[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613932":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":51,"locations":61,"responsibleParty":78,"collaborators":25,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":25,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Children referred for polysomnography for suspected OSA","EXPERIMENTAL","Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA",[13,14,15,16,17,18,19],"Other: Tongue Strength Assessment","Diagnostic Test: Polysomnography","Other: Subjective Assessment of Sleep-Disordered Breathing","Other: Subjective Assessment of Daytime Functioning","Other: Anthropometry","Other: Clinical Examination","Other: Orofacial Praxis Assessment",[21,26,31,35,39,43,47],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Tongue Strength Assessment","The following items will be assessed:\n\n1. Tongue peak pressure during 3 seconds of tongue protrusion\n2. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 seconds of tongue elevation\n3. Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DIAGNOSTIC_TEST","Polysomnography","Patients will undergo full-night polysomnography (including the JAWAC system to record mandibular movements) in the sleep unit of Hôpital Femme-Mère-Enfant (Bron, France) to explore OSA.",[9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":25},"Subjective Assessment of Sleep-Disordered Breathing","The following questionnaires will be filled out:\n\n* OSA-18\n* Pediatric Sleep Questionnaire (PSQ)\n* Spruyt \\& Gozal\n* Sleep Disturbance Scale for Children\n* Abreu et al.'s questionnaire",[9],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":25},"Subjective Assessment of Daytime Functioning","The following questionnaires will be filled out:\n\n* Epworth Sleepiness Scale\n* Conners",[9],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":25},"Anthropometry","The following measures will be collected via the Quick Tongue-Tie Assessment tool:\n\n1. Maximal mouth opening\n2. Maximal mouth opening with tongue to palate",[9],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":25},"Clinical Examination","The following variables will be collected during a clinical examination:\n\n1. Age\n2. Sex\n3. Weight\n4. Height\n5. BMI\n6. Friedman score\n7. Mallampati score\n8. Medical history",[9],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":25},"Orofacial Praxis Assessment","Bucco-Linguo-Facial Motor Skills will be assessed through the test \"Motricité Bucco-Linguo-Faciale\" (MBLF).",[9],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":25,"email":56},"Patricia FRANCO, MD, PhD","CONTACT","+33 4 27 85 60 52","patricia.franco@chu-lyon.fr",{"name":58,"role":54,"phone":59,"phoneExt":25,"email":60},"Aurore GUYON, PhD","+33 4 27 85 52","aurore.guyon@chu-lyon.fr",[62],{"facility":63,"status":64,"city":65,"state":25,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant","RECRUITING","Bron","69500","France","FR",{"type":70,"coordinates":71},"Point",[72,73],4.91303,45.73865,{"lat":73,"lon":72},[76],{"name":58,"role":54,"phone":77,"phoneExt":25,"email":60},"+33 4 27 85 52 47",{"type":79,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100613932","tongue-muscular-assessment-in-children-with-sleep-disordered-breathing-100613932",false,"NCT07273019","Tongue Muscular Assessment in Children With Sleep Disordered Breathing","Tongue Muscular Assessment in Children Referred for Polysomnography in a Context of Suspected Obstructive Sleep Apnea","TMAC-C","Inclusion Criteria:\n\n* With suspected sleep-disordered breathing\n* Referred for polysomnography\n* Affiliated to a social security scheme\n* With informed consent from both legal representatives\n\nExclusion Criteria:\n\n* Insufficient comprehension of French language\n* Regarding patients with suspected OSA type I or II:\n\n  * Neurological, cardiac, or unstable respiratory conditions other than sleep disorders and their repercussions\n  * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)\n  * Malformation of the skull, the upper airway or the oral cavity\n* Regarding patients with suspected OSA type III:\n\n  * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)\n  * Intellectual deficit impeding the understanding of instructions","ALL","4 Years","17 Years",{"count":92,"type":93},78,"ESTIMATED","INTERVENTIONAL",[96],"NA","Obstructive sleep apnea (OSA) is part of the sleep-disordered breathing spectrum. Its prevalence in children is 1-5%, and it can have negative consequences at the cardiovascular, cognitive as well as behavioral levels. In children, the first-line treatment is adenotonsillectomy. However, residual obstructive events can persist as the success rate of surgery reaches only 49% in non-obese children. Residual OSA may be explained by multiple sites of obstruction, found in 20-85% children concerned by persistent OSA. Indeed, the tongue appears among one possible primary sites of obstruction. Given the tongue's crucial role in upper-airway patency during sleep, its assessment can inform us about the myofunctional deficits involved in sleep-disordered breathing.\n\nThe primary objective of the present study is to assess tongue motor functions in children with sleep-disordered breathing and to compare them to those of healthy children (data collected in a current study (TMAC) conducted at UCLouvain, Belgium; NCT06166680), in order to document possible myofunctional deficits in children with OSA. The hypothesis is that tongue motor functions will be lower in children with sleep-disordered breathing.",[99],"Obstructive Sleep Apnea",[101,102,103,104],"Tongue","Motor functions","Sleep","Sleep apnea","2026-07-29",{"date":107,"type":108},"2026-07-30","ACTUAL",{"date":110,"type":108},"2026-03-26",{"date":112,"type":93},"2028-03-26",{"name":5,"class":6},1]