Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis

Официальное название

Evaluation of the Efficacy of BOARDING RING Glasses in the Treatment of Vestibular Neuritis

Обзор

Vestibular neuritis is a brutal and continuous dizzying syndrome of peripheral (vestibular) origin without cochlear or other associated involvement. Specifically, vestibular neuritis is inflammation of the nerve that innervates the vestibular canals (the inner ear). It is characterized by the sudden onset of intense and prolonged vertigo accompanied by postural imbalance, nausea and vomiting, without hearing impairment or other neurological symptoms. Vestibular neuritis is the second cause of peripheral vertigo after benign paroxysmal positional vertigo. It represents approximately 7% of patients consulting for vertigo. The purpose of this study is to evaluate if wearing Boarding Ring glasses can be accelerated vestibular compensation.

Вмешательства

• Диагностический тест Caloric test
  Lying, patientwill be placed so that he can introduce water (hot then cold) into his external ear canal. It is the reaction of the vestibular system (sensory organ responsible for balance) which is then measured with a helmet placed over his eyes and which measures the nystagmus (movement of the eye) which reflects vestibular activity.
• Диагностический тест Measurement of the speed of Nystagmus
  A helmet with an infrared camera will be placed in front of patient eyes. This will allow visualizing on screen and measuring eye movements spontaneous or induced in the dark by various tests.
• Диагностический тест Angle of deviation at Fukuda
  The patient will be asked to trample on the spot (30 steps) with the indexes pointed forward. In the event of vestibular asymmetry, the patient turns at a varying angle to the right or to the left. This will then measure what is called the angle of deflection of the fukuda.
• Диагностический тест Alexander's degree of nystagmus
  there are 3 degrees: * Degree I: nystagmus that exists only when the eyes are turned to the right. * Degree II: also exists when the eyes are to the right or to the front. * Degree Ill: exists when the eyes are on the right, front, or left
• Другое EHTEV questionnaire
  Handicap Scale for Balance Disorders and Vertigo
• Другое EEV questionnaire
  European Vertigo Assessment Questionnaire
• Другое anxiety VAS
  visual analog scale of anxiety

Первичные конечные точки

• Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7). [Срок оценки: 7 day]

Вторичные конечные точки (8)

• Speed of nystagmus [Срок оценки: 1 year]
• Alexander's degree of nystagmus [Срок оценки: 1 year]
• Duration of hospitalization (for hospitalized patients) [Срок оценки: 1 year]
• Anxiety visual analog scale [Срок оценки: 1 year]
• Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire) [Срок оценки: 1 year]
• European Vertigo Evaluation Scale (EEV questionnaire) [Срок оценки: 1 year]
• Vestibular deficit at caloric tests [Срок оценки: 1 year]
• Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12 [Срок оценки: 1 year]

Критерии участия

Критерии включения

• adult patients,
• patient with vestibular neuritis defined by appearance of continuous rotating vertigo with nausea
• patient with spontaneous horizonto-rotating nystagmus beating towards the healthy ear
• patient with a postural deviation towards the affected ear;
• vestibular hyporeflexia measured at the caloric tests greater than 25%
• patient who has given free, enlighten and written consent

Критерии исключения

• patient with a history of vertigo of vestibular origin or with vertigo developing for more than 4 days
• patient with associated hearing loss or tinnitus
• patient with an motor ocular abnormality of central origin
• patient refusal or inability to consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Франция · 2 центра

• CHU de Brest — Brest
• CH Pays de Morlaix — Morlaix

Идентификаторы

NCT: NCT04678167 · 29BRC20.0040

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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