Automated insomnia treatment system

• US 7,654,948 B2
• Filed: 03/01/2004
• Issued: 02/02/2010
• Est. Priority Date: 02/28/2003
• Status: Active Grant

• Current Assignee: Consolidated Research Incorporated
• Original Assignee: Consolidate Research of Richmond Incorporated
• Inventors: Loparo, Kenneth A., Kaplan, Richard
• Primary Examiner(s): Gilbert; Samuel G
• Application Number:
  US10/790,885
• Publication Number:
  US 20040225179A1
• Time in Patent Office: 2,164 Days
• Field of Search: 600/26, 600/300, 600/500, 600/509, 600/544, 600/484, 600/535, 600/564, 600/575, 600/301, 379/373.01, 368/12, 368/107, 362/231, 340/573.1, 340/575, 128/204.23, 128/204.21, 128/204.26, 128/897, 128/898, 607/2, 607/46
• US Class Current: 600/26
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61M 2021/0016 by the smell sense
• CPC Class Codes: A61M 2021/0022 by the tactile sense, e.g. vibrations
• CPC Class Codes: A61M 2021/0027 by the hearing sense
• CPC Class Codes: A61M 2021/0072 with application of electrical currents
• CPC Class Codes: A61M 21/00 Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/18 Rapid eye-movements [REM]
• CPC Class Codes: A61M 2230/42 Rate
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity

Abstract

Automated behavioral methods and systems for treating insomnia that use passive means for determining wake/sleep states.

Claims

1. An automated system for facilitating the implementation of behavioral therapy that uses information indicative of a subject'"'"'s wake/sleep state to treat subjects suffering from insomnia including difficulty falling asleep, difficulty staying asleep, or waking too early, comprising:

passive wake/sleep determination means for producing information indicative of the subject'"'"'s wake/sleep state; and

means for implementing the behavioral therapy utilizing the wake/sleep information to treat the subjects suffering from insomnia chosen from the group consisting of stimulus control therapy, sleep restriction therapy, relaxation therapy, and combinations of two or more of stimulus control therapy, sleep restriction therapy, or relaxation training.

2. The system of claim 1 including means for choosing the behavioral therapy to be implemented for a subject based on the subject'"'"'s personal wake/sleep information.

3. The system of claim 2 including means for obtaining information indicative of the subject'"'"'s wake/sleep state prior to the beginning of treatment.

4. The system of claim 2 including means for obtaining information indicative of the subject'"'"'s wake/sleep state during the course of treatment.

5. The system of claim 1 in which the passive wake/sleep determination means uses information taken from the group consisting of:

EEG, EKG, EMG, EOG, actigraphy, body movement, galvanic skin response, respiratory changes, or eye movements, and combinations of two or more of EEG, EKG, EMG, EOG, actigraphy, body movement, galvanic skin response, respiratory changes, or eye movements.

6. The apparatus of claim 5 including means for permitting the subject to review and adjust system settings chosen from the group consisting of time, age, sleep goals, alert preferences, language, setup parameters, and display preferences.

7. The system of claim 1 including drug therapy in conjunction with the behavioral therapy.

8. The system of claim 1 in which active means for determining the wake/sleep state are used to supplement the passive wake/sleep determination means.

9. The system of claim 1 in which the behavioral therapy is stimulus control therapy including means for implementing the stimulus control therapy using the following rules:

a) never alert a subject while they are asleep

b) alert a subject only when at least a first predetermined number of contiguous of wake epochs are achieved, and

c) if any sleep of at least a second predetermined number of contiguous epochs is achieved, designate the subject in a sleep maintenance mode and if any sleep of at least the second predetermined number of contiguous epochs is not achieved, designated the subject not in a sleep maintenance mode whereby

if the subject is in a sleep maintenance mode, examine a past third predetermined number of epochs and if the subject was awake for at least a fourth predetermined number of epochs out of the past third predetermined number of epochs, alert the subject, but

if the subject is not in a sleep maintenance mode and if there is no sleep of at least a fifth predetermined number of contiguous epochs within a first period of trying to fall asleep, then alert the subject upon a lapse of the first period; and

if the subject is not in a sleep maintenance mode and there is a contiguous sleep period contained within the first period of trying to fall asleep that is greater than or equal to the fifth predetermined number of epochs but less than the second predetermined number of epochs, then inhibit the alert for an additional period.

