Tongue Protrusion Assessment in Healthy Adult (FLEPI)

Recruiting

• Conditions: Healthy
• Interventions: Other: Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea

• Registration Number: NCT06169761
• Lead Sponsor: Université Catholique de Louvain

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).

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 Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Study Start: 2023-12-11
• Study First Posted: 2023-12-13
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Tongue protrusion peak pressure	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	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 Outcome Measures

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

Trial Locations

Locations (1)

UCLouvain; 🇧🇪 Louvain-la-Neuve, Belgium