Assessment of a New Tool to Measure Tongue Muscle Function (TOM1)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: TOngue Manometer (TOM) device; Device: IOPI

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Cnockaert, MSc; Phone Number: +32478136109; Email: pierre.cnockaert@outlook.com

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab
    • Contact: Pierre Cnockaert, MSc; Email: pierre.cnockaert@outlook.com
    • Principal Investigator: Pierre Cnockaert, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOM session	Device: TOngue Manometer (TOM) device; New, lab-made device
Active Comparator: IOPI session	Device: IOPI; The device currently identified as gold standard for tongue muscles assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Throughout the entire study, approximately during 14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (kg/m^2)		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).	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	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)	Throughout the entire study, approximately during 14 months

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Study Chair: William Poncin, PhD, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adults; Healthy; tongue; muscles
• Other Study ID Numbers: TOM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No