Automated treatment system for sleep

• US 8,512,221 B2
• Filed: 12/16/2009
• Issued: 08/20/2013
• Est. Priority Date: 02/28/2003
• Status: Active Grant

• Current Assignee: Consolidated Research Incorporated
• Original Assignee: Consolidated Research Incorporated
• Inventors: Loparo, Kenneth Alan, Wang, Ying, Kaplan, Kaplan Frederic
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US12/639,201
• Publication Number:
  US 20100094103A1
• Time in Patent Office: 1,343 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 acquires and analyzes information indicative of a user'"'"'s wake and sleep state to improve the user'"'"'s sleep or sleep hygiene, comprising:

means for passively acquiring information indicative of the user'"'"'s wake and sleep state; and

means for implementing steps of the Behavioral Therapy utilizing the user'"'"'s wake and sleep state information.

2. The system of claim 1 in which the Behavioral Therapy comprises Stimulus Control Therapy, Sleep Restriction Therapy, Relaxation Therapy, Cognitive Behavioral Therapy for Insomnia, Behavioral Therapy for Insomnia, and combinations of two or more of Stimulus Control Therapy, Sleep Restriction Therapy, Relaxation Therapy, Cognitive Behavioral Therapy for Insomnia, and Behavioral Therapy for Insomnia.

3. The system of claim 1 including means for choosing the Behavioral Therapy to be implemented for a user based on the user'"'"'s personal wake and sleep information.

4. The system of claim 1 in which information indicative of user'"'"'s sleep/wake state is taken from the group consisting of:

EEG, EMG, PAT, systolic upstroke time, ECG/EKG, EOG, oximetry, heart rate variations, heart rhythm variations, actigraphy, body movement, GSR, respiratory changes, respiratory variability, eye movements, and combinations of two or more of these means for passively determining information indicative of the user'"'"'s wake and sleep state.

5. The system of claim 1 including Drug Therapy in conjunction with Behavioral Therapy.

6. The system of claim 1 in which active means for determining the wake and sleep state are used to supplement the means for passively determining information indicative of the user'"'"'s wake and sleep state.

7. 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 user while they are asleep,

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

c) if any sleep of at least the second predetermined number of contiguous epochs is achieved, the maintenance flag is set and if any sleep of at least the second predetermined number of contiguous epochs is not achieved, the maintenance is not set whereby

if maintenance flag is set, examine a past third predetermined number of epochs and if the user was awake for at least a fourth predetermined number of epochs out of the past third predetermined number of epochs, alert the user, but

if the maintenance flag is not set 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 user upon a lapse of the first period; and

if the maintenance flag is not set 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.

8. The method of claim 7 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 contiguous 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.

9. The system of claim 1 in which the means for implementing steps of the Behavioral Therapy comprises optimizing Behavioral Therapy parameters for a user based upon the user'"'"'s wake and sleep information.

10. An apparatus for facilitating the implementation of Behavioral Therapy for a user seeking to improve the user'"'"'s sleep or sleep hygiene comprising:

means for processing information which is indicative of the user'"'"'s wake and sleep state;

means for implementing the Behavioral Therapy utilizing the wake and sleep state information.

11. The system of claim 10 in which means for processing information which is indicative of the user'"'"'s wake and sleep state is taken from the group consisting of:

EEG, EMG, PAT, systolic upstroke time, ECG/EKG, EOG, oximetry, heart rate variations, heart rhythm variations, actigraphy, body movement, GSR, respiratory changes, respiratory variability, eye movements, and combinations of two or more of these means for passively determining information indicative of the user'"'"'s wake and sleep state.

12. The apparatus of claim 10 in which the Behavioral Therapy is Stimulus Control Therapy comprising:

means for determining whether the user gets out of the bed in accordance with the rules of the Stimulus Control Therapy; and

means for alerting the user to leave the bed in accordance with the rules of Stimulus Control Therapy.

13. The apparatus of claim 12 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.

14. The apparatus of claim 12 including user-controlled means for canceling the alerting means.

15. The apparatus of claim 12 including a visual or audible presentation of instructions or information.

16. The apparatus of claim 12 including a means for providing an indication to the user after the user has been in bed for a recommended length of time.

17. The apparatus of claim 10 in which the Behavioral Therapy is Sleep Restriction Therapy comprising:

means for calculating program parameters including a sleep period for the upcoming sleep session based on previously acquired wake and sleep state information in accordance with the rules of Sleep Restriction Therapy;

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

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

18. The apparatus of claim 17 including means enabling the user to review and adjust the program parameters after display of such parameters for an upcoming sleep session.

19. The apparatus of claim 10 in which the Behavioral Therapy is chosen from the group consisting of Stimulus Control Therapy, Sleep Restriction Therapy, Relaxation Therapy, Cognitive Behavioral Therapy for Insomnia, Behavioral Therapy for Insomnia, and combinations of two or more of Stimulus Control Therapy, Sleep Restriction Therapy, Relaxation Therapy, Cognitive Behavioral Therapy for Insomnia, and Behavioral Therapy for Insomnia.

20. The apparatus of claim 10 including means permitting the user to review and adjust system settings chosen from the group consisting of time, age, sleep goals, alert preferences, language, setup parameters, and display preferences.

21. The apparatus of claim 10 in which the Behavioral Therapy is optimized for each user based upon the user'"'"'s wake and sleep state information and/or wake and sleep state history.

22. The apparatus of claim 10 including means permitting the user to review information previously acquired by the apparatus.

23. The apparatus of claim 10 including means for computing the user'"'"'s sleep statistics based on the user'"'"'s previous wake and sleep state history.

24. The apparatus of claim 10 in which an indication of whether the user is in bed or not is acquired along with the wake and sleep state information.

25. The apparatus of claim 10 in which there is a means for turning off any alert and a means to display the user'"'"'s current sleep statistics when a determination is made that the user is no longer in bed.

26. The apparatus of claim 10 in which there is a means for turning off any alert and a means of providing the user with sleep instructions when a determination is made that the user is no longer in bed.

27. The apparatus of claim 10 includes a means to allow the user to specify a predetermined wakeup time.

28. The apparatus of claim 10 in the form of a single portable unit wearable by the user.

29. The apparatus of claim 10 including means for calculating a time interval corresponding to the highest likelihood of being able to sleep to assist the user in planning the user'"'"'s sleep.

30. The apparatus of claim 29 including means for informing the user as the user approaches the time interval corresponding to the highest likelihood of sleeping.