10. The system of claim 9 in which an epoch is about 30 seconds, the first predetermined number of contiguous wake epochs is 2, and the second predetermined number of contiguous epochs is 20 epochs, the third predetermined number of epochs is 30 epochs, the fourth predetermined number of epochs is 28 epochs;

the fifth predetermined number of contiguous epochs is 10 epochs;

the first period is 40 epochs, and the additional period is 20 epochs.

11. The system of claim 1 in which the behavioral therapy is optimized for each subject based upon the subject'"'"'s wake/sleep information.

12. The system of claim 1 in which behavioral prompts in the form of alerts or messages are generated in accordance with the behavioral therapy being implemented.

13. The system of claim 1 in which the subject'"'"'s wake/sleep states, in-bed status, and other sleep behaviors are stored and used to update the parameters for the behavioral therapy being implemented.

14. An apparatus for facilitation the implementation of behavioral therapy for treating subjects suffering from insomnia including difficulty falling asleep, difficulty staying asleep, or waking too early, comprising:

means for processing information taken form the group consisting of;

EEG, EKG, EMG, EOG, actigraphy, body movement, galvanic skin response, respiratory changes, eye movements and combinations of two or more thereof to determine the subject'"'"'s wake/sleep state; and

means for implementing the behavioral therapy utilizing the wake/sleep state information to treat the subjects suffering from insomnia chosen from the group consisting of stimulus control therapy, sleep restriction therapy, relaxation therapy, and combinations of two or more of stimulus control therapy, sleep restriction therapy, or relaxation training.

15. The apparatus of claim 14 in which the behavioral therapy is stimulus control therapy in which program parameters are defined and stimulus control therapy rules are applied to implement the therapy comprising:

means for determining whether the subject should get out of the bed in accordance with the stimulus control therapy; and

means for alerting the subject to leave the bed in accordance with the rules of the stimulus control therapy if a determination is made.

16. The apparatus of claim 15 in which the alerting means are chosen from the group consisting of:

a text display of warning conditions, text display of instructions or information, a display backlight, a blinking light, an audible indication, a tactile indication, a synthesized or recorded voice, a low level electrical stimulus and an aroma generated by appropriate device.

17. The apparatus of claim 15 including subject-controlled means for canceling the alerting means.

18. The apparatus of claim 14 in which the behavioral therapy is sleep restriction therapy in which program parameters are defined and sleep restriction therapy rules are applied to implement the therapy comprising:

means for calculating the program parameters including a sleep period for the upcoming sleep session based on previously acquired wake/sleep state information in accordance with the rules of the sleep restriction therapy;

means for determining whether the subject has completed the sleep period; and

means for displaying the calculated program parameters to the subject for the upcoming sleep session.

19. The apparatus of claim 18 including means for enabling the subject to review and adjust the program parameters after display of such parameters for an upcoming sleep session.

20. The apparatus of claim 14 in which the behavioral therapy is chosen from the group consisting of stimulus control therapy, sleep restriction therapy, relaxation therapy, and combinations of two or more of stimulus control therapy, sleep restriction therapy, or relaxation training.

21. The apparatus of claim 14 in which the behavioral therapy is optimized for each subject based upon the subject'"'"'s wake/sleep state information and/or wake/sleep state history.

22. The apparatus of claim 14 including means permitting the subject to review information previously acquired by the apparatus.

23. The apparatus of claim 14 including means for computing the subject'"'"'s sleep statistics based on the subject'"'"'s previous wake/sleep state history.

24. The apparatus of claim 14 in which information as to whether the subject is in bed or not is acquired along with the wake/sleep state information.

25. The apparatus of claim 24 in which means are provided fro the turning off any alert and displaying the subject'"'"'s current sleep statistics when a determination is made that the subject is no longer in bed.

26. The apparatus of claim 24 in which means are provided for the turning off any alert and for providing the subject with sleep instructions when a determination is made that the subject is no longer in bed.

27. The apparatus of claim 14 including means for permitting the subject to specify a predetermined wakeup time.

28. The apparatus of claim 14 including a visual or audible presentation of instructions or information.

29. The apparatus of claim 14 including means for providing an indication to the subject after the subject has been in bed for a recommended length of time.

30. The apparatus of claim 14 in the form of a single portable unit wearable by the subject.

31. The apparatus of claim 14 including means for calculating a time interval corresponding to the highest likelihood of being able to sleep to assist the subject in planning the subject'"'"'s sleep.

32. The apparatus of claim 31 including means for informing the subject as the subject approaches the time interval corresponding to the highest likelihood of sleeping.

33. An automated system for facilitating the implementation of stimulus control therapy that uses information indicative of a subject'"'"'s wake/sleep state to improve the subject'"'"'s sleep or sleep hygiene, including subjects with insomnia or other sleep complaints, comprising:

passive wake/sleep determination means for producing information indicative of the subject'"'"'s wake/sleep state; and

means for implementing the stimulus control therapy utilizing the wake/sleep information and applying the following rules;

a) never alert a subject while they are asleep,

b) alert a subject only when at least a first predetermined number of contiguous of wake epochs are achieved, and

c) if any sleep of at least a second predetermined number of contiguous epochs is achieved, designate the subject in a sleep maintenance mode and if any sleep of at least the second predetermined number of contiguous epochs is not achieved, designate the subject not in a sleep maintenance mode whereby

if the subject is in a sleep maintenance mode, examine a past third predetermined number of epochs and if the subject was awake for at least a fourth predetermined number of epochs out of the past third predetermined number of epochs, alert the subject, but

if the subject is not in a sleep maintenance mode and if there is no sleep of at least a fifth predetermined number of contiguous epochs within a first period of trying to fall asleep, then alert the subject upon a lapse of the first period; and

if the subject is not in a sleep maintenance mode and there is a contiguous sleep period contained within the first period of trying to fall asleep that is greater than or equal to the fifth predetermined number of epochs but less than the second predetermined number of epochs, then the alert for an additional period.

34. The system of claim 33 in which an epoch is about 30 seconds, the first predetermined number of contiguous wake epochs is 2, and the second predetermined number of contiguous epochs is 20 epochs, the third predetermined number of epochs is 30 epochs, the fourth predetermined number of epochs is 28 epochs;

the fifth predetermined number of contiguous epochs is 10 epochs;

the first period is 40 epochs, and the additional period is 20 epochs.

35. An automated system for facilitating the implementation of stimulus control therapy that uses information indicative of a subject'"'"'s wake/sleep state to improve the subject'"'"'s sleep or sleep hygiene, including subjects with insomnia or other sleep complaints, comprising:

means for processing information taken from the group consisting of;

EEG, EKG, EMG, EOG, actigraphy, body movement, galvanic skin response, respiratory changes, eye movements and combinations of two or more thereof to determine the subject'"'"'s wake/sleep state and to acquire and alert as to whether the subject is in bed or not; and

means for implementing the behavioral therapy utilizing the wake/sleep state information and the in bed information.

36. The apparatus of claim 35 in which means are provided for the turning off any alert and displaying the subject'"'"'s current sleep statistics when a determination is made that the subject is no longer in bed.

37. The apparatus of claim 35 in which means are provided for the turning off any alert and for providing the subject with sleep instructions when a determination is made that the subject is no longer in bed.

38. An automated system for facilitation the implementation of behavioral therapy that uses information indicative of a subject'"'"'s wake/sleep state to improve the subject'"'"'s sleep or sleep hygiene, including subjects with insomnia or other sleep complaints, comprising:

passive wake/sleep determination means for producing information indicative of the subject'"'"'s wake/sleep state;

means for implementing the behavioral therapy utilizing the wake/sleep information; and

means for storing the subject'"'"'s wake/sleep states, in-bed status, and other sleep behaviors and using the stored information to update the information for the behavioral therapy being implemented.