About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Initial severe daytime sleepiness characterized
OSAS with ≥ 5 central apneas per hour of sleep at baseline recording
Body mass index ≥ 35 kg/m2
Known contraindication to OAM treatment
Trial design
Parallel
Treatments tested in this trial
Mandibular advancement device treatment
Devicea titratable thermoplastic mandibular advancement device will be proposed to patient in the experimental group during the 2 weeks of CPAP withdrawal.
Treatment groups
Trial outcomes
Primary outcomes
Change in subjective sleepiness
Sleepiness assessed using the Epworth Sleepiness Scale
Secondary outcomes
Change in objective sleepiness
Osler test
Change in subjective sleep quality
Pittsburgh sleep quality index
Change in executive function
trail making test
Change in 24 hour blood pressure
24 hours systolic, diastolic and mean blood pressure (Blood pressure holter)
Sponsors and contacts
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