Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Obesity; Obstructive Sleep Apnea (OSA); Obesity & Overweight
• Intervention / Treatment: Other: Submental ultrasound

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Frederic Paillaugue, MSc PT; Phone Number: +32485952930; Email: frederic.paillaugue@vub.be

Study Locations

• Belgium
  • Brussels, Belgium, 1160
    • Recruiting
    • ISEK-HE2B, av. Schalle 91
    • Contact: Frederic Paillaugue, MSc PT; Phone Number: +32485952930
  • De Haan, Belgium
    • Not yet recruiting
    • Zeepreventorium Koninklijke Baan 5
    • Contact: Steven Provyn, PhD; Phone Number: +32475454214; Email: steven.provyn@vub.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Tongue ultrasound via a submental approach. This non-invasive, risk-free and harmless protocol will study both morphological and dynamic characteristics of the tongue.; Other Names: Anthropometric measurements (height, weight, neck circumference)
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; Tongue ultrasound via a submental approach. This non-invasive, risk-free and harmless protocol will study both morphological and dynamic characteristics of the tongue.; Other Names: Anthropometric measurements (height, weight, neck circumference)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue thickness	Tongue thickness (expressed in cm) will be measured with ultrasound as the perpendicular distance from the deep fascia of the geniohyoid muscle to the highest lingual dorsum in the midsagittal plane	at baseline and after 30 weeks weight loss program
Echo Intensity	Echo intensity will be measured with ImageJ / Fiji software (ImageJ, US NIH, Bethesda, USA) and refers to the mean value of pixels of an area, based on a grey scale between 0 (black) and 255 (white)	at baseline and after a 30 weeks weight loss program
Tissue Attenuation Imaging index	Attenuation will be measured with ultrasound and depicts the quantitative measurement of ultrasound attenuation in tissues. It is expressed as an attenuation coefficient in dB/cm/MHz.	at baseline and after a 30 weeks weight loss program
OSA-18 questionnaire	The Obstructive Sleep Apnea - 18 questionnaire is specific to obstructive sleep apnea in children and will be used for correlation analysis. Quality of life is assessed using the Obstructive Sleep Apnea - 18 Quality of Life Survey (OSA-18), a validated questionnaire comprising 18 items. Total scores range from 18 to 126, with higher scores indicating poorer quality of life and greater disease impact, and lower scores reflecting better outcomes.	Baseline and after a 30-weeks weight loss program
Weight	Weight will be measured with a Tanita scale and expressed in kg	baseline and after a 30 weeks weight loss program
Height	Height will be measured with a stadiometer and expressed in cm	Baseline and after a 30 weeks weight loss program
BMI Z score	BMI Z score will be calculated using combined weight, heigt, sex and age, in reference with CDC tables	Baseline and after a 30-weeks weight loss program

Collaborators and Investigators

• Sponsor: Haute Ecole Bruxelles-Brabant
• Collaborators: Vrije Universiteit Brussel
• Investigators: Study Director: Steven Provyn, Prof PhD, Haute Ecole Bruxelles Brabant & Vrije Universiteit Brussel

Publications and helpful links

General 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, 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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 3, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Pediatric obesity; Shear-wave elastography; Tongue ultrasound
• Additional Relevant MeSH Terms: Nervous System Diseases; Nutrition Disorders; Overnutrition; Body Weight; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Sleep Apnea, Obstructive; Pediatric Obesity; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Physiological Phenomena; Physical Examination; Body Size; Body Weights and Measures; Body Constitution; Physical Appearance, Body; Anthropometry; Growth; Growth and Development; Weights and Measures; Body Height
• Other Study ID Numbers: 93018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to the inclusion of minors and data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No