comparison of two insomnia treatment protocols using transcranial direct current stimulation And its effects on cognitive functions and mood in women with chronic insomnia disorder
compare the effectiveness of two treatment protocols based on direct transcranial electrical stimulation in the treatment of insomnia and its effect on cognitive functions and mood of women with chronic insomnia
Design
Pre-test-post-test with control group, parallel groups, one-way blind and randomized with 6 blocks. The statistical sample will include 48 female patients with chronic insomnia.
Settings and conduct
In order to treat insomnia, direct electric current with a intensity of 2 mA for 20 to 30 minutes will be performed during 12 sessions. Two different protocols of direct transcranial electrical stimulation include 1) anodal stimulation on the primary motor cortex and cathodal stimulation on the dorsal-lateral frontal cortex; 2) Upper temporal anodal stimulation and cathodal stimulation of the dorsal-lateral prefrontal cortex and secondary motor cortex in two experimental groups and artificial stimulation in the control group are performed in the sleep clinic of Imam Khomeini Hospital in Tehran. Participants are not aware of what type of stimulation they received.
Participants/Inclusion and exclusion criteria
The women aged 18 to 55 years with chronic insomnia
Intervention groups
Two experimental groups that each received one type of stimulation protocol and one control group that received mock stimulation.
Main outcome variables
The primary outcome of the intervention is the treatment of insomnia, which is measured according to the difference of at least 10% between the pre-test and post-test scores of the participants on the Insomnia severity index. Also, the evaluation of this outcome in the implementation of two different treatment protocols is evaluated according to the difference of at least 10% of the post-test scores of insomnia severity index of the three intervention groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190620043954N2
Registration date:2022-01-23, 1400/11/03
Registration timing:registered_while_recruiting
Last update:2022-01-23, 1400/11/03
Update count:0
Registration date
2022-01-23, 1400/11/03
Registrant information
Name
Khosroo sadeghniiat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5546 0184
Email address
sadeghniiat@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2022-05-15, 1401/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of two insomnia treatment protocols using transcranial direct current stimulation And its effects on cognitive functions and mood in women with chronic insomnia disorder
Public title
comparison of two insomnia treatment protocols using transcranial direct current stimulation And its effects on cognitive functions and mood in women with chronic insomnia disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female
Ages 18 to 55 years
Get a score of 15 to 28 in the Insomnia severity index
Do not take sleeping pills or resist drug treatment despite taking the medication
Exclusion criteria:
Having a history of psychiatric neurological diseases (Alzheimer's, epilepsy, Parkinson's, mental retardation, etc.) and brain damage
Drug abuse, alcohol or caffeine according to DSM5 diagnostic criteria
Existence of bioelectric devices implanted in the body, such as a heart rate monitor
Being pregnant
Level of education less than diploma
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the subjects in the experimental and control groups and also to create a balance in the number of samples assigned to each group, the method of 6 random blocks will be used. The size of all blocks is equal and in each block 2 people in the first intervention group (group A), 2 people in the second intervention group (group B) and 2 people in the control group (group C) will be randomly placed. Random allocation software will also be random generation software. In this way, the software output includes different modes of AABBCC random order, which for each block, a different order is applied to assign participants to study groups. In this process, the order of the participants based on the blocks is not predictable.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this clinical trial, the assignment of participants to experimental groups 1 and 2 and the control group is random. In the present study, a one-way blind method is used to reduce bias or bias related to the intervention and evaluate the consequences. In this way, none of the participants knew which of the two intervention groups and the control group were assigned. In all three groups, the transcranial electrical stimulation device is used for the same duration and number of sessions, but participants do not know which treatment protocol or artificial stimulation they received, but the researcher and evaluator are aware of this. Participants agree to this type of blindness before conducting research in the consent form
Placebo
Used
Assignment
Parallel
Other design features
The treatment protocols mentioned in this study have not been used independently and specifically for the treatment of chronic insomnia.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Nursing and Midwifery & Rehabilitation - Tehran University of
Street address
2 th, No. 16, Between Nawab and Roudaki, 10 Meter Golkar, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
13467-78486
Approval date
2021-12-20, 1400/09/29
Ethics committee reference number
IR.TUMS.FNM.REC.1400.165
Health conditions studied
1
Description of health condition studied
insomnia
ICD-10 code
G47.0
ICD-10 code description
Insomnia
Primary outcomes
1
Description
In the present study, the primary outcome of the intervention is insomnia treatment, which is measured according to the difference of at least 10% between the pre-test and post-test scores of the participants in the scale of insomnia severity. Also, the evaluation of this outcome in the implementation of two different treatment protocols is evaluated according to the difference of at least 10% of the post-test scores of the participants' insomnia severity index.
