Controlling therapy based on sleep quality

• US 7,590,455 B2
• Filed: 03/16/2005
• Issued: 09/15/2009
• 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.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/081,155
• Publication Number:
  US 20050215947A1
• Time in Patent Office: 1,644 Days
• Field of Search: 607/2, 607/3, 607/63, 600/26, 128/897
• 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;

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,

wherein monitoring at least one physiological parameter comprises monitoring at least one of electrocardiogram morphology, subcutaneous temperature, muscular tone, electrical activity of a brain of the patient or eye motion.

2. 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.

3. 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.

4. 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.

5. The method of claim 4, wherein the sleep state comprises at least one of an S3 sleep state and an S4 sleep state.

6. The method of claim 1, wherein controlling delivery of the therapy comprises:

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

adjusting the therapy based on the comparison.

7. The method of claim 6, wherein adjusting the therapy comprises adjusting the therapy in an amount proportional to at least one of a difference and a ratio between the sleep quality metric value and the threshold value.

8. The method of claim 6, 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.

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

10. 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,

wherein the processor monitors at least one of electrocardiogram morphology, subcutaneous temperature, muscular tone, electrical activity of a brain of the patient or eye motion.

11. The medical device of claim 10, 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, end 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.

12. The medical device of claim 10, 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.

13. The medical device of claim 10, 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.

14. The medical device of claim 13, wherein the sleep state comprises at least one of an S3 sleep state and art S4 sleep state.

15. The medical device of claim 10, wherein the processor compares the sleep quality metric value to a threshold value, and adjusts the therapy based on the comparison.

16. The medical device of claim 15, wherein the processor adjusts the therapy in an amount proportional to at least one of a difference and a ratio between the sleep quality metric value and the threshold value.

17. The medical device of claim 15, wherein the processor increases the intensity of the therapy at a first rate and decreases the intensity of the therapy at a second rate.

18. The medical device of claim 10, wherein the medical device comprises at least one of an implantable neurostimulator or an implantable pump.

19. The medical device of claim 10, wherein the medical device delivers the therapy to the patient to treat chronic pain.

20. 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 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,

wherein the instructions that cause a programmable processor to monitor at least one physiological parameter comprise instructions that cause a programmable processor to monitor at least one of electrocardiogram morphology, subcutaneous temperature, muscular tone, electrical activity of a brain of the patient or eye motion.

21. The medium of claim 20, wherein the instructions that cause a programmable processor to control delivery of the therapy comprise instructions that cause the programmable processor to:

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

adjust the therapy based on the comparison.

22. 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 or 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,

wherein monitoring at least one physiological parameter comprises monitoring at least one of electrocardiogram morphology, subcutaneous temperature, muscular tone, electrical activity of a brain of the patient or eye motion.

23. 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,

wherein monitoring at least one physiological parameter comprises monitoring at least one of electrocardiogram morphology, subcutaneous temperature, muscular tone, electrical activity of a brain of the patient or eye motion.

24. A method comprising:

monitoring at least one physiological parameter of a patient via a medical device tat 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,

wherein monitoring at least one physiological parameter comprises monitoring at least one of electrocardiogram morphology, subcutaneous temperature, muscular tone, electrical activity of a brain of the patient or eye motion.

25. 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,

wherein monitoring at least one physiological parameter comprises monitoring at least one of electrocardiogram morphology, subcutaneous temperature, muscular tone, electrical activity of a brain of the patient or eye motion.