The Study of Neurofeedback Effect on Polysomnography Changes, Gene Expression of Hormone Receptors and Raising the Quality of Life of HIV+ Patients involved in Sleep Disorders
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 sleep test in the neurofeedback treatment group. the sleep test is done again after treatment.
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
Intervention groups
A control group in this study can make decisions under the control of neurofeedback, and the other group can be control what they can without intervention.
Main outcome variables
The study of treatment effect of sleep disturbance in neurofeedback method on Polysomnography Variables; hormone level ; gene Expression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180804040686N1
Registration date:2020-06-18, 1399/03/29
Registration timing:retrospective
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Maryam Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1583
Email address
salehi-m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-30, 1397/08/08
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-10-22, 1398/07/30
Actual recruitment end date
2020-05-08, 1399/02/19
Trial completion date
2020-05-08, 1399/02/19
Scientific title
The Study of Neurofeedback Effect on Polysomnography Changes, Gene Expression of Hormone Receptors and Raising the Quality of Life of HIV+ Patients involved in Sleep Disorders
Public title
Treatment of Sleep Disorders with Neurofeedback
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
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:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The numbers from 1 to 45 is written on 45 papers and placed inside a bag. Each time a patient enters the study according to entry criteria, a paper is removed from the bag and the number that is written on the paper will be the number of intervention medication.
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
2018-10-29, 1397/08/07
Ethics committee reference number
IR.TUMS.VCR.REC.1397.537
Health conditions studied
1
Description of health condition studied
Sleep Disorders
ICD-10 code
G 47.0
ICD-10 code description
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
1
Description
improvement of sleep quality
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
Polysomnography
2
Description
Interrupted sleep
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
Polysomnography
3
Description
time to fall asleep
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
Polysomnography
4
Description
restless leg syndrome
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
Polysomnography
5
Description
change in brain waves during sleep
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
Polysomnography
6
Description
Cortisol hormone level
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
ELISA
7
Description
Melatonin level
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
ELISA
8
Description
Acetylcholine level
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
ELISA
9
Description
Orexin level
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
ELISA
10
Description
GABA level
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
ELISA
11
Description
Expression of the glucorticoid receptor gene
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
PCR
12
Description
improving the quality of life
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
HIV/AIDS – Quality of Life (HAT-QoL) questionnaire
13
Description
Expression of the Ach receptor gene
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
PCR
14
Description
Expression of the Bmal1 receptor gene
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
PCR
15
Description
Expression of the CLOCK receptor gene
Timepoint
Early (before the onset of treatment)and the end of the study (after the end of treatment)
Method of measurement
PCR
Intervention groups
1
Description
Intervention group: 12 sessions of Neurofeedback treatment (20 minute,3 times a week)
Category
Treatment - Devices
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
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