Investigating the effectiveness of combined methods according to the cortical hubs in the tinnitus networks on improvement of loudness-annoyance and cognitive-auditory processing in tinnitus sufferers with hearing loss.
Investigating the effectiveness of combined methods according to the cortical hubs in the tinnitus networks on improvement of loudness-annoyance and cognitive-auditory processing in tinnitus sufferer with hearing loss.
Design
one blind clinical trial with 2 groups which is assigned to rehabilitation groups by the method of 4 random blocks.
Settings and conduct
persons after meeting the entry criteria will be included in the study. before the start of the intervention Quick Speech In Noise (Q-sin), Pich Patern Test (PPT), Dichotic Digit Test (DDT), Test of Everyday Attention - Elevator (TEA), n-back tests, and EEG will be performed. Then they will be divided into 2 groups. Each group receives A or B intervention the post-test phase will be conducted for behavioral auditory and cognitive tests and EEG recording. Follow-up for behavioral tests will be performed 1 and 3 months after the last session of intervention. this study is done in one blind and participants don't ever of kind of invention.
Participants/Inclusion and exclusion criteria
inclusion criteria; adults with chronic and subjective tinnitus with acoustic coverage and hearing loss and mild to severe hearing loss in the frequency range of 2-8 KHz, aged 25-55 years old, not using hearing AIDS and parallel treatments with a total score of mild to severe in Tinnitus Handicap Inventory (THI) and maximum 10 in Hospital Anxiety and Depression Scale (HADS ).
non-inclusion criteria; unwillingness to cooperate
Intervention groups
group A- customized sound therapy with transcranial direct current stimulation in the left temporoparietal area. group B- customized sound therapy with tDCS in the dorsolateral prefrontal cortex area.
Main outcome variables
Q-SIN test score; Dichotic Digit tes score; TEA test score; EEG parameter and n-back test score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230513058159N1
Registration date:2023-05-30, 1402/03/09
Registration timing:registered_while_recruiting
Last update:2023-05-30, 1402/03/09
Update count:0
Registration date
2023-05-30, 1402/03/09
Registrant information
Name
Seyedeh Manoosh Sobhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2296 7211
Email address
manooshsobhany@gamil.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of combined methods according to the cortical hubs in the tinnitus networks on improvement of loudness-annoyance and cognitive-auditory processing in tinnitus sufferers with hearing loss.
Public title
The combined effect of customized sound therapy and transcranial current stimulation in tinnitus sufferers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
sufferers with chronic and subjective tinnitus aged between 25-55 years
the average hearing threshold are between 20-60 in frequencies between 2-8 KHz in at least 1 hear
acoustic coverability of tinnitus
not using hearingAIDS and not perfuming paralleled drug and non drug treatment at the same time as this research
non-intensification of tinnitus in a residual inhibition assessment
absence of pulsatile or multitone tinnitus
absence of Meniere's disease or any fluctuation in hearing level
absence of conductive and severe to profound hearing lost and obvious complaint of hyperacusis
earn maximum points sever in HADS questionnaire
earn points mild to sever in THI questionnaire
complete the consent form to participate in the rehabilitation in the program
Exclusion criteria:
unwillingness to cooperate in each stage of the research
no infection of neurologic legion epilepsy convulsions and no evidence of cardiovascular disease
no taking sedatives
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
More than 1 sample in each individual
Number of samples in each individual:
2
binaural
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation, six blocks of 8, AABB، ABAB، ABBA، BBAA، BAAB, BABA will be prepared and placed in envelopes in order of entry of the persons, one of the envelopes was selected at random, and based on the obtained block 4 patients will be assigned into 2 groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
in each clinical trial design, 3 groups can influence the results of the study. experiments, researcher, evaluated, or analyst. in this study, by randomly selecting participants in 2 groups and applying 2 different independent variables to each group which is blinded to the type of intervention that received. also the analyst of EEG and statistic are not ewer of the kind of intervention in the groups and they become practically blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Social welfare and rehabilitation sciences
Street address
Kodakyar ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2023-01-22, 1401/11/02
Ethics committee reference number
IR.USWR.REC.1401.230
Health conditions studied
1
Description of health condition studied
tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
2
Description of health condition studied
hearing loss
ICD-10 code
H90
ICD-10 code description
Conductive and sensorineural hearing loss
Primary outcomes
1
Description
quick-speech in noise test score
Timepoint
before the intervention- after the intervention- 1 and 3 months after the end of the intervention
Method of measurement
the percentage of correctly expressed target words - the amount of SNR loss based on the calculation formula.
2
Description
Dichotic digit test
Timepoint
before the intervention- after the intervention- 1 and 3 months after the end of the intervention
Method of measurement
according to percentage of correct answers
3
Description
pitch patern test
Timepoint
before the intervention- after the intervention- 1 and 3 months after the end of the intervention
Method of measurement
according to percentage of correct answers
4
Description
sustained attention score in the test of everyday attention (TEA-elevator counting)
Timepoint
before the intervention- after the intervention- 1 and 3 months after the end of the intervention
Method of measurement
according to percentage of correct answers
5
Description
selective attention score in the test of everyday attention (TEA-elevator counting with distraction )
Timepoint
before the intervention- after the intervention- 1 and 3 months after the end of the intervention
Method of measurement
according to percentage of correct answers
6
Description
n-back test
Timepoint
before the intervention- after the intervention- 1 and 3 months after the end of the intervention
Method of measurement
according to percentage of correct answers
7
Description
componence of electroencephalography (EEG)
Timepoint
before the intervention- after the intervention
Method of measurement
with EEGlab software
8
Description
the score of Tinnitus Handicap Inventory (THI) questionnaire
Timepoint
before the intervention- after the intervention- 1 and 3 months after the end of the intervention
Method of measurement
Score obtained out of 100
9
Description
Visual Analog Score (VAS) of tinnitus
Timepoint
before the intervention- after the intervention- 1 and 3 months after the end of the intervention
Method of measurement
Score obtained out of 10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A- customize sound therapy will be provided together with LTA transcranial direct current stimulation (tDCS) for 20 min , the current intensity of 2 mA will be applied 6 sessions (3 sessions per week )
Category
Rehabilitation
2
Description
Intervention group: Intervention group: Group A- customize sound therapy will be provided together with DLPFC transcranial direct current stimulation (tDCS) for 20 min , the current intensity of 2 mA will be applied 6 sessions (3 sessions per week )
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Seyed Ali Hosseini
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7371 3228
Email
manooshsobhany@gamil.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khankeh
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7371 3228
Email
hamid.khankeh@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Manoosh Sobhani
Position
Student
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7371 3228
Email
manooshsobhany@gamil.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohana Javanbakht
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7371 3228
Email
m.javanbakht@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Manoosh Sobhani
Position
Student
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7371 3228
Email
manooshsobhany@gamil.com
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
Not applicable
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