Acute Unilateral Vestibulopathy and Corticosteroid Treatment

Phase 4TerminatedNCT02912182

Lund University78 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Vestibular Diseases Vestibular Neuronitis

Interventions

BetamethasoneDRUG

Betamethasone intravenous

PlaceboDRUG

Placebo intravenous NaCl intravenous administration Placebo tablets

PrednisoloneDRUG

Oral tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Dept OtoRhinoLaryngology

Helsingborg, Sweden

Dept. Otorhinolaryngology

Kristianstad, Sweden

Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital

Lund, Sweden

Outcomes

Primary Outcomes

Caloric function

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

Time frame: after 3 months

Caloric function

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

Time frame: 1 year

Secondary Outcomes

vHIT

measurement of vestibulo-ocular reflex in all semicircular canals. Gain \<0.7 (ratio between head and eye movement) is regarded as pathological

Time frame: 2-5 days after debut

Subjective visual vertical/horizontal

Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation

Time frame: 2-5 days after debut,

Covert saccades

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

Time frame: 2-5 days after debut,

Vertigo Diary

Self-assessment of vertigo according to a Liknert scale daily (1= no vertigo and 10= worst possible vertigo

Time frame: Daily from debut and until no subjective vertigo is experienced, longest 4 weeks

Sleep Diary

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)

Data from ClinicalTrials.gov

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