Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity
Condition(s) studied
Investigational drug(s) / intervention(s)
Submental ultrasound: Tongue ultrasound via a submental approach. This non-invasive, risk-free and harmless protocol will study both morphological and dynamic characteristics of the tongue.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Tongue stiffness — at baseline and after 30-weeks weight loss program
Tongue stiffness is measured by shear-wave elastography and expressed in kPa. - Intraclass correlation coefficient, ICC — Baseline
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.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| ISEK-HE2B, av. Schalle 91 | Brussels | Belgium | Recruiting |
| Zeepreventorium Koninklijke Baan 5 | De Haan | Belgium | Not Yet Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07370350 on ClinicalTrials.gov ↗ ← All trials in Belgium