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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOM session | Experimental |
| |
| IOPI session | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOngue Manometer (TOM) device | Device | New, lab-made device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Throughout the entire study, approximately during 14 months |
| 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 | Throughout the entire study, approximately during 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index (kg/m^2) | Throughout the entire study, approximately during 14 months | |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Cnockaert, MSc | Contact | +32478136109 | pierre.cnockaert@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| William Poncin, PhD | Université Catholique de Louvain | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab | Brussels | 1200 | Belgium |
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| IOPI |
| Device |
The device currently identified as gold standard for tongue muscles assessment |
|
| Throughout the entire study, approximately during 14 months |
| 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 | Throughout the entire study, approximately during 14 months |
| Tongue thickness (POCUS) | A submental and neck ultrasound will be performed to assess tongue muscles thickness (cm) | Throughout the entire study, approximately during 14 months |