Clinical trial NCT02912182: Acute Unilateral Vestibulopathy and Corticosteroid Treatment
Official title: Acute Unilateral Vestibulopathy and Corticosteroid Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Vestibular Diseases
Vestibular Neuronitis
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caloric function
timeFrame: after 3 months
measure: Caloric function
timeFrame: 1 year
Secondary outcomes:
measure: vHIT
timeFrame: 2-5 days after debut
measure: Subjective visual vertical/horizontal
timeFrame: 2-5 days after debut,
measure: Covert saccades
timeFrame: 2-5 days after debut,
measure: Vertigo Diary
timeFrame: Daily from debut and until no subjective vertigo is experienced, longest 4 weeks
measure: Sleep Diary
timeFrame: Daily from debut and 14 days onwards (2 days after last treatment)
measure: HADS-enquiry
timeFrame: 3 and 12 months after debut
measure: VSS-enquiry
timeFrame: 3 and 12 months after debut
measure: DHI-enquiry
timeFrame: 3 and 12 months after debut
measure: VHQ-enquiry
timeFrame: 3 and 12 months after debut
measure: Stress hormones
timeFrame: At debut and 1 year
measure: Saliva-Cortisol
timeFrame: At debut and up to 1 week
measure: Adverse Events
timeFrame: From debut to 1 year after
measure: Hospital stay
timeFrame: From debut up to 10 days
measure: vHIT
timeFrame: 1 year
measure: Subjective visual vertical/horizontal
timeFrame: 1 month
measure: Subjective visual vertical/horizontal
timeFrame: 3 months
measure: Subjective visual vertical/horizontal
timeFrame: 1 year
measure: Covert saccades
timeFrame: 3 months
measure: Covert saccades
timeFrame: 1 year
measure: Sick-leave
timeFrame: debut up to 1 year
measure: Daily living
timeFrame: debut up to 1 year
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Dept OtoRhinoLaryngology
city: Kristianstad
country: Sweden
facility: Dept. Otorhinolaryngology
city: Lund
country: Sweden
facility: Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital
Study officials:
affiliation: Lund University
name: Fredrik Tjernström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fishman JM, Burgess C, Waddell A. Corticosteroids for the treatment of idiopathic acute vestibular dysfunction (vestibular neuritis). Cochrane Database Syst Rev. 2011 May 11;(5):CD008607. doi: 10.1002/14651858.CD008607.pub2.
citation: Strupp M, Zingler VC, Arbusow V, Niklas D, Maag KP, Dieterich M, Bense S, Theil D, Jahn K, Brandt T. Methylprednisolone, valacyclovir, or the combination for vestibular neuritis. N Engl J Med. 2004 Jul 22;351(4):354-61. doi: 10.1056/NEJMoa033280.