Ireland
--:--IST
Recruiting Observational

Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity

NCT07370350 · tracked via the Priya Life Science Belgium tracker
Sponsor
Haute Ecole Bruxelles-Brabant
Phase
Observational
Started
2025-04-01
Last updated
2026-01-27

Condition(s) studied

Obesity & OverweightPediatric ObesityObstructive Sleep Apnea (OSA)

Investigational drug(s) / intervention(s)

Submental ultrasound

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

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
Accepted
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

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)

FacilityCityRegionStatus
ISEK-HE2B, av. Schalle 91 Brussels Belgium Recruiting
Zeepreventorium Koninklijke Baan 5 De Haan Belgium Not Yet Recruiting
Official registry record

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