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Recruiting Observational

Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing

NCT07861230 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2026-10-01
Last updated
2026-10-06

Condition(s) studied

Obstructive Sleep Disordered Breathing

Investigational drug(s) / intervention(s)

Cross-sectional assessment

Cross-sectional assessment: This cross-sectional assessment includes outcomes related to tongue structure, tongue function, and questionnaires

Study summary

The tongue plays a key role in maintaining upper airway patency during sleep, mainly through the genioglossus, the principal pharyngeal dilator muscle. Its dysfunction may be linked to the development of obstructive sleep-disordered breathing (oSDB), a condition affecting more than one in ten children and associated with cardiovascular and cognitive consequences. Although adenotonsillectomy remains the treatment of choice, it fails in a substantial proportion of cases because of persistent obstruction at other sites, the tongue base being involved in one third of these cases. Therefore, a better characterization of the tongue in children with oSDB is needed, since the extent to which its structure and function contribute to upper airway obstruction in this population remains largely unknown.

Our team has established the reproducibility of tongue function measurements in healthy children and is currently building a reference database. What is still lacking is an assessment of tongue structure and function in children with oSDB. Such data would allow comparison with healthy children, thereby improving the understanding of oSDB pathophysiology and informing clinical management.

Primary objective: To describe tongue structure and function in children with oSDB.

Secondary objective: To compare tongue structure and function between children with oSDB and healthy children, using data from a previous study conducted in healthy children (TMAC study, UCLouvain).

Eligibility

Sex
ALL
Min age
4 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Aged 4 to 17 years * Scheduled polysomnography, or polysomnography performed within the past 6 months * Positive Pediatric Sleep Questionnaire (8 "yes" answers or more) Exclusion Criteria: * Any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III * Any condition that could interfere with the assessments

Primary outcome measure(s)

  • Tongue strength assessment — At enrollment, during the single study visit (Day 1)
    Maximal pressure exerted by the tongue against an air-filled bulb (in kPa) in protrusion, elevation, and during swallowing.

Trial sites (1)

FacilityCityRegionStatus
CHC MontLégia hospital Liège Belgium Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07861230 on ClinicalTrials.gov ↗ ← All trials in Belgium