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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Pierre Cnockaert, MSc
- Telefoonnummer: +32478136109
- E-mail: pierre.cnockaert@outlook.com
Studie Locaties
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Brussels, België, 1200
- Werving
- Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab
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Contact:
- Pierre Cnockaert, MSc
- E-mail: pierre.cnockaert@outlook.com
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Hoofdonderzoeker:
- Pierre Cnockaert, MSc
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: TOM session
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New, lab-made device |
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Actieve vergelijker: IOPI session
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The device currently identified as gold standard for tongue muscles assessment |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Tongue Pmax in elevation (pElev)
Tijdsspanne: Throughout the entire study, approximately during 14 months
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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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Body mass index (kg/m^2)
Tijdsspanne: Throughout the entire study, approximately during 14 months
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Throughout the entire study, approximately during 14 months
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Mouth, tongue, and face assessment test (through MBLF test)
Tijdsspanne: Throughout the entire study, approximately during 14 months
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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
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Mouth breathing questionnaire
Tijdsspanne: Throughout the entire study, approximately during 14 months
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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)
Tijdsspanne: Throughout the entire study, approximately during 14 months
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A submental and neck ultrasound will be performed to assess tongue muscles thickness (cm) |
Throughout the entire study, approximately during 14 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: William Poncin, PhD, Université Catholique de Louvain
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- TOM1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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