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NCT Number: NCT07625761

Assessment of a New Tool to Measure Tongue Muscle Function

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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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab

Brussels, 1200, Belgium

Location contact

Pierre Cnockaert, MSc

CONTACT

[email protected]

Pierre Cnockaert, MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TOngue Manometer (TOM) device

Device

New, lab-made device

IOPI

Device

The device currently identified as gold standard for tongue muscles assessment

Primary outcomes

  1. Tongue Pmax in elevation (pElev)

    Time frame: 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

  2. Tongue endurance in elevation (eElev)

    Time frame: 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

Secondary outcomes

  1. Body mass index (kg/m^2)

    Time frame: Throughout the entire study, approximately during 14 months

  2. Mouth, tongue, and face assessment test (through MBLF test)

    Time frame: Throughout the entire study, approximately during 14 months

    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).

  3. Mouth breathing questionnaire

    Time frame: Throughout the entire study, approximately during 14 months

    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

  4. Tongue thickness (POCUS)

    Time frame: Throughout the entire study, approximately during 14 months

    A submental and neck ultrasound will be performed to assess tongue muscles thickness (cm)

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Cnockaert, MSc

CONTACT

[email protected]

+32478136109

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Acronym: TOM1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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