Using a mandibular advancement device to help with sleep apnea when stopping CPAP
Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment With Continuous Positive Airway Pressure: Randomized Controlled Trial
This study is testing if a mouthpiece can help people with sleep apnea manage their symptoms and heart health when they stop using their CPAP machine for a short time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 1 site (Angers) |
| Trial ID | NCT05939934 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a mandibular advancement device (MAD) as a complementary treatment for patients with obstructive sleep apnea who are temporarily discontinuing continuous positive airway pressure (CPAP) therapy. Patients with severe obstructive sleep apnea, who have been compliant with CPAP for over a year, will be randomized into two groups: one receiving the MAD and the other receiving no specific treatment. Assessments of endothelial function, blood pressure, and sleep quality will be conducted before and after a two-week period without CPAP. The goal is to determine if the MAD can help maintain symptom control and cardiovascular health during CPAP withdrawal.
Who should consider this trial
Good fit: Ideal candidates are patients with severe obstructive sleep apnea who have been treated with CPAP for more than 12 months and have excessive daytime sleepiness.
Not a fit: Patients with severe daytime sleepiness, central apneas, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide an alternative treatment option for patients struggling with CPAP compliance, potentially improving their quality of life and cardiovascular health.
How similar studies have performed: Previous studies have shown that mandibular advancement devices can be effective in managing obstructive sleep apnea, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient accepting MAD treatment * Patient with an apnea-hypopnea index (AHI) greater than 15 events per hour on the initial recording * Patient with excessive daytime sleepiness during initial treatment (ESE\>10) * Patient treated for more than 12 months by CPAP with average compliance greater than 5 hours per night Exclusion Criteria: * Initial severe daytime sleepiness characterized * OSAS with ≥ 5 central apneas per hour of sleep at baseline recording * Previously diagnosed severe cardiac and/or respiratory pathology: * Body mass index ≥ 35 kg/m2 * Known contraindication to OAM treatment
Where this trial is running
Angers
- Angers University Hospital — Angers, France (Recruiting)
Study contacts
- Principal investigator: wojciech Trzepizur, MD PHD — University Hospital, Angers
- Study coordinator: wojciech trzepizur, MD PHD
- Email: wotrezpizur@chu-angers.fr
- Phone: +3380575272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.