Controlling therapy based on sleep quality

• US 7,366,572 B2
• Filed: 04/15/2004
• Issued: 04/29/2008
• 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.
• Primary Examiner(s): Layno; Carl
• Assistant Examiner(s): Gedeon; Brian T.
• Application Number:
  US10/825,953
• Publication Number:
  US 20050209643A1
• Time in Patent Office: 1,475 Days
• Field of Search: 600/26, 128/897, 607/2, 607/3, 607/63
• US Class Current: 607/48
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood

Abstract

A medical device, such as an implantable medical device (IMD), determines values for one or more metrics that indicate the quality of a patient'"'"'s sleep, and controls delivery of a therapy based on the sleep quality metric values. For example, the medical device may compare a sleep quality metric value with one or more threshold values, and adjust the therapy based on the comparison. In some embodiments, the medical device adjusts the intensity of therapy based on the comparison, e.g., increases the therapy intensity when the comparison indicates that the patient'"'"'s sleep quality is poor. In some embodiments, the medical device automatically selects one of a plurality of therapy parameter set available for use in delivering therapy based on a comparison sleep quality metric values associated with respective therapy parameter sets within the plurality of available therapy parameter sets.

Claims

1. A method comprising:

monitoring at least one physiological parameter of a patient via a medical device that delivers a therapy to the patient, wherein the therapy comprises electrical stimulation;

determining a value of a metric that is indicative of sleep quality based on the at least one physiological parameter;

comparing the sleep quality metric value to a threshold value; and

adjusting a therapy parameter within a specified range based on the comparison, wherein adjusting the therapy parameter comprises adjusting at least one of a pulse amplitude, pulse rate, pulse width or duty cycle of the stimulation.

2. The method of claim 1, wherein monitoring at least one physiological parameter comprises monitoring at least one of activity level, posture, heart rate, respiration rate, respiratory volume, or core temperature.

3. The method of claim 1, wherein monitoring at least one physiological parameter 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, melatonin level within a bodily fluid, or galvanic skin response.

4. The method of claim 1, wherein the sleep quality metric comprises sleep efficiency, and determining the value of the sleep quality metric comprises:

identifying when the patient is attempting to sleep;

identifying when the patient is asleep; and

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

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

identifying a first time when the patient begins attempting to sleep;

identifying a second time when the patient falls asleep; and

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

6. The method of claim 1, wherein determining the value of the sleep quality metric comprises:

identifying when the patient is asleep; and

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

7. The method of claim 1, wherein determining the value of the sleep quality metric comprises:

identifying when the patient is asleep; and

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

8. The method of claim 1, wherein determining the value of the sleep quality metric comprises:

identifying when the patient is within a sleep state; and

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

9. The method of claim 8, wherein the sleep state comprises at least one of an S3 sleep state or an S4 sleep state.

10. The method of claim 1, wherein determining a value of a metric that is indicative of sleep quality comprises:

determining a value of each of a plurality of sleep quality metrics; and

determining a value of an overall sleep quality metric based on the plurality of sleep quality metric values.

11. The method of claim 10, wherein determining a value of an overall sleep quality metric comprises applying a weighting factor to at least one of the plurality of sleep quality metric values.

12. The method of claim 1, wherein the sleep quality metric value comprises one of a mean or a median sleep quality metric value.

13. The method of claim 1, wherein the therapy comprises neurostimulation.

14. The method of claim 1, wherein the therapy comprises a therapeutic agent, and adjusting the therapy parameter comprises adjusting at least one of a dosage or an infusion rate for the therapeutic agent.

15. The method of claim 1, wherein the medical device delivers the therapy to the patient to treat chronic pain.

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

17. A medical device comprising:

a therapy module to deliver a therapy to a patient, wherein the therapy comprises electrical stimulation;

a memory to store a specified range for a therapy parameter; and

a processor configured to monitor at least one physiological parameter of a patient based on at least one signal received from at least one sensor, determine a value of a metric that is indicative of sleep quality based on the at least one physiological parameter, compare the sleep quality metric value to a threshold value, and adjust the therapy parameter within the specified range based on the comparison, wherein the processor adjusts at least one of a pulse amplitude, pulse rate, pulse width or duty cycle of the stimulation based on the comparison.

18. The medical device of claim 17, wherein the processor monitors at least one of activity level, posture, heart rate, respiration rate, respiratory volume, or core temperature.

