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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04678167
Acronym
NEVRING
Enrollment
51
Registered
2020-12-21
Start date
2021-03-10
Completion date
2029-05-10
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Neuritis

Keywords

vestibular hyporeflexia, rotational vertigo, horizontal-rotational nystagmus

Brief 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.

Interventions

DIAGNOSTIC_TESTCaloric 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_TESTMeasurement 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_TESTAngle 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_TESTAlexander'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

OTHEREHTEV questionnaire

Handicap Scale for Balance Disorders and Vertigo

OTHEREEV questionnaire

European Vertigo Assessment Questionnaire

visual analog scale of anxiety

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Masking description

Only the investigator carrying out the follow-up consultations is blind. After examination by the ENT specialist (otorhinolaryngologist) who will diagnose vestibular neuritis, the patient will be randomized into one of three groups. The clinical follow-up will be performed by another practitioner, who will not know in which arm the patient is included (the patient will come to the consultation without his glasses). Only the practitioner who realized the randomization and the patient will have information about the arm in which they are located.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
Speed of nystagmus1 year
Alexander's degree of nystagmus1 yearMeasure 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.
Duration of hospitalization (for hospitalized patients)1 year
Anxiety visual analog scale1 year0 = no anxiety, 10 = maximum anxiety imaginable
Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire)1 yearIt 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).
European Vertigo Evaluation Scale (EEV questionnaire)1 yearMakes 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)
Vestibular deficit at caloric tests1 yearmeasures 7of nystagmus (= fluttering of the eye) which reflects vestibular activity
Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M121 year

Countries

France

Contacts

CONTACTJean-Christophe LECLERE, Dr
jean-christophe.leclere@chu-brest.fr02.98.22.33.78
PRINCIPAL_INVESTIGATORJean-Christophe LECLERE, Dr

University Hospital, Brest

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026