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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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 intervention

    Handicap Scale for Balance Disorders and Vertigo

  • EEV questionnaire

    Other intervention

    European Vertigo Assessment Questionnaire

  • anxiety VAS

    Other intervention

    visual analog scale of anxiety

Treatment groups

51 Participants
are divided into 3 treatment groups
Group A: Boarding ring glassesExperimental treatment 7 interventions
Group B: Placebo glassesPlacebo comparator 7 interventions
Group C: No glassesOther 7 interventions

Trial outcomes

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

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.

Time frame
1 year
3

Duration of hospitalization (for hospitalized patients)

Time frame
1 year
4

Anxiety visual analog scale

0 = no anxiety, 10 = maximum anxiety imaginable

Time frame
1 year

Other outcomes

Sponsors and contacts

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