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NCT Number: NCT07400861

Study of Min-Max APAP Recommender Tool

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Australian Sleep Disorders Research Institute

Perth, Western Australia, 6009, Australia

Location contact

Nigel McArdle, MD

CONTACT

[email protected]

(08) 9346 3154

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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)

Treatment and study plan

CPAP with min-max recommender tool

Device

CPAP where the settings are personalized to each patient, recommended by Pressure Match tool.

CPAP with default settings

Device

CPAP set up on default out-of-box clinical pressure settings.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Pongrass

CONTACT

[email protected]

0466015420

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Trial of a New Software Tool for Personalized Minimum and Maximum Pressure Recommendations in New CPAP Users With OSA

Acronym: SMART

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Feb 10, 2026
Registry last updated: Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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