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Completed

NCT Number: NCT00354614

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ApneaLink Sleep Screener

Device

Device used to evaluate for the presence of OSA

Other names: AL

Primary outcomes

  1. Sensitivity and Specificity

    Time frame: Simultaneous single night recording

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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 20, 2006
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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