The Study of TDCS (Transcranial Direct Current Stimulation) on sleep quality improvement, changes in the expression of the hormone receptor gene and improving the quality of life of HIV + patients with sleep disorders
The Study of TDCS (Transcranial Direct Current Stimulation) on sleep quality improvement, changes in the expression of the hormone receptor gene and improving the quality of life of HIV + patients with sleep disorders
Design
The open label clinical trial
Settings and conduct
The patients with AIDS Emam Khomeyni Hospital are divided into two groups. Without blinded. Blood samples are taken from all of them to measure some factors Then performing the tDCS and sleep test in treatment group.
Participants/Inclusion and exclusion criteria
Having at least 18 years and maximum 50 years
Ability to read and write
Lack of psychotic disorders based on clinical interviews
No use of hypnotic drugs
A change of dose and the type of psychiatric medications of two months before entering the project until to end of the follow up period
Not having history of Seizure
Diagnostics one type of sleep disorders according to interviews and questionnaire
Not having ulcer on the scalp
Not having of heart battery
Intervention groups
There is one intervention group in this study, which is treated with tDCS, and the other group is the control , which is without intervention.
Main outcome variables
The study of treatment effect of sleep disturbance in tDCS method and hormone level ; gene Expression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100601004076N25
Registration date:2020-08-25, 1399/06/04
Registration timing:registered_while_recruiting
Last update:2020-08-25, 1399/06/04
Update count:0
Registration date
2020-08-25, 1399/06/04
Registrant information
Name
Minoo Mohraz
Name of organization / entity
Iranian Research Center for HIV/AIDS, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 7984
Email address
minoomohraz@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-19, 1399/01/31
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study of TDCS (Transcranial Direct Current Stimulation) on sleep quality improvement, changes in the expression of the hormone receptor gene and improving the quality of life of HIV + patients with sleep disorders
Public title
The Study of TDCS on sleep quality improvement of HIV+ patients with sleep disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 18 years and maximum 50 years
Ability to read and write
Lack of psychotic disorders based on clinical interviews
No use of hypnotic drugs
A change of dose and the type of psychiatric medications of two months before entering the project until to end of the follow up period
Not having history of Seizure
Diagnostics one type of sleep disorders according to interviews and questionnaire
Not having ulcer on the scalp
Not having of heart battery
Exclusion criteria:
Lack of desire to continue treatment
Treatmenting ECT fromentering of the project to follow up period
To use of hypnotic drugs from entering of the project to end of follow up period
Having seizures from entering of the project to follow up period
Exacerbation of symptoms of HIV that they may not continue to the project
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients in two groups of test and control will be done by Block Balanced Randomization (BBR) method. The Randomization Sequence will be
generated with using the free website at http://www.randomization.com
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Porsina Ave,Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-01-24, 1398/11/04
Ethics committee reference number
IR.TUMS.VCR.REC.1398.839
Health conditions studied
1
Description of health condition studied
Sleep Disorders
ICD-10 code
G47.8
ICD-10 code description
Other sleep disorders
Primary outcomes
1
Description
Measurement of sleep quality
Timepoint
Before the onset of treatment and two weeks after starting treatment
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 12 sessions of tDCS treatment (2 mA,20 minutes) treatment of sleep disorders
Category
Treatment - Devices
2
Description
Control group: The control group does not receive the intervention and receives routine treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran AIDS Research Center
Full name of responsible person
Maryam Salehi
Street address
End of Keshavar Blvd - Imam Khomeini Hospital Complex- Back of Infection Building (Building 6) - Iran AIDS Research Center
City
Tehran
Province
Tehran
Postal code
۷۳۳۱۴۱-۱۹-۱۴
Phone
+98 21 6658 1583
Email
ircha@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Ms.Farhadi
Street address
Tehran Province, Tehran, Amir Abad, 5th St
City
Tehran
Province
Tehran
Postal code
13114-16846
Phone
+98 21 8216 1000
Email
support@insf.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Salehi
Position
Post - doctoral student
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
End of Keshavar Blvd - Imam Khomeini Hospital Complex- Back of Infection Building (Building 6) - Iran AIDS Research Center
City
Tehran
Province
Tehran
Postal code
۷۳۳۱۴۱-۱۹-۱۴
Phone
+98 21 6658 1583
Email
salehi-m@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Salehi
Position
Post - doctoral student
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
End of Keshavar Blvd - Imam Khomeini Hospital Complex- Back of Infection Building (Building 6) - Iran AIDS Research Center
City
Tehran
Province
Tehran
Postal code
۷۳۳۱۴۱-۱۹-۱۴
Phone
+98 21 6658 1583
Email
salehi-m@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Salehi
Position
Post - doctoral student
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
End of Keshavar Blvd - Imam Khomeini Hospital Complex- Back of Infection Building (Building 6) - Iran AIDS Research Center
City
Tehran
Province
Tehran
Postal code
۷۳۳۱۴۱-۱۹-۱۴
Phone
+98 21 6658 1583
Email
salehi-m@razi.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
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