[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560374":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":10,"responsibleParty":29,"collaborators":10,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":33,"sex":39,"minAge":40,"maxAge":10,"enrollmentInfo":41,"targetDuration":10,"studyType":44,"phases":10,"briefSummary":45,"conditions":46,"keywords":48,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":10},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OSA patients with mandibular advancement appliance",null,"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.",[13],"Device: Mandibular Advancement Device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Mandibular Advancement Device","In this research, participation in the protocol seamlessly integrates into routine care at the Odontology Department of the University Hospital of Toulouse. The visits include the provision of the orthosis at 3 weeks (T1), with EMGs and digital occlusal analysis. The 6-week follow-up visit (T2) adjusts therapeutic propulsion, subjectively resolving symptoms related to OSAS. At the T0 visit, the researchers collect the polysomnographic monitoring before fitting the orthosis (carried out in the patient's reference sleep laboratory) to assess treatment efficiency. The end-of-research visit (6 months after T1) comprehensively collects data, including questionnaires on stress, anxiety, sleep quality and quantity, oral habits, temporo mandibular dysfunction pain, and quality of life. Moreover, the researchers collect the polysomnographic monitoring after 3 months fitting the orthosis (carried out in the same patient's reference sleep laboratory than before fitting the orthosis).",[9],[21],{"name":22,"affiliation":5,"role":23},"Constance CUNY, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+33615282467","cuny.c@chut-toulouse.fr",{"type":30,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100560374","predictive-factors-for-occlusal-changes-in-obstructive-sleep-apnea-treatment-with-mandibular-advancement-appliance-100560374",false,"NCT06576310","Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance","Evaluation of Predictive Factors for Dental Occlusal Changes in the Treatment of Obstructive Sleep Apnea With Mandibular Advancement Appliance","APNEAMOUVE","Inclusion Criteria:\n\n* Patient with complete dentition (up to second molars)\n* Polysomnography or polygraphy\n* Diagnosis of OSA\n* Patient receiving OAM treatment at the Odontology Department of Toulouse University Hospital\n* Patient with contemporary panoramic and lateral cephalometric X-rays (common practice) taken at the time of orthotic treatment\n* Individual affiliated with or covered by a social security scheme\n* Voluntary, informed, written consent, signed by both participant and investigator (prior to inclusion and any necessary research-related examinations).\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Pregnant or breastfeeding patient\n* Patient with curators, guardians, or legal protection","ALL","18 Years",{"count":42,"type":43},118,"ESTIMATED","OBSERVATIONAL","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.",[47],"Obstructive Sleep Apnea Syndrome",[49,50,51,52],"MAD therapy","side effect","Dental occlusion","electromyography","NOT_YET_RECRUITING","2024-08-26",{"date":56,"type":57},"2024-08-28","ACTUAL",{"date":59,"type":43},"2024-11-01",{"date":61,"type":43},"2026-12-01",{"name":5,"class":6}]