An interventional study of TOngue Manometer (TOM) device and IOPI in Healthy, sponsored by Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Other
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.
Université Catholique de Louvain is the lead sponsor of 144 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: TOngue Manometer (TOM) device
Device: IOPI
New, lab-made device
The device currently identified as gold standard for tongue muscles assessment
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 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
Time frame: Throughout the entire study, approximately during 14 months
Body mass index (kg/m^2)
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: Throughout the entire study, approximately during 14 months
Plan to share: No
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Université Catholique de Louvain