Sleep Apnea, ObstructiveORTAPNCT05939934
Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal
A study testing Mandibular advancement device treatment in people with Sleep Apnea, Obstructive and Endothelial Dysfunction, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Endothelial Dysfunction
- What is being tested?
- Mandibular advancement device treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Angers University Hospital
Angers, 49100
Wojciech Trzepizur, MD Ph D, +33680575272, wotrzepizur@chu-angers.fr
About this study
Official title: Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment With Continuous Positive Airway Pressure: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive, Endothelial Dysfunction
- Being tested
- Mandibular advancement device treatment
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular advancement device treatmentDevice
a titratable thermoplastic mandibular advancement device will be proposed to patient in the experimental group during the 2 weeks of CPAP withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients will be ask not to use any OSAS treatment during the 2 weeks of the study (after the CPAP withdrawal) |
| mandibular advancement device | Experimental | Patients will be asked to use mandibular advancement device during the 2 weeks CPAP withdrawal Receives: Device: Mandibular advancement device treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective sleepiness
Sleepiness assessed using the Epworth Sleepiness Scale
Measured: before and two weeks after CPAP withdrawal
Secondary outcomes (11)
Change in objective sleepiness
Osler test
Measured: before and two weeks after CPAP withdrawal
Change in subjective sleep quality
Pittsburgh sleep quality index
Measured: before and two weeks after CPAP withdrawal
Change in executive function
trail making test
Measured: before and two weeks after CPAP withdrawal
Change in 24 hour blood pressure
24 hours systolic, diastolic and mean blood pressure (Blood pressure holter)
Measured: before and two weeks after CPAP withdrawal
Change in endothelial function
endothelial function (assessed by reactive hyperemia arterial tonometry)
Measured: before and two weeks after CPAP withdrawal
Change in cardiac repolarization
cardiac repolarization (QTc, TpTec intervals calculation on electrocardiographe))
Measured: before and two weeks after CPAP withdrawal
Change in catecholamines levels
urine catecholamines levels
Measured: before and two weeks after CPAP withdrawal
Change in glucose levels
blood glucose levels
Measured: before and two weeks after CPAP withdrawal
Change in Microparticles
blood microparticles levels
Measured: before and two weeks after CPAP withdrawal
Change in oxydative stress
blood 8-isoprostane levels
Measured: before and two weeks after CPAP withdrawal
Change in inflammation
blood CRPus levels
Measured: before and two weeks after CPAP withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start5 Mar 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- wojciech Trzepizur, MD PHD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939934
- Sponsor's protocol ID
- 49RC23_0078
- Acronym
- ORTAP
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment With Continuous Positive Airway Pressure: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05939934
- Acronym / sponsor ID
- ORTAP / 49RC23_0078
- Conditions
- Sleep Apnea, Obstructive, Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients will be ask not to use any OSAS treatment during the 2 weeks of the study (after the CPAP withdrawal) |
| mandibular advancement device | Experimental | Device: Mandibular advancement device treatmentPatients will be asked to use mandibular advancement device during the 2 weeks CPAP withdrawal |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular advancement device treatmenta titratable thermoplastic mandibular advancement device will be proposed to patient in the experimental group during the 2 weeks of CPAP withdrawal. | Device | mandibular advancement device |
Primary outcome
Change in subjective sleepiness
Time frame: before and two weeks after CPAP withdrawal
Sleepiness assessed using the Epworth Sleepiness Scale
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
wojciech Trzepizur, MD PHD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular advancement device treatment in people with Sleep Apnea, Obstructive and Endothelial Dysfunction, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wojciech trzepizur, MD PHD (+3380575272, wotrezpizur@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective sleepiness (time frame: before and two weeks after CPAP withdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.