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Assessment of a New Tool to Measure Tongue Muscle Function

Study acronym: TOM1
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of May 30, 2026 to Jun 4, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07625761
Lead Sponsor Université Catholique de Louvain
Conditions
(from sponsor)		 Healthy
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov