Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05939934

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

Led by University Hospital, Angers · Updated on 2026-04-06

40

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient accepting MAD treatment
  • Apnea-hypopnea index (AHI) greater than 15 events per hour on initial recording
  • Excessive daytime sleepiness during initial treatment (ESE > 10)
  • Treated for more than 12 months by CPAP with average compliance greater than 5 hours per night
Not Eligible

You will not qualify if you...

  • Severe daytime sleepiness at baseline
  • OSAS with 5 or more central apneas per hour of sleep at baseline
  • Severe cardiac and/or respiratory diseases
  • Body mass index 35 kg/m2 or higher
  • Known contraindication to mandibular advancement device treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Angers University Hospital

Angers, France, 49100

Actively Recruiting

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Research Team

W

wojciech trzepizur, MD PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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