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

Not Applicable

Recruiting

• Conditions: Vestibular Neuritis

• Registration Number: NCT04678167
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Study Start: 2021-03-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21
• Primary Completion: 2027-03-10
• Study Completion: 2027-03-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7).	7 day

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization (for hospitalized patients)	1 year
Speed of nystagmus	1 year
Alexander's degree of nystagmus	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.
Anxiety visual analog scale	1 year	0 = no anxiety, 10 = maximum anxiety imaginable
European Vertigo Evaluation Scale (EEV questionnaire)	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)
Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire)	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).
Vestibular deficit at caloric tests	1 year	measures 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, M12	1 year

Trial Locations

Locations (3)

CHU de Brest; 🇫🇷 Brest, France

CH Pays de Morlaix; 🇫🇷 Morlaix, France

CH de Cornouaille Quimper; 🇫🇷 Quimper, France