ApneaLink Air Home Sleep Testing (HST) Device Validation Study



Status:Active, not recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:April 11, 2018
End Date:June 2019

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Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography

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

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.

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
We found this trial at
2
sites
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Richard Berry, MD
Phone: 352-273-5870
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Alexandre Abreu, MD
Phone: 305-243-2568
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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