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Investigating the efficacy of rehabilitation using auditory-visual attentional training in adults with chronic tinnitus: A quantitative electroencephalography (qEEG) study

Protocol summary

Study aim
Design and evaluation of rehabilitation using a novel auditory-visual attention training program (mobile application) in adults with chronic tinnitus using quantitative electroencephalogram (qEEG) and behavioral tests.
Design
Interventional, randomized, controlled clinical trial
Settings and conduct
Volunteers who are visited in audiology clinic and meet the study entrance criteria participate in this study. Subjects are randomly selected for one of the study groups and are blinded.
Participants/Inclusion and exclusion criteria
Adults between the age of 20 t0 50 years can participate who meet the following criteria: Right-handedness, not using ant-depressant, anti-seizure, and anesthetic drugs, no history of neurologic disorders such as brain tumors, Meniere's disease, chronic headache, otosclerosis, or psychological disorders that need professional intervention.
Intervention groups
This study has an intervention group and two control groups: The attention training with the simultaneous auditory-visual stimulus is done in the intervention group while the control groups receive only auditory or visual training. The training is based on Posner's attention theory and is designed as a mobile application. After logging in, the subjects perform a daily tinnitus evaluation. Then, the cues are presented and after that, the subject should choose the correct answer. The numbers and colors are used as the auditory and visual stimulus respectively. The training levels are designed from easy to hard. The reaction time, error rate, and level progress are saved into the software database.
Main outcome variables
Electrophysiological parameters (quantitative electroencephalogram- qEEg and P300 response) and behavioral tests of the attention and questionnaires for tinnitus and depression and anxiety are evaluated before and after rehabilitation for comparison

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220206053952N2
Registration date: 2022-08-10, 1401/05/19
Registration timing: prospective

Last update: 2022-08-10, 1401/05/19
Update count: 0
Registration date
2022-08-10, 1401/05/19
Registrant information
Name
Farnoush Jarollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 0541
Email address
jarollahi.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy of rehabilitation using auditory-visual attentional training in adults with chronic tinnitus: A quantitative electroencephalography (qEEG) study
Public title
Investigating the efficacy of auditory-visual attention training in tinnitus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Right-handedness Chronic tinnitus (more than 6 months) Normal hearing (hearing thresholds less than 25 dB HL) in conventional audiometry (250-8000 Hz) Not using anti-depressant, anti-seizure, and anesthetic drugs No history of neurologic disease such as brain tumors, Meniere disease, chronic headache, and otosclerosis No major psychological problem seeking to professional
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random Sampling
Blinding (investigator's opinion)
Single blinded
Blinding description
Only participants are withhold until the end of the study
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Hemmat Highway, Near Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-07-27, 1401/05/05
Ethics committee reference number
IR.IUMS.REC.1401.399

Health conditions studied

1

Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus

Primary outcomes

1

Description
Reaction time in Attention Network Test (ANT)
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
Attention Network Test (ANT) software

2

Description
Error rate in Attention Network Test (ANT)
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
Attention Network Test (ANT) software

3

Description
The amplitude of P300 electrophysiology response
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
21 channel electroencephalography device

4

Description
The latency of P300 electrophysiology response
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
21 channel electroencephalography device

5

Description
The mean frequency of electroencephalogram (EEG) waves
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
21 channel electroencephalography device

6

Description
The absolute power of electroencephalogram (EEG) waves
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
21 channel electroencephalography device

7

Description
The relative power of electroencephalogram (EEG) waves
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
21 channel electroencephalography device

8

Description
Electroencephalogram (EEG) activity at the region of interests (ROIs)
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
21 channel electroencephalography device

9

Description
Reaction time in the Stroop task
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
Stroop task software

10

Description
Error rate in the Stroop task
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
Stroop task software

11

Description
Reaction time in the the Test of Attention in Listening (TAiL)
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
Test of Attention in Listening (TAiL) software

12

Description
Error rate in the the Test of Attention in Listening (TAiL)
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
Test of Attention in Listening (TAiL) software

13

Description
Hospital Anxiety and Depression Scale (HADS) questionnaire score
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
Hospital Anxiety and Depression Scale (HADS) questionnaire

14

Description
Tinnitus Handicap Questionnaire (THQ) score
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
Tinnitus Handicap Questionnaire (THQ)

15

Description
Tinnitus annoynce
Timepoint
At the beginning of the study and daily measurement during 21 days of rehabilitation (attention training)
Method of measurement
Visual Analogue Scale

16

Description
Tinnitus loudness
Timepoint
At the beginning of the study and daily measurement during 21 days of rehabilitation (attention training)
Method of measurement
Visual Analogue Scale

17

Description
Tinnitus loudness
Timepoint
At the beginning of the study and 21 days after rehabilitation (attention training)
Method of measurement
Psychoacoustic evaluation of tinnitus with audiometer device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The attention training with the simultaneous auditory-visual stimulus is done. The training is based on Posner's attention theory and is designed as a mobile application. After logging into the program, the subjects perform a daily evaluation of their tinnitus and then the training has begun. First, simultaneous auditory-visual cues are presented and then the subject should choose the correct answer in the next part of the training. The numbers and colors are used as the auditory and visual stimulus respectively. The subject directs to the next level after choosing the correct answer. The training levels are designed from easy to hard by decreasing the time of the cues and increasing the number of cues and items (the numbers and colors) in the training. The reaction time, error rate, and level progress are saved into the software database.
Category
Rehabilitation

2

Description
First control group: The attention training is done the same as in the intervention group, but using the auditory-only stimulus.
Category
Rehabilitation

3

Description
First control group: The attention training is done the same as in the intervention group, but using the visual-only stimulus.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Audiology clinic
Full name of responsible person
Hossein Namvar Arefi
Street address
First floor, Morvarid Building, In front of Ghaem Hospital, Ahmad Abad Blvd., Shariati Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9183717357
Phone
+98 51 3841 6901
Email
hnamvar91@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keyvani
Street address
Hemmat Highway, Near Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
keyvani.h@iums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hossein Namvar Arefi
Position
PhD. Candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology Department, Rehabilitation Science School of Iran University of Medical Sciences , Madadkaran St., Shah Nazari St., Madar Sq.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷۱۵۴۵۹
Phone
009822227124
Email
hnamvar91@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnoush Jarollahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Faculty of Rehabilitation Sciences, Madadkaran Str., Shahnazari Ave., Madar Sqr., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷۱۵۴۵۹
Phone
+98 21 2225 0541
Fax
Email
jarollahi.f@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Namvar Arefi
Position
PhD. Candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology Department, Rehabilitation Science School of Iran University of Medical Sciences , Madadkaran St., Shah Nazari St., Madar Sq.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷۱۵۴۵۹
Phone
009822227124
Email
hnamvar91@gmail.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
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
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