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The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis

NCT ID: NCT01231009

Last Updated: 2010-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vestibular Neuritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Corticosteroids

Patients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os

Group Type ACTIVE_COMPARATOR

Corticosteroids

Intervention Type DRUG

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

Intervention Type OTHER

Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist

Vestibular exercises

Patients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist

Group Type PLACEBO_COMPARATOR

Corticosteroids

Intervention Type DRUG

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

Intervention Type OTHER

Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist

Interventions

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Corticosteroids

Intravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days

Intervention Type DRUG

Vestibular exercises

Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with history of acute or sub-acute rotatory vertigo with postural imbalance, nausea and imbalance.
* Horizontal-rotatory spontaneous nystagmus.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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John Goudakos, Research fellow

Locations

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1st ENT Department, AHEPA University Hospital

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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John Goudakos, MD, MSc

Role: CONTACT

Phone: 00306944183682

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 24604142 (View on PubMed)

Other Identifiers

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VN-01-JG

Identifier Type: -

Identifier Source: org_study_id