Analysis of Sleep Apnea

• US 6,893,405 B2
• Filed: 01/22/2003
• Issued: 05/17/2005
• Est. Priority Date: 01/22/2002
• Status: Active Grant

• Current Assignee: Natus Medical Incorporated
• Original Assignee: Medcare Flaga Hf
• Inventors: Kumar, Anand, Burzelewski, William, Hofman, Winni
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US10/348,676
• Publication Number:
  US 20030139691A1
• Time in Patent Office: 846 Days
• Field of Search: 600529-538
• US Class Current: 600/538
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6805 Vests

Abstract

A non-intrusive and quantitative method and apparatus for diagnosing sleep apnea and detecting apnea events by monitoring during sleep abdominal effort and thoracic effort, determining the phase of each effort, determining the difference in phase between each type of effort, and then determining the rate of phase angle change and standard deviation over time. Also provided may be treatment when apnea events are detected to trigger therapy apparatus such as airway positive pressure apparatus.

Claims

1. A method for diagnosing sleep apnea comprising the steps of measuring thoracic volume of a patient as a function of time and determining the phase of the change of thoracic volume of said patient, measuring abdominal volume of said patient as a function of time and determining the phase of the change of abdominal volume of said patient, calculating the phase angle between said thoracic volume phase and said abdominal volume phase as a function of time, and observing changes of the phase angle over a selected time period to indicate the extent to which the phase angle between the two effort signals fluctuates.

2. The method according to claim 1 in which the phase angle calculation is made by cross-correlation between two signals created by the measurements, and the distance between two adjacent maxima in the cross correlation estimates the dominant period time with the distance between zero lag and the nearest maximum being a measure of phase lag with phase in degrees estimated by dividing estimated phase lag by the estimated period time.

3. The method according to claim 2 and further calculating the standard deviation of the phase angle over a certain time period to use as a statistical method to for the diagnosis.

4. The method according to claim 2 in which data from the measurements are sub-sampled at predetermined intervals of about 10 Hz, and the results of the phase calculation stored at about 1-second intervals.

5. The method according to claim 1 in which the measurements and calculations are analyzed to determine the standard deviation of the phase angle between the two effort signals over a sample period.

6. The method according to claim 5 in which the variability is measured over substantially the whole sleep period in about 10 second periods with more than about 10 standard deviations summed to calculate a flip-flop state index directly related to upper airway obstruction.

7. The method according to claim 6 in which a flip-flop state index higher than about 0.1 is used as a predictor of obstructive sleep apnea.

8. The method according to claim 1 in which a respiratory distress index by the number of times of arousal from sleep in a predetermined time is correlated with the instability of the phase angles for the diagnosis of apnea and/or hypopnea.

9. The method according to claim 1 in which the abdominal and thoracic phase information is input into a computer with a software utility that calculates phase change and determines significant change or changes in sets of data.

10. Apparatus for diagnosing sleep apnea comprising means for measuring thoracic effort and abdominal effort of a patient as a function of time and determining the phase of the change of each of the efforts, means for calculating the phase angle between the efforts as a function of time, means for plotting the measurements, determinations and calculations, and observing changes of the phase angle over a selected time period to indicate the extent to which the phase angle between the two effort signals fluctuates, means for determining change in phase angle, and statistical means for determining the standard deviation of the phase angle.

11. Apparatus according to claim 10 and further comprising means for recording the phase angles and standard deviations over time during sleep.

12. Apparatus according to claim 11 and further comprising means for administering therapy when the standard deviation exceeds a predetermined value.

13. Apparatus according to claim 12 in which the therapy comprises a pressurized air infusion device and further comprising means for determining the rate of change of phase angle between abdominal effort in breathing and thoracic effort in breathing and using the determining means with or without other signals of polysomnography for determining optimal pressure of the infusion device.

14. Apparatus according to claim 10 and further comprising means for determining the rate of change of phase angle between abdominal effort in breathing and thoracic effort in breathing.