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Exploration of Current and New Technologies for Accuracy of Diagnosing OSA 90 Medical Device

Not yet recruiting
Clinical Trial NCT07485582 is an observational study for Obstructive Sleep Apnea and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 90 participants. Led by ResMed, this study is expected to complete by 1 October 2026. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
Brief 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...
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Official Title

Exploration of Current and New Technologies for Accuracy of Diagnosing OSA

Conditions
Obstructive Sleep Apnea
Other Study IDs
  • MA280126
NCT ID Number
NCT07485582
Start Date (Actual)
2026-04
Last Update Posted
2026-03-20
Completion Date (Estimated)
2026-10
Enrollment (Estimated)
90
Study Type
Observational
Status
Not yet recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OSA
Suspected of obstructive sleep apnea and about to undergo assessment
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Sensitivity
Sensitivity is defined as the device's ability to correctly diagnose patients with OSA, relative to AHI 5
Single night PSG
Specificity
Specificity is defined as the device's ability to correctly identify patients without OSA, relative to AHI 5.
A single night PSG
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Severity Categorisation
Ability to correctly identify OSA severity category, based on AHI threshold values (normal, mild, moderate, severe).
A single night PSG
Total Sleep Time
Total portion of the recording identified as sleep time
A single night PSG
ODI
The Oxygen Desaturation Index (ODI) measures the number of times per hour of sleep that blood oxygen levels drop by a specific percentage from baseline
A single night PSG
Sleep Staging
Time in the various sleep stages, Stage 1 (light sleep), Stage 2 (deeper, intermediate), Stage 3 (deep, slow-wave sleep/restorative) and REM.
A single night PSG
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
ResMed logoResMed
KlinEra Global Services logoKlinEra Global Services
Study Central Contact
Contact: Alison Wimms, PhD, 02 8884 2203, [email protected]
7 Study Locations in 1 Countries

New South Wales

Peninsula Sleep Clinic, Sydney, New South Wales, Australia
Dr Jian Eu Tai, Contact, [email protected]

South Australia

Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University, Adelaide, South Australia, Australia
Prof Ching Li Chai-Coetzer, Contact
Flinders Health and Medical Research Institute, Adelaide, South Australia, Australia
Prof Robert Adams, Contact

UWA

Centre for Sleep Science, The University of Western Australia., Perth, UWA, Australia
Jen Walsh, Contact

Victoria

Box Hill Hospital, Box Hill, Victoria, Australia
Prof Denise O'Driscoll, Contact
Victorian Respiratory Support Service (VRSS), Heidelberg, Victoria, Australia
Prof Mark Howard, Contact
School of Psychological Science, Perth, Australia
Dr Alexander Sweetman, Contact