Tongue Muscular Assessment in Healthy Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2026-08-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Healthy children

Healthy children between the ages of 4 to 17 will undergo tongue motor functions assessment and their parents will fulfill the Pediatric Sleep Questionnaire

Sleep quality assessment

Intervention Type OTHER

The following item will be assessed in all subjects (n=420):

1\. Sleep, through the Pediatric Sleep Questionnaire.

Anthropometry

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Interventions

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Sleep quality assessment

The following item will be assessed in all subjects (n=420):

1\. Sleep, through the Pediatric Sleep Questionnaire.

Intervention Type 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)

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes