Status:
COMPLETED
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
Lead Sponsor:
Philips Respironics
Conditions:
Sleep Apnea
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The study is to compare the performance of a CPAP (continuous positive airway pressure) device to a clinical polysomnography (PSG) in identifying breathing events in patients with obstructive sleep ap...
Detailed Description
Purpose: The purpose of this study was to compare the AED algorithm used in a PAP device with manually scored events on PSG. The PAP device was modified to produce a square wave voltage output identif...
Eligibility Criteria
Inclusion
- Age 21-75
- Diagnosis of OSAHS with a baseline AHI ≥ 15 events/hr of sleep assessed January 01, 2007 or later
- CPAP prescription of 8cm of H20 or higher
- Able and willing to provide written informed consent
- Native English speaker
Exclusion
- Participation in another interventional research study within the last 30 days
- Major medical or psychiatric condition that would interfere with the demands of the study and adherence to PAP. Examples include unstable cardiovascular disease (Class III / IV CHF), neuromuscular disease, cancer, and renal failure.
- Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe continuous positive airway pressure (COPD) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\> 45 mmHg) while awake, or subjects requiring continuous oxygen therapy.
- Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
- Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)
- Presence of untreated or poorly managed,non-OSAHS related sleep disorders:
- moderate to severe periodic limb movements(≥ 30/hr with symptoms or arousals)
- arousals associated with periodic limb movements \> 10 per hour or
- anyone experiencing chronic and severe insomnia.
- Consumption of ethanol immediately prior to the research PSG
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00836758
Start Date
February 1 2009
End Date
August 1 2009
Last Update
January 16 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shands and UF Sleep Disorder Center
Gainesville, Florida, United States, 32606