NCT03470493

ApneaLink Air Home Sleep Testing (HST) Device Validation Study

Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Sleep-disordered Breathing

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ApneaLink Air	ApneaLink Air to be used on each participant undergoing PSG

Timeline

• Start date: 2018-04-11
• Primary completion: 2019-03-06
• Completion: 2019-07-31
• First posted: 2018-03-20
• Last updated: 2021-05-20
• Results posted: 2021-05-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study