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

NCT04678167 | Recruiting

• 1 other identifier: 29BRC20.0040
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Vestibular Neuritis

Keywords

vestibular hyporeflexia; rotational vertigo; horizontal-rotational nystagmus

Outcome Measures

Primary Outcomes (1)

• Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7).

  7 day

Secondary Outcomes (8)

• Speed of nystagmus

  1 year

• Alexander's degree of nystagmus

  1 year

• Duration of hospitalization (for hospitalized patients)

  1 year

• Anxiety visual analog scale

  1 year

• Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire)

  1 year

Study Arms (3)

Boarding ring glasses

EXPERIMENTAL

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; 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

Placebo glasses

PLACEBO COMPARATOR

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; 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

No glasses

OTHER

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; 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

Interventions

Measurement of the speed of Nystagmus DIAGNOSTIC_TEST

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.

Boarding ring glasses; No glasses; Placebo glasses

Angle of deviation at Fukuda DIAGNOSTIC_TEST

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.

Boarding ring glasses; No glasses; Placebo glasses

Alexander's degree of nystagmus DIAGNOSTIC_TEST

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

Boarding ring glasses; No glasses; Placebo glasses

EHTEV questionnaire OTHER

Handicap Scale for Balance Disorders and Vertigo

Boarding ring glasses; No glasses; Placebo glasses

EEV questionnaire OTHER

European Vertigo Assessment Questionnaire

Boarding ring glasses; No glasses; Placebo glasses

anxiety VAS OTHER

visual analog scale of anxiety

Boarding ring glasses; No glasses; Placebo glasses

Caloric test DIAGNOSTIC_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.

Also known as: Barany test

Boarding ring glasses; No glasses; Placebo glasses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHU de Brest

Brest, 29200, France

RECRUITING

CH Pays de Morlaix

Morlaix, 29672, France

TERMINATED

MeSH Terms

Conditions

Vestibular Neuronitis

Interventions

Caloric Tests

Condition Hierarchy (Ancestors)

Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vestibular Function Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jean-Christophe LECLERE, Dr

  University Hospital, Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Christophe LECLERE, Dr

CONTACT

02.98.22.33.78; jean-christophe.leclere@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: December 21, 2020
• Study Start: March 10, 2021
• Primary Completion (Estimated): March 17, 2028
• Study Completion (Estimated): May 10, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• 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.

Locations

FR (2)