NCT06169761

Tongue Protrusion Assessment in Healthy Adult (FLEPI)

Assessment of Tongue Protrusion Motor Skills in Healthy Adult

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-11
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-12-13
• Last updated: 2023-12-19

Locations

1 site across 1 country: Belgium