Tongue Protrusion Assessment in Healthy Adult (FLEPI)
ConditionHealthy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversité Catholique de Louvain
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being 18 years of age or older
Disqualifiers
Eating disorder
Dysphagia
Cardiorespiratory disorder
Previous or ongoing obstructive sleep apnea-hypopnea syndrome
Trial population
The study population comprised healthy adults from Belgium, including both men and women aged 18 years and older, who meet all eligibility criteria.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea
Other interventionThe 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Healthy adults1 intervention
Trial outcomes
Primary outcomes
1
Tongue protrusion peak pressure
Tongue peak pressure during protrusion movements will be measured via the IOPI device
Time frame
Measured two times: at baseline and after 2 to 4 weeks2
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).
Time frame
Measured two times: at baseline and after 2 to 4 weeksSecondary outcomes
1
Tongue elevation peak pressure
Tongue peak pressure during elevation movements will be measured via the IOPI device
Time frame
Measured two times: at baseline and after 2 to 4 weeks2
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).
Time frame
Measured two times: at baseline and after 2 to 4 weeks3
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
Time frame
Measured once at baseline4
Maximum Inspiratory and Expiratory Pressure
Maximum Inspiratory and Expiratory pressure will be measured via the MicroRPM device
Time frame
Measured once at baselineSponsors and contacts
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Source ClinicalTrials.gov