

4. The medical system of claim 1, wherein the processor determines when the patient is attempting to sleep based on the activity levels of the patient.

5. The medical system of claim 4, wherein the processor compares the activity levels to an activity level threshold, and compares an amount of time that the activity levels remain substantially below the activity level threshold to a time threshold to determine when the patient is attempting to sleep.

6. The medical system of claim 1, wherein the sleep quality metric comprises sleep efficiency, and the processor determines a percentage of time that the patient is asleep while the patient is attempting to sleep as a value of the sleep quality metric.

7. The medical system of claim 1, wherein the sleep quality metric comprises sleep latency, and the processor identifies a first time when the patient is attempting to fall asleep, identifies a second time when the patient falls asleep, and determines an amount of time between the first and second times as a value of the sleep quality metric.

8. The medical system of claim 1, wherein the processor determines an amount of time that the patient is asleep during a period as a value of the sleep quality metric.

9. The medical system of claim 1, wherein the processor identifies at least one of a number of arousal events or a number of apnea events during a period of sleep as a value of the sleep quality metric.

10. The medical system of claim 1, wherein the processor identifies when the patient is within a sleep state based on at least one of the physiological parameters, and determines an amount of time that the patient was within the sleep state as a value of the sleep quality metric.

11. The medical system of claim 10, wherein the sleep state comprises at least one of an S3 sleep state or an S4 sleep state.

12. The medical system of claim 1, wherein the processor determines at least one of a mean or a median of activity levels determined when the patient is not attempting to sleep as an activity metric value.

13. The medical system of claim 1, wherein the processor compares at least one of a mean or a median of activity levels determined when the patient is not attempting to sleep to at least one threshold, and selects the activity metric value from a plurality of predetermined possible activity metric values based on the comparison.

14. The medical system of claim 1, wherein the processor compares each of the activity levels determined when the patient is not attempting to sleep to a threshold value, and determines at least one of a percentage of time above the threshold or a percentage of time below the threshold as an activity metric value.

15. The medical system of claim 1, wherein the processor compares each of the activity levels determined when the patient is not attempting to sleep to a threshold value, and determines an average length of time that consecutively determined activity levels were above the threshold as an activity metric value.

16. The medical system of claim 1 wherein the processor periodically determines an activity level by periodically determining a number of activity counts.

17. The medical system of claim 1,

wherein the medical device delivers a therapy to the patient according to a plurality of therapy parameter sets,

wherein the processor associates each of the determined sleep quality metric values and each of the activity levels determined when the patient is not attempting to sleep 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,

wherein, for each of the plurality of therapy parameter sets, the processor determines 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

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

18. The medical system of claim 17, further comprising a programming device including a display that presents a list of the therapy parameter sets, associated representative sleep quality metric values, and associated activity metric values.

19. The medical system of claim 18, wherein the programming device receives user selection of one of the sleep quality metrics or the activity metric, and orders the list of therapy parameter sets according to values of the user selected one of the sleep quality metrics or activity metric.

20. The medical system of claim 17, wherein the therapy comprises a pain therapy.

21. The medical system of claim 20, wherein the therapy comprises spinal cord stimulation.

22. The medical system of claim 1, wherein the processor comprises a processor of the medical device.

23. The medical system of claim 1, further comprising a programming device, wherein the processor comprises a processor of the programming device.

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

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

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

27. A medical system comprising:

means for 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;

means for determining when the patient is attempting to sleep;

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

means for 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;

means for 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

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

28. The medical system of claim 27, wherein the means for determining when the patient is attempting to sleep comprises means for receiving an indication from the patient that the patient is attempting to sleep.

29. The medical system of claim 27,

wherein the means for monitoring a plurality of physiological parameters comprises means monitoring at least one signal that indicates posture of the patient, and

wherein the means for determining when the patient is attempting to sleep comprises means for determining when the patient is recumbent.

30. The medical system of claim 27, wherein the means for determining when the patient is attempting to sleep comprises means for determining when the patient is attempting to sleep based on the activity levels of the patient.

31. The medical system of claim 27, further comprising:

means for delivering a therapy to the patient according to a plurality of therapy parameter sets;

means for 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;

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

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

32. The medical system of claim 31, further comprising means for presenting a list of the therapy parameter sets, associated representative sleep quality metric values, and associated activity metric values.

33. The medical system of claim 27, further comprising means for 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.

34. The medical system of claim 27, 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.

35. A medical system comprising:

an implantable medical device comprising at least one accelerometer, wherein the implantable medical device delivers a therapy to a patient based on a plurality of therapy parameter sets, monitors a plurality of physiological parameters of the patient including at least one parameter indicative of patient physical activity monitored via the at least one accelerometer, determines when the patient is attempting to sleep, determines when the patient is asleep, determines 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 determines 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, associates each determined sleep quality metric value and each determined activity level 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, determines a representative value of each of the at least one sleep quality metric for each of the plurality of therapy parameter sets based on the sleep quality metric values associated with the therapy parameter set, and determines at least one activity metric value for each of the plurality of therapy parameter sets based on the activity levels associated with the therapy parameter set; and

an external programming device including a display that receives information identifying the plurality of therapy parameter sets and the sleep quality metric values and activity metric values associated with the therapy parameter sets from the implantable medical device, and presents a list of the therapy parameter sets and the associated sleep quality metric values and activity metric values to a user.

36. The medical system of claim 35, wherein the programming device includes a user interface, receives a selection of one of the sleep quality metric or the activity metric from a user via the user interface, and orders the list of therapy parameter sets according to the values of the selected sleep quality metric or activity metric.

37. The medical system of claim 35, wherein the implantable medical device comprises at least one of an implantable neurostimulator or an implantable drug pump.

38. A computer-readable medium comprising instructions that cause a programmable processor to:

monitor 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;

determine when the patient is attempting to sleep;

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

determine 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 determine 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

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