[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563118":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":33,"locations":10,"responsibleParty":39,"collaborators":42,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":10},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stepwise titration",null,"Patients will receive a MAD with an individualized stepwise titration protocol. Initially, the device is set at 60% advancement of the maximum protrusion. Over the first 3 months, the advancement is adjusted incrementally (to 75% or 90%) based on subjective improvement in OSA symptoms and side effects. If side effects occur, the advancement is decreased.",[13],"Device: Mandibular Advancement Device",{"label":15,"type":10,"description":16,"interventionNames":17},"Personalized titration","Patients will receive a MAD set to baseline settings. Instead of following a standard titration process, personalized titration will use both objective data and subjective patient feedback to determine the optimal advancement. This approach takes into account individual factors such as the patient's oral anatomy, sleep study results, and specific symptoms. The goal is to achieve a personalized, optimal setting that maximizes symptom improvement and comfort.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Mandibular Advancement Device","MADs are custom-fitted oral appliances designed to reposition the mandible (lower jaw) forward during sleep, which helps to keep the airway open by preventing upper airway collapse.",[15,9],[25,29,31],{"name":26,"affiliation":27,"role":28},"J. de Lange, Prof. Dr.","Amsterdam University Medical Center","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":27,"role":28},"J.P.T.F. Ho, Dr.",{"name":32,"affiliation":27,"role":28},"N.C.W. van der Kaaij, Dr.",[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"A. el Khalfioui, Bsc","CONTACT","0684900593","a.elkhalfioui@amsterdamumc.nl",{"type":28,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jan de lange","Prinicipal Investigator",[43],{"name":44,"class":6},"Academic Centre for Dentistry in Amsterdam","100563118","superimposition-of-intra-oral-scans-in-mad-therapy-for-osa-100563118",false,"NCT06612008","Superimposition of Intra-oral Scans in MAD Therapy for OSA","Superimposition of Intra-oral Scans in Mandibular Advancement Device (MAD) Therapy for Obstructive Sleep Apnea","SIMT-OSA","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Patients with a diagnosis of OSA\n* Patients with an apnea-hypopnea index (AHI) of 5 until 30 events per hour\n* Patients initially treated with MAD\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients without a diagnosis of mild to moderate OSA\n* Patients undergoing other treatments for OSA\n* Patients previously undergone MAD treatment (this also includes over the counter boil and bite MADs)\n* Patients diagnosed with central sleep apnea\n* Patients undergoing orthodontic treatment (e.g. braces)\n* Pregnant patients\n* Patients with craniofacial anomalies or syndromes (e.g., Treacher-Collins, Down, Pierre-Robin, Marfan),\n* Patients undergoing cancer treatment with chemotherapy or radiation\n* Patients with a history of maxillofacial surgery\n* Patients with select dental conditions like severe periodontal disease, temporomandibular joint disease, insufficient dentition to support appliance retention in the mouth\n* Patients who use bone resorption inhibitors (such as bisphosphonates, calcitonin, SERMs) or the prolonged use, ≥ 6 months of corticosteroids","ALL","18 Years",{"count":56,"type":57},250,"ESTIMATED","OBSERVATIONAL","Obstructive Sleep Apnea (OSA) affects quality of life and health. Mandibular Advancement Devices (MAD) can help with OSA but may cause dental and jaw changes. This study uses a new 3D scanning method to track these changes and compare two adjustment methods for MAD to find the best approach for patients.\n\nGoals:\n\n1. To track dental and jaw changes in OSA patients using 3D scans.\n2. To assess the impact of MAD on quality of life and cognitive function.\n\nStudy Details:\n\nThe aim of the study is to follow OSA patients at multiple centers over several years, comparing two MAD adjustment methods. Participants will undergo routine fitting and imaging.\n\nOutcome:\n\nThe study aims to reduce dental and jaw changes and to improve MAD treatment and patient outcomes.",[61],"Obstructive Sleep Apnea",[61,63,64,21],"Obstructive Sleep Apnea Syndrome","Oral Appliance Therapy","NOT_YET_RECRUITING","2025-07-04",{"date":68,"type":69},"2025-07-10","ACTUAL",{"date":71,"type":57},"2025-07",{"date":73,"type":57},"2029-07",{"name":5,"class":6}]