Protocol summary

Summary
The purpose of this study is to compare of the effectiveness of Dexamethasone and long-acting Betamethasone intratympanic injection of intratympanic in treatment of Sudden Sensorineural Hearing Loss (SSNHL). This study is in the form of a randomized clinical, that the patients are divided into two groups of 47 people through the random blocking method. The patients of 18-70 years old who suffered from SSNHL and did not respond to the systemic treatment by oral prednisolone foe 10 days, are randomly and single-blindly included in an intratympanic treatment groups based on certain criteria (a reduction of at least 30 dB in the hearing frequency in relation to 3 consecutive frequencies in a period of 3 days). It should be highlighted that the included patients must not state any history of ear disease. The following patients are excluded from this study: those with some pathological problems in the middle ear, those with experience of the intratympanic injection for similar disease, those with bilaretal SSNHL. The selective patients in their respective groups are given 2 intratympanic injections a week (twice a week); totally, 6 injections are given within 3 weeks. At the end of the 6th injection, the patients will undergo audiometry again, and the results will be compared with those of the first audiometry (before the intratympanic treatment starts); afterwards, the results are analyzed and recorded. After receiving treatment, the patients will be followed up by audiometry and evaluated in the intervals of 1 month, 2 month, and 6 months.At the end of the first month, and upon the termination of the treatment, the patient will undergo MRI and other required tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012832069N2
Registration date: 2017-08-17, 1396/05/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-17, 1396/05/26
Registrant information
Name
Ardavan Tajdini
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 3037
Email address
a-tajdini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-05-04, 1396/02/14
Expected recruitment end date
2018-05-03, 1397/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of effects of intratympanic Dexamethasone and intratympanic Betamethasone LA therapy for patients with Idiopathic Sudden Sensorineural Hearing Loss: A randomized clinical trial study
Public title
Betamethasone LA effects versus Dexamethasone in treatment of Sudden Sensory Hearing Loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-70 years old; patient with SSHL and history of systemic corticosteroids treatment without response to it; whitout history of ear disease; SSHL without certain causes. Exclusion criteria: pathology in the middle ear (tympanic membrane perforation, surgery on the ear) bilateral SSHL; previous intratympanic injection for the same disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Tehran University of Medical Sciences
Street address
Central Department Of University, 6th floor, Keshavarz blv, Qods st-
City
Tehran
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2201

Health conditions studied

1

Description of health condition studied
sudden sensorineural hearing loss
ICD-10 code
H91.2
ICD-10 code description
Sudden idiopathic hearing loss

Primary outcomes

1

Description
Hearing cutoff
Timepoint
Before intervation, after intervation at force,1month after intervation,2months after the end of the intervation,6months after the end of the intervation
Method of measurement
PTA

Secondary outcomes

1

Description
Vertigo
Timepoint
After the end of the intervation at force,1month and 2months and 6months after the end of the intervation
Method of measurement
Questionary

Intervention groups

1

Description
Intervation group: Using LA Betamethasone 0.4-0.6 cc for Intratympanic injection that performed 6 injections twice aweek.
Category
Treatment - Drugs

2

Description
Control group : Using Dexamethasone 0.4-0.6 cc for Intratympanic injection that performed 6 injections twice aweek.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Alam hospital
Full name of responsible person
Doctor Ardavan Tajdini
Street address
Amir Alam hospital, The North of Saadi street, Darvaze Dolat, Enqelab blv, Tehran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Doctor Masoud Yousefian
Street address
Central Department of University, 6th floor, Qods st, Keshavarz blv
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
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
Tehran University Of Medical Sciences
Full name of responsible person
Doctor Shima Hajibegloo
Position
ENT Resident
Other areas of specialty/work
Street address
Amir Alam Hospital, Darvaze Dolat, Saadi st, Enqelab blv
City
Tehran
Postal code
Phone
+98 21 6670 6106
Fax
Email
dr.hbegloo@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Dr Ardavan Tajdini
Position
ENT professor
Other areas of specialty/work
Street address
Darvaze Dolat, Saadi st, Engelab blv
City
Tehran
Postal code
Phone
+98 21 6670 6106
Fax
Email
ardavan-taj@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University Of Medical Science
Full name of responsible person
Dr Shima Hajibegloo
Position
ENT Resident
Other areas of specialty/work
Street address
Amir Alam hospital, Darvaze Dolat, Saadi st, enqelab blv
City
Tehran
Postal code
Phone
+98 21 6670 6106
Fax
Email
dr.hbegloo@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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