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 Details — Status: Completed

Administrative data

• NCT number: NCT00354614
• Other study ID #: CA-09-05
• Status: Completed
• Phase: N/A
• First received: July 18, 2006
• Last updated: July 2, 2008
• Start date: June 2006
• Est. completion date: July 2007

Study information

• Verified date: July 2008
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Any subject requiring home oxygen therapy

• Any subject currently receiving positive airway pressure therapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• ApneaLink Sleep Screener
Device used to evaluate for the presence of OSA

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United States,