An interventional study of Mandibular advancement device treatment in Sleep Apnea, Obstructive and Endothelial Dysfunction, sponsored by University Hospital, Angers. Recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Treatment
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.
Patients are recruited during sleep consultations in the Angers University Hospital pneumology department among patients followed for severe OSAHS and treated with CPAP. All of the scheduled examinations are carried out in the sleep laboratory of the CHU d'Angers.
Patients meeting the inclusion criteria and not having any non-inclusion criteria are randomized to the "MAD" group or to the "control" group. For patients in the "MAD" group, an appointment with a stomatologist is organized to make and adjust a thermo-molded type MAD.
An initial assessment is carried out for all patients during a day hospitalization specific to the study (study of endothelial function, blood pressure, Osler test, ECG, venous and urinary sampling, and completion of the study questionnaires).
Patients are then asked to stop CPAP treatment for two weeks. Patients in the OAM group use OAM during this period. Patients in the control group do not receive any specific treatment for their OSAHS during this period.
After 2 weeks of stopping CPAP, a second assessment, identical to the initial assessment, is carried out for all patients. This assessment is carried out during one night of hospitalization which also allows a PSG to be carried out under OAM or without treatment.
At the end of this assessment, the study is terminated and the patients resume their usual use of CPAP.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's planned enrollment of 40 is below the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
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Exclusion Criteria:
Patients will be ask not to use any OSAS treatment during the 2 weeks of the study (after the CPAP withdrawal)
Patients will be asked to use mandibular advancement device during the 2 weeks CPAP withdrawal
Device: 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.
Change in subjective sleepiness
Sleepiness assessed using the Epworth Sleepiness Scale
Time frame: before and two weeks after CPAP withdrawal
Change in objective sleepiness
Osler test
Time frame: before and two weeks after CPAP withdrawal
Change in subjective sleep quality
Pittsburgh sleep quality index
Time frame: before and two weeks after CPAP withdrawal
Change in executive function
trail making test
Time frame: before and two weeks after CPAP withdrawal
Change in 24 hour blood pressure
24 hours systolic, diastolic and mean blood pressure (Blood pressure holter)
Time frame: before and two weeks after CPAP withdrawal
Change in endothelial function
endothelial function (assessed by reactive hyperemia arterial tonometry)
Time frame: before and two weeks after CPAP withdrawal
Change in cardiac repolarization
cardiac repolarization (QTc, TpTec intervals calculation on electrocardiographe))
Time frame: before and two weeks after CPAP withdrawal
Change in catecholamines levels
urine catecholamines levels
Time frame: before and two weeks after CPAP withdrawal
Change in glucose levels
blood glucose levels
Time frame: before and two weeks after CPAP withdrawal
Change in Microparticles
blood microparticles levels
Time frame: before and two weeks after CPAP withdrawal
Change in oxydative stress
blood 8-isoprostane levels
Time frame: before and two weeks after CPAP withdrawal
Change in inflammation
blood CRPus levels
Time frame: before and two weeks after CPAP withdrawal
Plan to share: No
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University Hospital, Angers