Clinical trial NCT04678167: Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis
Official title: Evaluation of the Efficacy of BOARDING RING Glasses in the Treatment of Vestibular Neuritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Neuritis
Keywords: vestibular hyporeflexia
rotational vertigo
horizontal-rotational nystagmus
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7).
timeFrame: 7 day
Secondary outcomes:
measure: Speed of nystagmus
timeFrame: 1 year
measure: Alexander's degree of nystagmus
timeFrame: 1 year
measure: Duration of hospitalization (for hospitalized patients)
timeFrame: 1 year
measure: Anxiety visual analog scale
timeFrame: 1 year
measure: Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire)
timeFrame: 1 year
measure: European Vertigo Evaluation Scale (EEV questionnaire)
timeFrame: 1 year
measure: Vestibular deficit at caloric tests
timeFrame: 1 year
measure: Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12
timeFrame: 1 year
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
city: Morlaix
country: France
facility: CH Pays de Morlaix
city: Quimper
country: France
facility: CH de Cornouaille Quimper
Study officials:
affiliation: University Hospital, Brest
name: Jean-Christophe LECLERE, Dr
role: PRINCIPAL_INVESTIGATOR
References: