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

NCT ID: NCT05939934

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2025-11-30

Brief 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.

Detailed 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.

Conditions

Sleep Apnea, Obstructive; Endothelial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

Patients will be ask not to use any OSAS treatment during the 2 weeks of the study (after the CPAP withdrawal)

Group Type: NO_INTERVENTION

No interventions assigned to this group

mandibular advancement device

Patients will be asked to use mandibular advancement device during the 2 weeks CPAP withdrawal

Group Type: EXPERIMENTAL

Mandibular advancement device treatment

Intervention Type: DEVICE

a titratable thermoplastic mandibular advancement device will be proposed to patient in the experimental group during the 2 weeks of CPAP withdrawal.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

wojciech Trzepizur, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Angers University Hospital

Locations

Angers University Hospital

Angers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

wojciech trzepizur, MD PHD

Role: CONTACT

wotrezpizur@chu-angers.fr

+3380575272

Facility Contacts

Wojciech Trzepizur, MD Ph D

Role: primary

wotrzepizur@chu-angers.fr

+33680575272

Other Identifiers

49RC23_0078

Identifier Type: -

Identifier Source: org_study_id