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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vestibular Neuritis
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Christophe LECLERE, Dr; Phone Number: 02.98.22.33.78; Email: jean-christophe.leclere@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHU de Brest
    • Contact: Jean-Christophe LECLERE, Dr; Phone Number: 02.98.22.33.78; Email: jean-christophe.leclere@chu-brest.fr
  • Morlaix, France, 29672
    • Terminated
    • CH Pays de Morlaix
  • Quimper, France, 29107
    • Not yet recruiting
    • CH de Cornouaille Quimper
    • Contact: Charlotte MISTRETTA; Email: charlotte.mistretta@gmail.com
    • Principal Investigator: Charlotte MISTRETTA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Boarding ring glasses; 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; 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.; Other Names: Barany test; 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
Placebo Comparator: Placebo glasses; 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; 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.; Other Names: Barany test; 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
Other: No glasses; 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; 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.; Other Names: Barany test; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Jean-Christophe LECLERE, Dr, University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): March 10, 2027

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: vestibular hyporeflexia; rotational vertigo; horizontal-rotational nystagmus
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Otorhinolaryngologic Diseases; Peripheral Nervous System Diseases; Ear Diseases; Cranial Nerve Diseases; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neuritis; Vestibular Neuronitis
• Other Study ID Numbers: 29BRC20.0040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No