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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Change in subjective sleepiness [Time frame: before and two weeks after CPAP withdrawal]

Secondary outcome measures (11)

• Change in objective sleepiness [Time frame: before and two weeks after CPAP withdrawal]
• Change in subjective sleep quality [Time frame: before and two weeks after CPAP withdrawal]
• Change in executive function [Time frame: before and two weeks after CPAP withdrawal]
• Change in 24 hour blood pressure [Time frame: before and two weeks after CPAP withdrawal]
• Change in endothelial function [Time frame: before and two weeks after CPAP withdrawal]
• Change in cardiac repolarization [Time frame: before and two weeks after CPAP withdrawal]
• Change in catecholamines levels [Time frame: before and two weeks after CPAP withdrawal]
• Change in glucose levels [Time frame: before and two weeks after CPAP withdrawal]
• Change in Microparticles [Time frame: before and two weeks after CPAP withdrawal]
• Change in oxydative stress [Time frame: before and two weeks after CPAP withdrawal]
• Change in inflammation [Time frame: before and two weeks after CPAP withdrawal]

Eligibility criteria

Inclusion criteria

• Patient accepting MAD treatment
• Patient with an apnea-hypopnea index (AHI) greater than 15 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• Angers University Hospital — Angers

Identifiers

NCT: NCT05939934 · 49RC23_0078

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