NCT05939934 Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal
| NCT ID | NCT05939934 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Sleep Apnea, Obstructive |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-03-05 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
wojciech Trzepizur, MD PHD
PRINCIPAL INVESTIGATOR
University Hospital, Angers
Frequently Asked Questions
Who can join the NCT05939934 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Sleep Apnea, Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05939934 currently recruiting?
Yes, NCT05939934 is actively recruiting participants. Contact the research team at wotrezpizur@chu-angers.fr for enrollment information.
Where is the NCT05939934 trial being conducted?
This trial is being conducted at Angers, France.
Who is sponsoring the NCT05939934 clinical trial?
NCT05939934 is sponsored by University Hospital, Angers. The principal investigator is wojciech Trzepizur, MD PHD at University Hospital, Angers. The trial plans to enroll 40 participants.