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IRCT20230527058307N1 IRCT 2023-06-15 Tabriz University of Medical Sciences Improving sleep quality and cognitive functions and psychotherapy during sleep Investigating the effect of time-locked auditory with electrical brain stimulation on the day sleep microstructures and cognitive functions through meaningful stimulus-targeted reactivation from memory 2024-01-21 anticipated 131 Complete https://irct.ir/trial/70408 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Randomization in this study is done as restricted randomization. Because all the study groups have the same sample size. The restricted randomization method is also the law of random allocation. This method represents a large block for the entire sample size, which means that the balance in the number of people assigned to each group will be achieved at the end of the study. For this purpose, first, a total sample size will be determined and then a number of them will be randomly placed in group A and the rest in group B. This method is used for two or more group experiments, Blinding description: In this project, neutral and meaningful sounds are presented during sleep and its effect on the depth and quality of sleep will be investigated. For this purpose, a group will not receive any sound and finally the changes in the brain waves of people in this group will be compared with receiving groups. In fact, everyone is taught sounds. But people do not know whether they are presented or not during sleep, and only the researcher who has to play the sounds knows about this. N/A Improving sleep quality and cognitive functions using simultaneous auditory and electrical stimulation, psychotherapy during sleep through meaningful auditory stimulation. Intervention 1: The first group: Electrical stimulation. Intervention 2: The second group: Neutral rhythmic sound stimulation simultaneously with Electrical stimulation. Intervention 3: The third group: neutral rhythmic sound stimulation without electrical stimulation. Intervention 4: The fourth group: meaningful sound stimulation simultaneously with electrical stimulation. Intervention 5: The fifth group: meaningful rhythmic sound stimulation without electrical stimulation(meaningful rhythmic sound stimulation group). Intervention 6: The sixth group: Neutral sound stimulation simultaneously with electrical stimulation, then stopping the two stimulations and using meaningful closed loop. Intervention 7: The seventh group: neutral sound stimulation without electrical stimulation and then stopping sound stimulation and the using of meaningful closed loop. Intervention 8: Control group. Yes - There is a plan to make this available What will be shared: The information collected before and after the intervention, as well as the changes in brain waves due to the desired intervention, can be shared while preserving the individual's personal information. When: The access period starts 6 months after the results are published To whom: It will be available for the public freely. Conditions: Bringing up the goals and reasons for requesting documents Bringing up the desired analysis on the requested data Mentioning the names of data collectors in reports or articles provided from the requested data Permitting the use of data in order to use appropriate treatment methods for the treatment of sleep disorders Where to obtain: Mohammad Reza Saebipour: saebipour@gmail.com Parviz Shahabi: parvizshahabi@gmail.com Zahra Keshtgar:keshtgarz@gmail.com How to obtain: By sending an email to one of the mentioned people, if all people agree, the data will be accessible to the applicant. Comments:
public Mohammad Reza Saebipour
South Khorasan Province, Birjand, Ghaffari Blvd,
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۴۴۴۷۱ +98 56 3162 6000 saebipour@gmail.com Birjand University of Medical Sciences scientific Mohammad Reza Saebipour
Ghaffari Street, Razi Hospital
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۴۴۴۷۱ +98 56 3162 6000 saebipour@gmail.com Razi hospital Iran (Islamic Republic of) The average body mass index is 23/0 kg/m2 The average duration of normal sleep is 6-7 hours Obtaining a score of less than 6 in the PSQI questionnaire to evaluate the quality of sleep at night before the test session Having a regular sleep and wake rhythm (these two items are confirmed by using actigraphy or recording sleep and wake hours for 7 days before each intervention) lacking any known sleep disorders Not taking medicine during the test No smoking in the past year Avoiding any caffeinated beverages in the morning before the test sessions The normality of normal test results No history of psychiatric, endocrine, cardiac disorders Persian language 20 years 30 years Both Diagnosed medical, psychiatric, and hearing disorders taking psychoactive drugs, narcotics or nicotine pregnant or lactating woman Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices N/A The first group: Electrical stimulation The second group: Neutral rhythmic sound stimulation simultaneously with Electrical stimulation The third group: neutral rhythmic sound stimulation without electrical stimulation The fourth group: meaningful sound stimulation simultaneously with electrical stimulation The fifth group: meaningful rhythmic sound stimulation without electrical stimulation(meaningful rhythmic sound stimulation group) The sixth group: Neutral sound stimulation simultaneously with electrical stimulation, then stopping the two stimulations and using meaningful closed loop The seventh group: neutral sound stimulation without electrical stimulation and then stopping sound stimulation and the using of meaningful closed loop Control group K-complex, spindle waves and slow oscillations. Timepoint: Before and after interventions. Method of measurement: examination of waves changes with fast Fourier transform method. Stanford sleepiness scale questionnaire. Timepoint: Before and after interventions. Method of measurement: Comparison of scores of questionnaire with statistical method of paired t-test. Positive and Negative Affect Schedule (PANAS). Timepoint: Before and after interventions. Method of measurement: Comparison of scores of questionnaire with statistical method of paired t-test. Pittsburgh Sleep Quality Index (PSQI). Timepoint: Before and after interventions. Method of measurement: Comparison of scores of questionnaire with statistical method of paired t-test. Salivary cortisol. Timepoint: Before and after interventions. Method of measurement: changes in salivary cortisol level with statistical method of paired t-test. Cognitive functions (declarative memory, control of general alertness and vigilance, and investigation of sustained attention and reaction time). Timepoint: Before and after interventions. Method of measurement: Comparison of individual performance in cognitive tasks(Paired Associate Learning(PAL), Psychomotor Vigilance Task (PVT)) with statistical method of paired t-test. Tabriz University of Medical Sciences Approved 2023-05-22 Ethics Committee of Tabriz University of Medical Sciences East Azerbaijan - Azadi St., Golgasht St., Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)