Exploration of Current and New Technologies for Accuracy of Diagnosing OSA

NCT07485582 | Not Yet Recruiting FDA Device

• 1 other identifier: MA280126
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 7

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. 1.Products performance against PSG
2. 2.comparison against other products, and
3. 3.Assessments of potential new technologies

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Severity Categorisation

  A single night PSG

• Total Sleep Time

  A single night PSG

• ODI

  A single night PSG

• Sleep Staging

  A single night PSG

Study Arms (1)

OSA

Suspected of obstructive sleep apnea and about to undergo assessment

Device: Device A; Device: Device B; Device: Device C; Device: Device D; Device: Device E; Diagnostic Test: Screener A

Interventions

Device C DEVICE

Ring: wellness device

OSA

Device D DEVICE

Torso and limb worn patches

OSA

Device E DEVICE

An eye mask

OSA

Screener A DIAGNOSTIC_TEST

A mobile app screener

OSA

Device A DEVICE

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

OSA

Device B DEVICE

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

OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient suspected or known to have OSA

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead
• KlinEra Global Services: collaborator

Study Sites (7)

Peninsula Sleep Clinic

Sydney, New South Wales, Australia

Location

Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University

Adelaide, South Australia, Australia

Location

Flinders Health and Medical Research Institute

Adelaide, South Australia, Australia

Location

Centre for Sleep Science, The University of Western Australia.

Perth, UWA, Australia

Location

Box Hill Hospital

Box Hill, Victoria, Australia

Location

Victorian Respiratory Support Service (VRSS)

Heidelberg, Victoria, Australia

Location

School of Psychological Science

Perth, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Alison Wimms, PhD

CONTACT

02 8884 2203; Alison.Wimms@resmed.com.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7)