HealthyTMACNCT06166680
Tongue Muscular Assessment in Healthy Children
An observational study of Healthy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study aims to obtain normative values for tongue motor functions in healthy children. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sleep quality assessment, Anthropometry and Tongue strength assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Oct 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children between the ages of 4 to 17
Who may be able to join
- Being between the ages of 4 and 17
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Woluwe-Saint-Lambert, 1200
William Poncin, Prof
About this study
Official title: Assessment of Tongue Motor Functions in Healthy Children
This study aims to obtain normative values for tongue motor functions in healthy children.
Read the 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.
- Conditions
- Healthy
- Being tested
- Sleep quality assessment, Anthropometry, Tongue strength assessment, Tongue endurance assessment, Orofacial praxis assessment
- Keywords
- Tongue, Motor functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep quality assessmentOther
The following item will be assessed in all subjects (n=420):
- Sleep, through the Pediatric Sleep Questionnaire.
AnthropometryOther
The following items will be assessed in all subjects (n=420):
- 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 assessmentOther
The following items will be assessed in all subjects (n=420):
- Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing.
- Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 sec. of tongue elevation.
- Tongue peak pressure during 3 sec. of tongue protrusion.
Tongue endurance assessmentOther
The following items will be assessed in all subjects (n=420):
- 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.
- The tongue endurance during tongue protrusion.
Orofacial praxis assessmentOther
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Sleep quality assessment; Other: Anthropometry; Other: Tongue strength assessment; Other: Tongue endurance assessment; Other: Orofacial praxis assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue peak pressure during elevation and protrusion movements
Tongue peak pressure during elevation and protrusion movements will be measured via the IOPI (Iowa Oral Performance Instrument) device
Measured: At baseline
Secondary outcomes (4)
Tongue mobility restriction
Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured with the Quick Tongue-Tie Assessment tool
Measured: At baseline
Orofacial praxis
In a subset of subjects (n=31), orofacial praxis will be assessed through the Motricité Bucco-Linguo-Faciale (MBLF) test
Measured: At baseline
Tongue endurance during elevation and protrusion movements
Tongue endurance during elevation and protrusion movements will be measured via the IOPI device and a timer
Measured: At baseline
Tongue pressure during swallowing
Tongue pressure during swallowing will be measured via the IOPI device
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start7 Oct 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, Université Catholique de Louvain
- Investigators
- William Poncin, PT, PhD, Prof, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166680
- Sponsor's protocol ID
- TMAC
- Acronym
- TMAC
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41827090
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tongue Motor Functions in Healthy Children
- ClinicalTrials.gov ID
- NCT06166680
- Acronym / sponsor ID
- TMAC / TMAC
- Conditions
- Healthy
- Keywords
- Tongue, Motor functions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy children | – | Other: Sleep quality assessment, Other: Anthropometry, Other: Tongue strength assessment, Other: Tongue endurance assessment, Other: Orofacial praxis assessmentHealthy children between the ages of 4 to 17 will undergo tongue motor functions assessment and their parents will fulfill the Pediatric Sleep Questionnaire |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children between the ages of 4 to 17
Key inclusion criteria (1 listed)
- Being between the ages of 4 and 17
Key exclusion criteria (10 listed)
- Eating disorder
- Dysphagia
- Cardiorespiratory disorder
- Neurological disorder (including neuromuscular disorders)
- Previous or ongoing obstructive sleep apnea-hypopnea syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep quality assessmentThe following item will be assessed in all subjects (n=420): 1. Sleep, through the Pediatric Sleep Questionnaire. | Other | Healthy children |
| AnthropometryThe 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 | Healthy children |
| Tongue strength assessmentThe 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 | Healthy children |
| Tongue endurance assessmentThe 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 | Healthy children |
| 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. | Other | Healthy children |
Primary outcome
Tongue peak pressure during elevation and protrusion movements
Time frame: At baseline
Tongue peak pressure during elevation and protrusion movements will be measured via the IOPI (Iowa Oral Performance Instrument) device
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 41827090Cnockaert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Poncin, PT, PhD, Prof principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Poncin, PT, PhD, Prof (+32470592032, william.poncin@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue peak pressure during elevation and protrusion movements (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06166680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.