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NCT07485582
Exploration of Current and New Technologies for Accuracy of Diagnosing OSA
Conditions: Obstructive Sleep Apnea
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 90
Sponsor: ResMed
Location: Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University Adelaide South Australia
Summary
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
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 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
* Participants are unsuitable to participate in the study in the opinion of the investigator
* Participant has a permanent pacemaker, sustained non-sinus cardiac arrhythmias, and/or takes alpha blocker or short acting nitrate medication.
* Shift workers who worked an overnight shift in the past 3 days
* Participant who are contraindicated to use the NightOwl sensor
Source: ClinicalTrials.gov (NCT07485582). StuddyBuddy aggregates publicly available trial information.