[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639473":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":19,"studyPopulation":19,"armGroups":34,"interventions":45,"overallOfficials":55,"centralContacts":59,"locations":65,"responsibleParty":82,"collaborators":19,"id":84,"slug":19,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":19,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":107,"whyStopped":19,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Université Catholique de Louvain","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":19},[9,13],{"measure":10,"description":11,"timeFrame":12},"Tongue Pmax in elevation (pElev)","Tongue maximal pressure (kPa) in elevation, either with the TOM or the IOPI, depending on the visit and the randomization order","Throughout the entire study, approximately during 14 months",{"measure":14,"description":15,"timeFrame":12},"Tongue endurance in elevation (eElev)","Endurance time (sec.), i.e., time during which the tongue can sustain 50% of its Pmax in elevation, measured either with the TOM or the IOPI, depending on the visit and the randomization order",[17,20,23,26],{"measure":18,"description":19,"timeFrame":12},"Body mass index (kg\u002Fm^2)",null,{"measure":21,"description":22,"timeFrame":12},"Mouth, tongue, and face assessment test (through MBLF test)","This test (MBLF test, for 'test de motricité bucco-linguo-faciale') features an assessment of several muscles (e.g., lips, tongue, and face area) that are assessed on a scale from 0 (no contraction \u002F severe asymmetry) to 3 (normal contraction \u002F complete symmetry).",{"measure":24,"description":25,"timeFrame":12},"Mouth breathing questionnaire","A score 0-3 suggests high likelihood of habitual nose breathing; 4-7 a suspicion of mouth breathing; 8 or higher a high likelihood of habitual mouth breathing",{"measure":27,"description":28,"timeFrame":12},"Tongue thickness (POCUS)","A submental and neck ultrasound will be performed to assess tongue muscles thickness (cm)",{"allocation":30,"interventionModel":31,"interventionModelDescription":19,"primaryPurpose":6,"observationalModel":19,"timePerspective":19,"maskingInfo":32},"RANDOMIZED","CROSSOVER",{"masking":33,"maskingDescription":19,"whoMasked":19},"NONE",[35,40],{"label":36,"type":37,"description":19,"interventionNames":38},"TOM session","EXPERIMENTAL",[39],"Device: TOngue Manometer (TOM) device",{"label":41,"type":42,"description":19,"interventionNames":43},"IOPI session","ACTIVE_COMPARATOR",[44],"Device: IOPI",[46,51],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":19},"DEVICE","TOngue Manometer (TOM) device","New, lab-made device",[36],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":19},"IOPI","The device currently identified as gold standard for tongue muscles assessment",[41],[56],{"name":57,"affiliation":5,"role":58},"William Poncin, PhD","STUDY_CHAIR",[60],{"name":61,"role":62,"phone":63,"phoneExt":19,"email":64},"Pierre Cnockaert, MSc","CONTACT","+32478136109","pierre.cnockaert@outlook.com",[66],{"facility":67,"status":19,"city":68,"state":19,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab","Brussels","1200","Belgium","BE",{"type":73,"coordinates":74},"Point",[75,76],4.34878,50.85045,{"lat":76,"lon":75},[79,80],{"name":61,"role":62,"phone":19,"phoneExt":19,"email":64},{"name":61,"role":81,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":83,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100639473",false,"NCT07625761","Assessment of a New Tool to Measure Tongue Muscle Function","TOM1","Inclusion Criteria:\n\n* Being a healthy adult aged 18 to 65 years old\n* Being able to understand and speak French\n\nExclusion Criteria:\n\n* Being diagnosed with a cardiorespiratory or neuromuscular disease\n* Being diagnosed with obstructive sleep apnea-hypopnea syndrome\n* Any reason preventing the participant from completing the measurement protocol (e.g., oral pain, severe cognitive impairment, lack of cooperation, illiteracy)\n* Being involved in an oropharyngeal rehabilitation program\n* Having dysphagia",true,"ALL","18 Years","65 Years",{"count":95,"type":96},58,"ESTIMATED","INTERVENTIONAL",[99],"NA","The Iowa Oral Performance Instrument (IOPI) is currently the reference tool for assessing tongue muscle function, measuring the pressure exerted by the tongue on an air-filled bulb. However, several limitations reduce its precision and clinical relevance. To overcome these, the TOngue Manometer (TOM) has been developed. This crossover study compares the two devices in healthy adults, hypothesizing that the TOM's interface will enable participants to produce higher maximal tongue pressure and endurance values, closer to their ground truth.",[102],"Healthy",[104,102,105,106],"Adults","tongue","muscles","NOT_YET_RECRUITING","2026-05-28",{"date":110,"type":111},"2026-06-04","ACTUAL",{"date":113,"type":96},"2026-05-30",{"date":115,"type":96},"2027-12-01",{"name":5,"class":6},1]