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

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).

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Disordered Breathing
• Intervention / Treatment: Other: Cross-sectional assessment

• Study Type: Observational
• Enrollment (Estimated): 39

Contacts and Locations

• Study Contact: Name: William Poncin, Professor; Phone Number: 0471 90 66 23; Email: william.poncin@uclouvain.be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • CHC MontLégia hospital
    • Contact: Matthieu Thimmesch, MD; Phone Number: 0032 4 355 50 20; Email: Matthieu.THIMMESCH@chc.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with obstructive sleep-disordered breathing, with a scheduled polysomnography or who received a polysomnography within the past 6 months, and without any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: CASE_CONTROL
• Time Perspectives: CROSS_SECTIONAL

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Unique arm, cross-sectional assessment; Single assessment visit	Other: Cross-sectional assessment; This cross-sectional assessment includes outcomes related to tongue structure, tongue function, and questionnaires

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue morphology assessment	Submental ultrasound in frontal and sagittal plane, to assess the thickness of tongue muscles (cm)	At enrollment, during the single study visit (Day 1)
Tongue frenulum assessment	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).	At enrollment, during the single study visit (Day 1)
Tongue mobility score	Motricité Bucco-Linguo-Faciale (MBLF) test, where several movements are scored between 0 and 3 regarding muscular contraction or symmetry.	At enrollment, during the single study visit (Day 1)
Obstructive apnea-hypopnea index	Number of obstructive apneas and hypopneas per hour of sleep (events/hour) assessed through polysomnography	At enrollment, during the single study visit (Day 1)
Breathing pattern questionnaire	Mouth breathing questionnaire from Abreu et al., considered positive if two major items, or one major and two minor items, are answered "yes"	At enrollment, during the single study visit (Day 1)
Quality of life questionnaire	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.	At enrollment, during the single study visit (Day 1)
Sleep quality questionnaire	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.	At enrollment, during the single study visit (Day 1)
Sleep-related quality of life questionnaire	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.	At enrollment, during the single study visit (Day 1)

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Collaborators: CHC MontLégia

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: September 24, 2026
• First Submitted That Met QC Criteria: October 2, 2026
• First Posted (Actual): October 6, 2026

Study Record Updates

• Last Update Posted (Actual): October 6, 2026
• Last Update Submitted That Met QC Criteria: October 2, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: children; sleep apnea; tongue; obstructive sleep disordered breathing
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes
• Other Study ID Numbers: TMAC-C2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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