[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659091":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":42,"armGroups":43,"interventions":49,"overallOfficials":38,"centralContacts":54,"locations":60,"responsibleParty":79,"collaborators":81,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":38,"eligibilityCriteria":90,"healthyVolunteers":87,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":38,"studyType":97,"phases":38,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":63,"whyStopped":38,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Université Catholique de Louvain","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Tongue strength assessment","Maximal pressure exerted by the tongue against an air-filled bulb (in kPa) in protrusion, elevation, and during swallowing.","At enrollment, during the single study visit (Day 1)",[14,17,20,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":12},"Tongue morphology assessment","Submental ultrasound in frontal and sagittal plane, to assess the thickness of tongue muscles (cm)",{"measure":18,"description":19,"timeFrame":12},"Tongue frenulum assessment","Tongue range of motion ratio, reflecting the restriction imposed by the lingual frenulum. It is computed as the maximal mouth opening with the tongue tip held at the incisive papilla (mm) divided by the maximal mouth opening (mm).",{"measure":21,"description":22,"timeFrame":12},"Tongue mobility score","Motricité Bucco-Linguo-Faciale (MBLF) test, where several movements are scored between 0 and 3 regarding muscular contraction or symmetry.",{"measure":24,"description":25,"timeFrame":12},"Obstructive apnea-hypopnea index","Number of obstructive apneas and hypopneas per hour of sleep (events\u002Fhour) assessed through polysomnography",{"measure":27,"description":28,"timeFrame":12},"Breathing pattern questionnaire","Mouth breathing questionnaire from Abreu et al., considered positive if two major items, or one major and two minor items, are answered \"yes\"",{"measure":30,"description":31,"timeFrame":12},"Quality of life questionnaire","PedsQL questionnaire (Pediatric Quality of Life Inventory), divided into parent report and child self-report questionnaires, with several items scored from 0 to 4. Higher scores indicate more problems related to the quality of life.",{"measure":33,"description":34,"timeFrame":12},"Sleep quality questionnaire","The Pediatric Sleep Questionnaire will be administered to parents. Items are answered \"yes\", \"no\", or \"I don't know\", and higher scores indicate more signs of obstructive sleep-disordered breathing.",{"measure":36,"description":37,"timeFrame":12},"Sleep-related quality of life questionnaire","The Obstructive Sleep Apnea-18 (OSA-18) questionnaire will be administered to parents. Higher scores indicate a greater impact of sleep-disordered breathing on quality of life.",null,{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":40,"timePerspective":41,"maskingInfo":38},"CASE_CONTROL","CROSS_SECTIONAL","Children with obstructive sleep-disordered breathing, with a scheduled polysomnography or who received a polysomnography within the past 6 months, and without any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III",[44],{"label":45,"type":38,"description":46,"interventionNames":47},"Unique arm, cross-sectional assessment","Single assessment visit",[48],"Other: Cross-sectional assessment",[50],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":38},"Cross-sectional assessment","This cross-sectional assessment includes outcomes related to tongue structure, tongue function, and questionnaires",[45],[55],{"name":56,"role":57,"phone":58,"phoneExt":38,"email":59},"William Poncin, Professor","CONTACT","0471 90 66 23","william.poncin@uclouvain.be",[61],{"facility":62,"status":63,"city":64,"state":38,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"CHC MontLégia hospital","RECRUITING","Liège","4000","Belgium","BE",{"type":69,"coordinates":70},"Point",[71,72],5.56749,50.63373,{"lat":72,"lon":71},[75],{"name":76,"role":57,"phone":77,"phoneExt":38,"email":78},"Matthieu Thimmesch, MD","0032 4 355 50 20","Matthieu.THIMMESCH@chc.be",{"type":80,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[82],{"name":83,"class":84},"CHC MontLégia","UNKNOWN","100659091","characterization-of-the-tongue-in-children-with-obstructive-sleep-disordered-breathing-100659091",false,"NCT07861230","Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing","Inclusion Criteria:\n\n* Aged 4 to 17 years\n* Scheduled polysomnography, or polysomnography performed within the past 6 months\n* Positive Pediatric Sleep Questionnaire (8 \"yes\" answers or more)\n\nExclusion Criteria:\n\n* Any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III\n* Any condition that could interfere with the assessments","ALL","4 Years","17 Years",{"count":95,"type":96},39,"ESTIMATED","OBSERVATIONAL","The tongue plays a key role in maintaining upper airway patency during sleep, mainly through the genioglossus, the principal pharyngeal dilator muscle. Its dysfunction may be linked to the development of obstructive sleep-disordered breathing (oSDB), a condition affecting more than one in ten children and associated with cardiovascular and cognitive consequences. Although adenotonsillectomy remains the treatment of choice, it fails in a substantial proportion of cases because of persistent obstruction at other sites, the tongue base being involved in one third of these cases. Therefore, a better characterization of the tongue in children with oSDB is needed, since the extent to which its structure and function contribute to upper airway obstruction in this population remains largely unknown.\n\nOur team has established the reproducibility of tongue function measurements in healthy children and is currently building a reference database. What is still lacking is an assessment of tongue structure and function in children with oSDB. Such data would allow comparison with healthy children, thereby improving the understanding of oSDB pathophysiology and informing clinical management.\n\nPrimary objective: To describe tongue structure and function in children with oSDB.\n\nSecondary objective: To compare tongue structure and function between children with oSDB and healthy children, using data from a previous study conducted in healthy children (TMAC study, UCLouvain).",[100],"Obstructive Sleep Disordered Breathing",[102,103,104,105],"obstructive sleep disordered breathing","children","sleep apnea","tongue","2026-10-02",{"date":108,"type":109},"2026-10-06","ACTUAL",{"date":111,"type":96},"2026-10-01",{"date":113,"type":96},"2029-01-01",{"name":5,"class":6},1]