Healthy
Conditions
Keywords
Adults, Healthy, tongue, muscles
Brief summary
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.
Interventions
DEVICETOngue Manometer (TOM) device
New, lab-made device
DEVICEIOPI
The device currently identified as gold standard for tongue muscles assessment
Sponsors
Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Being a healthy adult aged 18 to 65 years old * Being able to understand and speak French
Exclusion criteria
* 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 * Having dysphagia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tongue Pmax in elevation (pElev) | Throughout the entire study, approximately during 14 months | Tongue maximal pressure (kPa) in elevation, either with the TOM or the IOPI, depending on the visit and the randomization order |
| Tongue endurance in elevation (eElev) | Throughout the entire study, approximately during 14 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (kg/m^2) | Throughout the entire study, approximately during 14 months | — |
| Mouth, tongue, and face assessment test (through MBLF test) | Throughout the entire study, approximately during 14 months | 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). |
| Mouth breathing questionnaire | Throughout the entire study, approximately during 14 months | 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 |
| Tongue thickness (POCUS) | Throughout the entire study, approximately during 14 months | A submental and neck ultrasound will be performed to assess tongue muscles thickness (cm) |
Countries
Belgium
Contacts
CONTACTPierre Cnockaert, MSc
STUDY_CHAIRWilliam Poncin, PhD
Université Catholique de Louvain
Outcome results
None listed