Obstructive Sleep ApneaNCT07485582
Exploration of Current and New Technologies for Accuracy of Diagnosing OSA
An observational study of Obstructive Sleep Apnea, run by ResMed at 5 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Device A, Device B and Device C
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 5 sitesAustralia
- Study dates
- Sep 2026to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient suspected or known to have OSA
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites
Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University
Adelaide, South Australia
Prof Ching Li Chai-Coetzer
Flinders Health and Medical Research Institute
Adelaide, South Australia
Prof Robert Adams
Victorian Respiratory Support Service (VRSS)
Heidelberg, Victoria
Prof Mark Howard
Centre for Sleep Science, The University of Western Australia.
Perth, UWA
Jen Walsh
Queen Elizabeth hosptial respiratory and sleep unit
Woodville South, South Australia
Thomas Altree
About this study
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:
- Products performance against PSG
- comparison against other products, and
- Assessments of potential new technologies
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Device A, Device B, Device C, Device D, Device E
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device ADevice
A finger worn OSA home sleep test (HST) diagnostic device
Device BDevice
A wrist worn OSA home sleep test (HST) diagnostic device
Device CDevice
Ring: wellness device
Device DDevice
Torso and limb worn patches
Device EDevice
An eye mask
Screener ADiagnostic test
A mobile app screener
| Study group | Role | What they receive |
|---|---|---|
| OSA | Suspected of obstructive sleep apnea and about to undergo assessment Receives: Device: Device A; Device: Device B; Device: Device C; Device: Device D; Device: Device E; Diagnostic Test: Screener A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity is defined as the device's ability to correctly diagnose patients with OSA, relative to AHI 5
Measured: Single night PSG
Specificity
Specificity is defined as the device's ability to correctly identify patients without OSA, relative to AHI 5.
Measured: A single night PSG
Secondary outcomes (4)
Severity Categorisation
Ability to correctly identify OSA severity category, based on AHI threshold values (normal, mild, moderate, severe).
Measured: A single night PSG
Total Sleep Time
Total portion of the recording identified as sleep time
Measured: 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
Measured: 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.
Measured: A single night PSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KlinEra Global Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485582
- Sponsor's protocol ID
- MA280126
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Current and New Technologies for Accuracy of Diagnosing OSA
- ClinicalTrials.gov ID
- NCT07485582
- Acronym / sponsor ID
- MA280126
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- KlinEra Global Services
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Products performance against PSG
- comparison against other products, and
- Assessments of potential new technologies
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA | – | Device: Device A, Device: Device B, Device: Device C, Device: Device D, Device: Device E, Diagnostic Test: Screener ASuspected of obstructive sleep apnea and about to undergo assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient suspected or known to have OSA
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device AA finger worn OSA home sleep test (HST) diagnostic device | Device | OSA |
| Device BA wrist worn OSA home sleep test (HST) diagnostic device | Device | OSA |
| Device CRing: wellness device | Device | OSA |
| Device DTorso and limb worn patches | Device | OSA |
| Device EAn eye mask | Device | OSA |
| Screener AA mobile app screener | Diagnostic test | OSA |
Primary outcome
Sensitivity
Time frame: Single night PSG
Sensitivity is defined as the device's ability to correctly diagnose patients with OSA, relative to AHI 5
Specificity
Time frame: A single night PSG
Specificity is defined as the device's ability to correctly identify patients without OSA, relative to AHI 5.
4 secondary outcomes
Severity Categorisation
Time frame: A single night PSG
Total Sleep Time
Time frame: A single night PSG
ODI
Time frame: A single night PSG
Sleep Staging
Time frame: A single night PSG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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RecruitingPhase 1/2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by ResMed at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Wimms, PhD (02 8884 2203, Alison.Wimms@resmed.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Single night PSG). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.