Comparing Oronasal and Nasal CPAP with Chinstrap to Reduce Unintentional Leak in Adults with Moderate to Severe Obstructive Sleep Apnea

What this Trial Is About

Researchers are investigating how to manage unintentional oral leaks that occur during continuous positive airway pressure CPAP treatment for obstructive sleep apnea OSA. This study focuses on evaluating different mask types and strategies to reduce excessive leaks, which are common side effects that have not been standardized or well studied. The trial is part of a controlled, randomized crossover design to compare oral leaks with oronasal masks versus nasal masks combined with chinstraps. Participants who continue to have excessive leaks after an initial phase Study A will enter Study B, where they will use CPAP with either an oronasal mask or a nasal mask plus chinstrap for 7 days each. The order of these interventions will be randomized and separated by a 7-day washout period using nasal CPAP alone. This sequence will allow comparison of leak control between the two mask approaches. During the study, participants will be monitored for unintentional leak levels, sleep apnea severity, and side effects using questionnaires such as the CPAP Side-effects questionnaire, the Functional Outcomes of Sleep Questionnaire, and the Pittsburgh questionnaire. The main outcome is the 95th percentile of unintentional leak measured over 27 days. The total study duration includes both intervention periods and washout, with assessments conducted throughout to evaluate treatment effects and participant experience.

Addressing Unintentional Leakage When Using Nasal CPAP - Study B