Comparing the results of hearing improvement with two methods of routine injection and injection with catheter in the middle ear in patients with severe sudden sensorineural hearing loss.
Design
The research is a prospective clinical trial. Two treatment groups with random selection of patients in each group, A double-blind study, each group 30 patients, a total of 60 patients, randomization with Random Allocation software.
Settings and conduct
All patients of severe SSNH will Including in the study at Kashani and Al-Zahra Hospital in Isfahan. Blinding will be done at the level of data collection and statistical analysis. Classic Intratympanic injection for one group and injection via gray catheter for another group will done
Participants/Inclusion and exclusion criteria
Including criteria:
Adults (18 to 75 years old)
Severe sensorineural hearing loss (SRT equal to or higher than 60 dB)
Less than two weeks from the onset of the disease
Excluding criteria:
Lack of consent for treatment at any stage
Presence of active Otologic infection
More than a month after the onset of the disease
Presence of other causes of hearing loss (tumor, toxic drugs, Acoustic trauma, ear surgery)
Intervention groups
In the catheter injection treatment group, dexamethasone injection treatment is performed by inserting a catheter in the ear for two weeks.
In the classical intratympanic injection treatment group, six dexamethasone injections are performed every other day
Main outcome variables
Hearing threshold pure tone (PTA), speech reception threshold (SRT)
General information
Reason for update
Acronym
SSNHL
IRCT registration information
IRCT registration number:IRCT20211125053181N2
Registration date:2023-11-11, 1402/08/20
Registration timing:prospective
Last update:2023-11-11, 1402/08/20
Update count:0
Registration date
2023-11-11, 1402/08/20
Registrant information
Name
Sohrab Rabiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 0410
Email address
sohrabrabiei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-05, 1402/09/14
Expected recruitment end date
2024-07-04, 1403/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intratympanic injection of dexamethasone via catheter in Sudden Sensory Neural Hearing Loss (SSNHL)
Public title
Effect of Intratympanic injection of dexamethasone via catheter in Sudden Sensory Neural Hearing Loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult age (18-75 age old)
Hearing loss greater than 60db based on SRT
In the first two weeks of the disease
Exclusion criteria:
Lack of consent for treatment at any stage
Presence of active infectious ear disease
Referral more than a month after the onset of the disease
Presence of other causes of hearing loss (ear tumor, toxic drugs, sound trauma, ear surgery)
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation method is used
In this way, the total size of the sample is determined and the set of group A and group B is randomly defined. Patients are entered randomly in the group by lottery. Random allocation software is used to speed up the work
Blinding (investigator's opinion)
Double blinded
Blinding description
The treatment methods are explained to the patient and the patient is aware of his treatment group, so there is no possibility of blinding the study for the patient. For this reason, blinding is done only for the outcome evaluator and data analyst. The data are in the form of audiometry results, so the outcome evaluator and the analyst are not in contact with the patient and do not know the patient's treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
For treat sudden-onset sensorineural hearing loss by using a catheter, previous researchers had used very invasive methods, which was to create a subcutaneous tunnel in the ear canal and pass the catheter through the Middle ear, which is an invasive method. In our method, as simple as VT surgery, first myringotomy is performed and by measuring the appropriate length of the catheter, the end of the catheter is inserted into the middle ear, and the end of the catheter that exits the ear canal is stitched to the skin at several points, which minimized catheter mobility and therefore this method is less invasive in the ear canal and can be performed technically by any otolaryngologist.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
No. 110, Nik Nafs Alley, Vahid St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8175817393
Approval date
2023-05-24, 1402/03/03
Ethics committee reference number
IR.MUI.MED.REC.1402.223
Health conditions studied
1
Description of health condition studied
Sudden Sensory-Neural Hearing Loss (SSNHL)
ICD-10 code
H91.20
ICD-10 code description
Sudden idiopathic hearing loss, unspecified ear
Primary outcomes
1
Description
Hearing threshold pure tone (PTA) and speech reception threshold (SRT) in the initial audiometry and then their changes in the follow-up period.
Timepoint
At the beginning of the study and 14, 30, 90 days after the start of treatment
Method of measurement
Pure tone audiometry (PTA) and assessment of changes in speech perception threshold (SRT) before and after treatment.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with severe sudden hearing loss in the catheter injection group. In these patients, under local anesthesia of the ear canal, a tympanotomy will perform in the posterior inferior of the tympanic membrane and the catheter will be measure and the end of the catheter will place in the myringotomy site as in the VT operation, and the outer end of the catheter will be sutured to the upper part of the auricle at the level of helix junction and the rest of catheter is fixed behind the patient's ear. A gray feeding tube catheter will be used for patients. During two weeks, the patient will undergo two injection per day, and inject two milligrams of dexamethasone slowly with a needle-free insulin syringe at the catheter, and the infusion will be done by a assistant who collaborates with the study. The patients will followed up for three months and immediately after the completion of the treatment, two weeks later, one month later and three months later, hearing evaluation is done for the patients and the results are recorded.
Category
Treatment - Drugs
2
Description
Control group: For patients with severe Sudden Sensorineural hearing loss who are in the classic ear injection group, dexamethasone injection will be performed every other day using spinal needle number 25. At least four injections are given to the patient during an eight-day period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital, Isfahan
Full name of responsible person
Mohammad Shahab Akhwan
Street address
department of Otolaryngology head and neck surgery, Al-Zahra Hospital, Soffeh st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
dr.m.shahab.akhavan@gmail.com
2
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital Isfahan
Full name of responsible person
Mohammad Shahab Akhwan
Street address
Ayatollah Kashani Street, Department of Otolaryngology head and neck surgey
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3303 3700
Email
dr.m.shahab.akhavan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mojgan Mortazavi
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
esearch@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sohrab Rabiei
Position
Associate Professor of Otology & Neurotology
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ayatollah Kashani Street, Office of Ear Throat Nose and Head and Neck Surgery
City
isfahan
Province
Isfehan
Postal code
8343481839
Phone
+98 31 3629 0410
Email
sohrabrabiei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sohrab Rabiei
Position
Associate Professor of Otology & Neurotology
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ayatollah Kashani Street, Office of Ear Throat Nose and Head and Neck Surgery
City
isfahan
Province
Isfehan
Postal code
8343481839
Phone
0098 32 36290410
Email
sohrabrabiei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sohrab Rabiei
Position
Associate Professor of Otology & Neurotology
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ayatollah Kashani Street, Office of Ear Throat Nose and Head and Neck Surgery
City
Isfahan
Province
Isfehan
Postal code
8343481839
Phone
+98 31 3629 0410
Email
sohrabrabiei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Start the access period immediately after printing the results
To whom data/document is available
For researchers working in academic and scientific institutions and researchers in industrial centers
Under which criteria data/document could be used
Analysis with reference to the data source is allowed
From where data/document is obtainable
Dr. Mohammad Shahab Akhavan
dr.m.shahab.akhavan@gmail.com
09103986427
What processes are involved for a request to access data/document
ontact the researcher and announce the email, receive the documents by email after a maximum of one week