[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578375":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":38,"locations":26,"responsibleParty":47,"collaborators":26,"id":49,"slug":26,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":26,"enrollmentInfo":58,"targetDuration":26,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"Ziekenhuis Oost-Limburg","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"MRA1MRA2","EXPERIMENTAL","Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months",[13,14,15],"Diagnostic Test: Polygraphy","Other: Questionaire","Other: Question",{"label":17,"type":10,"description":18,"interventionNames":19},"MRA2MRA1","Use of MRA device 2 for 3 months, use of MRA device 1 for 3 months",[13,14,15],[21,27,31,34],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Polygraphy","Polygraphy will be caried out at the patients home to evaluate each MRA after 3 monhts",[9,17],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Questionaire","Epworth Sleepiness Scale\n\no Johns, Murray W. \"A New Method for Measuring Daytime Sleepiness: The Epworth Sleepiness Scale.\" Sleep, vol. 14, no. 6, 1991, pp. 540-545.",[9,17],{"type":6,"name":28,"description":32,"armGroupLabels":33,"otherNames":26},"Patient experience questionnaire\n\no Ng, E.T., Perez-Garcia, A., en Lagravère-Vich, M.O. \"Development and Initial Validation of a Questionnaire to Measure Patient Experience with Oral Appliance Therapy.\" Journal of Clinical Sleep Medicine, vol. 19, nr. 8, 1 aug. 2023, pp. 1437-1445. doi: 10.5664\u002Fjcsm.10562. PMID: 37082817; PMCID: PMC10394373",[9,17],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":26},"Question","Patient final choice of preferred MRA",[9,17],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Joeri Meyns, MD, DDS","CONTACT","+3289 32 50 50","joeri.meyns@zol.be",{"name":45,"role":41,"phone":42,"phoneExt":26,"email":46},"Adriaan Blok, MD, DDS","adriaanjohannes.blok@zol.be",{"type":48,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100578375",false,"NCT06810479","A Study Comparing Two Mandibular Advancement Devices in the Treatment of Sleep Apnea","A Randomised, Controlled Cross Over Study Comparing Two Mandibular Advancement Devices in the Treatment of Mild-to-moderate Obstructive Sleep Apnea","MRA OSA","In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Provide signed and dated informed consent\n* Males or females aged 18 and above\n* Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour diagnosed by a polysomnography\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Previous surgery on the upper airways\n* Prior treatment of OSA (CPAP or MRA)\n* Presence of unstable cardiovascular conditions, neurological, mental, or psychiatric disorders\n* Insufficient dental or periodontal condition for a mandibular repositioning appliance (MRA)\n* Presence of temporomandibular joint dysfunction","ALL","18 Years",{"count":59,"type":60},20,"ESTIMATED","INTERVENTIONAL",[63],"NA","The goal of this randomised, controlled cross-over study is to compare two mandibular repositioning devices (MRA) already on the market in the treatment of mild-to-moderate obstructive sleep apnea.\n\nPatiënt will test the first MRA for 3 months, after a wash out period of 2 weeks they will test the second MRA for 3 months. It will be randomised what type of MRA will be tested first and second.",[66],"Apnea, Obstructive",[68,69,70],"sleep apnea","MRA","mandibular repositioning appliance","NOT_YET_RECRUITING","2025-03-20",{"date":74,"type":75},"2025-03-21","ACTUAL",{"date":72,"type":60},{"date":78,"type":60},"2026-04-01",{"name":5,"class":6}]