NCT00354614

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	ApneaLink Sleep Screener	Device used to evaluate for the presence of OSA

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-03-01
• Completion: 2007-07-01
• First posted: 2006-07-20
• Last updated: 2017-06-28
• Results posted: 2017-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study