To find the effect of Stapedotomy surgery to improve Tinnitus in Otosclerosis patients.
Design
A prospective trial will be conducted on Otosclrosis patients at Loghman Hakim hospital in Isfahan, Iran, from 2021 to 2022.
Settings and conduct
This study will be performed in Loghman Hakim hospital in Isfahan, Iran. To compare tinnitus pitch, otosclerosis patients will be divided into A) high pitch tinnitus frequency (2 kHz and more), B) medium pitch tinnitus frequency (500 – 2000 Hz), and C) low pitch tinnitus frequency (≤500 Hz). Informed consent will be obtained from each participant. All surgeries will be performed by one surgeon with the same methods. The audiometry will be performed for all groups at baseline, one and six months after stapedotomy.
Participants/Inclusion and exclusion criteria
All patients referred to Loghman Hakim hospital for stapedotomy surgery in 2021-2022 will be included and those who may get harmed or disadvantaged by the intervention will be excluded.
Intervention groups
Patients with high pitch tinnitus (2 kHz and more), B) patients with medium pitch frequency (500 – 2000 Hz), and C) patients with low pitch frequency (≤500 Hz).
Main outcome variables
tinnitus frequency changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191114045437N1
Registration date:2022-06-01, 1401/03/11
Registration timing:registered_while_recruiting
Last update:2022-06-01, 1401/03/11
Update count:0
Registration date
2022-06-01, 1401/03/11
Registrant information
Name
Niloufar Iraji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 7673
Email address
niloufar.iraji@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-23, 1400/10/02
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Stapedotomy surgery on tinnitus in Otosclerosis patients
Public title
Effect of Stapedotomy on tinnitus
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Otosclerosis patients who refer to Loghman Hakim Hospital, Isfahan, Iran for stapedotomy surgery
Exclusion criteria:
Acoustic trauma
Blood biochemistry abnormalities, including anemia, vitamin B12 deficiency, thyroid function test abnormalities
Previous ear surgery history
Decline to participate in study
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
national research ethics committee
Street address
loghman hakim hospital
City
tehran
Province
Tehran
Postal code
13333625445
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.SBMU.MSP.REC.1398.064
Health conditions studied
1
Description of health condition studied
otosclerosis
ICD-10 code
H80
ICD-10 code description
Otosclerosis
Primary outcomes
1
Description
tinnitus frequency and loudness changes in patients with stapes surgery
Timepoint
before , one month, six months after surgery
Method of measurement
Audiometry
Secondary outcomes
empty
Intervention groups
1
Description
Patients with Otosclerosis who will undergo stapedotomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
loghman Hakim hospital
Full name of responsible person
Niloufar Iraji
Street address
Makhsus st. Hor squ.
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5102 5182
Email
niloufar.iraji@yahoo.com
Web page address
http://lhmc.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloufar Iraji
Street address
Daneshjoo squ. Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 5102 5182
Email
niloufar.iraji@yahoo.com
Web page address
https://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
10
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloufar iraji
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Loghman Hakim hospital
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5102 5182
Email
niloufar.iraji@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloufar Iraji
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Loghman Hakim hospital
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5102 5182
Email
Niloufar.iraji@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloufar Iraji
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Loghman Hakim hospital
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5102 5182
Email
niloufar.iraji@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
for patients privacy
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
we publish all information with detail in article
When the data will become available and for how long
now we can present information
To whom data/document is available
all people
Under which criteria data/document could be used
for increase researcher's data
From where data/document is obtainable
Loghman Hakim Hospital recordes
What processes are involved for a request to access data/document