NCT06576310 Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
| NCT ID | NCT06576310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Obstructive Sleep Apnea Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 118 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2027-10-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 118 participants in total. It began in 2025-01-06 with a primary completion date of 2027-10-06.
⚠ 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
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.
Eligibility Criteria
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
Contact & Investigator
Constance CUNY, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT06576310 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06576310 currently recruiting?
Yes, NCT06576310 is actively recruiting participants. Contact the research team at cuny.c@chut-toulouse.fr for enrollment information.
Where is the NCT06576310 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT06576310 clinical trial?
NCT06576310 is sponsored by University Hospital, Toulouse. The principal investigator is Constance CUNY, MD at University Hospital, Toulouse. The trial plans to enroll 118 participants.