Assessment of a New Tool to Measure Tongue Muscle Function

NCT07625761 | Not Yet Recruiting

• 1 other identifier: TOM1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Adults; Healthy; tongue; muscles

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Body mass index (kg/m^2)

  Throughout the entire study, approximately during 14 months

• Mouth, tongue, and face assessment test (through MBLF test)

  Throughout the entire study, approximately during 14 months

• Mouth breathing questionnaire

  Throughout the entire study, approximately during 14 months

• Tongue thickness (POCUS)

  Throughout the entire study, approximately during 14 months

Study Arms (2)

TOM session

EXPERIMENTAL

Device: TOngue Manometer (TOM) device

IOPI session

ACTIVE COMPARATOR

Device: IOPI

Interventions

TOngue Manometer (TOM) device DEVICE

New, lab-made device

TOM session

IOPI DEVICE

The device currently identified as gold standard for tongue muscles assessment

IOPI session

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a healthy adult aged 18 to 65 years old
• Being able to understand and speak French

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

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

Brussels, 1200, Belgium

Location

Study Officials

• William Poncin, PhD

  Université Catholique de Louvain

  STUDY CHAIR

Central Study Contacts

Pierre Cnockaert, MSc

CONTACT

+32478136109; pierre.cnockaert@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: June 4, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)