Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)

Completed

Conditions studied: Obstructive Sleep Apnea

In brief

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 coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL.

Key facts

Study ID

NCT00354614

Run by

ResMed

People needed

81

Starts

2006-06-01

Expected to finish

2007-07-01

Last updated by the study team

2017-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any subject requiring home oxygen therapy
• Any subject currently receiving positive airway pressure therapy

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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