NCT07613944Not yet recruiting
Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders
Standardised Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disordered Breathing: a Research Protocol
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
Obstructive sleep-disordered breathing, including obstructive sleep apnea (OSA), represents a significant yet underdiagnosed condition in the pediatric population, particularly among adolescents with obesity. The tongue is a central anatomical contributor to upper airway collapsibility; however, its biomechanical properties have been investigated almost exclusively in adult populations, leaving a critical gap in knowledge regarding younger individuals. This study aims to assess tongue biomechanical and echographic characteristics using quantitative ultrasound modalities - shear-wave elastography (SWE), acoustic attenuation, and echo intensity - in adolescents aged 12 to 18 years with obesity and obstructive sleep disorders. The study adopts a mixed design combining (1) an observational cross-sectional comparison between participants with obesity and OSDB and age- and sex-matched healthy controls at baseline, and (2) a prospective longitudinal cohort component evaluating changes in tongue ultrasound characteristics over the course of a 30-week multidisciplinary inpatient weight-loss program delivered as standard care at the Zeepreventorium (De Haan, Belgium). An additionnal methodological objective consists in determining intra-rater and inter-rater reliability of the ultrasound acquisition protocol providing a reproducible framework for future studies.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 21 May 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Vrije Universiteit Brussel
- Diseases
- Obesity
- NCT number
- NCT07613944
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Sept 2026 to the primary completion date, Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Self-reported alcohol or recreational drug consumption within 48 hours preceding the experimental session
Other illness
- Any other orthopedic, traumatic, or rheumatologic condition affecting the cervicocephalic region
- Syndromic or neuromuscular disorders
- Cognitive impairment limiting compliance with study procedures
Other
- Inability to provide informed consent
Who the study is looking for
- Aged 12-18 years
- Already enrolled in Zeepreventorium weight-loss program as Standard Care Diagnosed Obstructive Sleep Apnea (AHI ≥ 1)1 or any Obstructive sleep disordered breathing detected by any of the specific sleep questionnaire (OSA-18, ESS, SSS-Ad, PDSS)
Age in the registry: 12 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KidZ Health Castle - Universitair Ziekenhuis Brussel Brussels - Health Campus Avenue du Laerbeek 101 1090 Jette Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Zeepreventorium, Koninklijke Baan 5, 8420 De Haan Coordinator of this site? Confirm its status | De Haan | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.