ApneaLink Air Home Sleep Testing (HST) Device Validation Study

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03470493
Study type	Interventional
Source	ResMed
Contact
Status	Completed
Phase	N/A
Start date	April 11, 2018
Completion date	July 31, 2019

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