1. Home
  2. Approved trials
  3. » فارسی

The effectiveness of intratympanic injection of nanogel dexamethasone versus non-nanogel dexamethasone in treatment of patients with Sudden Sensorineural Hearing Loss (SSNHL), a double blind clinical trial

Protocol summary

Study aim
The aim is to evaluate the effect of intratympanic injection of dexamethasone in the form of nanogel in the treatment of patients with Sudden Sensorineural Hearing Loss.
Design
The clinical trial has a control group, with parallel, non-randomized, phase 3 groups on 90 patients, each group consisting of 45 patients.
Settings and conduct
Research location is Shafa clinical research base in Kerman. Study population: All patients who come to the ENT clinic of Shafa Hospital with the complaint of sudden sensorineural hearing loss. The study is double-blinded, both the researcher and the patient are blind. for double blinding, the nanogel form and the usual form of dexamethasone were prepared by a nanopharmacologist and presented to the researcher in containers of the same shape with a specific number that only the manufacturer had the information about it.And the patients in both groups received drugs with similar shape.
Participants/Inclusion and exclusion criteria
Inclusion condition: Sudden unilateral sensorineural hearing loss. Exclusion conditions: otitis media, history of ear surgery, Meniere's disease, acoustic trauma, barotrauma, evidence of retrocuclear disease, genetic hearing loss or known inner ear abnormality, diabetes, immune deficiency, heart disease and Sensorineural hearing loss with other known causes
Intervention groups
Intervention group: dexamethasone as 20-mg nanogel form will be injected in the tympanic membrane.4 times during a period of 8 days, with one day in between. Also, for14 days, they will receive oral prednisolone at the rate of1mg/kg up to maximum of 60 mg/day.Control group: recieved doses of usual dexamethasone (4 mg) and they will also receive oral prednisolone, similar to intervention group.
Main outcome variables
Hearing loss; vertigo; tinnitus

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220307054210N1
Registration date: 2023-04-05, 1402/01/16
Registration timing: retrospective

Last update: 2023-04-05, 1402/01/16
Update count: 0
Registration date
2023-04-05, 1402/01/16
Registrant information
Name
Fereshteh Fazlinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3246 1031
Email address
ffazlinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-26, 1401/01/06
Expected recruitment end date
2023-03-26, 1402/01/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of intratympanic injection of nanogel dexamethasone versus non-nanogel dexamethasone in treatment of patients with Sudden Sensorineural Hearing Loss (SSNHL), a double blind clinical trial
Public title
The efficacy of intratympanic injection of nanogel dexamethasone in Sudden Sensorineural Hearing Loss (SSNHL) treatment,
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
One-way SSNHL at 30 dB at three consecutive frequencies generated in 72 hours or less The time period from the time of hearing loss until the patient is admitted to the hospital for the procedure is less than or equal to 45 days
Exclusion criteria:
Evidence of otitis media on examination and history Known history of ear anomaleis Evidence of retrocuclear disease, history of meniere's disease history of acoustic trauma history of immunodeficiency history of sudden sensory neural hearing loss with other known couses history of heart disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to make blind the researcher and the interpreter, the concentrated form of dexamethasone (nanogel)and the usual form of dexamethasone were prepared by a nanopharmacologist and presented to the researcher in containers of the same shape with specific numbers. We did not have the power to distinguish the control group from intervention group.Only the manufacturer of the concentrated solution had the information about which drug each container number corresponded to. And the patients in both groups received intratympanic injection treatment and oral medication, which were similar, and the patient did not know whether he was in the control or intervention group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
City
kerman
Province
Kerman
Postal code
7616913355
Approval date
2022-10-23, 1401/08/01
Ethics committee reference number
IR.KMU.AH.REC.1401.158

Health conditions studied

1

Description of health condition studied
Sudden Sensorineural Hearing Loss
ICD-10 code
H91.20
ICD-10 code description
Sudden idiopathic hearing loss, unspecified ear

Primary outcomes

1

Description
Hearing level
Timepoint
Measurement of the patient's hearing level at the beginning of the study (before the intervention) and 2 weeks after and 2 months after the start of the treatment period.
Method of measurement
The hearing level was measured with audiometric criteria (PTA and srt) using an audiogram.

2

Description
vertigo
Timepoint
Vertigo was examined before the start of treatment and 2 weeks and 2 months after the start of treatment
Method of measurement
Dizziness was investigated using a questionnaire

3

Description
tinnitus
Timepoint
tinnitus was examined before the start of treatment and 2 weeks and 2 months after the start of treatment
Method of measurement
tinnitus was investigated using a questionnaire

Secondary outcomes

1

Description
SRT :(speech recognition threshold)
Timepoint
before intervention and 2 and 4 weeks after intervention
Method of measurement
audiometry

2

Description
PTA:( pure tone audiometry)
Timepoint
before intervention and 2 and 4 weeks after intervention
Method of measurement
audiometry

Intervention groups

1

Description
Control group: Patients in this group will receive oral prednisolone at a dose of 1 mg per kg to a maximum of 60 mg daily for 14 days.
Category
Treatment - Drugs

2

Description
Intervention group: for patients of this group, 4 doses of 20 mg nano-gel form of dexamethasone ampule will be injected into the posterior-inferior quadrant of the tympanic membrane by the pink angiocatheter (20 G) with the patient's head rotated 45 degrees to the other side. The injection will be performed under a microscope, and the success of the injection will depend on the observation of the tympanic membrane protruding from the fluid injected into the middle ear; If unsuccessful, re-injection will be given with less dexamethasone. This operation will be performed 4 times during an 8-day period every other day. Each patient will also receive oral prednisolone at a dose of 1 mg per kg for a maximum of 60 mg daily for 14 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Maryam Amizadeh
Street address
Shafa Hospital, Kowsar Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
m.amizadeh@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5829
Fax
+98 34 3132 5830
Email
m.amizadeh@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fereshteh Fazlinezhad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shafa Hospital, Kowsar Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 56 3246 1031
Fax
Email
ffazlinejad@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fereshteh Fazlinezhad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shafa Hospital, Kowsar Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 56 3246 1031
Fax
Email
ffazlinejad@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fereshteh Fazlinezhad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shafa Hospital, Kowsar Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 56 3246 1031
Fax
Email
ffazlinejad@kmu.ac.ir

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
Data can be shared after deidentifying people. The specific titles of the documents include the demographic characteristics of the people participating in the study and the data obtained from the audiometry of the patients including pta and srt before and after the intervention and qualitative data such as dizziness and tinnitus and can be shared. .
When the data will become available and for how long
Access to data is possible 6 months after publishing the results.
To whom data/document is available
The data of this study will be available only to professionals working in academic and scientific institutions.
Under which criteria data/document could be used
I do not have special conditions for access and use of data by others.
From where data/document is obtainable
Data applicants can access the data by sending a request through my email or mobile phone. fereshtehfa@ymail.com 09158671902
What processes are involved for a request to access data/document
It does not go through a special process and the data will be sent to them as soon as the request is received.
Comments
Loading...