Quantitative sleep analysis method and system

• US 6,993,380 B1
• Filed: 06/04/2003
• Issued: 01/31/2006
• 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): Marmor, Charles
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US10/454,156
• Time in Patent Office: 972 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, 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 analyzing a subject for sleep disorders over a test time period comprising the steps of:

a) determining that a subject has maintained a normal sleeping pattern prior to the analysis;

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

c) analyzing the subject'"'"'s brain wave signals to estimate or determine a number or a power spectrum profile for each time segment; and

d) making a determination that the subject has a sleep disorder based in part on a computed number based on the number for each time segment over the measurement time period exceeding a predetermined threshold number, a profile of the numbers over the measurement time period exceeding a predetermined threshold profile over the time period, or the power spectrum profile exceeding a predetermined threshold power spectrum profile over the measurement time period.

2. The method in claim 1, wherein the subject'"'"'s brain wave signals are analyzed to estimate or determine a power spectrum profile for each time segment comprising an alpha component and one or more sub-alpha components, and a ratio of the one or more sub-alpha components to the alpha component for each time segment, and the determination of whether the subject has a sleep disorder is based in part on the ratio over the measurement time period.

3. The method in claim 2, wherein the sensor measures EEG signals from the subject'"'"'s brain.

4. The method in claim 3, further including a step of providing one or more types of stimulus to the subject.

5. The method in claim 4, wherein the subject is instructed to respond after recognizing one or more of the types of the stimulus.

6. The method in claim 5, 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.

7. The method in claim 6, wherein the determination that the subject has a sleep disorder 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) 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 the subject'"'"'s brain wave signals to estimate or determine a power spectrum profile for each of the time segments of the measurement time period, the power spectrum for each time segment comprising an alpha component and at least one sub-alpha component, and from these components a ratio of the one or more sub-alpha components to the alpha components for each time segment; and

c) making a determination of the degree of excessive daytime sleepiness based in part on the ratio of the over the measurement time period.

9. The method in claim 8, wherein the sensor measures EEG signals from the subject'"'"'s brain.

10. The method in claim 9, 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 that the subject has a sleep disorder is further based in part on the subjects response to the one or more types of stimulus.

14. The method in claim 8, wherein the measurement time period begins at least about 2 minutes after the test time period beings and wherein the test time period is less than about 60 minutes.

15. A method of analyzing a subject for sleep disorders comprising the steps of:

a) placing electrodes onto a subjects head having a brain wave signal;

b) providing a stimulus to the subject;

c) measuring the subject'"'"'s response to the stimulus and the brain wave signal;

d) analyzing the brain wave signal; and

e) making a determination that the subject has a sleep disorder based in part on the brain wave signal analysis over a period of time, and in part on the subjects response to the stimulus over the period of time.

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

17. The method in claim 16, wherein the measured brain wave signal is filtered before analyzing.

18. The method in claim 17, wherein the stimulus is provided on an intermittent basis.

19. The method in claim 18, wherein a power spectrum profile is estimated or determined for each time segment of the analyzed brain wave signal, the power spectrum profile comprising an alpha component and one or more sub-alpha components and a ratio is calculated of the one or more sub-alpha components to the alpha component.

20. The method in claim 19, wherein the determination that the subject has a sleep disorder is based in part on an average of the ratio of the one or more sub-alpha components to the alpha component either exceeding a predetermined threshold number over a period of time or a profile of the ratio over a period of time.