Study of a New Auto-Adjusting Positive Airway Pressure Device for Treating Obstructive Sleep Apnea

What this Trial Is About

Researchers are evaluating a new auto-adjusting positive airway pressure algorithm for treating obstructive sleep apnea OSA. This randomized, single-blind study compares the investigational algorithm to an established control algorithm by measuring device data and user experiences. The study includes two phases Phase 1 focuses on confirming the algorithms function and making minor software adjustments, while Phase 2 assesses its performance in a broader group of participants. An optional extension is offered to those who wish to continue using the investigational algorithm after the main phases. Participants will use both the investigational and control algorithms in random order, each for up to four weeks at home, replacing their usual therapy device. The study device settings will match their current therapy as closely as possible. During the study, participants may also wear a wellness wearable device to track sleep and activity data throughout the study period. The study involves up to eight weeks of device use across both algorithms. Participants will attend up to three visits giving informed consent and receiving the first device setup, switching to the alternate algorithm after the first trial period, and returning the device at the end. They will complete questionnaires about their therapy experiences and preferences. Researchers will monitor apnea-hypopnea index AHI to measure algorithm effectiveness and gather device usage, leak, pressure data, as well as subjective scores and wearable-collected sleep and activity metrics. The total participation lasts up to eight weeks, with reimbursement provided at study completion.

Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study