Trial of a New Software Tool for Personalized Minimum and Maximum Pressure Recommendations in New CPAP Users With OSA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mean residual AHI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
APAP Pressure Match
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.
干预措施: CPAP with min-max recommender tool (Device)
Default CPAP settings
Default out-of-box min and max settings for CPAP.
干预措施: CPAP with default settings (Device)
结局指标
主要结局
Mean residual AHI
时间窗: 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.
次要结局
未报告次要终点