Clinical trial

Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT07370350

Recruiting nowNot applicableObservational

What this study is about

This longitudinal observational study aims to validate ultrasound-based tongue markers related to tongue characteristics, including fat accumulation, morphologic and mechanical properties of the tongue in children and adolescents with obesity. Participants are assessed at baseline and after completion of a standardized 30-week inpatient weight-loss rehabilitation program at the Zeepreventorium (De Haan, Belgium). Tongue ultrasound parameters are examined in relation to anthropometric characteristics and obstructive sleep apnea condition.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 18 Years

SexAll

Healthy volunteersAccepted

ConditionObesity & Overweight, Pediatric Obesity, Obstructive Sleep Apnea (OSA)

Full registry criteria

Inclusion Criteria: * Children and adolescents aged 6 to 18 years * Diagnosis of obesity * Already enrolled in the inpatient weight-loss rehabilitation program at the Zeepreventorium * Written informed consent from legal guardian and assent from the participant, following the legal requirements Exclusion Criteria: * Known orthopedic, traumatic, or rheumatologic conditions affecting the cervicocephalic region * Contraindication to ultrasound examination * Inability to comply with study procedures * Inability to understand the procedures

Treatments and study arms

Submental ultrasound

Other

Tongue ultrasound via a submental approach. This non-invasive, risk-free and harmless protocol will study both morphological and dynamic characteristics of the tongue.

Primary outcomes

Tongue stiffnessat baseline and after 30-weeks weight loss program

Tongue stiffness is measured by shear-wave elastography and expressed in kPa.

Intraclass correlation coefficient, ICCBaseline

Intraclass correlation coefficient will be used to assess intra and inter-rater reliability of ultrasound markersUltrasound reliability and repeatability of tongue measurements will be assessed with intraclass correlation coefficients (ICC), along with their 95% confidence intervals. Each ultrasound measurement (tongue size and morphological parameters, echo intensity, stiffness, tissue attenuation imaging, tissue scatter distribution imaging, and fat fraction) in sagittal and coronal planes will be performed twice in fifteen participants by the principal investigator, with a 24-hour interval between examinations.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

ISEK-HE2B, av. Schalle 91🇧🇪 Brussels, Belgium

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Frederic Paillaugue, MSc PTContact

Call +32485952930

Zeepreventorium Koninklijke Baan 5🇧🇪 De Haan, Belgium

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Steven Provyn, PhDContact

Email · Call +32475454214