[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657875":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":43,"studyPopulation":40,"armGroups":44,"interventions":51,"overallOfficials":40,"centralContacts":57,"locations":40,"responsibleParty":63,"collaborators":40,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":54,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":40,"enrollmentInfo":76,"targetDuration":40,"studyType":79,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":87,"whyStopped":40,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":40},{"fullName":5,"class":6},"University of Lausanne Hospitals","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Apnea Hypopnea Index","Number of apneas and hypopneas per hour of sleep measured by home polysomnography under the 3 study conditions: no treatment, standard MAD, and BioMAD.","Baseline, Day 15, Day 30",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"The hypoxic burden","The sum of oxygen drops following apneas and hypopneas in %\u002Fmin\u002Fh measured by home polysomnography under the 3 study conditions: no treatment, standard MAD, and BioMAD",{"measure":18,"description":19,"timeFrame":12},"Sleep efficiency and EEG-based sleep microstructure metrics","Assessment of sleep efficiency (TST\u002Ftime in bed) and EEG based sleep microstructure analysed by FFT measured by home polysomnography under the 3 study conditions: no treatment, standard MAD, and BioMAD",{"measure":21,"description":22,"timeFrame":12},"Subjective daytime sleepiness","Measured using the Epworth sleepiness scale",{"measure":24,"description":25,"timeFrame":12},"Patients reported outcome measures (PROMS)","Patient-Reported Outcomes Measurement Information System:PROMIS questionnaire (min 8 max 40 points, lower score is better)",[27,31],{"measure":28,"description":29,"timeFrame":30},"Patients comfort under treatment","Specific tolerance and comfort questionnaire Will be compared between the standard MAD treatment and the BioMAD treatment: qualitative assessment (no score)","Baseline, day 30",{"measure":32,"description":33,"timeFrame":34},"Adverse effects related to BioMAD","Adverse effects evaluated by a specific ad hoc questionnaire","At baseline (day 1) and at day 30",{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":40,"timePerspective":40,"maskingInfo":41},"NA","SINGLE_GROUP","Non inferiority trial","TREATMENT",null,{"masking":42,"maskingDescription":40,"whoMasked":40},"NONE","The severity of OSA and associated symptoms will be assessed with the patients' usual mandibular devive (MAD), with no treatment (after a wash-out period), and with the new treatment (BioMAD)",[45],{"label":46,"type":47,"description":48,"interventionNames":49},"single arm","ACTIVE_COMPARATOR","The patients will be recorded with their usual MAD Device, after a 2 week wash out period and under the new BioMAD device",[50],"Device: BioMAD",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":40},"DEVICE","BioMAD","Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea",[46],[58],{"name":59,"role":60,"phone":61,"phoneExt":40,"email":62},"Martin Broome, Prof","CONTACT","004121314 4199","martin.broome@chuv.ch",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Raphael Heinzer","Associate Professor","100657875","biomad---a-non-inferiority-study-100657875",false,"NCT07845331","BioMAD - A Non-inferiority Study","Evaluation of the Effectiveness of a New Mandibular Advancement Device (BioMAD) in the Treatment of Obstructive Sleep Apnea","Inclusion Criteria:\n\n1. Adult (≥ 18 years) with diagnosis of obstructive sleep apnea (AHI ≥ 5\u002Fh).\n2. Current use of a ResMed or SomnoMed MAD for at least 3 months with reported adherence ≥ 4 hours\u002Fnight.\n3. Ability and willingness to stop using the current MAD for a two-week wash-out period.\n4. Agrees to be informed on incidental findings\n5. Capable of giving informed consent.\n\nExclusion Criteria:\n\n1. Predominant central sleep apnea.\n2. Known temporo-mandibular joint disorders or significant dental conditions that preclude MAD use.\n3. Recent dental surgery (\\\u003C 1 month) or planned during the investigation.\n4. Known pregnancy, breastfeeding or planning pregnancy during the study;\n5. Professional drivers or occupations requiring constant vigilance (due to risk of increased sleepiness during wash-out).\n6. Participation in another interventional trial or use of medications affecting sleep (sedative\u002Fhypnotic agents, opioids, muscle relaxants).","ALL","18 Years",{"count":77,"type":78},20,"ESTIMATED","INTERVENTIONAL",[36],"Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea.",[83],"OSA - Obstructive Sleep Apnea",[85,86],"osa","MAD","NOT_YET_RECRUITING","2026-09-24",{"date":90,"type":91},"2026-09-28","ACTUAL",{"date":93,"type":78},"2026-11-01",{"date":95,"type":78},"2027-12-15",{"name":5,"class":6}]