ApneaLink Air Home Sleep Testing (HST) Device Validation Study
Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography
1 other identifier
interventional
130
1 country
2
Brief Summary
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
March 20, 2018
CompletedStudy Start
First participant enrolled
April 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedResults Posted
Study results publicly available
May 20, 2021
CompletedMay 20, 2021
April 1, 2021
11 months
February 28, 2018
March 23, 2021
April 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events
Day 1
Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG
Day 1
Positive Likelihood Ratio of Apnealink Air
Day 1
Study Arms (1)
Participants
EXPERIMENTALApneaLink Air
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (2)
University of Florida
Gainesville, Florida, 32611, United States
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Benjafield
- Organization
- ResMed
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Berry, MD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2018
First Posted
March 20, 2018
Study Start
April 11, 2018
Primary Completion
March 6, 2019
Study Completion
July 31, 2019
Last Updated
May 20, 2021
Results First Posted
May 20, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share