Using a mandibular advancement device to help with sleep apnea when stopping CPAP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.