Therapeutic effect of intra tympanic injection of Dexamethasone-Hyaluronic acid combination in comparison with intra tympanic Dexamethasone in sudden sensorineural hearing loss
Sudden hearing loss is fairly a common disorder of unknown etiology which usually is treated by variety of drugs. Corticosteroids are used routinely as a main therapeutic agent via both systemic administration and/or intra tympanic injection. Since Hyaluronic acid is a safe and biocompatible substance that remains longer than Dexamethasone within middle ear cavity, this study was conducted and aimed to compare the effectiveness of intra tympanic injection of dexamethasone as a single drug with its combination with hyaluronic acid in patients with sudden sensorineural hearing loss.
In this clinical trial that is being performed in Ayatollah Kashani Medical Center, Isfahan, Iran, 40 patients with diagnostic criteria of sudden hearing loss, were randomly assigned to two groups; 20 patients (one group) received 2.4 mg of intra tympanic dexamethasone while, in the other group the injection content were 2.4 mg of dexamethasone plus 2 mg of hyaluronic acid in combination. The volume of the syringes were equally adjusted by distilled water so that the surgeon is unaware about the kind of drug to be injected. Patients of both groups were injected every other day to the sum of three injections. Hearing status of patients have been evaluated by pure tone audiometry and defining the hearing theresholds of different frequencies, before and two weeks after the intervention.
For enrolling the study, patients must be compatible to the medical definition of "sudden hearing loss" (at least 30 db loss in three successive frequencies in less than three days) and also the duration of hearing loss must not be more than one week, and also, their past medical history must be free of any otologic disorder in association with hearing loss or ear surgery.
All patients have been undergone otoscopic examination the day after the last injection and one week later for detecting possible complications such as infection or tympanic membrane perforation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611306699N3
Registration date:2017-01-05, 1395/10/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-05, 1395/10/16
Registrant information
Name
Mehrdad Rogha
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3664 0352
Email address
rogha@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of intra tympanic injection of Dexamethasone-Hyaluronic acid combination in comparison with intra tympanic Dexamethasone in sudden sensorineural hearing loss
Public title
Effectiveness of intra tympanic injection of the mixture of Dexamethason+hyaluronic acid in the treatment of sudden hearing loss.
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria consisted of unilateral hearing loss (occurring within 72 hours), the hearing threshold average greater than 50 dB, symptoms appearance within 7 days from our intervention, patient's pure tone audiogram at frequencies 250 500, 1000, 2000, 4000 and 8000 Hz, age range 18-80 years, lack of acoustic tumor, middle ear diseases, autoimmune diseases, vestibular problem (Menier disease&..), cardiovascular disorders and diabetes, no history of ear surgery and the patient’s consent to participate in the study.
Meanwhile patient’s refusal to attend on time for follow up visits, any limitation to inject intra tympanum via external auditory canal such as stenosis, anatomical deformities and external and middle ear infections were considered as exclusion criteria.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib st,
City
Isfahan,
Postal code
Approval date
2015-12-29, 1394/10/08
Ethics committee reference number
Ir.mui.rec.1394.3.756
Health conditions studied
1
Description of health condition studied
Hearing loss
ICD-10 code
H91.2
ICD-10 code description
Sudden idiopathic hearing loss
2
Description of health condition studied
Sudden hearing loss
ICD-10 code
H91.2
ICD-10 code description
Sudden idiopathic hearing loss
Primary outcomes
1
Description
Hearing threshold in different frequencies
Timepoint
Before & two weeks after intervention
Method of measurement
Pure tone audiometry
Secondary outcomes
1
Description
Infection
Timepoint
One week after intervention
Method of measurement
Ear examination
Intervention groups
1
Description
In intervention group, patients receive three intratympanic injections of 2 mg hyaluronic acid +2.4 mg Dexamethasone in combination.
Category
Treatment - Drugs
2
Description
The control group, receive three injections of 2.4 mg Dexamethasone intratympanically.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Medical Center
Full name of responsible person
Dr.Amin Kalcoo
Street address
Kashani st,
City
Isfahan,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Nematbakhsh
Street address
Hezar Jerib st.
City
Isfahan
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, Isfahan 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
Faculty of Medicin
Full name of responsible person
Dr. Amin Kalcoo
Position
Resident of Otolaryngology
Other areas of specialty/work
Street address
Kashani Medical Center,
City
Isfahan,
Postal code
Phone
+98 31 3233 0098
Fax
Email
Amin_dr_60@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mehrdad Rogha
Position
Otolaryngologist
Other areas of specialty/work
Street address
Kashani Medical Center,
City
Isfahan,
Postal code
Phone
+98 31 3233 0098
Fax
Email
rogha@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mehrdad Rogha
Position
Otolaryngolosist
Other areas of specialty/work
Street address
Kashani Medical Center,
City
Isfahan,
Postal code
Phone
+98 31 3233 0098
Fax
Email
rogha@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)