Determination of sleep quality for neurological disorders

• US 20070123758A1
• Filed: 10/31/2006
• Published: 05/31/2007
• Est. Priority Date: 03/16/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: LaPorte, Steve, Heruth, Kenneth, Graves, Nina, Miesel, Keith, Werder, Jonathan
• Granted Patent: US 8,725,244 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/372 Analysis of electroencephalograms
• 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 5/6814 Head
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• 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 1/36025 : for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36064 : Epilepsy
• CPC Class Codes: A61N 1/36067 : Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36071 : Pain
• CPC Class Codes: A61N 1/36082 : Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36135 : using physiological parameters
• 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
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means

Abstract

A device determines values for one or more metrics that indicate the quality of a patient'"'"'s sleep based on sensed physiological parameter values. Sleep efficiency, sleep latency, and time spent in deeper sleep states are example sleep quality metrics for which values may be determined. The sleep quality metric values may be used, for example, to evaluate the effectiveness of a therapy delivered to the patient by a medical device. In some embodiments, determined sleep quality metric values are automatically associated with the therapy parameter sets according to which the medical device delivered the therapy when the physiological parameter values were sensed, and used to evaluate the effectiveness of the various therapy parameter sets. The medical device may deliver the therapy to treat a non-respiratory neurological disorder, such as epilepsy, a movement disorder, or a psychological disorder. The therapy may be, for example, deep brain stimulation (DBS) therapy.

Claims

1. A method comprising:

delivering a therapy from a medical device to a patient to treat a non-respiratory neurological disorder of the patient;

sensing at least one physiological parameter signal during treatment of the patient with the medical device;

determining values of a sleep quality metric based on the at least one physiological parameter signal; and

providing the sleep quality metric values to a user for evaluation of the therapy.

2. The method of claim 1, wherein sensing at least one physiological parameter signal comprises sensing at least one of electrical activity of a brain of the patient or electroencephalogram morphology, and at least one of activity level, posture, heart rate, electrocardiogram morphology, or core temperature.

3. The method of claim 1, wherein sensing at least one physiological parameter signal comprises sensing at least one signal via a lead implanted in a brain of the patient.

4. The method of claim 1, wherein the sleep quality metric comprises at least one of sleep efficiency or sleep latency.

5. The method of claim 1, wherein determining values of the sleep quality metric comprises at least one of determining an amount of time that the patient is asleep during a period, or identifying a number of arousal events during a period of sleep.

6. The method of claim 1, wherein determining values of the sleep quality metric comprises determining an amount of time that the patient was within at least one of an S3 sleep state or an S4 sleep state.

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

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

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

8. The method of claim 1, wherein providing the sleep quality metric values to a user comprises presenting a graphical representation of the sleep quality metric.

9. The method of claim 8, wherein presenting a graphical representation comprises presenting at least one of a trend diagram, a histogram, or a pie chart based on the plurality of values of the sleep quality metric.

10. The method of claim 1, further comprising presenting a message related to sleep quality to the patient via a patient programmer based on the sleep quality metric values.

11. The method of claim 1, wherein delivering therapy comprises delivering therapy according to a plurality of therapy parameter sets, the method further comprising:

associating each of the determined sleep quality metric values with the one of the therapy parameter sets according to which the therapy was delivered when the signal based on which the sleep quality metric value was determined was sensed; and

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.

12. The method of claim 11, further comprising:

presenting a list of the therapy parameter sets and the associated representative values to a user; and

ordering the list of therapy parameter sets according to the associated representative values.

13. The method of claim 11, further comprising selecting one of the therapy parameter sets for delivery of therapy based on the associated sleep quality metric values.

14. The method of claim 1, wherein delivering therapy comprises delivering therapy according to a plurality of therapy parameter sets, the method further comprising:

determining a plurality of values over time for each of a plurality of sleep quality metrics based on the at least one physiological parameter signal;

associating each of the determined sleep quality metric values with the one of the therapy parameter sets according to which the therapy was delivered when the signal based on which the sleep quality metric value was determined was sensed; and

for each of the therapy parameter sets, determining a representative value for each of the sleep quality metrics based on the values of that sleep quality metric associated with the therapy parameter set.

15. The method of claim 14, further comprising:

presenting a list of the therapy parameter sets and the associated representative values to a user; and

ordering the list of therapy parameter sets according to the representative values of a user-selected one of the sleep quality metrics.

16. The method of claim 1, further comprising modifying the therapy based on the sleep quality metric values.

17. The method of claim 1, wherein delivering a therapy comprises delivering at least one of an epilepsy therapy, a movement disorder therapy, or a psychological disorder therapy.

18. The method of claim 1, wherein delivering a therapy comprises delivering deep brain stimulation (DBS).

19. A medical system comprising:

a medical device that delivers a therapy to a patient to treat a non-respiratory neurological disorder of the patient; and

a processor that determines values of a sleep quality metric based on at least one physiological parameter signal sensed during treatment of the patient with the medical device, and provides the sleep quality metric values to a user for evaluation of the therapy.

20. The medical system of claim 19, wherein the processor determines values of the sleep quality metric based on at least one of electrical activity of a brain of the patient or electroencephalogram morphology, and at least one of activity level, posture, heart rate, electrocardiogram morphology, or core temperature.

