HealthyNCT06169761
Tongue Protrusion Assessment in Healthy Adult (FLEPI)
An observational study of Healthy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study aims to evaluate tongue protrusion motor skills in healthy adults and to assess the reliability of these measurements as well as their validity in relation to other motor functions (handgrip and respiratory muscles). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Dec 2023to 31 May 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprised healthy adults from Belgium, including both men and women aged 18 years and older, who meet all eligibility criteria.
Who may be able to join
- Being 18 years of age or older
Who cannot join
- Eating disorder
- Dysphagia
- Cardiorespiratory disorder
- Previous or ongoing obstructive sleep apnea-hypopnea syndrome
- Neurological conditions (including neuromuscular disorders)
- Previous or ongoing cancer of the head or neck
- Pregnancy
- Any physical or mental condition that may affect the ability to consent
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
UCLouvain
Louvain-la-Neuve
William Poncin, 0032 10 47 21 11, william.poncin@uclouvain.be
About this study
Official title: Assessment of Tongue Protrusion Motor Skills in Healthy Adult
This study aims to evaluate tongue protrusion motor skills in healthy adults and to assess the reliability of these measurements as well as their validity in relation to other motor functions (handgrip and respiratory muscles).
Read the detailed description
The tongue is an organ involved in multiple essential daily functions (such as eating, speaking, and breathing). Normative values exist for the motor skills of tongue elevation in individuals. However, data regarding protrusion are lacking. Yet, the protrusive strength of the tongue is of particular interest. Indeed a weak protrusive tongue strength may contribute to sleep apnea and swallowing disorders. Therefore, this study aims to collect normative and clinimetric (validity and reliability) data of tongue protrusion strength and endurance among healthy adults.
- Conditions
- Healthy
- Being tested
- Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea
- Keywords
- Tongue, Motor skills, Protrusion, Strength, Fatigability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apneaOther
The following items will be assessed:
- Risk for sleep apnea, through the STOP-BANG Questionnaire.
- Anthropometric data: Height, weight, neck circumference, maximal mouth opening and maximal mouth opening with tongue to palate (with the Quick Tongue-Tie Assessment tool).
- Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb in kPa) during 3 sec. of tongue protrusion and elevation.
- Tongue endurance (i.e., the time to task failure in maintaining a pressure equal to a fixed percentage of Pmax against the IOPI bulb) during tongue protrusion and elevation
- Tongue mobility restriction measured with the Quick Tongue-Tie Assessment Tool
- Maximum inspiratory and expiratory pressures measured with MicroRPM in cmH2O
- Handgrip strength (measured with a JAMAR dynamometer in kg)
Tongue skills measurements will be repeated 2 to 4 weeks after baseline to assess the reliability of these measurements.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy adults of 18 years and older will fill out the STOP-BANG Questionnaire and undergo protrusive motor skills measurements. Receives: Other: Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue protrusion peak pressure
Tongue peak pressure during protrusion movements will be measured via the IOPI device
Measured: Measured two times: at baseline and after 2 to 4 weeks
Tongue protrusion endurance
Tongue endurance during protrusion movements will be measured via a timer (the time in seconds until the participant is not able to sustain tongue protrusion as controlled via the IOPI).
Measured: Measured two times: at baseline and after 2 to 4 weeks
Secondary outcomes (5)
Tongue elevation peak pressure
Tongue peak pressure during elevation movements will be measured via the IOPI device
Measured: Measured two times: at baseline and after 2 to 4 weeks
Tongue elevation endurance
will be measured via a timer (the time in seconds until the participant is not able to sustain tongue protrusion as controlled via the IOPI).
Measured: Measured two times: at baseline and after 2 to 4 weeks
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: Measured once at baseline
Maximum Inspiratory and Expiratory Pressure
Maximum Inspiratory and Expiratory pressure will be measured via the MicroRPM device
Measured: Measured once at baseline
Handgrip Strength
Handgrip Strength will be measured with a JAMAR Hand Dynamometer
Measured: Measured once at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start11 Dec 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169761
- Sponsor's protocol ID
- FLEPI
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 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
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 Protrusion Motor Skills in Healthy Adult
- ClinicalTrials.gov ID
- NCT06169761
- Acronym / sponsor ID
- FLEPI
- Conditions
- Healthy
- Keywords
- Tongue, Motor skills, Protrusion, Strength, Fatigability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 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 evaluate tongue protrusion motor skills in healthy adults and to assess the reliability of these measurements as well as their validity in relation to other motor functions (handgrip and respiratory muscles).
Detailed description
The tongue is an organ involved in multiple essential daily functions (such as eating, speaking, and breathing). Normative values exist for the motor skills of tongue elevation in individuals. However, data regarding protrusion are lacking. Yet, the protrusive strength of the tongue is of particular interest. Indeed a weak protrusive tongue strength may contribute to sleep apnea and swallowing disorders. Therefore, this study aims to collect normative and clinimetric (validity and reliability) data of tongue protrusion strength and endurance among healthy adults.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Other: Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apneaHealthy adults of 18 years and older will fill out the STOP-BANG Questionnaire and undergo protrusive motor skills measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised healthy adults from Belgium, including both men and women aged 18 years and older, who meet all eligibility criteria.
Key inclusion criteria (1 listed)
- Being 18 years of age or older
Key exclusion criteria (8 listed)
- Eating disorder
- Dysphagia
- Cardiorespiratory disorder
- Previous or ongoing obstructive sleep apnea-hypopnea syndrome
- Neurological conditions (including neuromuscular disorders)
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 |
|---|---|---|
| Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apneaThe following items will be assessed: 1. Risk for sleep apnea, through the STOP-BANG Questionnaire. 2. Anthropometric data: Height, weight, neck circumference, maximal mouth opening and maximal mouth opening with tongue to palate (with the Quick Tongue-Tie Assessment tool). 3. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb in kPa) during 3 sec. of tongue protrusion and elevation. 4. Tongue endurance (i.e., the time to task failure in maintaining a pressure equal to a fixed percentage of Pmax against the IOPI bulb) during tongue protrusion and elevation 5. Tongue mobility restriction measured with the Quick Tongue-Tie Assessment Tool 6. Maximum inspiratory and expiratory pressures measured with MicroRPM in cmH2O 7. Handgrip strength (measured with a JAMAR dynamometer in kg) Tongue skills measurements will be repeated 2 to 4 weeks after baseline to assess the reliability of these measurements. | Other | Healthy adults |
Primary outcome
Tongue protrusion peak pressure
Time frame: Measured two times: at baseline and after 2 to 4 weeks
Tongue peak pressure during protrusion movements will be measured via the IOPI device
Tongue protrusion endurance
Time frame: Measured two times: at baseline and after 2 to 4 weeks
Tongue endurance during protrusion movements will be measured via a timer (the time in seconds until the participant is not able to sustain tongue protrusion as controlled via the IOPI).
5 secondary outcomes
Tongue elevation peak pressure
Time frame: Measured two times: at baseline and after 2 to 4 weeks
Tongue elevation endurance
Time frame: Measured two times: at baseline and after 2 to 4 weeks
Tongue mobility restriction
Time frame: Measured once at baseline
Maximum Inspiratory and Expiratory Pressure
Time frame: Measured once at baseline
Handgrip Strength
Time frame: Measured once 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.
- 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.
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 8 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 (+3227641111, 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 protrusion peak pressure (time frame: Measured two times: at baseline and after 2 to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.