Sleep quality data collection and evaluation

• US 8,915,741 B2
• Filed: 08/23/2011
• Issued: 12/23/2014
• Est. Priority Date: 08/18/2003
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hatlestad, John D., Ni, Quan, Stahmann, Jeffrey E., Hartley, Jesse, Zhu, Qingsheng, KenKnight, Bruce H., Daum, Douglas R., Lee, Kent
• Primary Examiner(s): Musselman, Timothy A
• Application Number:
  US13/215,592
• Publication Number:
  US 20110306850A1
• Time in Patent Office: 1,218 Days
• Field of Search: 434262-275, 600/28, 600/300, 600/544, 128/630, 128670-671, 128/716, 128/731, 128/733, 340575-576, 446/83
• US Class Current: 434/262
• 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 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/398 Electrooculography [EOG], e.g. detecting nystagmus; Electroretinography [ERG]
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A sleep quality assessment approach involves collecting data based on detected physiological or non-physiological patient conditions. At least one of detecting patient conditions and collecting data is performed using an implantable device. Sleep quality may be evaluated using the collected data by an implantable or patient-external sleep quality processor. One approach to sleep quality evaluation involves computing one or more summary metrics based on occurrences of movement disorders or breathing disorders during sleep.

Claims

1. An implantable sleep quality evaluation device for implantation into a patient, comprising:

a detector system including one or more patient-internal sensors for detecting and determining a first measure related to a heart rate of the patient, a second measure related to a respiration of the patient, and a third measure related to an activity of the patient;

a memory; and

a sleep quality processor coupled to the detector system and configured to;

determine a sleep condition of the patient based on the first measure related to the heart rate of the patient, the second measure related to the respiration of the patient, and the third measure related to the activity of the patient, in combination with one or more thresholds, wherein the sleep quality processor uses the second measure related to respiration to characterize a minute ventilation (MV) of the patient, and uses a measure related to minute ventilation (MV) of the patient in determining the sleep condition of the patient; and

store the sleep condition into the memory of the implantable sleep quality evaluation device.

2. The device of claim 1, wherein the sleep quality processor repeatedly determines a new sleep condition of the patient over time.

3. The device of claim 2, wherein the sleep quality processor calculates at least one composite sleep metric based, at least in part, on two or more of the sleep conditions that are determined over time.

4. The device of claim 3, wherein the sleep quality processor is configured to trend over time the composite sleep metric.

5. The device of claim 1, wherein at least one of the one or more thresholds is dependent upon at least one of the first, second and third measures.

6. A method for assessing sleep quality, comprising:

detecting a first measure related to a heart rate of the patient and a second measure related to a respiration of the patient, wherein the first measure related to a heart rate of the patient is detected using one or more implanted pacemaker leads and the second measure related to the respiration of the patient is detected using one or more implanted transthoracic impedance sensors;

using an implantable device to determine one or more metrics associated with sleep quality based at least in part on the detected first measure related to the heart rate of the patient and the second measure related to the respiration of the patient, in combination with one or more thresholds, wherein at least one of the one or more thresholds is dependent upon at least one of the first and second measures; and

storing the one or more metrics into a memory of an implantable device.

7. The method of claim 6, wherein the second measure is used to characterize minute ventilation (MV) of the patient, and wherein the implantable device determines one or more metrics associated with sleep quality based at least in part on the minute ventilation (MV) of the patient.

8. The method of claim 6, wherein the second measure is used to characterize disordered breathing of the patient, and wherein the implantable device determines one or more metrics associated with sleep quality based at least in part on the disordered breathing of the patient.

9. The method of claim 6, further comprising repeating the detecting, using and storing steps over time.

10. The method of claim 6, further comprising detecting a third measure related to an activity of the patient, wherein the one or more metrics includes a composite sleep quality metric that is based at least in part on the detected first measure related to the heart rate of the patient, the second measure related to the respiration of the patient, and the detected third measure related to the activity of the patient.

11. The method of claim 10, further comprising detecting a fourth measure related to a posture of the patient, wherein the composite sleep quality metric is based at least in part on the detected first measure related to the heart rate of the patient, the second measure related to the respiration of the patient, the detected third measure related to the activity of the patient, and the fourth measure related to a posture of the patient.

12. The method of claim 10, wherein the third measure related to the activity of the patient is detected using an implanted accelerometer.

13. The method of claim 10, wherein determining the composite sleep quality metric comprises determining a sleep disturbance index.

14. The method of claim 10, wherein determining the composite sleep quality metric comprises determining an undisturbed sleep time metric.

15. The method of claim 10, wherein determining the composite sleep quality metric comprises determining an undisturbed sleep efficiency metric.

16. The method of claim 6, further comprising detecting a measure indicative of a movement disorder.

17. The method of claim 6, further comprising adjusting a cardiac or respiration therapy that is delivered to the patient via the implantable device based at least in part on one or more of the metrics.

18. An implantable sleep quality evaluation device for implantation into a patient, comprising:

a detector system including one or more patient-internal sensors for detecting and determining a first measure related to a heart rate of the patient, a second measure related to a respiration of the patient, and a third measure related to an activity of the patient;

a memory; and

a sleep quality processor coupled to the detector system and configured to;

determine a sleep condition of the patient based on the first measure related to the heart rate of the patient, the second measure related to the respiration of the patient, and the third measure related to the activity of the patient, in combination with one or more thresholds; and

store the sleep condition into the memory of the implantable sleep quality evaluation device;

wherein the detector system includes one or more patient-internal sensors for detecting and determining a fourth measure related to a patient'"'"'s posture, and wherein the sleep quality processor is configured to determine the sleep condition of the patient based on the first measure related to the heart rate of the patient, the second measure related to the respiration of the patient, the third measure related to the activity of the patient, and the fourth measure related to the patient'"'"'s posture, and in combination with one or more thresholds.

19. An implantable device for implantation into a patient, comprising:

one or more patient-internal sensors for detecting a first measure related to a heart rate of the patient and a second measure related to a respiration of the patient;

a memory; and

a processor in communication with the one or more patient-internal sensors and the memory, the processor configured to determine one or more metrics associated with sleep quality of the patient based on the first measure related to the heart rate of the patient and the second measure related to the respiration of the patient, the processor further configured to store the one or more metrics into the memory of the implantable device and to adjust a cardiac or respiration therapy that is delivered to the patient via the implantable device based at least in part on one or more of the metrics; and

a communications block for wirelessly transmitting the one or more metrics from the implantable device to a location remote from the patient.