Actively Recruiting
Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal
Led by University Hospital, Angers · Updated on 2026-04-06
40
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obstructive sleep apnea hypopnea syndrome (OSAS) is a frequent disease with neuropsychological and cardiovascular (CV) consequences. Continuous positive pressure (CPAP), the main treatment for OSAHS, is effective on the majority of symptoms but restrictive, which can promote non-compliance. Treatment interruptions are often observed in connection with intercurrent events such as nasal obstructions or even when patients are on the move. However, randomized trials have shown that stopping treatment, even for a short time, leads to a recurrence of symptoms and significant CV disturbances (increase in blood pressure, endothelial dysfunction, cardiac repolarization disorders). It seems important to consider strategies that promote therapeutic continuity. The mandibular advancement device (MAD) is an interesting tool in this regard. MAD is as effective as CPAP on symptoms and CV data. The investigators want to assess its effectiveness as a complementary treatment during treatment discontinuation on the main consequences of OSAHS.
CONDITIONS
Official Title
Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient accepting MAD treatment
- Apnea-hypopnea index (AHI) greater than 15 events per hour on initial recording
- Excessive daytime sleepiness during initial treatment (ESE > 10)
- Treated for more than 12 months by CPAP with average compliance greater than 5 hours per night
You will not qualify if you...
- Severe daytime sleepiness at baseline
- OSAS with 5 or more central apneas per hour of sleep at baseline
- Severe cardiac and/or respiratory diseases
- Body mass index 35 kg/m2 or higher
- Known contraindication to mandibular advancement device treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Angers University Hospital
Angers, France, 49100
Actively Recruiting
Research Team
W
wojciech trzepizur, MD PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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