Exploration of Current and New Technologies for Accuracy of Diagnosing OSA

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Device A; Device: Device B; Device: Device C; Device: Device D; Device: Device E; Diagnostic test: Screener A

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Alison Wimms, PhD; Phone Number: 02 8884 2203; Email: Alison.Wimms@resmed.com.au

Study Locations

• Australia
  • Perth, Australia
    • School of Psychological Science
    • Contact: Dr Alexander Sweetman
  • New South Wales
    • Sydney, New South Wales, Australia
      • Peninsula Sleep Clinic
      • Contact: Dr Jian Eu Tai; Email: reception@nbrespiratoryandsleep.com.au
  • South Australia
    • Adelaide, South Australia, Australia
      • Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University
      • Contact: Prof Ching Li Chai-Coetzer
    • Adelaide, South Australia, Australia
      • Flinders Health and Medical Research Institute
      • Contact: Prof Robert Adams
  • UWA
    • Perth, UWA, Australia
      • Centre for Sleep Science, The University of Western Australia.
      • Contact: Jen Walsh
  • Victoria
    • Box Hill, Victoria, Australia
      • Box Hill Hospital
      • Contact: Prof Denise O'Driscoll
    • Heidelberg, Victoria, Australia
      • Victorian Respiratory Support Service (VRSS)
      • Contact: Prof Mark Howard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient suspected or known to have OSA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSA; Suspected of obstructive sleep apnea and about to undergo assessment	Device: Device A; A finger worn OSA home sleep test (HST) diagnostic device; Device: Device B; A wrist worn OSA home sleep test (HST) diagnostic device; Device: Device C; Ring: wellness device; Device: Device D; Torso and limb worn patches; Device: Device E; An eye mask; Diagnostic test: Screener A; A mobile app screener

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: KlinEra Global Services

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: MA280126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No