Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity

NCT07370350 | Recruiting

• 1 other identifier: 93018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity & Overweight; Pediatric Obesity; Obstructive Sleep Apnea (OSA)

Keywords

Tongue ultrasound; Shear-wave elastography; Pediatric obesity; Obstructive sleep apnea

Outcome Measures

Primary Outcomes (2)

• Tongue stiffness

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

  at baseline and after 30-weeks weight loss program

• Intraclass correlation coefficient, ICC

  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.

  Baseline

Secondary Outcomes (7)

• Tongue thickness

  at baseline and after 30 weeks weight loss program

• Echo Intensity

  at baseline and after a 30 weeks weight loss program

• Tissue Attenuation Imaging index

  at baseline and after a 30 weeks weight loss program

• OSA-18 questionnaire

  Baseline and after a 30-weeks weight loss program

• Weight

  baseline and after a 30 weeks weight loss program

Study Arms (2)

Study group

Children and adolescents with obesity participating in a specialized inpatient multidisciplinary weight-loss rehabilitation program (30 weeks). As this is an observational study, tongue ultrasound (via a submental approach, a non-invasive, risk-free and harmless procedure) will be performed and basic anthropometric data (height, weight, neck circumference, hydration status) will be collected.

Other: Submental ultrasound

Control group

Healthy children and adolescents. As this is an observational study, tongue ultrasound (via a submental approach, a non-invasive, risk-free and harmless procedure) will be performed and basic anthropometric data (height, weight, neck circumference, hydration status) will be collected.

Other: Submental ultrasound

Interventions

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.

Also known as: Anthropometric measurements (height, weight, neck circumference)

Control group; Study group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children and adolescents with obesity participating in a specialized inpatient multidisciplinary weight-loss rehabilitation program in Zeepreventorium de Haan.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haute Ecole Bruxelles-Brabant: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (2)

ISEK-HE2B, av. Schalle 91

Brussels, 1160, Belgium

RECRUITING

Zeepreventorium Koninklijke Baan 5

De Haan, Belgium

NOT YET RECRUITING

Related Publications (1)

• 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, 654667. https://doi.org/10.3389/fphys.2021.654667 da Silva Gusmão Cardoso, T., Pompéia, S., & Miranda, M. C. (2018). Cognitive and behavioral effects of obstructive sleep apnea syndrome in children: A systematic literature review. Sleep Medicine, 46, 46-55. https://doi.org/10.1016/j.sleep.2017.12.020 Gipson, K., Lu, M., & Kinane, T. B. (2019). Sleep-Disordered Breathing in Children. Pediatrics in Review, 40(1), 3-13. https://doi.org/10.1542/pir.2018-0142 Glicksman, A., Hadjiyannakis, S., Barrowman, N., Walker, S., Hoey, L., & Katz, S. L. (2017). Body Fat Distribution Ratios and Obstructive Sleep Apnea Severity in Youth With Obesity. Journal of Clinical Sleep Medicine: JCSM: Official Publication of the American Academy of Sleep Medicine, 13(4), 545-550. https://doi.org/10.5664/jcsm.6538 Halbower, A. C., Degaonkar, M., Barker, P. B., Earley, C. J., Marcus, C. L., Smith, P. L., Prahme, M. C., & Mahone, E. M. (2006). Childhood Obstructive Sleep Apnea Associates with Neuropsychological Deficits and Neuronal Brain Injury. PLoS Medicine, 3(8), e301. https://doi.org/10.1371/journal.pmed.0030301 Yu, J. L., Wiemken, A., Schultz, S. M., Keenan, B. T., Sehgal, C. M., & Schwab, R. J. (2022). A comparison of ultrasound echo intensity to magnetic resonance imaging as a metric for tongue fat evaluation. Sleep, 45(2), zsab295. https://doi.org/10.1093/sleep/zsab295

  BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Pediatric Obesity; Sleep Apnea, Obstructive

Interventions

Body Height; Weights and Measures

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Appearance, Body; Anthropometry; Investigative Techniques; Physiological Phenomena; Growth; Growth and Development

Study Officials

• Steven Provyn, Prof PhD

  Haute Ecole Bruxelles Brabant & Vrije Universiteit Brussel

  STUDY DIRECTOR

Central Study Contacts

Frederic Paillaugue, MSc PT

CONTACT

+32485952930; frederic.paillaugue@vub.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MSc PT Drs

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 27, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)