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Recruiting NCT06166680

Tongue Muscular Assessment in Healthy Children

— Observational Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep quality assessment, Anthropometry, Tongue strength assessment, Tongue endurance assessment.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 4 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Assessment of Tongue Motor Functions in Healthy Children

Overview

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.

Interventions

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

Primary outcome measures

  • Tongue peak pressure during elevation and protrusion movements [Time frame: At baseline]
Secondary outcome measures (4)
  • Tongue mobility restriction [Time frame: At baseline]
  • Orofacial praxis [Time frame: At baseline]
  • Tongue endurance during elevation and protrusion movements [Time frame: At baseline]
  • Tongue pressure during swallowing [Time frame: At baseline]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Belgium · 1 center
  • Cliniques universitaires Saint-Luc — Woluwe-Saint-Lambert

Publications

  • Cnockaert P, Fondeur A, Gabillet E, Poncin W. Intra- and Inter-Rater Reliability of Tongue Physical Function Assessments in Children. J Oral Rehabil. 2026 Jul;53(7):1327-1336. doi: 10.1111/joor.70177. Epub 2026 Mar 13. PMID 41827090

Identifiers

NCT: NCT06166680 · TMAC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