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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vestibular Neuritis

Intervention / Treatment
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* Diagnostic Test: Caloric test
* Diagnostic Test: Measurement of the speed of Nystagmus
* Diagnostic Test: Angle of deviation at Fukuda
* Diagnostic Test: Alexander's degree of nystagmus
* Other: EHTEV questionnaire
* Other: EEV questionnaire
* Other: anxiety VAS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomization list is established by the Brest CHRU data management unit before the start of the trial. Based on a ratio (1:1:1) with stratification on the center.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boarding ring glasses<br>Realization of the following examinations WITH Boarding ring glasses : caloric tests, measurement of the speed of Nystagmus, angle of deviation in Fukuda, Alexander's degree of nystagmus, EHTEV and EEV questionnaires, anxiety VAS | Diagnostic Test: Caloric test<br>* 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.<br>* Other names: Barany test;Diagnostic Test: Measurement of the speed of Nystagmus<br>* 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.<br>Diagnostic Test: Angle of deviation at Fukuda<br>* 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.<br>Diagnostic Test: Alexander's degree of nystagmus<br>* 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<br>Other: EHTEV questionnaire<br>* Handicap Scale for Balance Disorders and Vertigo<br>Other: EEV questionnaire<br>* European Vertigo Assessment Questionnaire<br>Other: anxiety VAS<br>* visual analog scale of anxiety<br>|
| Placebo Comparator: Placebo glasses<br>Realization of the following examinations WITH Placebo glasses : caloric tests, measurement of the speed of Nystagmus, angle of deviation in Fukuda, Alexander's degree of nystagmus, EHTEV and EEV questionnaires, anxiety VAS | Diagnostic Test: Caloric test<br>* 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.<br>* Other names: Barany test;Diagnostic Test: Measurement of the speed of Nystagmus<br>* 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.<br>Diagnostic Test: Angle of deviation at Fukuda<br>* 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.<br>Diagnostic Test: Alexander's degree of nystagmus<br>* 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<br>Other: EHTEV questionnaire<br>* Handicap Scale for Balance Disorders and Vertigo<br>Other: EEV questionnaire<br>* European Vertigo Assessment Questionnaire<br>Other: anxiety VAS<br>* visual analog scale of anxiety<br>|
| Other: No glasses<br>Realization of the following examinations WITHOUT glasses : caloric tests, measurement of the speed of Nystagmus, angle of deviation in Fukuda, Alexander's degree of nystagmus, EHTEV and EEV questionnaires, anxiety VAS | Diagnostic Test: Caloric test<br>* 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.<br>* Other names: Barany test;Diagnostic Test: Measurement of the speed of Nystagmus<br>* 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.<br>Diagnostic Test: Angle of deviation at Fukuda<br>* 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.<br>Diagnostic Test: Alexander's degree of nystagmus<br>* 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<br>Other: EHTEV questionnaire<br>* Handicap Scale for Balance Disorders and Vertigo<br>Other: EEV questionnaire<br>* European Vertigo Assessment Questionnaire<br>Other: anxiety VAS<br>* visual analog scale of anxiety<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7). |  | 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of nystagmus |  | 1 year | 
| Alexander's degree of nystagmus | Measure of the degree of intensity of nystagmus. There are 3 degrees : Degree I: nystagmus which 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. | 1 year | 
| Duration of hospitalization (for hospitalized patients) |  | 1 year | 
| Anxiety visual analog scale | 0 = no anxiety, 10 = maximum anxiety imaginable | 1 year | 
| Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire) | It helps to determine the physical, emotional and functional difficulties experienced in everyday life. EHTEV questionnaire is scored on 100 points. The physical score from 0 to 28 points, the emotional score from 0 to 36 points and the functional score from 0 to 36 points. ( 0 = no difficulty). | 1 year | 
| European Vertigo Evaluation Scale (EEV questionnaire) | Makes it possible to quantify vertigo and the associated vestibular symptoms and to monitor their evolution. EEV questionnaire is scored on 20 points (0 = no symptoms, 20 = maximum symptoms) | 1 year | 
| Vestibular deficit at caloric tests | measures 7of nystagmus (= fluttering of the eye) which reflects vestibular activity | 1 year | 
| Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12 |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vestibular hyporeflexia, rotational vertigo, horizontal-rotational nystagmus