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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Pierre Cnockaert, MSc
- Telefonnummer: +32478136109
- E-post: pierre.cnockaert@outlook.com
Studieorter
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Brussels, Belgien, 1200
- Rekrytering
- Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab
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Kontakt:
- Pierre Cnockaert, MSc
- E-post: pierre.cnockaert@outlook.com
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Huvudutredare:
- Pierre Cnockaert, MSc
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: TOM session
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New, lab-made device |
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Aktiv komparator: IOPI session
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The device currently identified as gold standard for tongue muscles assessment |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tongue Pmax in elevation (pElev)
Tidsram: 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 |
Throughout the entire study, approximately during 14 months
|
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Tongue endurance in elevation (eElev)
Tidsram: Throughout the entire study, approximately during 14 months
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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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body mass index (kg/m^2)
Tidsram: Throughout the entire study, approximately during 14 months
|
Throughout the entire study, approximately during 14 months
|
|
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Mouth, tongue, and face assessment test (through MBLF test)
Tidsram: 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). |
Throughout the entire study, approximately during 14 months
|
|
Mouth breathing questionnaire
Tidsram: 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 |
Throughout the entire study, approximately during 14 months
|
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Tongue thickness (POCUS)
Tidsram: Throughout the entire study, approximately during 14 months
|
A submental and neck ultrasound will be performed to assess tongue muscles thickness (cm) |
Throughout the entire study, approximately during 14 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: William Poncin, PhD, Université Catholique de Louvain
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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