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NCT Number: NCT05939934

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angers University Hospital

Angers, 49100, France

Location status: Recruiting

Location contact

Wojciech Trzepizur, MD Ph D

CONTACT

[email protected]

+33680575272

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular advancement device treatment

Device

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

Primary outcomes

  1. Change in subjective sleepiness

    Time frame: before and two weeks after CPAP withdrawal

    Sleepiness assessed using the Epworth Sleepiness Scale

Secondary outcomes

  1. Change in objective sleepiness

    Time frame: before and two weeks after CPAP withdrawal

    Osler test

  2. Change in subjective sleep quality

    Time frame: before and two weeks after CPAP withdrawal

    Pittsburgh sleep quality index

  3. Change in executive function

    Time frame: before and two weeks after CPAP withdrawal

    trail making test

  4. Change in 24 hour blood pressure

    Time frame: before and two weeks after CPAP withdrawal

    24 hours systolic, diastolic and mean blood pressure (Blood pressure holter)

  5. Change in endothelial function

    Time frame: before and two weeks after CPAP withdrawal

    endothelial function (assessed by reactive hyperemia arterial tonometry)

  6. Change in cardiac repolarization

    Time frame: before and two weeks after CPAP withdrawal

    cardiac repolarization (QTc, TpTec intervals calculation on electrocardiographe))

  7. Change in catecholamines levels

    Time frame: before and two weeks after CPAP withdrawal

    urine catecholamines levels

  8. Change in glucose levels

    Time frame: before and two weeks after CPAP withdrawal

    blood glucose levels

  9. Change in Microparticles

    Time frame: before and two weeks after CPAP withdrawal

    blood microparticles levels

  10. Change in oxydative stress

    Time frame: before and two weeks after CPAP withdrawal

    blood 8-isoprostane levels

  11. Change in inflammation

    Time frame: before and two weeks after CPAP withdrawal

    blood CRPus levels

Study contacts

Contact information is provided by the study sponsor or research team.

wojciech trzepizur, MD PHD

CONTACT

[email protected]

+3380575272

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: ORTAP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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