Exploration of Current and New Technologies for Accuracy of Diagnosing OSA
ConditionObstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorResMed
About this trial
Resmed is the manufacturer of medical devices which screen, diagnose, treat and monitor people with sleeping and respiratory disorders, such as obstructive sleep apnea (OSA).
From time to time, for regulatory, quality, and marketing purposes, there may be a need to test the various products performance against PSG (gold standard technology), and other products.
The purpose of this study is:
1. Products performance against PSG 2. comparison against other products, and 3. Assessments of potential new technologies
Eligibility criteria
Qualifiers
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
Disqualifiers
Unable to cease PAP therapy during PSG (if currently using)
Requires use of oxygen therapy during sleep
Diagnosis of untreated clinically relevant sleep disorder (other than SDB, e.g. severe insomnia)
Who are or may be pregnant
Trial design
Treatments tested in this trial
- Device A
- Device B
- Device C
- Device D
- Device E
- Screener A
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
ResMed
Lead sponsor
KlinEra Global Services
Collaborator
Source ClinicalTrials.gov