Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
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|ClinicalTrials.gov Identifier: NCT00750165|
Recruitment Status : Completed
First Posted : September 10, 2008
Results First Posted : April 9, 2019
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Device: SleepStyle 200 Auto Series CPAP Humidifier||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome.|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
Experimental: Titration Night
Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device
Device: SleepStyle 200 Auto Series CPAP Humidifier
The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
Other Name: HC254
- Apnea Hypopnea Index (AHI) [ Time Frame: 1 night ]The Apnea Hypopnea Index (AHI) measure of severity of Obstructive Sleep Apnea (OSA). It is a calculation of the number of apnea events and the number of hypopnea events divided by the total sleep time. Mild OSA is characterized between 5-15 events per hour. Moderate OSA is characterized as 15-30 events per hour. Severe OSA is characterized as greater than 30 events per hour.
- Percent of Time With Less Than 90% Oxygen Saturation [ Time Frame: 1 Night ]Oxygen saturation is a measurement of the amount of oxygen present in the blood. An oxygen saturation of less than 90% is considered low, resulting in hypoxemia. Normal blood oxygen level is considered between 95-100%.
- Respiratory Disturbance Index (RDI) [ Time Frame: 1 Night ]Similar to AHI, the RDI is a calculation of the total number of respiratory disturbances in sleep. The calculation includes apneas and hypopneas, but also includes respiratory effort related arousals.
- Arousal Index (AI) [ Time Frame: 1 Night ]The Arousal Index is a calculation of the frequency of awakenings per hour of sleep. The higher the number, the more awakenings per hour.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750165
|United States, New York|
|NYU Sleep Disorders Center|
|New York, New York, United States, 10016|
|Principal Investigator:||David M Rapoport, MD||NYU School of Medicine|