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

NCT00354614 | Completed Results FDA Device

• 1 other identifier: CA-09-05
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

  Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater

  Simultaneous single night recording

Interventions

ApneaLink Sleep Screener DEVICE

Device used to evaluate for the presence of OSA

Also known as: AL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pts. with suspected OSA.

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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Oktay B, Rice TB, Atwood CW Jr, Passero M Jr, Gupta N, Givelber R, Drumheller OJ, Houck P, Gordon N, Strollo PJ Jr. Evaluation of a single-channel portable monitor for the diagnosis of obstructive sleep apnea. J Clin Sleep Med. 2011 Aug 15;7(4):384-90. doi: 10.5664/JCSM.1196.

  PMID: 21897775 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: VP Medical Affairs
• Organization: ResMed

ResmedScienceCenter@resmed.com.au

858 836 6782

Study Officials

• Patrick J Strollo, MD

  Associate Professor of medicine and Medical Director, UPMC Sleep Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 20, 2006
• Study Start: June 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: July 1, 2007
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)