19. The medical device of claim 17, wherein the processor monitors 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, melatonin level within a bodily fluid, or galvanic skin response.

20. The medical device of claim 17, wherein the sleep quality metric comprises sleep efficiency, and the processor identifies when the patient is attempting to sleep, identifies when the patient is asleep, and determines a percentage of time that the patient is asleep while the patient is attempting to sleep as the value of the sleep quality metric.

21. The medical device of claim 17, wherein the sleep quality metric comprises sleep latency, and the processor identifies a first time when the patient begins attempting to sleep, identifies a second time when the patient falls asleep, and determines an amount of time between the first and second times as the value of the sleep quality metric.

22. The medical device of claim 17, wherein the processor identifies when the patient is asleep, and determines an amount of time that the patient is asleep during a period as the value of the sleep quality metric.

23. The medical device of claim 17, wherein the processor identifies when the patient is asleep, and identifies at least one of a number of arousal events or a number of apnea events during a period of sleep as the value of the sleep quality metric.

24. The medical device of claim 17, wherein the processor identifies when the patient is within a sleep state, and determines an amount of time that the patient was within the sleep state as the value of the sleep quality metric.

25. The medical device of claim 24, wherein the sleep state comprises at least one of an S3 sleep state or an S4 sleep state.

26. The medical device of claim 17, wherein the processor determines a value of each of a plurality of sleep quality metrics, and determines a value of an overall sleep quality metric based on the plurality of sleep quality metric values.

27. The medical device of claim 26, wherein the processor applies a weighting factor to at least one of the plurality of sleep quality metric values to determine the value of the overall sleep quality metric.

28. The medical device of claim 17, wherein the sleep quality metric value comprises one of a mean or a median sleep quality metric value.

29. The medical device of claim 17, wherein the therapy module delivers a therapeutic agent, and the processor adjusts at least one of a dosage or an infusion rate for the therapeutic agent based on the comparison.

30. The medical device of claim 17, wherein the medical device comprises an implantable medical device.

31. The medical device of claim 30, wherein the implantable medical device comprises at least one of an implantable neurostimulator or an implantable pump.

32. The medical device of claim 17, wherein the medical device delivers the therapy to the patient to treat chronic pain.

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

monitor at least one physiological parameter of a patient via a medical device that delivers a therapy to the patient;

determine a plurality of values of a metric that is indicative of sleep quality over time based on the at least one physiological parameter;

associate each of the determined values of the sleep quality metric with a current therapy parameter set;

for each of the therapy parameter sets, determine a representative value of the sleep quality metric based on the values of the sleep quality metric associated with the therapy parameter set; and

automatically select one of the therapy parameter sets for delivery of the therapy based on the representative sleep quality metric values for the therapy parameter sets.

34. A method comprising:

monitoring at least one physiological parameter of a patient via a medical device that delivers a therapy to the patient;

determining a value of a metric that is indicative of sleep quality based on the at least one physiological parameter;

comparing the sleep quality metric value to a threshold value; and

adjusting the therapy in an amount proportional to at least one of a difference or a ratio between the sleep quality metric value and the threshold value.

35. The method of claim 34, wherein the medical device delivers the therapy to the patient to treat chronic pain.

36. The method of claim 34, wherein the medical device comprises at least one of an implantable neurostimulator or an implantable pump.

37. The method of claim 34, wherein the sleep quality metric comprises at least one of sleep latency or sleep efficiency.

38. A method comprising:

monitoring at least one physiological parameter of a patient via a medical device that delivers a therapy to the patient;

determining a value of a metric that is indicative of sleep quality based on the at least one physiological parameter;

comparing the sleep quality metric value to a threshold value; and

adjusting the therapy based on the comparison,

wherein adjusting the therapy comprises increasing the intensity of the therapy at a first rate and decreasing the intensity of the therapy at a second rate.

39. The method of claim 38, wherein the medical device delivers the therapy to the patient to treat chronic pain.

40. The method of claim 38, wherein the medical device comprises at least one of an implantable neurostimulator or an implantable pump.

41. The method of claim 38, wherein the sleep quality metric comprises at least one of sleep latency or sleep efficiency.

