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

RecruitingNAAges 18 Years - 75 YearsAllUniversity Hospital, Angers
NCT05939934 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 inve

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📋 Eligibility rules (as published)
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
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What it tests

  • Mandibular advancement device treatment
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Where

1 site
Angers University Hospital
Angers, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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