ApneaLink Air Home Sleep Testing (HST) Device Validation Study

Sleep-disordered Breathing Clinical Trial

Official title:

Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470493
• Other study ID #: SLP-17-10-01
• Status: Completed
• Phase: N/A
• Start date: April 11, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: April 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 31, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep-disordered Breathing

Intervention

Diagnostic Test:
• ApneaLink Air
ApneaLink Air to be used on each participant undergoing PSG

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG)	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.	Day 1
Secondary	Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events	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	Day 1
Secondary	Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG	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	Day 1
Secondary	Positive Likelihood Ratio of Apnealink Air	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.	Day 1