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Recruiting Not applicable

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

NCT05939934 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-03-05
Last updated
2026-04-06

Condition(s) studied

Sleep Apnea, ObstructiveEndothelial Dysfunction

Investigational drug(s) / intervention(s)

Mandibular advancement device treatment

Mandibular advancement device treatment: a titratable thermoplastic mandibular advancement device will be proposed to patient in the experimental group during the 2 weeks of CPAP withdrawal.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in subjective sleepiness — before and two weeks after CPAP withdrawal
    Sleepiness assessed using the Epworth Sleepiness Scale

Trial sites (1)

FacilityCityRegionStatus
Angers University Hospital Angers France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05939934 on ClinicalTrials.gov ↗ ← All trials in France