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

Vestibular Neuritis Clinical Trial

— NEVRING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04678167
• Other study ID #: 29BRC20.0040
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: March 10, 2027

Study information

• Verified date: July 2023
• Source: University Hospital, Brest
• Contact: Jean-Christophe LECLERE, Dr
• Phone: 02.98.22.33.78
• Email: jean-christophe.leclere[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: March 10, 2027
• Est. primary completion date: March 10, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuritis
• Vestibular Neuritis
• Vestibular Neuronitis

Intervention

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.
• 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.
• 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.
• 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
• EEV questionnaire
European Vertigo Assessment Questionnaire
• anxiety VAS
visual analog scale of anxiety

Locations

Country	Name	City	State
France	CHU de Brest	Brest
France	CH Pays de Morlaix	Morlaix
France	CH de Cornouaille Quimper	Quimper

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7).		7 day
Secondary	Speed of nystagmus		1 year
Secondary	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
Secondary	Duration of hospitalization (for hospitalized patients)		1 year
Secondary	Anxiety visual analog scale	0 = no anxiety, 10 = maximum anxiety imaginable	1 year
Secondary	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
Secondary	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
Secondary	Vestibular deficit at caloric tests	measures 7of nystagmus (= fluttering of the eye) which reflects vestibular activity	1 year
Secondary	Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12		1 year