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Completed

NCT Number: NCT03470493

ApneaLink Air Home Sleep Testing (HST) Device Validation Study

This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.

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Key information

Conditions

Sleep-Disordered Breathing Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

The current gold standard for sleep disordered breathing (SDB) diagnosis is in-laboratory polysomnography (PSG). A barrier of acceptance of Home Sleep Apnea Testing (HSAT) devices as a diagnostic test is their inability to accurately measure total sleep time (TST). A novel algorithm developed by ResMed, Ltd. allows the AL device to accurately calculate TST, however, this algorithm has not yet been validated.

The ApneaLink Air (AL) device is a type III HSAT device. The device is capable of recording up to four channels of data including: flow and snore via a nasal cannula attached to a pressure transducer, a respiratory effort belt, a pulse oximeter to measure pulse and oxygen saturation, and an actigraphy monitor to measure TST along with flow. The AL device has been validated against PSG for AHI, and Cheyne-Stoke respiration detection . Further validation of the effort belt is necessary to determine the accuracy of the AL ability to differentiate between obstructive and central apneic events.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant is 18 years of age or older
  • Participant is willing to provide informed consent
  • Participant is willing to participate in all study related procedures

Exclusion criteria

  • Unable to cease positive airway pressure (PAP) therapy during PSG (if currently using)
  • Requires use of oxygen therapy during sleep
  • Diagnosis of uncontrolled clinically relevant sleep disorder (e.g., untreated insomnia or restless leg syndrome)
  • Pregnant
  • Participant is unsuitable to participate in the study in the opinion of the investigator

Treatment and study plan

ApneaLink Air

Diagnostic Test

ApneaLink Air to be used on each participant undergoing PSG

Primary outcomes

  1. Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG)

    Time frame: Day 1

    The Respiratory Event Index (REI) provided by the AL will be compared with the REI provided by the PSG test. REI will be scored according to American Academy of Sleep Medicine (AASM) 2012 guidelines.

    The REI provided by the AL for each participant is divided by the REI provided by the PSG for the same participant to get the diagnostic sensitivity of the Apnealink.

Secondary outcomes

  1. Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events

    Time frame: Day 1

    Total number of Obstructive events reported by the ApneaLink (AL) compared with total number of Obstructive Events reported by polysomnography (PSG). The Obstructive events of the AL are divided by the Obstructive events of the PSG to get the diagnostic sensitivity. This is then compared with the threshold of 0.825

  2. Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG

    Time frame: Day 1

    Total number of Central events reported by the ApneaLink (AL) compared with total number of Central Events reported by polysomnography (PSG). The Central events of the AL are divided by the Central events of the PSG to get the diagnostic sensitivity. This is then compared with the threshold of 0.825

  3. Positive Likelihood Ratio of Apnealink Air

    Time frame: Day 1

    The positive likelihood ratio (the estimated sensitivity divided by 1 minus the estimated specificity) was calculated along with the associated one-sided 97.5% confidence interval. The positive likelihood ratio was compared with the threshold of 5 (AASM criteria for out-of-center testing devices12) using a Wald test.

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2018
Registry last updated
May 20, 2021

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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