Angers University Hospital
Angers, 49100, France
Location status: Recruiting
NCT Number: NCT05939934
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Angers, 49100, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a titratable thermoplastic mandibular advancement device will be proposed to patient in the experimental group during the 2 weeks of CPAP withdrawal.
Time frame: before and two weeks after CPAP withdrawal
Sleepiness assessed using the Epworth Sleepiness Scale
Time frame: before and two weeks after CPAP withdrawal
Osler test
Time frame: before and two weeks after CPAP withdrawal
Pittsburgh sleep quality index
Time frame: before and two weeks after CPAP withdrawal
trail making test
Time frame: before and two weeks after CPAP withdrawal
24 hours systolic, diastolic and mean blood pressure (Blood pressure holter)
Time frame: before and two weeks after CPAP withdrawal
endothelial function (assessed by reactive hyperemia arterial tonometry)
Time frame: before and two weeks after CPAP withdrawal
cardiac repolarization (QTc, TpTec intervals calculation on electrocardiographe))
Time frame: before and two weeks after CPAP withdrawal
urine catecholamines levels
Time frame: before and two weeks after CPAP withdrawal
blood glucose levels
Time frame: before and two weeks after CPAP withdrawal
blood microparticles levels
Time frame: before and two weeks after CPAP withdrawal
blood 8-isoprostane levels
Time frame: before and two weeks after CPAP withdrawal
blood CRPus levels
Contact information is provided by the study sponsor or research team.
University Hospital, Angers
Other Gov
Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment With Continuous Positive Airway Pressure: Randomized Controlled Trial
Acronym: ORTAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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