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

Primary Purpose

Vestibular Neuritis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Caloric test
Measurement of the speed of Nystagmus
Angle of deviation at Fukuda
Alexander's degree of nystagmus
EHTEV questionnaire
EEV questionnaire
anxiety VAS
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vestibular Neuritis focused on measuring vestibular hyporeflexia, rotational vertigo, horizontal-rotational nystagmus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de BrestRecruiting
  • CH Pays de Morlaix
  • CH de Cornouaille Quimper

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Boarding ring glasses

Placebo glasses

No glasses

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Speed of nystagmus
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.
Duration of hospitalization (for hospitalized patients)
Anxiety visual analog scale
0 = no anxiety, 10 = maximum anxiety imaginable
Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire)
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).
European Vertigo Evaluation Scale (EEV questionnaire)
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)
Vestibular deficit at caloric tests
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

Full Information

First Posted
October 2, 2020
Last Updated
July 20, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04678167
Brief Title
Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis
Acronym
NEVRING
Official Title
Evaluation of the Efficacy of BOARDING RING Glasses in the Treatment of Vestibular Neuritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
March 10, 2027 (Anticipated)
Study Completion Date
March 10, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Neuritis
Keywords
vestibular hyporeflexia, rotational vertigo, horizontal-rotational nystagmus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Boarding ring glasses
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo glasses
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
No glasses
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Caloric test
Other Intervention Name(s)
Barany test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Measurement of the speed of Nystagmus
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Angle of deviation at Fukuda
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Alexander's degree of nystagmus
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
EHTEV questionnaire
Intervention Description
Handicap Scale for Balance Disorders and Vertigo
Intervention Type
Other
Intervention Name(s)
EEV questionnaire
Intervention Description
European Vertigo Assessment Questionnaire
Intervention Type
Other
Intervention Name(s)
anxiety VAS
Intervention Description
visual analog scale of anxiety
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Speed of nystagmus
Time Frame
1 year
Title
Alexander's degree of nystagmus
Description
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
Title
Duration of hospitalization (for hospitalized patients)
Time Frame
1 year
Title
Anxiety visual analog scale
Description
0 = no anxiety, 10 = maximum anxiety imaginable
Time Frame
1 year
Title
Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire)
Description
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).
Time Frame
1 year
Title
European Vertigo Evaluation Scale (EEV questionnaire)
Description
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)
Time Frame
1 year
Title
Vestibular deficit at caloric tests
Description
measures 7of nystagmus (= fluttering of the eye) which reflects vestibular activity
Time Frame
1 year
Title
Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christophe LECLERE, Dr
Phone
02.98.22.33.78
Email
jean-christophe.leclere@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe LECLERE, Dr
Organizational Affiliation
University Hospital, Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe LECLERE, Dr
Phone
02.98.22.33.78
Email
jean-christophe.leclere@chu-brest.fr
Facility Name
CH Pays de Morlaix
City
Morlaix
ZIP/Postal Code
29672
Country
France
Individual Site Status
Terminated
Facility Name
CH de Cornouaille Quimper
City
Quimper
ZIP/Postal Code
29107
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte MISTRETTA
Email
charlotte.mistretta@gmail.com
First Name & Middle Initial & Last Name & Degree
Charlotte MISTRETTA

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing 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.

Learn more about this trial

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

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