Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boarding ring glasses | Experimental | Realization of the following examinations WITH Boarding ring glasses :
|
|
| Placebo glasses | Placebo Comparator | Realization of the following examinations WITH Placebo glasses :
|
|
| No glasses | Other | Realization of the following examinations WITHOUT glasses :
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7). | 7 day |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of nystagmus | 1 year | |
| Alexander's degree of nystagmus | Measure of the degree of intensity of nystagmus. There are 3 degrees :
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Christophe LECLERE, Dr | Contact | 02.98.22.33.78 | jean-christophe.leclere@chu-brest.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Christophe LECLERE, Dr | University Hospital, Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Brest | Recruiting | Brest | 29200 | France |
All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
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.
Not provided
Not provided
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.
Not provided
Not provided
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.
|
|
| 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:
|
|
| 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 |
|
| 1 year |
| Duration of hospitalization (for hospitalized patients) | 1 year |
| Anxiety visual analog scale | 0 = no anxiety, 10 = maximum anxiety imaginable | 1 year |
| 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). | 1 year |
| 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) | 1 year |
| Vestibular deficit at caloric tests | measures 7of nystagmus (= fluttering of the eye) which reflects vestibular activity | 1 year |
| Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12 | 1 year |
| CH Pays de Morlaix | Terminated | Morlaix | 29672 | France |
| ID | Term |
|---|---|
| D020338 | Vestibular Neuronitis |
| ID | Term |
|---|---|
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002150 | Caloric Tests |
| ID | Term |
|---|---|
| D014724 | Vestibular Function Tests |
| D003939 | Diagnostic Techniques, Otological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided