Quantitative method for the therapeutic treatment of sleep disorders

• US 7,865,234 B1
• Filed: 12/22/2004
• Issued: 01/04/2011
• Est. Priority Date: 06/04/2003
• Status: Expired due to Fees

• Current Assignee: Cleveland Medical Devices Inc.
• Original Assignee: Cleveland Medical Devices Inc.
• Inventors: Modarres, Mo
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US11/021,594
• Time in Patent Office: 2,204 Days
• Field of Search: 600/544, 600/545, 600/300, 607/42
• US Class Current: 600/544
• CPC Class Codes: A61B 5/374 Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4818 Sleep apnoea

Abstract

The present invention relates to a method of analyzing a subject for excessive daytime sleepiness, and more particularly to a quick (short duration), quantitative method of sleep disorder analysis. The present invention additionally relates to a method, which can be used to quantitatively measure the treatment endpoints for the subject, i.e., appropriate levels of stimulants. Additionally, the present invention relates to a device for sleep disorder analysis.

Claims

1. A method of therapeutically treating a subject for sleep disorders comprising the steps of:

a) determining that a subject has maintained what the subject believes sleeping pattern;

b) using a processor or computer to quantitatively analyze a subject'"'"'s brain wave signals and using the quantitative analysis in estimating or determining whether the subject has a sleeping disorder;

c) a physician, technician or veterinarian recommending a change in the physical sleeping conditions of the subject or giving or prescribing the subject medication to make an improvement to the subject'"'"'s sleeping disorder based in part on the quantitative analysis;

d) using a processor or computer to quantitatively analyze a second time the subject'"'"'s brain wave signals to estimate or determine the extent of the improvement to the subject'"'"'s sleeping disorder; and

e) making an additional, change to the physical sleeping conditions of the subject or reducing or increasing the medication based on the extent of the improvement to the subject'"'"'s sleeping disorder estimated or determined in previous step, or, alternatively, determining that no change to the physical sleeping conditions of the subject and no reduction or increase of the medication is necessary based on the extent of the improvement to the subject'"'"'s sleeping disorder estimated of determined, in the previous step.

2. The method in claim 1, further including a step of providing one or more types of stimulus to the subject while the subject'"'"'s brain wave signals are collected or measured.

3. The method in claim 2, wherein the subject is instructed to respond after recognizing one or more of the types of stimulus.

4. The method in claim 3, further including the step of measuring the subject'"'"'s response to one or more types of stimulus and wherein the stimulus is provided on an intermittent basis.

5. The method in claim 1, wherein the subject brain wave signals are not reviewed by a human prior to the quantitative analysis.

6. The method in claim 1, wherein the subject is given medication and the amount of medication is decreased based on the extent of the improvement to the subject'"'"'s sleeping disorder estimated of determined by quantitatively analyzing the subject'"'"'s brain wave signals a second time.

7. A method of therapeutically treating a subject for sleep disorders comprising the steps of:

a) using a processor or computer to quantitatively analyze a subject'"'"'s brain wave signals and using the quantitative analysis in estimating or determining whether the subject has a sleeping disorder;

b) making a change in the physical sleeping conditions of the subject to make an improvement to the subject'"'"'s sleeping disorder based in part on the quantitative analysis; and

c) using a processor or computer to quantitatively analyze a second time the subject'"'"'s brain wave signals to estimate or determine the extent of the improvement to the subject'"'"'s sleeping disorder; and

d) making an additional change in the physical sleeping conditions of the subject based on the extent of the improvement to the subject'"'"'s sleeping disorder estimated or determined in the previous step, or, alternatively, determining that no change to the physical sleeping conditions of the subject is necessary based on the extent of the improvement to the subject'"'"'s sleeping disorder estimated or determined in the previous step.

8. The method of claim 7 wherein die measurement time period is less than about 15 minutes.

9. The method of claim 7, wherein the subject'"'"'s EEG is acquired using at least one dry physiological electrode.

10. The method of claim 7, wherein the subject'"'"'s brain wave signals are not reviewed by a human prior to the quantitative analysis.

11. The method in claim 7, further including a step of providing one or more types of stimulus to the subject while the subject'"'"'s brain wave signals are collected or measured.

12. The method in claim 11, wherein the subject is instructed respond after recognizing one or more of the types of stimulus.

13. The method in claim 12, further including the step of measuring the subject'"'"'s response to one or more types of stimulus and wherein the stimulus is provided on an intermittent basis.

14. A method of therapeutically treating a subject for sleep disorders comprising the steps of:

a) acquiring the subject'"'"'s electroencephalogram (EEG) over a measurement time period, the measurement time period comprising a number of time segments, and during which measurement time period the subject is asked to respond to one or more types of stimulus;

b) using a processor or computer to quantitatively analyze the subject'"'"'s EEG to estimate or determine a number or power spectrum profile for each of the time segments, and using the quantitative analysis in estimating or determining whether the subject has sleeping-disorder by comparing the number or power spectrum profile with a predetermined threshold number or profile, the predetermined threshold number or profile having been calculated based on numbers or power spectrum profiles of individuals with no known sleeping disorders or individuals with known sleeping disorders;

c) making a change in the physical sleeping conditions of the subject or giving the subject a medication to make an improvement to the subject'"'"'s sleeping disorder based in part on the quantitative analysis.

15. The method of claim 14 wherein the measurement time period is less than about 15 minutes.

16. The method of claim 14 wherein the measurement time period is less than about 10 minutes.

17. The method of claim 14, additionally comprising the step of determining that the subject has maintained a normal sleeping pattern prior to the analysis.

18. The method of claim 14, wherein the subject'"'"'s EEG is acquired using at least one dry physiological electrode.

19. The method of claim 14, wherein the subject'"'"'s EEG is acquired using only two physiological electrodes, one of two electrodes being a reference electrode.

20. The method of claim 14, wherein at least one of the one or more types of stimulus provided to the subject during the measurement time period is an auditory stimulus, the auditory stimulus being provided on an intermittent basis, and wherein the subject is instructed to respond after recognizing one or more of the types of stimulus.