Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Adva… (NCT06576310) | Clinical Trial Compass
RecruitingNot Applicable
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
France118 participantsStarted 2025-01-06
Plain-language summary
This research addresses obstructive sleep apnea syndrome (OSAS), affecting 6-12% of French adults, often treated with mandibular advancement devices (MADs). MADs may lead to occlusal modifications, causing a 50% treatment abandonment rate. The study employs surface electromyography to assess masticatory muscle activity before and during MAD use, correlating it with occlusal changes after 6 months. The primary goal is to determine dental displacement profiles post-6-month MAD treatment, providing insights for personalized care and minimizing treatment failures.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with complete dentition (up to second molars)
* Polysomnography or polygraphy
* Diagnosis of OSA
* Patient receiving OAM treatment at the Odontology Department of Toulouse University Hospital
* Patient with contemporary panoramic and lateral cephalometric X-rays (common practice) taken at the time of orthotic treatment
* Individual affiliated with or covered by a social security scheme
* Voluntary, informed, written consent, signed by both participant and investigator (prior to inclusion and any necessary research-related examinations).
Exclusion Criteria:
* Inability to provide informed consent
* Pregnant or breastfeeding patient
* Patient with curators, guardians, or legal protection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
OCCLUSAL MODIFICATIONS AFTER 6 MONTHS OF OAM TREATMENT