Collecting sleep quality information via a medical device

• US 8,758,242 B2
• Filed: 03/12/2010
• Issued: 06/24/2014
• Est. Priority Date: 03/16/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miesel, Keith A., Heruth, Kenneth T.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): BERHANU, ETSUB D
• Application Number:
  US12/723,501
• Publication Number:
  US 20100174155A1
• Time in Patent Office: 1,565 Days
• Field of Search: 600/300, 600/301, 600/481, 600/544
• US Class Current: 600/301
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• 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 5/4815 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: 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 1/36078 Inducing or controlling sleep or relaxation non-implantable stimulator A61M21/00
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• 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 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means

Abstract

At least one of a medical device, such as an implantable medical device, and a programming device determines values for one or more metrics that indicate the quality of a patient'"'"'s sleep. Sleep efficiency, sleep latency, and time spent in deeper sleep states are example sleep quality metrics for which values may be determined. In some embodiments, determined sleep quality metric values are associated with a current therapy parameter set. In some embodiments, a programming device presents sleep quality information to a user based on determined sleep quality metric values. A clinician, for example, may use the sleep quality information presented by the programming device to evaluate the effectiveness of therapy delivered to the patient by the medical device, to adjust the therapy delivered by the medical device, or to prescribe a therapy not delivered by the medical device in order to improve the quality of the patient'"'"'s sleep.

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;

determining, with a processor of the medical device or a processor of a computing device configured to communicate with the medical device, a plurality of scalable values of a metric that is indicative of sleep quality over time, each of the scalable values of the sleep quality metric determined based on values of the at least one physiological parameter that were determined during delivery of the therapy according to at least one of a plurality of therapy parameter sets;

for each of the plurality of scalable sleep quality metric values, identifying, with the processor of the medical device or the processor of the computing device, at least one of the plurality of therapy parameter sets used to deliver the therapy by the medical device when the sleep quality metric value was determined;

associating, with the processor of the medical device or the processor of the computing device, each of the determined values of the scalable sleep quality metric values with the at least one of the plurality of therapy parameter sets;

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

for each of the plurality of therapy parameter sets, storing, with the processor of the medical device or the processor of the computing device, the representative value of the sleep quality metric in a non-transitory memory.

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, and 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, and 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 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.

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 and 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 and an S4 sleep state.

10. The method of claim 1, wherein determining a value of the sleep quality metric 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 scalable 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 scalable sleep quality metric values.

12. The method of claim 1, further comprising presenting sleep quality information to a user based on the plurality of scalable sleep quality metric values.

13. The method of claim 12, wherein presenting sleep quality information to the user comprises presenting a graphical representation of the plurality of scalable sleep quality metric values.

14. The method of claim 13, wherein presenting a graphical representation comprises presenting at least one of a trend diagram, a histogram and a pie chart based on the plurality of scalable values of the sleep quality metric.

15. The method of claim 12, wherein presenting sleep quality information to a user comprises presenting a message related to sleep quality to the patient via a patient programmer.

16. The method of claim 1, 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.

17. The method of claim 1, 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.

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

19. The method of claim 18, wherein the implantable medical device comprises at least one of an implantable neurostimulator and an implantable drug pump.

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

21. The method of claim 1, further comprising:

delivering the therapy to the patient;

wherein monitoring at least one physiological parameter of the patient via the medical device comprises monitoring a plurality of signals, each of the signals generated by a sensor as a function of the at least one physiological parameter of the patient;

identifying when the patient is attempting to sleep; and

identifying when the patient is asleep based on at least one of the signals, wherein determining the plurality of scalable values of the metric that is indicative of sleep quality over time is based on the identifications of when the patient is attempting to sleep and when the patient is asleep.

22. The method of claim 21, wherein identifying when the patient is attempting to sleep comprises receiving an indication from the patient that the patient is attempting to sleep.

23. The method of claim 21, wherein monitoring a plurality of signals comprises monitoring at least one signal that indicates posture of the patient, and identifying when the patient is attempting to sleep comprises identifying when the patient is recumbent.

24. The method of claim 23, wherein monitoring a plurality of signals comprises monitoring a signal from each of a plurality of orthogonally aligned accelerometers, and identifying when the patient is recumbent comprises identifying when the patient is recumbent based on a DC component of each of the signals.

25. The method of claim 21, wherein monitoring a plurality of signals comprises monitoring at least one signal that varies as a function of activity of the patient, and wherein identifying when the patient is attempting to sleep comprises identifying when the patient is attempting to sleep based on an activity level of the patient.

26. The method of claim 21, wherein identifying when the patient is asleep comprises identifying when the patient is asleep based on at least one of activity level, heart rate, respiration rate, respiratory volume, and core temperature.

27. The method of claim 21, wherein identifying when the patient is asleep comprises identifying when the patient is asleep based on 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, and galvanic skin response.

28. The method of claim 21, wherein the sleep quality metric comprises sleep efficiency, and determining the value of the sleep quality metric comprises determining a percentage of time that the patient is asleep while the patient is attempting to sleep.

29. The method of claim 21, 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.

30. The method of claim 21, further comprising:

determining the plurality of scalable values of the sleep quality metric over time; and

presenting sleep quality information to a user based on the plurality of scalable values.

31. The method of claim 30, wherein presenting sleep quality information to the user comprises presenting a graphical representation of the scalable sleep quality metric values.

32. The method of claim 31, wherein presenting a graphical representation comprises presenting at least one of a trend diagram, a histogram and a pie chart based on the plurality of scalable values of the sleep quality metric.

33. The method of claim 30, wherein presenting sleep quality information to a user comprises presenting a message related to sleep quality to the patient via a patient programmer.

34. The method of claim 1, wherein the representative values for each therapy parameter set comprises one of a mean or a median value.

35. A method comprising:

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

determining, with a processor of the medical device or a processor of a computing device configured to communicate with the medical device, a plurality of values of a metric that is indicative of sleep quality over time, each of the values of the sleep quality metric determined based on values of the at least one physiological parameter that were determined during delivery of the therapy according to at least one of a plurality of therapy parameter sets;

for each of the plurality of sleep quality metric values, identifying, with the processor of the medical device or the processor of the computing device, at least one of the plurality of therapy parameter sets used to deliver the therapy by the medical device when the sleep quality metric value was determined;

associating, with the processor of the medical device or the processor of the computing device, each of the determined values of the sleep quality metric values with the at least one of the plurality of therapy parameter sets;

for each of the plurality of therapy parameter sets, determining, with the processor of the medical device or the processor of the computing device, a representative value of the sleep quality metric based on the values of the sleep quality metric associated with the therapy parameter set;

for each of the plurality of therapy parameter sets, storing, with the processor of the medical device or the processor of the computing device, the representative value of the sleep quality metric in a non-transitory memory;

delivering the therapy to the patient,

wherein monitoring at least one physiological parameter of the patient via the medical device comprises monitoring a plurality of signals, each of the signals generated by a sensor as a function of the at least one physiological parameter of the patient;

identifying when the patient is attempting to sleep; and

identifying when the patient is asleep based on at least one of the signals, wherein determining the plurality of values of the metric that is indicative of sleep quality over time is based on the identifications of when the patient is attempting to sleep and when the patient is asleep, wherein monitoring a plurality of signals comprises monitoring a signal that varies as a function of a level of melatonin within bodily fluid of the patient, and identifying when the patient is attempting to sleep comprises identifying when the patient is attempting to sleep based the melatonin level.