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Not yet recruiting NCT07625761

Assessment of a New Tool to Measure Tongue Muscle Function

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TOngue Manometer (TOM) device, IOPI.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device TOngue Manometer (TOM) device
    New, lab-made device
  • Device IOPI
    The device currently identified as gold standard for tongue muscles assessment

Primary outcome measures

  • Tongue Pmax in elevation (pElev) [Time frame: Throughout the entire study, approximately during 14 months]
  • Tongue endurance in elevation (eElev) [Time frame: Throughout the entire study, approximately during 14 months]
Secondary outcome measures (4)
  • 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) [Time frame: Throughout the entire study, approximately during 14 months]
  • Mouth breathing questionnaire [Time frame: Throughout the entire study, approximately during 14 months]
  • Tongue thickness (POCUS) [Time frame: Throughout the entire study, approximately during 14 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Belgium · 1 center
  • Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin ( — Brussels

Identifiers

NCT: NCT07625761 · TOM1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