Evaluation of dexamethasone injection in the middle ear cavity for the treatment of sudden sensorineural hearing loss and comparison with standard methods
Evaluation of dexamethasone injection in the middle ear cavity for the treatment of sudden sensorineural hearing loss and comparison with standard methods
Design
Randomized clinical trial using closed-door envelope with control group, and parallel groups, double-blind, phase 3 on 120 patients
Settings and conduct
This double-blind clinical trial (participants in the study and analyzers have been blinded) is performed on 120 patients with sudden sensorineural deafness referred to Imam Reza Hospitals in Mashhad. Eligible patients are divided into control group and two intervention groups after obtaining consent. Injection of dexamethasone in the middle ear cavity in control group is performed according to the standard guideline three times every 4 days in a 12-day period and other two interventions groups give the same amount of injection but over a 10-day period, twice a day in the first intervention group and once a day in the second intervention group.
Participants/Inclusion and exclusion criteria
Patients with sudden sensorineural hearing loss that is 72 hours to less than 30 days after the onset of symptoms and who do not have a known genetic sensorineural hearing loss or anomaly of the inner ear and lack sensitivity to prescription drugs and evidence of acute or chronic otitis media
Intervention groups
In the control group, 40 patients with sudden sensorineural hearing loss, in addition to routine treatment, injected dexamethasone into the middle ear cavity three times every 4 days for a period of 12 days. In the other two intervention groups, the same amount was injected. But in a 10-day period that is done twice a day in the first intervention group and once a day in the second intervention group.
Main outcome variables
Average hearing threshold
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211010052721N1
Registration date:2021-10-25, 1400/08/03
Registration timing:registered_while_recruiting
Last update:2021-10-25, 1400/08/03
Update count:0
Registration date
2021-10-25, 1400/08/03
Registrant information
Name
Navid nourizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
nourizadehn@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of dexamethasone injection in the middle ear cavity for the treatment of sudden sensorineural hearing loss and comparison with standard methods
Public title
The effect of dexamethasone on sudden sensorineural hearing loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with sudden sensorineural hearing loss lasting from 72 hours to less than 30 days after the onset of symptoms
Conscious consent to participate in the study
Exclusion criteria:
Consumption other medications in addition to prescribed medicationsPregnancy
Allergy to prescription drugs
Known genetic neurosensory deafness or known anomaly of the inner ear
Pregnancy
Breastfeeding
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects and those evaluating the outcome will be unaware of the intervention and control groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9117699199
Approval date
2020-02-18, 1398/11/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.232
Health conditions studied
1
Description of health condition studied
Sudden sensorineural hearing loss
ICD-10 code
H90.4
ICD-10 code description
Sensorineural hearing loss, unilateral with unrestricted hearing on the contralateral side
Primary outcomes
1
Description
Average hearing threshold
Timepoint
Mean hearing threshold before study and 10 and 12 days after using dexamethasone
Method of measurement
Audiometry
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: In this group, 40 patients with sudden sensorineural hearing loss (SSNHL) in addition to routine treatment, would take middle ear cavity injection of dexamethasone in the amount of 0.5 cc twice a day for 10 days
Category
Treatment - Drugs
2
Description
Second Intervention group: In this group, 40 patients with sudden sensorineural hearing loss (SSNHL) in addition to routine treatment, injection of dexamethasone in the middle ear cavity amount of 0.5 cc once a day for 10 days
Category
Treatment - Drugs
3
Description
Control group: In this group, 40 patients with sudden sensorineural hearing loss (SSNHL) in addition to routine treatment, injection of dexamethasone in the middle ear cavity amount of 0.5 cc and three times every 4 days in a 12-day period is performed, which is the guideline standard method of the American Society of Otolaryngology
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Navid Nourizadeh
Street address
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91379 13316
Phone
+98 51 3854 3031
Email
nourizadehn@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Navid Nourizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91379 13316
Phone
+98 51 3854 3031
Email
nourizadehn@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Navid Nourizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91379 13316
Phone
+98 51 3854 3031
Email
nourizadehn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Navid Nourizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91379 13316
Phone
+98 51 3854 3031
Email
nourizadehn@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available