Assessment of a New Tool to Measure Tongue Muscle Function
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversité Catholique de Louvain
About this trial
The Iowa Oral Performance Instrument (IOPI) is currently the reference tool for assessing tongue muscle function, measuring the pressure exerted by the tongue on an air-filled bulb. However, several limitations reduce its precision and clinical relevance. To overcome these, the TOngue Manometer (TOM) has been developed. This crossover study compares the two devices in healthy adults, hypothesizing that the TOM's interface will enable participants to produce higher maximal tongue pressure and endurance values, closer to their ground truth.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being a healthy adult aged 18 to 65 years old
Being able to understand and speak French
Disqualifiers
Being diagnosed with a cardiorespiratory or neuromuscular disease
Being diagnosed with obstructive sleep apnea-hypopnea syndrome
Any reason preventing the participant from completing the measurement protocol (e.g., oral pain, severe cognitive impairment, lack of cooperation, illiteracy)
Being involved in an oropharyngeal rehabilitation program
Trial design
Design model
Crossover
Treatments tested in this trial
TOngue Manometer (TOM) device
DeviceNew, lab-made device
IOPI
DeviceThe device currently identified as gold standard for tongue muscles assessment
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: TOM sessionExperimental treatment 1 intervention
Group B: IOPI sessionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Tongue Pmax in elevation (pElev)
Tongue maximal pressure (kPa) in elevation, either with the TOM or the IOPI, depending on the visit and the randomization order
Time frame
Throughout the entire study, approximately during 14 months2
Tongue endurance in elevation (eElev)
Endurance time (sec.), i.e., time during which the tongue can sustain 50% of its Pmax in elevation, measured either with the TOM or the IOPI, depending on the visit and the randomization order
Time frame
Throughout the entire study, approximately during 14 monthsSecondary outcomes
1
Body mass index (kg/m^2)
Time frame
Throughout the entire study, approximately during 14 months2
Mouth, tongue, and face assessment test (through MBLF test)
This test (MBLF test, for 'test de motricité bucco-linguo-faciale') features an assessment of several muscles (e.g., lips, tongue, and face area) that are assessed on a scale from 0 (no contraction / severe asymmetry) to 3 (normal contraction / complete symmetry).
Time frame
Throughout the entire study, approximately during 14 months3
Mouth breathing questionnaire
A score 0-3 suggests high likelihood of habitual nose breathing; 4-7 a suspicion of mouth breathing; 8 or higher a high likelihood of habitual mouth breathing
Time frame
Throughout the entire study, approximately during 14 months4
Tongue thickness (POCUS)
A submental and neck ultrasound will be performed to assess tongue muscles thickness (cm)
Time frame
Throughout the entire study, approximately during 14 monthsSponsors and contacts
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Source ClinicalTrials.gov