Ireland
--:--IST
Recruiting Not applicable

Assessment of a New Tool to Measure Tongue Muscle Function

NCT07625761 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2026-06-04
Last updated
2026-09-21

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

TOngue Manometer (TOM) deviceIOPI

TOngue Manometer (TOM) device: New, lab-made device

IOPI: The device currently identified as gold standard for tongue muscles assessment

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab Brussels Belgium Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07625761 on ClinicalTrials.gov ↗ ← All trials in Belgium