Endothelial Dysfunction Clinical Trial
— ORTAPOfficial title:
Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment With Continuous Positive Airway Pressure: Randomized Controlled 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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | November 2025 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patient accepting MAD treatment - Patient with an apnea-hypopnea index (AHI) greater than 30 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 |
Country | Name | City | State |
---|---|---|---|
France | Angers University Hospital | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in subjective sleepiness | Sleepiness assessed using the Epworth Sleepiness Scale | before and two weeks after CPAP withdrawal | |
Secondary | Change in objective sleepiness | Osler test | before and two weeks after CPAP withdrawal | |
Secondary | Change in subjective sleep quality | Pittsburgh sleep quality index | before and two weeks after CPAP withdrawal | |
Secondary | Change in executive function | trail making test | before and two weeks after CPAP withdrawal | |
Secondary | Change in 24 hour blood pressure | 24 hours systolic, diastolic and mean blood pressure (Blood pressure holter) | before and two weeks after CPAP withdrawal | |
Secondary | Change in endothelial function | endothelial function (assessed by reactive hyperemia arterial tonometry) | before and two weeks after CPAP withdrawal | |
Secondary | Change in cardiac repolarization | cardiac repolarization (QTc, TpTec intervals calculation on electrocardiographe)) | before and two weeks after CPAP withdrawal | |
Secondary | Change in catecholamines levels | urine catecholamines levels | before and two weeks after CPAP withdrawal | |
Secondary | Change in glucose levels | blood glucose levels | before and two weeks after CPAP withdrawal | |
Secondary | Change in Microparticles | blood microparticles levels | before and two weeks after CPAP withdrawal | |
Secondary | Change in oxydative stress | blood 8-isoprostane levels | before and two weeks after CPAP withdrawal | |
Secondary | Change in inflammation | blood CRPus levels | before and two weeks after CPAP withdrawal |
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