42. A method comprising:

monitoring at least one physiological parameter of a patient via a medical device that delivers a therapy to the patient;

determining a plurality of values of a metric that is indicative of sleep quality over time based on the at least one physiological parameter;

associating each of the determined values of the sleep quality metric with a current therapy parameter set;

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

automatically selecting one of the therapy parameter sets for delivery of the therapy based on the representative sleep quality metric values for the therapy parameter sets.

43. The method of claim 42, wherein the representative value for each of the therapy parameter sets comprises one of a mean value or a median value.

44. The method of claim 42, wherein the medical device delivers the therapy to the patient to treat chronic pain.

45. The method of claim 42, wherein the medical device comprises at least one of an implantable neurostimulator or an implantable pump.

46. The method of claim 42, wherein the sleep quality metric comprises at least one of sleep latency or sleep efficiency.

47. A medical device comprising:

a therapy module to deliver a therapy to a patient; and

a processor to monitor at least one physiological parameter of a patient based on at least one signal received from at least one sensor, determine a value of a metric that is indicative of sleep quality based on the at least one physiological parameter, compare the sleep quality metric value to a threshold value, and adjust the therapy in an amount proportional to at least one of a difference or a ratio between the sleep quality metric value and the threshold value.

48. The medical device of claim 47, wherein the medical device delivers the therapy to the patient to treat chronic pain.

49. The medical device of claim 47, wherein the medical device comprises at least one of an implantable neurostimulator or an implantable pump.

50. The medical device of claim 47, wherein the sleep quality metric comprises at least one of sleep latency or sleep efficiency.

51. A medical device comprising:

a therapy module to deliver a therapy to a patient; and

a processor to monitor at least one physiological parameter of a patient based on at least one signal received from at least one sensor, determine a value of a metric that is indicative of sleep quality based on the at least one physiological parameter, compare the sleep quality metric value to a threshold value, and adjust the therapy based on the comparison,

wherein the processor increases the intensity of the therapy at a first rate and decreases the intensity of the therapy at a second rate.

52. The medical device of claim 51, wherein the medical device delivers the therapy to the patient to treat chronic pain.

53. The medical device of claim 51, wherein the medical device comprises at least one of an implantable neurostimulator or an implantable pump.

54. The medical device of claim 51, wherein the sleep quality metric comprises at least one of sleep latency or sleep efficiency.

55. A medical device comprising:

a therapy module to deliver a therapy to a patient;

a memory to store information identifying a plurality of therapy parameter sets; and

a processor to monitor at least one physiological parameter of a patient based on at least one signal received from at least one sensor, determine a plurality of values of a metric that is indicative of sleep quality over time based on the at least one physiological parameter, associate each of the determined values of the sleep quality metric with a current one of the therapy parameter sets, for each of the therapy parameter sets, determine a representative value of the sleep quality metric based on the values of the sleep quality metric associated with the therapy parameter set, store the representative value of the sleep quality metric in association with the therapy parameter set within the memory, and automatically select one of the therapy parameter sets for delivery of the therapy based on the representative sleep quality metric values for the therapy parameter sets.

56. The medical device of claim 55, wherein the representative value for each therapy parameter set comprises one of a mean value or a median value.

57. The medical device of claim 55, wherein the medical device delivers the therapy to the patient to treat chronic pain.

58. The medical device of claim 55, wherein the medical device comprises at least one of an implantable neurostimulator or an implantable pump.

59. The medical device of claim 55, wherein the sleep quality metric comprises at least one of sleep latency or sleep efficiency.

60. A method comprising:

monitoring at least one physiological parameter of a patient via a medical device that delivers a therapy to the patient, wherein the therapy comprises a therapeutic agent;

determining a value of a metric that is indicative of sleep quality based on the at least one physiological parameter;

comparing the sleep quality metric value to a threshold value; and

adjusting a therapy parameter within a specified range based on the comparison, wherein adjusting the therapy parameter comprises adjusting at least one of a dosage or an infusion rate for the therapeutic agent.

61. A medical device comprising:

a therapy module to deliver a therapy to a patient, wherein the therapy module delivers a therapeutic agent;

a memory to store a specified range for a therapy parameter; and

a processor configured to monitor at least one physiological parameter of a patient based on at least one signal received from at least one sensor, determine a value of a metric that is indicative of sleep quality based on the at least one physiological parameter, compare the sleep quality metric value to a threshold value, and adjust the therapy parameter within the specified range based on the comparison, wherein processor adjusts at least one of a dosage or an infusion rate for the therapeutic agent based on the comparison.