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

Official title

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

Overview

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.

Interventions

• Diagnostic test 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.
• Diagnostic test 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.
• Diagnostic test 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.
• Diagnostic test 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
• Other EHTEV questionnaire
  Handicap Scale for Balance Disorders and Vertigo
• Other EEV questionnaire
  European Vertigo Assessment Questionnaire
• Other anxiety VAS
  visual analog scale of anxiety

Primary outcome measures

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

Secondary outcome measures (8)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

France · 2 centers

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

Identifiers

NCT: NCT04678167 · 29BRC20.0040

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