Obstructive Sleep Apnea (OSA)
Conditions
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.
Interventions
DEVICECPAP with min-max recommender tool
CPAP where the settings are personalized to each patient, recommended by Pressure Match tool.
DEVICECPAP with default settings
CPAP set up on default out-of-box clinical pressure settings.
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean residual AHI | 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. |
Countries
Australia
Contacts
CONTACTSarah Pongrass
Outcome results
None listed