Evaluation of the effectiveness of binaural beat stimuli on integrated auditory-visual sustained attention performance and electroencephalographic parameters in normal individuals aged 18-40 years
Evaluation of the effectiveness of binaural beat stimuli on the integrated function of continuous auditory-visual attention and electroencephalographic components in normal individuals
Design
In this study, Integrated visual and auditory continuous function test and EEG will be used to evaluate the effect of the binaural beat stimuli on 22 normal right-handed individuals without neurological disorders.
Settings and conduct
In this study, the integrated auditory-visual sustained attention test and EEG will be performed with and without intervention in the rehabilitation faculty of the University of Medical Sciences, .
Participants/Inclusion and exclusion criteria
Normal hearing sensitivity; Right-handed; Rule out of neurological disorders; Rule out of ADHD according to DSM-V criteria (adults version)
Intervention groups
The binaural beat stimuli produced by the software will be used as the intervention. Integrated visual and auditory continuous function test and EEG will be used to evaluate the effect of the intervention.
Main outcome variables
Absolute power
Relative power
Functional communication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111113008082N4
Registration date:2022-02-06, 1400/11/17
Registration timing:registered_while_recruiting
Last update:2022-02-06, 1400/11/17
Update count:0
Registration date
2022-02-06, 1400/11/17
Registrant information
Name
Ghassem Mohammadkhani
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7768 4889
Email address
mohamadkhani@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of binaural beat stimuli on integrated auditory-visual sustained attention performance and electroencephalographic parameters in normal individuals aged 18-40 years
Public title
Effect of binaural beat stimuli on integrated auditory-visual sustained attention performance and electroencephalographic parameters
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Normal hearing sensitivity
Right-handed
Rule out of neurological disorders
Rule out of ADHD according to DSM-V criteria (adults version)
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Tehran University of Medical Sciences
Street address
No 226, corner of Ghods Street, Keshavarz Blvd, corner of Ghods Street, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-03-01, 1398/12/11
Ethics committee reference number
IR.TUMS.FNM.REC.1398.226
Health conditions studied
1
Description of health condition studied
Normal individuals
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Absolute power
Timepoint
With and without intervention
Method of measurement
Using EEG
2
Description
Relative power
Timepoint
With and without intervention
Method of measurement
Using MATLAB software
3
Description
Functional communication
Timepoint
With and without intervention
Method of measurement
Using LORETA software
Secondary outcomes
empty
Intervention groups
1
Description
The binaural beat stimuli as intervention will be produced using Audacity software. For this purpose we use two pure tones of 400 Hz and 416 Hz to create 16 Hz bands that are within the beta band range of the brain rhythm. Integrated auditory-visual sustained attention performance and EEG will be performed with and without the binaural beat stimuli.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Ghassem Mohammadkhani
Street address
No 336, Enghelab Ave., Corner of safialishah street, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7768 4889
Email
mohamadkhani@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
No 226, corner of Ghods street, Keshavarz Blvd., Tehran IRAN
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ghassem Mohammadkhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
No 336, Corner of Safialishah st., Enghelab Ave., Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7768 4889
Email
mohamadkhani@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghassem Mohammadkhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
No 336, corner of Safialishah St., Enghelab Ave., Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7768 4889
Email
mohamadkhani@tuma.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghassem Mohammadkhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
No. 34, 66th West st., South Shiraz Ave.
City
Tehran
Province
Tehran
Postal code
1436913545
Phone
+98 21 7768 4889
Email
mohamadkhani@tums.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
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
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