Obstructive Sleep Apnea (OSA)SMARTNCT07400861
Study of Min-Max APAP Recommender Tool
A study testing CPAP with min-max recommender tool and CPAP with default settings in people with Obstructive Sleep Apnea (OSA), run by ResMed at 1 site in Australia.
Trial summary
Pressure Match (The APAP Min-Max tool) is a software-based clinical decision-support tool, developed using a causal-inference modelling approach based on data from thousands of OSA patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- CPAP with min-max recommender tool and CPAP with default settings
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Apr 2026to 1 Mar 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients who are ≥ 18 years of age
- Patients newly diagnosed with OSA (AHI ≥ 5) and indicated for CPAP therapy.
Who cannot join
- Patients who have previously used PAP therapy
- Patients who require a bilevel device
- Patients who are or may be pregnant
- Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury
- Patients whose physician has dictated specific therapy settings (e.g. fixed pressure CPAP, or specific AutoSet minimum and/ or maximum settings)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
West Australian Sleep Disorders Research Institute
Perth, Western Australia, 6009
Nigel McArdle, MD, (08) 9346 3154, nigel.mcardle@health.wa.gov.au
About this study
Official title: Trial of a New Software Tool for Personalized Minimum and Maximum Pressure Recommendations in New CPAP Users With OSA
Pressure Match (The APAP Min-Max tool) is a software-based clinical decision-support tool, developed using a causal-inference modelling approach based on data from thousands of OSA patients. The model takes as inputs from patient variables (e.g., baseline AHI, gender, weight/BMI, mask interface type), and outputs recommended AutoSet minimum and maximum pressure settings (cmH₂O) tailored for that patient phenotype.
The intended clinical role of the Pressure Match tool is to assist the clinician's choice of AutoSet pressure range when initiating CPAP therapy, with the goal of reducing clinician time/effort in manual titration and follow-up adjustments without compromising safety, efficacy or patient satisfaction.
The purpose of this trial is to test Pressure Match in a clinical trial setting, to demonstrate non-inferiority against standard APAP settings.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- CPAP with min-max recommender tool, CPAP with default settings
- 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.
CPAP with min-max recommender toolDevice
CPAP where the settings are personalized to each patient, recommended by Pressure Match tool.
CPAP with default settingsDevice
CPAP set up on default out-of-box clinical pressure settings.
| Study group | Role | What they receive |
|---|---|---|
| APAP Pressure Match | Experimental | CPAP clinical min-max pressure settings provided by the APAP Pressure Match recommender tool. The tool utilizes machine learning to identify optimal clinical settings for each patient. Receives: Device: CPAP with min-max recommender tool |
| Default CPAP settings | Placebo comparator | Default out-of-box min and max settings for CPAP. Receives: Device: CPAP with default settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean residual AHI
The primary endpoint is comparison of the mean residual AHI of the active group compared with the control group, to demonstrate non-inferiority.
Apnea-Hypopnea Index (AHI) is defined as the number of obstructive apnea and hypopnea events per hour of sleep. Apneas are episodes of complete cessation of airflow, and hypopneas are episodes of partial reduction in airflow.
Residual AHI is the AHI calculated from device-recorded data via validated detection algorithms collected while the participant is receiving therapy with the study device. Residual AHI reflects the frequency of obstructive respiratory events that remain during treatment and is used to assess treatment effectiveness.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400861
- Sponsor's protocol ID
- MA011025
- Acronym
- SMART
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IP protected
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of a New Software Tool for Personalized Minimum and Maximum Pressure Recommendations in New CPAP Users With OSA
- ClinicalTrials.gov ID
- NCT07400861
- Acronym / sponsor ID
- SMART / MA011025
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Feb 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.
Pressure Match (The APAP Min-Max tool) is a software-based clinical decision-support tool, developed using a causal-inference modelling approach based on data from thousands of OSA patients. The model takes as inputs from patient variables (e.g., baseline AHI, gender, weight/BMI, mask interface type), and outputs recommended AutoSet minimum and maximum pressure settings (cmH₂O) tailored for that patient phenotype.
The intended clinical role of the Pressure Match tool is to assist the clinician's choice of AutoSet pressure range when initiating CPAP therapy, with the goal of reducing clinician time/effort in manual titration and follow-up adjustments without compromising safety, efficacy or patient satisfaction.
The purpose of this trial is to test Pressure Match in a clinical trial setting, to demonstrate non-inferiority against standard APAP settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APAP Pressure Match | Experimental | Device: CPAP with min-max recommender toolCPAP clinical min-max pressure settings provided by the APAP Pressure Match recommender tool. The tool utilizes machine learning to identify optimal clinical settings for each patient. |
| Default CPAP settings | Placebo comparator | Device: CPAP with default settingsDefault out-of-box min and max settings for CPAP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients who are ≥ 18 years of age
- Patients newly diagnosed with OSA (AHI ≥ 5) and indicated for CPAP therapy.
Key exclusion criteria (5 listed)
- Patients who have previously used PAP therapy
- Patients who require a bilevel device
- Patients who are or may be pregnant
- Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury
- Patients whose physician has dictated specific therapy settings (e.g. fixed pressure CPAP, or specific AutoSet minimum and/ or maximum settings)
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 |
|---|---|---|
| CPAP with min-max recommender toolCPAP where the settings are personalized to each patient, recommended by Pressure Match tool. | Device | APAP Pressure Match |
| CPAP with default settingsCPAP set up on default out-of-box clinical pressure settings. | Device | Default CPAP settings |
Primary outcome
Mean residual AHI
Time frame: 3 months
The primary endpoint is comparison of the mean residual AHI of the active group compared with the control group, to demonstrate non-inferiority. Apnea-Hypopnea Index (AHI) is defined as the number of obstructive apnea and hypopnea events per hour of sleep. Apneas are episodes of complete cessation of airflow, and hypopneas are episodes of partial reduction in airflow. Residual AHI is the AHI calculated from device-recorded data via validated detection algorithms collected while the participant is receiving therapy with the study device. Residual AHI reflects the frequency of obstructive respiratory events that remain during treatment and is used to assess treatment effectiveness.
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 12 Feb 2026.
- Individual participant dataSharing planned: No. IP protected
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP with min-max recommender tool and CPAP with default settings in people with Obstructive Sleep Apnea (OSA), run by ResMed at 1 site 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 4 inclusion and 5 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Sarah Pongrass (0466015420, sarahjane.pongrass@resmed.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean residual AHI (time frame: 3 months). 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 12 Feb 2026.