Tongue Protrusion Assessment in Healthy Adult (FLEPI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of Tongue Protrusion Motor Skills in Healthy Adult
Overview
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.
Interventions
- 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 pressu
Primary outcome measures
- Tongue protrusion peak pressure [Time frame: Measured two times: at baseline and after 2 to 4 weeks]
- Tongue protrusion endurance [Time frame: Measured two times: at baseline and after 2 to 4 weeks]
Secondary outcome measures (5)
- Tongue elevation peak pressure [Time frame: Measured two times: at baseline and after 2 to 4 weeks]
- Tongue elevation endurance [Time frame: Measured two times: at baseline and after 2 to 4 weeks]
- Tongue mobility restriction [Time frame: Measured once at baseline]
- Maximum Inspiratory and Expiratory Pressure [Time frame: Measured once at baseline]
- Handgrip Strength [Time frame: Measured once at baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Belgium · 1 center
- UCLouvain — Louvain-la-Neuve
Identifiers
NCT: NCT06169761 · FLEPI