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

NCT07861230 — Recruiting, 39 participants, Université Catholique de Louvain

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Registry	NCT07861230
Status	Recruiting
Study type	Observational
Enrollment	39 (Estimated)
Sponsor	Université Catholique de Louvain (Other); collaborators: CHC MontLégia
Conditions	Obstructive Sleep Disordered Breathing
Interventions	Cross-sectional assessment (Other)
Dates	start 2026-10-01 (estimated), primary completion 2028-09-01 (estimated), completion 2029-01-01 (estimated), first posted 2026-10-06, last updated 2026-10-06
Locations	1 site in Belgium

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Unique arm, cross-sectional assessment		Other: Cross-sectional assessment	Single assessment visit

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

+Outcome measures

Primary outcomes

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.

Secondary outcomes

Tongue morphology assessment [At enrollment, during the single study visit (Day 1)]: Submental ultrasound in frontal and sagittal plane, to assess the thickness of tongue muscles (cm)
Tongue frenulum assessment [At enrollment, during the single study visit (Day 1)]: Tongue range of motion ratio, reflecting the restriction imposed by the lingual frenulum. It is computed as the maximal mouth opening with the tongue tip held at the incisive papilla (mm) divided by the maximal mouth opening (mm).
Tongue mobility score [At enrollment, during the single study visit (Day 1)]: Motricité Bucco-Linguo-Faciale (MBLF) test, where several movements are scored between 0 and 3 regarding muscular contraction or symmetry.
Obstructive apnea-hypopnea index [At enrollment, during the single study visit (Day 1)]: Number of obstructive apneas and hypopneas per hour of sleep (events/hour) assessed through polysomnography
Breathing pattern questionnaire [At enrollment, during the single study visit (Day 1)]: Mouth breathing questionnaire from Abreu et al., considered positive if two major items, or one major and two minor items, are answered "yes"
Quality of life questionnaire [At enrollment, during the single study visit (Day 1)]: PedsQL questionnaire (Pediatric Quality of Life Inventory), divided into parent report and child self-report questionnaires, with several items scored from 0 to 4. Higher scores indicate more problems related to the quality of life.
Sleep quality questionnaire [At enrollment, during the single study visit (Day 1)]: The Pediatric Sleep Questionnaire will be administered to parents. Items are answered "yes", "no", or "I don't know", and higher scores indicate more signs of obstructive sleep-disordered breathing.
Sleep-related quality of life questionnaire [At enrollment, during the single study visit (Day 1)]: The Obstructive Sleep Apnea-18 (OSA-18) questionnaire will be administered to parents. Higher scores indicate a greater impact of sleep-disordered breathing on quality of life.

+Eligibility

Sex: All, ages: 4 Years to 17 Years

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

+Locations (1)

Facility	City	Country	Status
CHC MontLégia hospital	Liège	Belgium	Recruiting

My Notes

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