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Obesity & OverweightNCT07370350

Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity

An observational study of Obesity & Overweight and Pediatric Obesity, run by Haute Ecole Bruxelles-Brabant at 2 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 yearsHealthy volunteers can take part
What is being tested?
Submental ultrasound
How many people
100 participants
Where
2 sitesBelgium
Study dates
1 Apr 2025to 1 Aug 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Frederic Paillaugue, MSc PT contact

+32485952930

frederic.paillaugue@vub.be

Belgium2 sites, 2 recruiting

  • ISEK-HE2B, av. Schalle 91

    Brussels, 1160

    Frederic Paillaugue, MSc PT, +32485952930

    Recruiting

  • Zeepreventorium Koninklijke Baan 5

    De Haan

    Steven Provyn, PhD, +32475454214, steven.provyn@vub.be

    Not yet recruiting

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
Submental ultrasound
Keywords
Tongue ultrasound, Shear-wave elastography, Pediatric obesity, Obstructive sleep apnea
Medical subject headings
Obesity, Overweight, Pediatric Obesity, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Submental ultrasoundOther

    Also called Anthropometric measurements (height, weight, neck circumference)

    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 groups in NCT07370350
Study groupRoleWhat they receive
Study groupChildren 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.
Receives: Other: Submental ultrasound
Control groupHealthy 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.
Receives: Other: Submental ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tongue stiffness

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

    Measured: at baseline and after 30-weeks weight loss program

  2. 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.

    Measured: Baseline

Secondary outcomes (7)

  1. 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

    Measured: at baseline and after 30 weeks weight loss program

  2. 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)

    Measured: at baseline and after a 30 weeks weight loss program

  3. 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.

    Measured: at baseline and after a 30 weeks weight loss program

  4. 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.

    Measured: Baseline and after a 30-weeks weight loss program

  5. Weight

    Weight will be measured with a Tanita scale and expressed in kg

    Measured: baseline and after a 30 weeks weight loss program

  6. Height

    Height will be measured with a stadiometer and expressed in cm

    Measured: Baseline and after a 30 weeks weight loss program

  7. BMI Z score

    BMI Z score will be calculated using combined weight, heigt, sex and age, in reference with CDC tables

    Measured: Baseline and after a 30-weeks weight loss program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2026
  2. Study start1 Apr 2025
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07370350
Sponsor's protocol ID
93018
Status last verified
Jan 2026
First submitted
3 Jan 2026
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to the inclusion of minors and data protection regulations.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity & Overweight and Pediatric Obesity, run by Haute Ecole Bruxelles-Brabant at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frederic Paillaugue, MSc PT (+32485952930, frederic.paillaugue@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tongue stiffness (time frame: at baseline and after 30-weeks weight loss program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07370350, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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