Study of Min-Max APAP Recommender Tool

NCT07400861 | Not Yet Recruiting

• 1 other identifier: MA011025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

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.

Device: CPAP with min-max recommender tool

Default CPAP settings

PLACEBO COMPARATOR

Default out-of-box min and max settings for CPAP.

Device: CPAP with default settings

Interventions

CPAP with min-max recommender tool DEVICE

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

APAP Pressure Match

CPAP with default settings DEVICE

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

Default CPAP settings

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

West Australian Sleep Disorders Research Institute

Perth, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Sarah Pongrass

CONTACT

0466015420; sarahjane.pongrass@resmed.com.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)