ClinicalTrials.gg
Not yet recruitingNCT07485582Updated Aug 19, 2026

Exploration of Current and New Technologies for Accuracy of Diagnosing OSA

An observational study in Obstructive Sleep Apnea, sponsored by ResMed. Not yet recruiting at 5 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by ResMed · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 50 studies in Sleep Apnea, Obstructive by ResMed — 9 open to participants now, 10 under way, none of them phase 3. Sleep Apnea, Obstructive · ResMed.

Started
2026
with 3 others
Other kind
Only one
of the 50
Registered
48th of 50
by date

Among the 50 studies in Sleep Apnea, Obstructive by ResMed, this one is one of 4 that started in 2026, is the only one of another kind, and was the 48th registered.

By phase

50 studies; the count open now beside each. This study's row is marked.

No phase40 · 6 open
Observational7 · 1 open
Other kindthis study1 · 1 open
Phase 21 · 0 open
Phase 41 · 1 open

By the year they started

First in 2005; this study’s year is marked. 4 started in 2026.

Size and results

Median enrollment 30 across the 42 interventional studies, 430 across the 8 observational. Of the 38 that completed or were terminated, 15 (39%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 50 studies in Sleep Apnea, Obstructive by ResMed, or all of them as a file.
02

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
03

Conditions studied

  • Obstructive Sleep Apnea
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient suspected or known to have OSA

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant is 18 years of age or older
  • Participant is willing to provide
  • Participant is willing to participate in all study related procedures

Exclusion criteria

Exclusion Criteria:

  • Unable to cease PAP therapy during PSG (if currently using)
  • Requires use of oxygen therapy during sleep
  • Diagnosis of untreated 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 to use the NightOwl sensor
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceDevice A

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

  • DeviceDevice B

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

  • DeviceDevice C

    Ring: wellness device

  • DeviceDevice D

    Torso and limb worn patches

  • DeviceDevice E

    An eye mask

  • Diagnostic testScreener A

    A mobile app screener

06

What researchers measure

Primary outcomes

  1. Sensitivity

    Sensitivity is defined as the device's ability to correctly diagnose patients with OSA, relative to AHI 5

    Time frame: Single night PSG

  2. Specificity

    Specificity is defined as the device's ability to correctly identify patients without OSA, relative to AHI 5.

    Time frame: A single night PSG

Secondary outcomes

  1. Severity Categorisation

    Ability to correctly identify OSA severity category, based on AHI threshold values (normal, mild, moderate, severe).

    Time frame: A single night PSG

  2. Total Sleep Time

    Total portion of the recording identified as sleep time

    Time frame: A single night PSG

  3. 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

    Time frame: A single night PSG

  4. 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.

    Time frame: A single night PSG

07

Study locations

5 sites
  • 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
  • Queen Elizabeth hosptial respiratory and sleep unit
    Woodville South, South Australia, Australia
    • Thomas Altree · Contact
  • Centre for Sleep Science, The University of Western Australia.
    Perth, UWA, Australia
    • Jen Walsh · Contact
  • Victorian Respiratory Support Service (VRSS)
    Heidelberg, Victoria, Australia
    • Prof Mark Howard · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07485582
Lead sponsor
ResMed
Collaborators
KlinEra Global Services
Responsible party
Sponsor
First posted
Mar 20, 2026
Start date
Sep 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Aug 19, 2026

Study contacts

Alison Wimms, PhD
Contact
Alison.Wimms@resmed.com.au
02 8884 2203

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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