Meniere disease (MD) is a chronic inner disease presenting with intermittent vertigo attacks, sensorineural hearing loss, and tinnitus. Endolymphatic hydropsis is considered as the etiology. Vestibular Evoked Myogenic Potential (VEMP) evaluates SCM relaxation in response to sound stimuli. Intratympanic dexamethasone was showed a 82% success rate over the placebo in controling vertigo. This study was designed to survey VEMP change following the intratympanic injection. Patients complained of unilateral definite Meniere Disease with unresponsive vertigo attacks to medical treatment (at least 3 months), were enrolled. The following exclusion criteria were applied at baseline: CNS disease, Neuromuscular disease, conductive hearing loss, bilateral Meniere Disease, patients with only hearing state. A well-prepared questionnaire was used to gather demographic data and audiometric results. VEMP will be arranged before intratympanic injection, 2-4 weeks following the injection and then every 6 weeks for 6 months to one year. Intratympanic dexamethasone (1cc/4mg) will be injected in anterosuperior of tympanic membrane trice a week for one week. Finally outcome of the injections will be surveyed by VEMP and vertigo scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013030412691N1
Registration date:2013-03-17, 1391/12/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-17, 1391/12/27
Registrant information
Name
Nasrin Yazdani
Name of organization / entity
Tehran univesity of Medical Sciences, Amir Alam Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6676 0269
Email address
n_yazdani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
ENT Researc h Center, Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surveying saccular system with VEMP before and after intratympanic dexamethasone in patients with unilateral definite Meniere disease
Public title
Surveying saccular system with VEMP before and after intratympanic dexamethasone in patients with unilateral definite Meniere disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Unilateral definite Meniere Disease presenting with unresponsive vertigo attacks to medical treatment.
Exclusion criteria: CNS disease, Neuromuscular disease, conductive hearing loss, bilateral Meniere Disease, patients with only hearing state
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ENT Research Center, Tehran University of Medical Sciences
Street address
Amir-AAlam Hospital
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
In Process
Health conditions studied
1
Description of health condition studied
Meniere Disease
ICD-10 code
H81.0
ICD-10 code description
Ménière disease
Primary outcomes
1
Description
Vertigo
Timepoint
Every 6 weeks for 6 months to one year
Method of measurement
VEMP, Vertigo scale
Secondary outcomes
1
Description
side effects
Timepoint
during each visit
Method of measurement
ear eamination
Intervention groups
1
Description
Following local anesthesia with Lidocaine, intratympanic dexamethasone will be injected in antrosuperior of tympanic membrane, trice during one week period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Aalam Hospital
Full name of responsible person
Farzaneh Nezhadian, MD
Street address
Ear Clinic
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ENT Research Center
Full name of responsible person
Ms. Mokhtari
Street address
Amir Aalam Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ENT Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
ENT Research Center
Full name of responsible person
Farzaneh Nezhadian, MD
Position
Resident
Other areas of specialty/work
Street address
Amir Aalam Hospital
City
Tehran
Postal code
Phone
+98 21 6670 1768
Fax
Email
dr.fnezhadian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ENT research Center, TUMS
Full name of responsible person
Farzaneh Nezhadian
Position
Resident
Other areas of specialty/work
Street address
Amir Aalam HSopital
City
Tehran
Postal code
Phone
+98 21 6670 1768
Fax
Email
dr.fnezhadian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Farzaneh Nezhadian, MD
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)