- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07749573
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
The Effect of Chewing Gum in Addition to Standard Treatment on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department: A Randomized Controlled Clinical Trial
Dizziness is a common reason for emergency department visits. Posterior canal benign paroxysmal positional vertigo (BPPV) is one of the most frequent causes of peripheral vertigo. Intravenous dimenhydrinate is among the standard treatments administered in the emergency setting; however, this and similar drug classes may cause sedation and delay central compensation.
This study tests the hypothesis that chewing gum may modulate the vestibular system via trigeminal and cervical neuromuscular pathways, thereby reducing dizziness and nausea symptoms. Patients diagnosed with posterior canal BPPV who are started on intravenous dimenhydrinate will be randomly assigned to two groups: the intervention group will chew sugar-free mint-flavored gum for 20 minutes in addition to standard treatment, while the control group will receive standard treatment only. Dizziness and nausea severity will be assessed using VAS at baseline, 20 minutes, and 60 minutes.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ankara, Turquía (Türkiye)
- Ankara Ataturk Sanatorium Training and Research Hospital
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Contacto:
- Şeref Kerem Çorbacıoğlu
- Número de teléfono: +905437656176
- Correo electrónico: serefkeremcorbacioglu@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Aged 18-65 years
- Duration of dizziness complaint less than 24 hours
- Posterior canal BPPV diagnosis confirmed by the emergency physician via the Dix-Hallpike test
- Intravenous administration of 50 mg dimenhydrinate in 100 cc 0.9% NaCl initiated by the responsible emergency physician
- Symptomatic dizziness with VAS ≥ 4
- Alert, cooperative, and able to chew gum
- Willingness to participate and provision of written informed consent
Exclusion Criteria:
- Findings suggestive of central vertigo (vertical nystagmus, diplopia, ataxia, hemiparesis, focal neurological deficit, etc.)
- Pregnancy
- Known gum intolerance, history of allergy to gum or its excipients, temporomandibular joint dysfunction, significant tooth loss, use of dentures or removable prosthetics that would prevent chewing
- Altered level of consciousness
- Central pathology detected on investigations performed during the visit
- Hemodynamic and/or respiratory instability
- Diagnosis other than posterior canal BPPV as the cause of vertigo
- Treatment other than pharmacological therapy planned or already administered by the responsible emergency physician
- Active vomiting at the time of enrollment
- Severe dizziness with VAS ≥ 8 (excluded due to high likelihood of requiring additional treatment, risk of protocol deviation, and safety concerns regarding gum chewing)
- Patients who initially consented but subsequently wish to withdraw from the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Control Group
Patients receive only the standard treatment initiated by the responsible emergency physician: 50 mg dimenhydrinate in 100 cc 0.9% NaCl administered intravenously
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Dimenhydrinate 50 mg diluted in 100 mL of 0.9% sodium chloride administered intravenously as standard treatment for posterior canal benign paroxysmal positional vertigo in the emergency department.
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Experimental: Intervention Group
In addition to standard treatment (50 mg dimenhydrinate in 100 cc 0.9% NaCl IV), patients receive sugar-free mint-flavored chewing gum simultaneously with the start of treatment and chew it under observation for 20 minutes.
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Dimenhydrinate 50 mg diluted in 100 mL of 0.9% sodium chloride administered intravenously as standard treatment for posterior canal benign paroxysmal positional vertigo in the emergency department.
Participants chew one piece of sugar-free mint-flavored chewing gum under observation for 20 minutes, starting simultaneously with standard intravenous treatment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in dizziness Visual Analog Scale score from baseline to 20 minutes
Periodo de tiempo: Baseline and 20 minutes after treatment initiation
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The primary outcome is the change in dizziness severity measured using a 10-cm Visual Analog Scale, ranging from 0 (no dizziness) to 10 (worst imaginable dizziness), with higher scores indicating greater dizziness severity, between baseline and 20 minutes after treatment initiation.
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Baseline and 20 minutes after treatment initiation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Nausea Visual Analog Scale score at 20 minutes
Periodo de tiempo: 20 minutes after treatment initiation
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Nausea severity will be assessed 20 minutes after treatment initiation using a 10-cm Visual Analog Scale, ranging from 0 (no nausea) to 10 (worst imaginable nausea), with higher scores indicating greater nausea severity.
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20 minutes after treatment initiation
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Otorrinolaringológicas
- Trastornos sensoriales
- Enfermedades del oído
- Enfermedades del laberinto
- Enfermedades Vestibulares
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Vértigo
- Vértigo posicional paroxístico benigno
- Mareo
- Químicos orgánicos
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Preparaciones farmacéuticas
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Amina
- Purinones
- Purinas
- Derivados de benceno
- Etilaminas
- Combinaciones de drogas
- Compuestos de benzhydryl
- Xantino
- Teofilina
- Difenhidramina
- Dimenhidrinato
Otros números de identificación del estudio
- 2024-KAEK-24/43
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .