The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis
1 other identifier
interventional
40
1 country
1
Brief Summary
Aim of present study is to determine whether corticosteroids and vestibular exercises are equal effective in the recovery of balance in patients with acute vestibular neuritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jan 2010
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 29, 2010
CompletedFirst Posted
Study publicly available on registry
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedNovember 1, 2010
January 1, 2010
2 years
October 29, 2010
October 29, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
clinical recovery of vestibular function
clinical examination (nystagmus, Romberg test, head-thrust test, head-shaking test) and questionnaires (Greek edition of Dizziness Handicap Inventory and European Evaluation of Vertigo Scale)
1 year
Laboratory recovery of vestibular
caloric test and vestibular evoked myogenic potentials
1 year
Study Arms (2)
Corticosteroids
ACTIVE COMPARATORPatients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os
Vestibular exercises
PLACEBO COMPARATORPatients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist
Interventions
Intravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days
Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist
Eligibility Criteria
You may qualify if:
- Patients with history of acute or sub-acute rotatory vertigo with postural imbalance, nausea and imbalance.
- Horizontal-rotatory spontaneous nystagmus.
You may not qualify if:
- History of vestibular disfunction before the acute onset of symptoms
- Simultaneous Hearing loss
- Neurologic disorder
- Pregnancy or lactation
- History of psychiatric disorders
- History of glaucoma
- Diabetes
- Hypertension
- Contraindication in receiving corticosteroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1st ENT Department, AHEPA University Hospital
Thessaloniki, 54636, Greece
Related Publications (1)
Goudakos JK, Markou KD, Psillas G, Vital V, Tsaligopoulos M. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2014 May;140(5):434-40. doi: 10.1001/jamaoto.2014.48.
PMID: 24604142DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 29, 2010
First Posted
November 1, 2010
Study Start
January 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2013
Last Updated
November 1, 2010
Record last verified: 2010-01