Status:
COMPLETED
ApneaLink Air Home Sleep Testing (HST) Device Validation Study
Lead Sponsor:
ResMed
Conditions:
Sleep-disordered Breathing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03470493
Start Date
April 11 2018
End Date
July 31 2019
Last Update
May 20 2021
Active Locations (2)
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1
University of Florida
Gainesville, Florida, United States, 32611
2
University of Miami
Miami, Florida, United States, 33136