Study of Min-Max APAP Recommender Tool
ConditionObstructive Sleep Apnea (OSA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorResMed
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CPAP with min-max recommender tool
DeviceCPAP where the settings are personalized to each patient, recommended by Pressure Match tool.
CPAP with default settings
DeviceCPAP set up on default out-of-box clinical pressure settings.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: APAP Pressure MatchExperimental treatment 1 intervention
Group B: Default CPAP settingsPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
3 months Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: