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NCT Number: NCT04678167

Boarding Ring Glasses Versus Placebo Glasses or Not 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.

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Key information

Conditions

Vestibular Neuritis Cranial Nerve Diseases Ear Diseases Nervous System Diseases Otorhinolaryngologic Diseases Retrocochlear Diseases Vestibular Neuronitis Vestibulocochlear Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Barany test

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.

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.

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

EHTEV questionnaire

Other

Handicap Scale for Balance Disorders and Vertigo

EEV questionnaire

Other

European Vertigo Assessment Questionnaire

anxiety VAS

Other

visual analog scale of anxiety

Primary outcomes

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

    Time frame: 7 day

Secondary outcomes

  1. Speed of nystagmus

    Time frame: 1 year

  2. Alexander's degree of nystagmus

    Time frame: 1 year

    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.

  3. Duration of hospitalization (for hospitalized patients)

    Time frame: 1 year

  4. Anxiety visual analog scale

    Time frame: 1 year

    0 = no anxiety, 10 = maximum anxiety imaginable

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

    Time frame: 1 year

    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).

  6. European Vertigo Evaluation Scale (EEV questionnaire)

    Time frame: 1 year

    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)

  7. Vestibular deficit at caloric tests

    Time frame: 1 year

    measures 7of nystagmus (= fluttering of the eye) which reflects vestibular activity

  8. Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Christophe LECLERE, Dr

CONTACT

[email protected]

02.98.22.33.78

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: NEVRING

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Dec 21, 2020
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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