Timepoint
1 to 5 days before the intervention and 1 to 5 days after the intervention
Method of measurement
Insomnia Severity Index
Secondary outcomes
1
Description
Memory
Timepoint
1 to 5 days before the intervention and 1 to 5 days after the intervention
Method of measurement
N-back Test
2
Description
Attention
Timepoint
1 to 5 days before the intervention and 1 to 5 days after the intervention
Method of measurement
Stroop Test
3
Description
Problem Solving
Timepoint
1 to 5 days before the intervention and 1 to 5 days after the intervention
Method of measurement
Wisconsin Card Sorting Test
4
Description
Mood
Timepoint
1 to 5 days before the intervention and 1 to 5 days after the intervention
Method of measurement
Positive and Negative Affection Scale
Intervention groups
1
Description
Intervention group 1: Direct current of 2 mA will be applied for 20 to 30 minutes in 12 sessions (3 times a week). In this group, direct transcranial electrical excitation includes anodal excitation on the primary motor cortex (M1) and cathodal excitation on the dorsal-lateral pre-frontal cortex (DLPFC), that electric current is induced by a transcranial electrical excitation device
Category
Treatment - Devices
2
Description
Intervention group 2: Direct current of 2 mA will run for 20 to 30 minutes in 12 sessions (3 times a week). In this group, direct transcranial electrical stimulation includes anodal stimulation of the supper temporal region (STG), cathodal stimulation of the dorsal-lateral pre-frontal cortex (DLPFC), and secondary motor area (SMA), that electric current is induced by a transcranial electrical stimulation device.
Category
Treatment - Devices
3
Description
Control group: In the sham control group, it is performed during 12 sessions and three sessions per week and each session for 20 to 30 minutes using a transcranial electrical stimulation device.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Occupational Sleep Disorders Research Center
Full name of responsible person
Dr. Khosrow Sadegh Niiat Haghighi
Street address
2nd floor, No. 16, Between Nawab and Roudaki, 10 Meter Golkar, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
13467-78486
Phone
+98 921 383 2338
Email
tt.motevalli@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Sleep Clinic of Imam Khomeini Hospital
Full name of responsible person
Dr. Khosrow Sadegh Niiat
Street address
2nd floor, No. 16, Between Nawab and Roudaki, 10 Meter Golkar, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
13467-78486
Phone
+98 936 372 6007
Email
tt.motevalli@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Khosrow Sadegh Niiat Haghighi
Street address
2nd floor, No. 16, Between Nawab and Roudaki, 10 Meter Golkar, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
13467-78486
Phone
+98 21 5567 7333
Email
sadeghniiat@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Occupational Sleep Disorders Research Center of Baharloo Hospital
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
Tahereh Motevalizadeh
Position
researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
2nd floor, No. 16, Between Nawab and Roudaki, 10 Meter Golkar, Imam Khomeini Ave
City
Tehran
Province
Tehran
Postal code
13467-78486
Phone
+98 21 6683 2371
Email
tt.motevalli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Motevalizadeh
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
2nd floor, No. 16, Between Nawab and Roudaki, 10 Meter Golkar, Imam Khomeini Ave
City
Tehran
Province
Tehran
Postal code
13467-78486
Phone
+98 21 6683 2371
Email
tt.motevalli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Motevalizadeh
Position
researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
2nd floor, No. 16, Between Nawab and Roudaki, 10 Meter Golkar, Imam Khomeini Ave
City
Tehran
Province
Tehran
Postal code
13467-78486
Phone
+98 21 6683 2371
Email
tt.motevalli@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Publication of study protocol in the form of a scientific-research article
When the data will become available and for how long
6 months after the end of the study
To whom data/document is available
Scientific researchers and therapists
Under which criteria data/document could be used
Use the results of this study in other scientific studies and therapy
From where data/document is obtainable
Tahereh Motevalizadeh
00989363726007
tt.motevalli@gmail.com
Occupational Sleep Research Center
sadeghniiat@yahoo.com
What processes are involved for a request to access data/document
Send the request by e-mail, then the documents will be sent.