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

Endothelial Dysfunction Clinical Trial

— ORTAP  

Official title:

Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment With Continuous Positive Airway Pressure: Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05939934
• Other study ID #: 49RC23_0078
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: November 2025

Study information

• Verified date: June 2023
• Source: University Hospital, Angers
• Contact: wojciech trzepizur, MD PHD
• Phone: +3380575272
• Email: wotrezpizur[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Apnea
• Endothelial Dysfunction
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

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