Menu
Recruiting NCT07370350

Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity

— Observational Obesity & Overweight Pediatric Obesity Obstructive Sleep Apnea (OSA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Submental ultrasound.
Who it may be relevant to
Registry conditions: Obesity & Overweight, Pediatric Obesity, Obstructive Sleep Apnea (OSA). Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Standardized Tongue Ultrasound Protocol for Tongue Characteristics in Children and Adolescents With Obesity After a 30-week Inpatient Weight Loss Program

Overview

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.

Detailed description

This prospective observational cohort study investigates ultrasound-based tongue characteristics in children and adolescents with obesity. Participants undergo standardized submental tongue ultrasound examinations at baseline and after completion of a 30-week inpatient multidisciplinary weight-loss rehabilitation program.

Ultrasound measures include tongue morphology, fat-related imaging biomarkers, and mechanical properties assessed using shear-wave elastography. Anthropometric data and validated sleep-disordered breathing questionnaires are collected in parallel. Measurement reliability is evaluated, and associations between ultrasound parameters, anthropometric characteristics, and sleep-related outcomes are explored.

Interventions

  • Other 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.

Primary outcome measures

  • Tongue stiffness [Time frame: at baseline and after 30-weeks weight loss program]
  • Intraclass correlation coefficient, ICC [Time frame: Baseline]
Secondary outcome measures (7)
  • Tongue thickness [Time frame: at baseline and after 30 weeks weight loss program]
  • Echo Intensity [Time frame: at baseline and after a 30 weeks weight loss program]
  • Tissue Attenuation Imaging index [Time frame: at baseline and after a 30 weeks weight loss program]
  • OSA-18 questionnaire [Time frame: Baseline and after a 30-weeks weight loss program]
  • Weight [Time frame: baseline and after a 30 weeks weight loss program]
  • Height [Time frame: Baseline and after a 30 weeks weight loss program]
  • BMI Z score [Time frame: Baseline and after a 30-weeks weight loss program]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Belgium · 2 centers
  • ISEK-HE2B, av. Schalle 91 — Brussels
  • Zeepreventorium Koninklijke Baan 5 — De Haan

Publications

  • Brockmann, P., & Gozal, D. (2022). Neurocognitive Consequences in Children with Sleep Disordered Breathing: Who Is at Risk? Children, 9(9), 1278. https://doi.org/10.3390/children9091278 Chu, C.-A., Chen, Y.-J., Chang, K.-V., Wu, W.-T., & Özçakar, L. (2021). Reliability of Sonoelastography Measurement of Tongue Muscles and Its Application on Obstructive Sleep Apnea. Frontiers in Physiology, 12, 654

Identifiers

NCT: NCT07370350 · 93018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