Vestibular Diseases, Vestibular Neuronitis
Conditions
Brief summary
Randomized placebo controlled trial on patients suffering from acute unilateral vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days). Vestibular function as well as subjective symptoms will be estimated in the acute stage and regularly up to one year after the debut.
Detailed description
Randomized controlled trial in 3 arms to see if a short or a even shorter period of steroid treatment on patients diagnosed with vestibular neuritis can be as effective as the only comparable study thus far (Strupp et al, NEJM 22, 351(4) 354-61). If a shorter treatment with a lower dose has the same outcome, then more patients might be eligible for the treatment as many are excluded due to risk for adverse effects. Corticosteroid treatment in acute unilateral vestibulopathy has recently been the subject for a Cochrane review with the conclusion of insufficient evidence for treatment effect and recommend studies with subjective symptom based evaluation together with functional testing. Patients with acute unilateral vestibulopathy diagnosed within 48hrs after debut. The patients (after acceptance) will be randomized into either of 3 arms and will receive placebo/short treatment (3days)/standard treatment (in Sweden 11 days). Patients will record subjective symptoms according to Liknert scale during the acute stage and fill out enquiries after 3 and 12 months. Vestibular function will be assessed with caloric irrigation and video-Head-Impulse-Test (vHIT) as soon as possible after the debut and again after 1, 3 and 12 months.
Interventions
DRUGBetamethasone
Betamethasone intravenous
DRUGPlacebo
Placebo intravenous NaCl intravenous administration Placebo tablets
DRUGPrednisolone
Oral tablets
Sponsors
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* definite unilateral vestibulopathy * no pathological HINTS (examination criteria in acute vestibular syndrome) * capable of making their own decisions
Exclusion criteria
* tinnitus or hearing loss with same debut as vertigo * history of bleeding peptic ulcer * glaucoma * pregnancy or non-acceptance to use anticonception measures during 13 days after debut * high blood pressure \>180 systolic, 105, diastolic * ketoacidosis with a Base Excess \>=2 * psychic disorder (not including mild depression) * serious infection (neutropenia, tuberculosis) * chronic otitis * history of vertiginous disease; Ménière, Vertiginous migraine, atypical BPPV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caloric function | after 3 months | Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective visual vertical/horizontal | 2-5 days after debut, | Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation |
| Covert saccades | 2-5 days after debut, | Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures |
| Vertigo Diary | Daily from debut and until no subjective vertigo is experienced, longest 4 weeks | Self-assessment of vertigo according to a Liknert scale daily (1= no vertigo and 10= worst possible vertigo |
| Sleep Diary | Daily from debut and 14 days onwards (2 days after last treatment) | Patients often experience troubled sleep when treated with corticosteroids. How much has not been assessed. The patients will assess their sleep the previous night according to a Liknert scale (1=good nights sleep, 10=hardly slept at all) |
| HADS-enquiry | 3 and 12 months after debut | Hospital Anxiety and Depression Scale. To asses the degree of anxiety and depression among the patients, often associated with chronic dizziness |
| VSS-enquiry | 3 and 12 months after debut | Vertigo sympton score, To assess vertigo symptoms |
| DHI-enquiry | 3 and 12 months after debut | Dizziness Handicap Inventory, to assess the degree of how dizziness affect daily life |
| vHIT | 2-5 days after debut | measurement of vestibulo-ocular reflex in all semicircular canals. Gain \<0.7 (ratio between head and eye movement) is regarded as pathological |
| Stress hormones | At debut and 1 year | Measurement of Plasma thyroid hormones, adrenocorticoid hormones (ACTH, Cortisone) as stress indicators in acute vertigo. Baseline will be taken 1 year after debut |
| Saliva-Cortisol | At debut and up to 1 week | Daily measurement of saliva cortisol as measurement of stress |
| Adverse Events | From debut to 1 year after | Analysis of adverse events to treatment as well as functional outcome |
| Hospital stay | From debut up to 10 days | Duration of hospital stay |
| Sick-leave | debut up to 1 year | Time needed for sick-leave |
| Daily living | debut up to 1 year | Time until daily activities are as prior to th disease |
| VHQ-enquiry | 3 and 12 months after debut | Vertigo Handicap Questionnaire. To assess the degree of how vertigo affect daily life |
Countries
Sweden
Outcome results
None listed