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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pierre Cnockaert, MSc
- Número de teléfono: +32478136109
- Correo electrónico: pierre.cnockaert@outlook.com
Ubicaciones de estudio
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Brussels, Bélgica, 1200
- Reclutamiento
- Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab
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Contacto:
- Pierre Cnockaert, MSc
- Correo electrónico: pierre.cnockaert@outlook.com
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Investigador principal:
- Pierre Cnockaert, MSc
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: TOM session
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New, lab-made device |
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Comparador activo: IOPI session
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The device currently identified as gold standard for tongue muscles assessment |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Tongue Pmax in elevation (pElev)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body mass index (kg/m^2)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: William Poncin, PhD, Université Catholique de Louvain
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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