Tongue Muscular Assessment in Healthy Children

Recruiting

• Conditions: Healthy

• Registration Number: NCT06166680
• Lead Sponsor: Université Catholique de Louvain

Brief Summary

This study aims to obtain normative values for tongue motor functions in healthy children.

Detailed Description

Since the tongue is a complex structure consisting of a continuous array of muscle fibers with varying orientation, tongue motor functions (strength, endurance) are likely to differ according to a protrusion (pulling out the tongue), elevation (lifting the tongue to the roof of the mouth) or swallowing movement.

There are currently no normative data for the motor functions of the tongue in children. After their parents fulfilled the Pediatric Sleep Questionnaire, each included children will undergo an anthropometric and a tongue motor functions assessment.

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-12-03
• Study First Posted: 2023-12-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Being between the ages of 4 and 17

Exclusion Criteria

• Eating disorder
• Dysphagia
• Cardiorespiratory disorder
• Neurological disorder (including neuromuscular disorders)
• Previous or ongoing obstructive sleep apnea-hypopnea syndrome
• Previous or ongoing cancer of the head or neck
• Previous oral or pharyngeal surgery (except for the surgical removal of wisdom teeth)
• Cranial, oral or upper airway malformation (ex.: nasal cavities, pharynx)
• Previous or ongoing orthodontic treatment (e.g. braces)
• More than 33% of positive answers to the Pediatric Sleep Questionnaire (8/22)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tongue peak pressure during elevation and protrusion movements	At baseline	Tongue peak pressure during elevation and protrusion movements will be measured via the IOPI (Iowa Oral Performance Instrument) device

Secondary Outcome Measures

Name	Time	Method
Orofacial praxis	At baseline	In a subset of subjects (n=31), orofacial praxis will be assessed through the Motricité Bucco-Linguo-Faciale (MBLF) test
Tongue mobility restriction	At baseline	Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured with the Quick Tongue-Tie Assessment tool
Tongue endurance during elevation and protrusion movements	At baseline	Tongue endurance during elevation and protrusion movements will be measured via the IOPI device and a timer
Tongue pressure during swallowing	At baseline	Tongue pressure during swallowing will be measured via the IOPI device

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Woluwe-Saint-Lambert, Belgium