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IRCT20190620043954N2 IRCT 2022-01-23 Tehran University of Medical Sciences 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 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 2022-01-15 anticipated 48 Complete https://irct.ir/trial/61050 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The treatment protocols mentioned in this study have not been used independently and specifically for the treatment of chronic insomnia, 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 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. N/A insomnia. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Tahereh Motevalizadeh
2nd floor, No. 16, Between Nawab and Roudaki, 10 Meter Golkar, Imam Khomeini Ave
Tehran Iran (Islamic Republic of) 13467-78486 +98 21 6683 2371 tt.motevalli@gmail.com Tehran University of Medical Sciences scientific Tahereh Motevalizadeh
2nd floor, No. 16, Between Nawab and Roudaki, 10 Meter Golkar, Imam Khomeini Ave
Tehran Iran (Islamic Republic of) 13467-78486 +98 21 6683 2371 tt.motevalli@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 55 years Female 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 G47.0 Insomnia Treatment - Devices Treatment - Devices Placebo 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 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. 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. 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. Memory. Timepoint: 1 to 5 days before the intervention and 1 to 5 days after the intervention. Method of measurement: N-back Test. Attention. Timepoint: 1 to 5 days before the intervention and 1 to 5 days after the intervention. Method of measurement: Stroop Test. 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. 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. Occupational Sleep Disorders Research Center of Baharloo Hospital Approved 2021-12-20 Research Ethics Committee of School of Nursing and Midwifery & Rehabilitation - Tehran University of 2 th, No. 16, Between Nawab and Roudaki, 10 Meter Golkar, Imam Khomeini Ave. Tehran Tehran Iran (Islamic Republic of)