Exploration of Current and New Technologies for Accuracy of Diagnosing OSA

NCT07485582 · tracked via the Priya Life Science Australia tracker

Sponsor

ResMed

Phase

Observational

Started

2026-09

Last updated

2026-08-19

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Device ADevice BDevice CDevice DDevice EScreener A

Device A: A finger worn OSA home sleep test (HST) diagnostic device

Device B: A wrist worn OSA home sleep test (HST) diagnostic device

Device C: Ring: wellness device

Device D: Torso and limb worn patches

Device E: An eye mask

Screener A: A mobile app screener

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Sensitivity — Single night PSG
Sensitivity is defined as the device's ability to correctly diagnose patients with OSA, relative to AHI 5
Specificity — A single night PSG
Specificity is defined as the device's ability to correctly identify patients without OSA, relative to AHI 5.

Trial sites (5)

Facility	City	Region
Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University	Adelaide	South Australia
Flinders Health and Medical Research Institute	Adelaide	South Australia
Queen Elizabeth hosptial respiratory and sleep unit	Woodville South	South Australia
Centre for Sleep Science, The University of Western Australia.	Perth	UWA
Victorian Respiratory Support Service (VRSS)	Heidelberg	Victoria

More ResMed trials in Australia

Data Collection Study to Review Novel Methods for Diagnosing Obstructive Sleep Apnea Recruiting

Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study Recruiting

Post Market Clinical Follow up of ResMed Mask Systems Recruiting

Study of Min-Max APAP Recommender Tool Starting soon

Other trials for the same condition

CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects Starting soon

Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study Recruiting

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy Active, not recruiting

The Effect of OSA on Brain Waste Clearance Enrolling by invitation

Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07485582 on ClinicalTrials.gov ↗ ← All trials in Australia