Assessment of a New Tool to Measure Tongue Muscle Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Tongue Pmax in elevation (pElev)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
TOM session
Intervention: TOngue Manometer (TOM) device (Device)
IOPI session
Intervention: IOPI (Device)
Outcomes
Primary Outcomes
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
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
- 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)