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

Obstructive Sleep Apnea Clinical Trial

Official title:
Validation of the ApneaLink Sleep Screener in a Suspected Sleep Disordered Breathing Population

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

Clinical Trial 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 Disordered Breathing (SDB), using the ApneaLink (AL) Sleep Screener. Subjects initially will be tested for SDB in the home environment. Following an AL home test, subjects will undergo a simultaneous, attended diagnostic polysomnography (PSG) sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00354614
Study type Observational
Source ResMed
Contact
Status Completed
Phase N/A
Start date June 2006
Completion date July 2007
View Details
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