HealthyTOM1NCT07625761
Assessment of a New Tool to Measure Tongue Muscle Function
A study testing TOngue Manometer (TOM) device and IOPI in people with Healthy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TOngue Manometer (TOM) device and IOPI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jun 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a healthy adult aged 18 to 65 years old
- Being able to understand and speak French
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab
Brussels, 1200
Pierre Cnockaert, MSc, pierre.cnockaert@outlook.com
Pierre Cnockaert, MSc
About this study
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
- Being tested
- TOngue Manometer (TOM) device, IOPI
- Keywords
- Adults, Healthy, tongue, muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOngue Manometer (TOM) deviceDevice
New, lab-made device
IOPIDevice
The device currently identified as gold standard for tongue muscles assessment
| Study group | Role | What they receive |
|---|---|---|
| TOM session | Experimental | Not described Receives: Device: TOngue Manometer (TOM) device |
| IOPI session | Active comparator | Not described Receives: Device: IOPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Throughout the entire study, approximately during 14 months
Secondary outcomes (4)
Body mass index (kg/m^2)
Measured: 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).
Measured: 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
Measured: 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)
Measured: Throughout the entire study, approximately during 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start4 Jun 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Poncin, PhD, Study chair, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625761
- Sponsor's protocol ID
- TOM1
- Acronym
- TOM1
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a New Tool to Measure Tongue Muscle Function
- ClinicalTrials.gov ID
- NCT07625761
- Acronym / sponsor ID
- TOM1 / TOM1
- Conditions
- Healthy
- Keywords
- Adults, Healthy, tongue, muscles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOM session | Experimental | Device: TOngue Manometer (TOM) device |
| IOPI session | Active comparator | Device: IOPI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being a healthy adult aged 18 to 65 years old
- Being able to understand and speak French
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOngue Manometer (TOM) deviceNew, lab-made device | Device | TOM session |
| IOPIThe device currently identified as gold standard for tongue muscles assessment | Device | IOPI session |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Poncin, PhD study chair
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOngue Manometer (TOM) device and IOPI in people with Healthy, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Cnockaert, MSc (+32478136109, pierre.cnockaert@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue Pmax in elevation (pElev) (time frame: Throughout the entire study, approximately during 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.