Quantitative method for assessment of excessive daytime sleepiness

• US 8,335,561 B1
• Filed: 11/30/2010
• Issued: 12/18/2012
• 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, MoHammad
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US12/957,098
• Time in Patent Office: 749 Days
• Field of Search: 600/544, 600/545
• 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 that 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 analyzing a subject for excessive daytime sleepiness over a test time period comprising the steps of:

a) using at least one sensor to measure a subject'"'"'s brain wave signals over a measurement time period, the measurement time period comprising a number of time segments;

b) analyzing with a processor the subject'"'"'s brain wave signals to estimate or determine a number from the power spectrum of the brain wave signals in the from about 0 to about 30 Hz range or a power spectrum profile from the signal components from the brain wave signals in the from about 0 to about 30 Hz range for each time segment; and

c) making a determination of the degree of excessive daytime sleepiness based in part on the number or the power spectrum profile for the time segments over the measurement time period

wherein the measurement time period begins at least about 2 minutes after the test time period begins and wherein the test time period is less than about 60 minutes.

2. The method in claim 1, wherein the test time period is less than about 30 minutes.

3. The method in claim 1, wherein the test time period is less than about 15 minutes.

4. The method in claim 1, wherein the test time period is less than about 10 minutes.

5. The method in claim 1, wherein the measurement time period begins at least about 4 minutes after the test time period begins.

6. The method in claim 2, wherein the measurement time period begins at least about 6 minutes after the test time period begins.

7. The method in claim 6, wherein the determination of the degree of excessive daytime sleepiness is further based in part on the subject'"'"'s response to the one or more types of stimulus.

8. A method of analyzing a subject for excessive daytime sleepiness over a test time period comprising the steps of:

a) measuring a subject'"'"'s brain wave signals over a measurement time period, the measurement time period comprising a number of time segments;

b) analyzing the subject'"'"'s brain wave signals with a processor to estimate or determine a number from the power spectrum of the brain wave signals in the from about 0 to about 30 Hz range or a power spectrum profile from the signal components from the brain wave signals in the from about 0 to about 30 Hz range for each time segment; and

c) making a determination of the degree of excessive daytime sleepiness based in part on the number or the power spectrum profile for the time segments over the measurement time period.

9. The method in claim 8, wherein the measurement is taken using a dry electrode.

10. The method in claim 8, further including a step of providing one or more types of stimulus to the subject.

11. The method in claim 10, wherein the subject is instructed to respond after recognizing one or more of the types of the stimulus.

12. The method in claim 11, further including the step of measuring the subject'"'"'s response to the one or more types of stimulus and wherein the stimulus is provided on an intermittent basis.

13. The method in claim 12, wherein the determination of the degree of excessive daytime sleepiness is further based in part on the subject'"'"'s response to the one or more types of stimulus.

14. The method in claim 10, wherein the stimulus is an auditory tone.

15. A method of analyzing a subject for excessive daytime sleepiness over a test time period comprising the steps of:

a) providing a stimulus to a subject to which the subject is instructed to respond;

b) measuring the subject'"'"'s electroencephalogram (EEG) over a measurement time period, the measurement time period comprising a number of time segments, the measurement time period only beginning after the subject'"'"'s measured EEG evolves into a consistent pattern;

c) analyzing the subject'"'"'s EEG with a processor to estimate or determine a number from the power spectrum of the brain wave signals in the from about 0 to about 30 Hz range or a power spectrum profile from the signal components from the EEG in the from about 0 to about 30 Hz range for each time segment; and

d) making a determination of the degree of excessive daytime sleepiness based in part on the number or the power spectrum profile for the time segments over the measurement time period and based in part on the subject'"'"'s responses to the stimulus.

16. The method in claim 15, wherein the stimulus is one or more phonemes.

17. The method in claim 15, wherein the measured brain wave signal is filtered before analyzing.

18. The method in claim 15, wherein the subject is instructed to close the subject'"'"'s eyes.

19. The method in claim 15, wherein the subject'"'"'s response is not manual.

20. The method in claim 15, wherein the subject'"'"'s response to the stimulus is used as an indicator as to whether the subject is cooperating by comparing the subject'"'"'s response to the stimulus with the analyzed EEG over the same time period.