Evaluating the Effect of a Mandibular Advancement Device During Temporary CPAP Treatment Pause in Adults with Severe Obstructive Sleep Apnea

What this Trial Is About

Researchers are evaluating the use of a mandibular advancement device MAD as a complementary treatment during periods when patients with severe obstructive sleep apnea hypopnea syndrome OSAS stop using their usual continuous positive airway pressure CPAP therapy. OSAS is a common condition with neuropsychological and cardiovascular effects, and while CPAP is effective, interruptions in its use can cause symptom recurrence and cardiovascular issues. This study aims to assess MADs effectiveness during CPAP withdrawal to promote continuous treatment and reduce these negative effects. Participants are patients with severe OSAS who have been treated with CPAP for more than 12 months. They are randomized into two groups one uses MAD during a two-week CPAP withdrawal period, and the other receives no treatment during this time. Before and after the two weeks, participants undergo assessments including endothelial function tests, blood pressure monitoring, ECG, venous and urinary sampling, questionnaires, and overnight polysomnography. The MAD is a thermo-molded device adjusted by a specialist for those in the experimental group. During the study, patients attend the sleep laboratory for initial and follow-up evaluations to measure changes in sleepiness, sleep quality, executive function, cardiovascular markers, and biochemical indicators. After the two-week CPAP withdrawal and assessment, patients resume their usual CPAP treatment. The study measures changes in subjective and objective sleepiness as the primary outcome, along with various secondary outcomes related to cardiovascular and metabolic health, over the two-week period.

Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal