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IRCT20190620043954N1 IRCT 2020-10-20 Iran National Science Foundation Treatment of Sleep Disorders with Neurofeedback The study of neurofeedback effect on broken sleep, duration of sleep, restless leg syndrome changes and improvement of the quality of life HIV patients with sleep disorders. 2018-10-29 anticipated 30 Complete https://irct.ir/trial/51368 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The numbers from 1 to 30 is written on 30 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. N/A Sleep Disorders. Intervention 1: Intervention group: 12 sessions of Neurofeedback treatment (20 minute,3 times a week). Intervention 2: Control group: The control group does not receive the intervention and receives routine treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The research team's colleagues have not yet reached the final agreement
public Maryam Salehi
end of Keshavar Blvd - Imam Khomeini Hospital Complex- Back of Infection Building (Building 6) - Iran AIDS Research Center
Tehran Iran (Islamic Republic of) 73314119014 +98 21 6658 1583 salehi-m@razi.tums.ac.ir Tehran University of Medical Sciences scientific Maryam Salehi
end of Keshavar Blvd - Imam Khomeini Hospital Complex- Back of Infection Building (Building 6) - Iran AIDS Research Center
Tehran Iran (Islamic Republic of) 73314119014 +98 21 6658 1583 salehi-m@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 50 years Both 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 G47 Sleep disorders Treatment - Devices Treatment - Drugs Intervention group: 12 sessions of Neurofeedback treatment (20 minute,3 times a week) Control group: The control group does not receive the intervention and receives routine treatment. Measurement of sleep quality. Timepoint: Before the onset of treatment and two weeks after starting treatment. Method of measurement: Pittsburgh Sleep Quality Index. 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. Interrupted sleep. Timepoint: Early (before the onset of treatment)and the end of the study (after the end of treatment). Method of measurement: Polysomnography. 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. 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. 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. Iran National Science Foundation Approved 2019-06-17 Ethics committee of Tehran University of Medical Sciences Porsina Ave,Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)