21. The medical system of claim 19, further comprising a lead coupled to the medical device and implanted in the brain of the patient, wherein the processor determines values of the sleep quality metric based on at least one signal sensed via the lead.

22. The medical system of claim 19, wherein the sleep quality metric comprises at least one of sleep efficiency or sleep latency.

23. The medical system of claim 19, wherein the sleep quality metric comprises at least one of an amount of time that the patient is asleep during a period, or a number of arousal events during a period of sleep.

24. The medical system of claim 19, wherein the sleep quality metric comprises an amount of time that the patient was within at least one of an S3 sleep state or an S4 sleep state.

25. The medical system of claim 19, wherein the processor determines values of each of a plurality of sleep quality metrics, and determines values of an overall sleep quality metric based on the values of the plurality of sleep quality metrics.

26. The medical system of claim 19, further comprising a user interface that presents a graphical representation of the values of the sleep quality metric.

27. The medical system of claim 26, wherein the graphical representation comprises at least one of a trend diagram, a histogram, or a pie chart.

28. The medical system of claim 19, further comprising a user interface that provides a message related to sleep quality to the patient based on the sleep quality metric values.

29. The medical system of claim 19,

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

wherein the processor associates each of the determined sleep quality metric values with the one of the therapy parameter sets according to which the therapy was delivered when the signal based on which the sleep quality metric value was determined was sensed, and, for each of a plurality of therapy parameter sets, determines a representative value of the sleep quality metric based on the values of the sleep quality metric associated with the therapy parameter set.

30. The medical system of claim 29, further comprising a user interface that presents a list of the therapy parameter sets ordered according to the associated representative values.

31. The medical system of claim 29, wherein the processor selects one of the therapy parameter sets for delivery of therapy by the medical device based on the associated sleep quality metric values.

32. The medical system of claim 19,

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

wherein the processor determining a plurality of values over time for each of a plurality of sleep quality metrics based on the at least one physiological parameter signal, associates each of the determined sleep quality metric values with the one of the therapy parameter sets according to which the therapy was delivered when the signal based on which the sleep quality metric value was determined was sensed, and, for each of the therapy parameter sets, determines a representative value for each of the sleep quality metrics based on the values of that sleep quality metric associated with the therapy parameter set.

33. The medical system of claim 32, further comprising a user interface that presents a list of the therapy parameter sets and the associated representative values ordered according to the representative values of a user-selected one of the sleep quality metrics.

34. The medical system of claim 19, wherein the processor modifies the therapy based on the sleep quality metric values.

35. The medical system of claim 19, wherein the medical device delivers at least one of an epilepsy therapy, a movement disorder therapy, or a psychological disorder therapy.

36. The medical system of claim 19, wherein the medical device is coupled to a lead implanted within the brain and delivers deep brain stimulation (DBS) via the lead.

37. The medical system of claim 36, wherein the medical device is configured for implantation beneath a scalp of the patient.

38. The medical system of claim 19, wherein the processor is housed within the medical device.

39. A method comprising:

delivering deep brain stimulation (DBS) therapy from a medical device to a patient via a lead implanted in a brain of the patient;

sensing at least one physiological parameter signal during treatment of the patient with the medical device;

determining values of a sleep quality metric based on the at least one physiological parameter signal; and

providing the sleep quality metric values to a user for evaluation of the DBS therapy.

40. The method of claim 39, wherein sensing at least one physiological parameter signal comprises sensing at least one of electrical activity of the brain or electroencephalogram morphology via the lead, and at least one of activity level, posture, heart rate, electrocardiogram morphology, or core temperature.

41. The method of claim 39, wherein delivering DBS therapy comprises delivering DBS therapy according to a plurality of therapy parameter sets, the method further comprising:

associating each of the determined sleep quality metric values with the one of the therapy parameter sets according to which the therapy was delivered when the signal based on which the sleep quality metric value was determined was sensed; and

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.

42. The method of claim 39, wherein delivering DBS therapy comprises delivering DBS to treat at least one of epilepsy, a movement disorder, or a psychological disorder.

43. A medical system comprising

a lead implanted in a brain of a patient;

a medical device coupled to the lead that delivers deep brain stimulation (DBS) therapy to the patient via the lead; and

a processor that determines values of a sleep quality metric based on at least one physiological parameter signal sensed during treatment of the patient with the medical device, and provides the sleep quality metric values to a user for evaluation of the DBS therapy.

44. The medical system of claim 43, wherein the at least one physiological parameter signal comprises electrical activity of the brain sensed via the lead, and at least one of activity level, posture, heart rate, electrocardiogram morphology, or core temperature.

45. The medical system of claim 43,

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

the processor associates each of the determined sleep quality metric values with the one of the therapy parameter sets according to which the therapy was delivered when the signal based on which the sleep quality metric value was determined was sensed, and, for each of a plurality of therapy parameter sets, determines a representative value of the sleep quality metric based on the values of the sleep quality metric associated with the therapy parameter set.

46. The medical system of claim 43, wherein the medical device delivers DBS to treat at least one of epilepsy, a movement disorder, or a psychological disorder.

47. The medical system of claim 43, wherein the medical device is configured for implantation beneath a scalp of the patient.