Acute vestibular syndrome better known as Vestibular neuritis MedDRA version: 17.1 Level: LLT Classification code 10047392 Term: Vestibular nerve damage System Organ Class: 100000004863 MedDRA version: 17.1 Level: LLT Classification code 10047388 Term: Vestibular function disorder System Organ Class: 100000004854 MedDRA version: 17.1 Level: LLT Classification code 10051781 Term: Vestibular paralysis System Organ Class: 100000004862 MedDRA version: 17.1 Level: LLT Classification code 10013285
Conditions
Interventions
Trade Name: Betapred
Product Name: Betapred
Pharmaceutical Form: Solution for injection/infusion
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intravenous use
Sponsors
Lund University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -between 18 and 80 years of age -disease duration =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: -history of perforated ulcus -tinnitus and hearing loss that started at the same time as vertigo -psychiatric disease requiring treatment (other than mild depression treated with SSRIs) -chronic otitis media -serious infection, neutropenia or tuberculosis -pregnancy or not wanting to prevent pregnancy during the time of medication (11 days) -blood pressure; systolic >180 and/or diastolic >110 -impaired ability to make decision (dementia or up to treating physician) -diabetes with ketoacidosis (Base excess >=2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether cortisone treatment enhances return of vestibular function ;Secondary Objective: 1) to examine whether short treatment is as efficient as standard treatment in Skåne 2) to examine subjective disability both in acute and chronic stages of the disease, and to see if short and standard treatment is as efficient 3) to examine level of induced stress at the acute stage 4) to determine the correlation of vestibular function and subjective discomfort both in acute and chronic stages 5) to determine level of minor discomfort caused by cortisone treatment (sleep) 6) to examine wether length of hospital stay, return to work and leisure activities are affected by cortisone treatment;Primary end point(s): Caloric response. Both ears are irrigated with cold (30 degrees) and warm water (44 degrees) in a fixed order. The extent of vestibular paralysis is calculated with Jongkees formula (((Right44 + Right30) -(Left44+Left30))/(Right44+Right30+Left44+Left30)) A value less than 25% indicates that there is no difference of right and left horizontal semicircular canal;Timepoint(s) of evaluation of this end point: Baseline at inclusion and reevaluated after 3months + 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -vHIT (head impulse test), tests the function of all 6 semicircular canals -Subjective visual horizon/vertical, a measure of utricular function -Diary to assess dizziness -Diary to assess quality of sleep -Questionnaires DHI (Dizziness Handicap Inventory), HADS (Hospital Anxiety and Depression Scale), VSS (Vertigo Symptom Scale), VHQ (Vertigo Handicap Questionnaire) -Saliva cortisol -Positional testing for BPPV (benign positional paroxysmal vertigo);Timepoint(s) of evaluation of this end point: -Vestibular tests at inclusion, + 1 and 3 months and after 1 year -Diaries during the acute stage (up to 4 weeks) -Questionnaires 3 months and 1 year after inclusion -Saliva cortisol during the hospital stay (up to 1 week) | — |
Countries
Sweden
Contacts
Public ContactFredrik Tjernström
Lund University
Outcome results
None listed