Status:
COMPLETED
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Brief Summary
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficie...
Detailed Description
All subjects with suspected Sleep Disordered Breathing (SDB) scheduled for diagnostic polysomnography (PSG) will be invited to participate in the study to be tested to determine if they have Sleep Dis...
Eligibility Criteria
Inclusion
- Adult subjects ( greater than 18 years of age) of either gender or any race
- Suspected sleep disordered breathing
- Untreated sleep disordered breathing
- Willingness to use AL at home within 2 days of receipt and instruction on the AL
- Willingness to use AL at home and undergo PSG within 2 to 4 weeks of completing the at home AL test
Exclusion
- Any subject requiring home oxygen therapy
- Any subject currently receiving positive airway pressure therapy
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00354614
Start Date
June 1 2006
End Date
July 1 2007
Last Update
June 28 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213