[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638872":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":66,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":25,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":25,"overallStatus":90,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Vrije Universiteit Brussel","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group","EXPERIMENTAL","Adolescents (12-18 y.o.) with obesity and sleep-disordered breathing, recruited at the Zeepreventorium de Haan and at the KidZ Health Castle UZ-VUB.\n\nThe intervention will consist of a submental ultrasound examination - a pain-free, non-ionizing, and non-invasive imaging procedure - aimed at quantifying tongue biomechanical properties, complemented by the collection of descriptive and anthropometric measures including standing height, body weight, impedance analysis, and neck circumference.",[13],"Device: Submental ultrasound",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","A control group of healthy participants (without obesity nor sleep disorders), matched for gender and age, will be recruited from among the researchers' acquaintances. The intervention will be the same, consisting of a submental ultrasound examination - a pain-free, non-ionizing, and non-invasive imaging procedure - aimed at quantifying tongue biomechanical properties, complemented by the collection of descriptive and anthropometric measures including standing height, body weight, impedance analysis, and neck circumference.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Submental ultrasound","Tongue ultrasound via a submental approach. This non-invasive, pain-free and non-radiating protocol will study both morphological and dynamic characteristics of the tongue. Ultrasonographic assessment will be performed with participants in a resting, supine position and ultrasound gel will be used to optimise submental probe contact.",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Frederic Paillaugue, MSc PT","CONTACT","+32485952930","frederic.paillaugue@vub.be",[33,54],{"facility":34,"status":25,"city":35,"state":25,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"KidZ Health Castle - Universitair Ziekenhuis Brussel Brussels - Health Campus Avenue du Laerbeek 101 1090 Jette","Brussels","1090","Belgium","BE",{"type":40,"coordinates":41},"Point",[42,43],4.34878,50.85045,{"lat":43,"lon":42},[46,50,51],{"name":47,"role":29,"phone":48,"phoneExt":25,"email":49},"Inge Gies, MD","+324774111","inge.gies@uzbrussel.be",{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},{"name":52,"role":53,"phone":25,"phoneExt":25,"email":25},"Steven Provyn, Prof PhD","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":25,"city":56,"state":25,"zip":57,"country":37,"countryCode":38,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Zeepreventorium, Koninklijke Baan 5, 8420 De Haan","De Haan","8420",{"type":40,"coordinates":59},[60,61],3.03446,51.27261,{"lat":61,"lon":60},[64,65],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":25},{"name":52,"role":53,"phone":25,"phoneExt":25,"email":25},{"type":67,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100638872","ultrasound-assessment-of-tongue-characteristics-in-adolescents-with-obesity-and-obstructive-sleep-disorders-100638872",false,"NCT07613944","Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders","Standardised Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disordered Breathing: a Research Protocol","Inclusion Criteria:\n\n* Aged 12-18 years\n* Already enrolled in Zeepreventorium weight-loss program as Standard Care Diagnosed Obstructive Sleep Apnea (AHI ≥ 1)1 or any Obstructive sleep disordered breathing detected by any of the specific sleep questionnaire (OSA-18, ESS, SSS-Ad, PDSS)\n\nExclusion Criteria:\n\n* Any other orthopedic, traumatic, or rheumatologic condition affecting the cervicocephalic region\n* Syndromic or neuromuscular disorders\n* Cognitive impairment limiting compliance with study procedures\n* Inability to provide informed consent\n* Self-reported alcohol or recreational drug consumption within 48 hours preceding the experimental session",true,"ALL","12 Years","18 Years",{"count":80,"type":81},80,"ESTIMATED","INTERVENTIONAL",[84],"NA","Obstructive sleep-disordered breathing, including obstructive sleep apnea (OSA), represents a significant yet underdiagnosed condition in the pediatric population, particularly among adolescents with obesity. The tongue is a central anatomical contributor to upper airway collapsibility; however, its biomechanical properties have been investigated almost exclusively in adult populations, leaving a critical gap in knowledge regarding younger individuals.\n\nThis study aims to assess tongue biomechanical and echographic characteristics using quantitative ultrasound modalities - shear-wave elastography (SWE), acoustic attenuation, and echo intensity - in adolescents aged 12 to 18 years with obesity and obstructive sleep disorders. The study adopts a mixed design combining (1) an observational cross-sectional comparison between participants with obesity and OSDB and age- and sex-matched healthy controls at baseline, and (2) a prospective longitudinal cohort component evaluating changes in tongue ultrasound characteristics over the course of a 30-week multidisciplinary inpatient weight-loss program delivered as standard care at the Zeepreventorium (De Haan, Belgium). An additionnal methodological objective consists in determining intra-rater and inter-rater reliability of the ultrasound acquisition protocol providing a reproducible framework for future studies.",[87,88,89],"Obesity & Overweight Sleep","Obstructive Sleep Disordered Breathing","Pediatric Obesity","NOT_YET_RECRUITING","2026-05-21",{"date":93,"type":94},"2026-05-29","ACTUAL",{"date":96,"type":81},"2026-09",{"date":98,"type":81},"2027-12-31",{"name":5,"class":6},2]