ApneaLink Air Home Sleep Testing (HST) Device Validation Study

ResMed

Status: Completed

Conditions: Sleep-disordered Breathing

Treatments: Diagnostic Test: ApneaLink Air

Study type: Interventional

Funder types: Industry

Identifiers

NCT03470493

SLP-17-10-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

130 participants in 1 patient group

Participants

Experimental group

Description:

ApneaLink Air

Treatment:

Diagnostic Test: ApneaLink Air