Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA) - Full Text View

Sponsored by:	ResMed
Information provided by:	ResMed
ClinicalTrials.gov Identifier:	NCT00354614

Purpose

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.

Condition	Intervention
Obstructive Sleep Apnea	Device: ApneaLink Sleep Screener

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Validation of the ApneaLink Sleep Screener in a Suspected Sleep Disordered Breathing Population

Further study details as provided by ResMed:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	81
Study Start Date:	June 2006
Study Completion Date:	July 2007

Intervention Details:

Device used to evaluate for the presence of OSA

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Pts. with suspected OSA.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354614

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

ResMed

Investigators

Principal Investigator:

Patrick J Strollo, MD

Associate Professor of medicine and Medical Director, UPMC Sleep Medicine

More Information

Responsible Party:	ResMed Corp ( Eileen Casal, RN, MSN )
Study ID Numbers:	CA-09-05
Study First Received:	July 18, 2006
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00354614
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009