Obstructive Sleep Apnea Clinical Trials

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Evaluation of Predictive Factors for Dental Occlusal Changes in the Treatment of Obstructive Sleep Apnea With Mandibular Advancement Appliance

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
University Hospital of Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Constance CUNY, MD
cuny.c@chut-toulouse.fr
+33615282467
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2027-10-06
Participants
Target number of participants: 118
Treatments
OSA patients with mandibular advancement appliance
Patients with obstructive sleep apnea (OSA) treated with a mandibular advancement device (MAD), monitored for changes in masticatory muscle activity and occlusal modifications over a 6-month period. The study involves routine clinical visits and additional assessments including electromyography (EMG) with and without the appliance, optical impressions, digital occlusion recordings, patient diaries, and questionnaires on quality of life, temporo mandibular dysfunction pain, oral habits, stress and anxiety, and sleep evaluation.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov