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Recruiting NCT05939934

NCT05939934 Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal

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Clinical Trial Summary
NCT ID NCT05939934
Status Recruiting
Phase
Sponsor University Hospital, Angers
Condition Sleep Apnea, Obstructive
Study Type INTERVENTIONAL
Enrollment 40 participants
Start Date 2024-03-05
Primary Completion 2026-11

Trial Parameters

Condition Sleep Apnea, Obstructive
Sponsor University Hospital, Angers
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-03-05
Completion 2026-11
Interventions
Mandibular advancement device treatment

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Brief Summary

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.

Eligibility 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

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