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Clinical Trials in Belgium / NCT06166680
Recruiting Observational

Tongue Muscular Assessment in Healthy Children

NCT06166680 · tracked via the Priya Life Science Belgium tracker
Sponsor
Université Catholique de Louvain
Phase
Observational
Started
2023-10-07
Last updated
2026-05-04

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

Sleep quality assessmentAnthropometryTongue strength assessmentTongue endurance assessmentOrofacial praxis assessment

Sleep quality assessment: The following item will be assessed in all subjects (n=420): 1\. Sleep, through the Pediatric Sleep Questionnaire.

Anthropometry: The following items will be assessed in all subjects (n=420): 2\. Anthropometric data : 2.1 Height; 2.2 Weight; 2.3 Maximal mouth opening; 2.4 Maximal mouth opening with tongue to palate (with the Quick Tongue-Tie assessment tool)

Tongue strength assessment: The following items will be assessed in all subjects (n=420): 3\. Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing. 4\. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 sec. of tongue elevation. 5\. Tongue peak pressure during 3 sec. of tongue protrusion.

Tongue endurance assessment: The following items will be assessed in all subjects (n=420): 6\. The tongue endurance (i.e., the time to task failure in maintaining a pressure equal to 50%Pmax against the IOPI bulb) during tongue elevation. 7\. The tongue endurance during tongue protrusion.

Orofacial praxis assessment: \- The following item will be assessed in a subset of subjects (n=31): 8. Orofacial praxis through the Motricité Bucco-Linguo-Faciale (MBLF) test.

Study summary

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

Eligibility

Sex
ALL
Min age
4 Years
Max age
17 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Cliniques universitaires Saint-Luc Woluwe-Saint-Lambert Belgium Recruiting

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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 NCT06166680 on ClinicalTrials.gov ↗ ← All trials in Belgium