To assess the effect of using simultaneous transcranial random noise stimulation with and without sound therapy on tinnitus
Design
This is a randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the drawing of lots to the intervention and control groups
Settings and conduct
This study will be performed in the Besat Hospital in Hamadan city on 40 eligible patients with chronic tinnitus. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 70 years
Chronic tinnitus for at least 6 month
Exclusion criteria:
History of ear surgery
Intervention groups
Intervention group:
Random noise transcranial stimulation for 20 minutes with a flow rate of 2 mA twice a week for 4 weeks plus sound therapy by providing sound stimulation to both ears.
Control group:
Random noise transcranial stimulation for 20 minutes with a flow rate of 2 mA twice a week for 4 weeks
Main outcome variables
Primary outcome:
Loudness of tinnitus; tinnitus annoyance; tinnitus disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N462
Registration date:2023-02-15, 1401/11/26
Registration timing:prospective
Last update:2023-02-15, 1401/11/26
Update count:0
Registration date
2023-02-15, 1401/11/26
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of using simultaneous transcranial random noise stimulation with and without sound therapy on tinnitus: a randomized clinical trial
Public title
Effect of using simultaneous transcranial random noise stimulation with and without sound therapy on tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 70 years
Chronic tinnitus for at least 6 month
Exclusion criteria:
History of ear surgery
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Not 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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-02-07, 1401/11/18
Ethics committee reference number
IR.UMSHA.REC.1401.982
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Loudness of tinnitus
Timepoint
Before the intervention and immediately after the intervention as well as two weeks and one month later
Method of measurement
using an audiometer
2
Description
Tinnitus annoyance
Timepoint
Before the intervention and immediately after the intervention as well as two weeks and one month later
Method of measurement
Using Visual Analog Scale (VAS)
3
Description
Tinnitus disability
Timepoint
Before the intervention and immediately after the intervention as well as two weeks and one month later
Method of measurement
Using the Tinnitus Handicap Inventory (THI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Random noise transcranial stimulation for 20 minutes with a flow rate of 2 mA twice a week for 4 weeks plus sound therapy by providing sound stimulation to both ears.
Category
Treatment - Other
2
Description
Control group: Random noise transcranial stimulation for 20 minutes with a flow rate of 2 mA twice a week for 4 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr Maryam Emadi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
maryamemadi1396@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Maryam Emadi
Position
Audiologist
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
maryamemadi1396@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Maryam Emadi
Position
Audiologist
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
maryamemadi1396@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available