Tongue Protrusion Assessment in Healthy Adult (FLEPI)

Healthy Clinical Trial

Official title:

Assessment of Tongue Protrusion Motor Skills in Healthy Adult

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169761
• Other study ID #: FLEPI
• Status: Recruiting
• Start date: December 11, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Université Catholique de Louvain
• Contact: William Poncin, PT, PhD
• Phone: +3227641111
• Email: william.poncin[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Belgium	UCLouvain	Louvain-la-Neuve

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

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