ApneaLink Air Home Sleep Testing (HST) Device Validation Study

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.

Study Overview

• Status: Completed
• Conditions: Sleep-disordered Breathing
• Intervention / Treatment: Diagnostic test: ApneaLink Air

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants; ApneaLink Air	Diagnostic test: ApneaLink Air; ApneaLink Air to be used on each participant undergoing PSG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Richard Berry, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: SLP-17-10-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No