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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05939934
Acronym
ORTAP
Enrollment
40
Registered
2023-07-11
Start date
2024-03-05
Completion date
2026-11-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Sleep Apnea, Obstructive

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.

Interventions

DEVICEMandibular 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.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in subjective sleepinessbefore and two weeks after CPAP withdrawalSleepiness assessed using the Epworth Sleepiness Scale

Secondary

MeasureTime frameDescription
Change in objective sleepinessbefore and two weeks after CPAP withdrawalOsler test
Change in subjective sleep qualitybefore and two weeks after CPAP withdrawalPittsburgh sleep quality index
Change in executive functionbefore and two weeks after CPAP withdrawaltrail making test
Change in 24 hour blood pressurebefore and two weeks after CPAP withdrawal24 hours systolic, diastolic and mean blood pressure (Blood pressure holter)
Change in endothelial functionbefore and two weeks after CPAP withdrawalendothelial function (assessed by reactive hyperemia arterial tonometry)
Change in cardiac repolarizationbefore and two weeks after CPAP withdrawalcardiac repolarization (QTc, TpTec intervals calculation on electrocardiographe))
Change in catecholamines levelsbefore and two weeks after CPAP withdrawalurine catecholamines levels
Change in glucose levelsbefore and two weeks after CPAP withdrawalblood glucose levels
Change in Microparticlesbefore and two weeks after CPAP withdrawalblood microparticles levels
Change in oxydative stressbefore and two weeks after CPAP withdrawalblood 8-isoprostane levels
Change in inflammationbefore and two weeks after CPAP withdrawalblood CRPus levels

Countries

France

Contacts

CONTACTwojciech trzepizur, MD PHD
wotrezpizur@chu-angers.fr+3380575272
PRINCIPAL_INVESTIGATORwojciech Trzepizur, MD PHD

Angers University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026