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Study of the efficacy of theta binaural beat on the activity of brain waves in primary insomniacs

Protocol summary

Study aim
Purpose: Can theta binaural beat change the pattern of brain waves in primary insomniacs? If the theta binaural beat efficacy is shown to be based on the pattern of brain waves in primary insomniacs, they can be used to make other interventions in this field as a low-cost and non-invasive method.
Design
A clinical trial with a control group and the sample size of 24 12 patients in each group are enrolled in the study. In the experimental group, binaural beat and in the control group, white noise (as placebo) will be used for 15 minutes. A total of 25 minutes of brain waves are recorded for each patient, which is the first 5 minutes without music, then 15 minutes with music, and in the end 5 minutes without music.
Settings and conduct
This treatment consists of experimental and control groups. The experimental group receives the theta binaural beat and control group receives the White Noise. Each group consists of 12 people. The intervention is done individually and lasts for 25 minutes per person. Binaural beats exist at various frequencies, have shown that they can change brain waves. This study is without blindness. Intervention is done at Farabi Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent and willingness to participate in research, Diagnosis of primary insomnia in a clinical interview by a psychiatrist, Healthy physical and auditory condition Exclusion criteria: The occurrence of any physical and psychological warning signs such as headache, Unwillingness to continue protocol of intervention by the patient, such as shaking or talking, the annoying nature of the music used, Many artifacts during brain wave recordings
Intervention groups
In the experimental group, the theta binaural beat is used as an intervention, but in the control group, White Noise will be used as a placebo.
Main outcome variables
Theta and beta waves of the brain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180205038630N3
Registration date: 2019-01-16, 1397/10/26
Registration timing: prospective

Last update: 2019-01-16, 1397/10/26
Update count: 0
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
Ali Akbar Foroughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 4371
Email address
aliakbar.foroughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the efficacy of theta binaural beat on the activity of brain waves in primary insomniacs
Public title
effect of theta binaural beat on primary insomniacs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent and willingness to participate in research Evaluation of the index of insomnia severity index (ISI) at the clinical level (Score above 15) In order to enter the clinical interview Diagnosis of primary insomnia in a clinical interview by a psychiatrist The absence of severe neurological and psychiatric disorders Healthy physical and auditory condition No history of drug abuse Lack of cardiovascular problems Non-pregnant female participants Avoiding alcohol and drugs 12 hours before intervention
Exclusion criteria:
The annoying nature of the music used The occurrence of any physical and psychological warning signs such as headache Unwillingness to continue protocol of intervention by the patient Many artifacts during brain wave recordings, such as shaking or talking
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Parastar Blvd, faculty of medicine
City
Kermanshah
Province
Kermanshah
Postal code
9186364357
Approval date
2018-12-26, 1397/10/05
Ethics committee reference number
IR.KUMS.REC.1397.771

Health conditions studied

1

Description of health condition studied
Primary insomnia
ICD-10 code
F51.0
ICD-10 code description
Insomnia not due to a substance or known physiological condition

Primary outcomes

1

Description
brain wave pattern
Timepoint
Within 5 minutes before the intervention, 15 minutes during the intervention and 5 minutes later
Method of measurement
Electroencephalography (EEG)

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group: Binaural beats are generated through Audacity software. The produced Binaural beat is at 6 Hz (theta) frequency. First, it is recorded for 5 minutes with closed eyes of the patient's brain waves through electroencephalography. Then, immediately for 15 minutes, with closed eyes, the theta binaural beat is heard through the headphones by the patient. In the final stage, the brain waves of the patient with closed eyes will be recorded for 5 minutes without receiving the binaural beat. For each patient, only one session is performed, which runs for the first 5 minutes as a pre-test, 15 second, post-test, and the last 5 minutes as follow-up.
Category
Treatment - Other

2

Description
Control group: White noise is a signal whose power density is the same at all frequencies. Such a sound will have all the audible frequencies of the same intensity. Therefore, they can be used as a placebo as in the research literature. First, it is recorded for 5 minutes with closed eyes of the patient's brain waves through electroencephalography. Then, immediately for 15 minutes, with closed eyes, the theta binaural beat is heard through the headphones by the patient. In the final stage, the brain waves of the patient with closed eyes will be recorded for 5 minutes without receiving the binaural beat. For each patient, only one session is performed, which runs for the first 5 minutes as a pre-test, 15 second, post-test, and the last 5 minutes as the follow-up.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Habibollah khazaie
Street address
Dolatabad Blvd, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
9186364357
Phone
+98 83 3836 7333
Email
amirpsy3@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kermanshah University of Medical Sciences
Street address
Parastar Blvd, faculty of medical sciences
City
Kermanshah
Province
Kermanshah
Postal code
9186364357
Phone
+98 83 3836 7333
Email
amirpsy3@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Bavafa
Position
MSc student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Parastar Blvd, boostan enghelab dormity
City
Kermanshah
Province
Kermanshah
Postal code
9186364357
Phone
+98 83 3836 7333
Email
amirpsy3@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Akbar Foroughi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah university of medical science., medical school, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
9186364357
Phone
+98 83 3837 4371
Fax
Email
aliakbar.foroughi@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Akbar Foroughi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah university of medical science., medical school, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
9186364357
Phone
+98 83 3837 4371
Fax
Email
aliakbar.foroughi@kums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only,
When the data will become available and for how long
Start the access period from 1398
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
After qualification, any activity is subject to the observance of ethical standards
From where data/document is obtainable
amirpsy3@gmail.com Amir Bavafa +989158018060 Kermanshah, Parastar Blvd, Boostan enghelab dormity
What processes are involved for a request to access data/document
The request is sent via e-mail and the information is sent within 1 month. ٍEmail: amirpsy3@gmail.com
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