Tongue Protrusion Assessment in Healthy Adult (FLEPI)

NCT06169761 | Recruiting

• 1 other identifier: FLEPI
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy

Keywords

Tongue; Motor skills; Protrusion; Strength; Fatigability

Outcome Measures

Primary Outcomes (2)

• Tongue protrusion peak pressure

  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

  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 Outcomes (5)

• Tongue elevation peak pressure

  Measured two times: at baseline and after 2 to 4 weeks

• Tongue elevation endurance

  Measured two times: at baseline and after 2 to 4 weeks

• Tongue mobility restriction

  Measured once at baseline

• Maximum Inspiratory and Expiratory Pressure

  Measured once at baseline

• Handgrip Strength

  Measured once at baseline

Study Arms (1)

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

Interventions

Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea OTHER

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.

Healthy adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Being 18 years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

UCLouvain

Louvain-la-Neuve, Belgium

RECRUITING

MeSH Terms

Interventions

Risk

Intervention Hierarchy (Ancestors)

Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

William Poncin, PT, PhD

CONTACT

+3227641111; william.poncin@uclouvain.be

Julien Da Purificaçao, PT

CONTACT

+33788734941; dapurificacaojulien.kine@uclouvain.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: December 11, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)