Tongue Protrusion Assessment in Healthy Adult (FLEPI)

April 28, 2026 updated by: William Poncin, Université Catholique de Louvain

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Being 18 years of age or older

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy adults
Healthy adults of 18 years and older will fill out the STOP-BANG Questionnaire and undergo protrusive motor skills measurements.
Other: Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea

The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured two times: at baseline and after 2 to 4 weeks
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).
Measured two times: at baseline and after 2 to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tongue elevation peak pressure
Time Frame: Measured two times: at baseline and after 2 to 4 weeks
Tongue peak pressure during elevation movements will be measured via the IOPI device
Measured two times: at baseline and after 2 to 4 weeks
Tongue mobility restriction
Time Frame: Measured once at baseline
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 once at baseline
Maximum Inspiratory and Expiratory Pressure
Time Frame: Measured once at baseline
Maximum Inspiratory and Expiratory pressure will be measured via the MicroRPM device
Measured once at baseline
Handgrip Strength
Time Frame: Measured once at baseline
Handgrip Strength will be measured with a JAMAR Hand Dynamometer
Measured once at baseline
Tongue elevation endurance
Time Frame: Measured two times: at baseline and after 2 to 4 weeks
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 two times: at baseline and after 2 to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLEPI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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