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NCT Number: NCT06169761

Tongue Protrusion Assessment in Healthy Adult (FLEPI)

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).

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. 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

  2. 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).

Secondary outcomes

  1. 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

  2. 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).

  3. 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

  4. Maximum Inspiratory and Expiratory Pressure

    Time frame: Measured once at baseline

    Maximum Inspiratory and Expiratory pressure will be measured via the MicroRPM device

  5. Handgrip Strength

    Time frame: Measured once at baseline

    Handgrip Strength will be measured with a JAMAR Hand Dynamometer

Study contacts

Contact information is provided by the study sponsor or research team.

Julien Da Purificaçao, PT

CONTACT

[email protected]

+33788734941

William Poncin, PT, PhD

CONTACT

[email protected]

+3227641111

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

Assessment of Tongue Protrusion Motor Skills in Healthy Adult

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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