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
Improving sleep quality and cognitive functions,
Psychotherapy in psychiatric disorders
Design
The sample size includes 131 people. 17 people are placed randomly in each group (8 groups). Randomization is done for intervention and control groups.
Settings and conduct
interventions will be performed 4 minutes after the subjects enter the N2 stage of sleep. The duration of simultaneous sound and electrical stimulation and the position of neutral and meaningful sound stimulation relative to electrical stimulation will be applied based on the findings of the first stage of the study.
Sound stimulation is below the threshold of awakening(51.34 ± 2.75 dB) and does not wake up the person. For the purpose of blinding, the order of the sessions and the conceptual content of the meaningful sound stimulations will vary between individuals.
Participants/Inclusion and exclusion criteria
they are listed in general information section.
Intervention groups
The first group will receive electrical stimulation.
In the second group, electrical stimulation will be applied simultaneously with sound stimulation.
In the third group, only neutral sound stimulation will be applied rhythmically.
In the fourth group, meaningful sound stimulation will be applied simultaneously with electrical stimulation.
In the fifth group, meaningful sound stimulation will be applied rhythmically.
In the sixth group, after the simultaneous acoustic and electrical stimulation, stimulations will stop and meaningful closed loop stimulation will be applied.
In the seventh group, sound stimulation will be applied rhythmically. Then the sound stimulation will stop and meaningful close loop will be applied.
The eighth group is the control group and will not receive any stimulation.
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
Public title
Improving sleep quality and cognitive functions and psychotherapy during sleep
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Diagnosed medical, psychiatric, and hearing disorders
taking psychoactive drugs, narcotics or nicotine
pregnant or lactating woman
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
131
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
East Azerbaijan - Azadi St., Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2023-05-22, 1402/03/01
Ethics committee reference number
IR.TBZMED.REC.1402.157
Health conditions studied
1
Description of health condition studied
Improving sleep quality and cognitive functions using simultaneous auditory and electrical stimulation, psychotherapy during sleep through meaningful auditory stimulation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
K-complex, spindle waves and slow oscillations
Timepoint
Before and after interventions
Method of measurement
examination of waves changes with fast Fourier transform method
2
Description
Stanford sleepiness scale questionnaire
Timepoint
Before and after interventions
Method of measurement
Comparison of scores of questionnaire with statistical method of paired t-test
3
Description
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
4
Description
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
5
Description
salivary cortisol
Timepoint
Before and after interventions
Method of measurement
changes in salivary cortisol level with statistical method of paired t-test
6
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
The first group: Electrical stimulation
Category
Treatment - Devices
2
Description
The second group: Neutral rhythmic sound stimulation simultaneously with Electrical stimulation
Category
Treatment - Devices
3
Description
The third group: neutral rhythmic sound stimulation without electrical stimulation
Category
Treatment - Devices
4
Description
The fourth group: meaningful sound stimulation simultaneously with electrical stimulation
Category
Treatment - Devices
5
Description
The fifth group: meaningful rhythmic sound stimulation without electrical stimulation(meaningful rhythmic sound stimulation group)
Category
Treatment - Devices
6
Description
The sixth group: Neutral sound stimulation simultaneously with electrical stimulation, then stopping the two stimulations and using meaningful closed loop
Category
Treatment - Devices
7
Description
The seventh group: neutral sound stimulation without electrical stimulation and then stopping sound stimulation and the using of meaningful closed loop
Category
Treatment - Devices
8
Description
Control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Mohammad Reza Saebipour
Street address
Ghaffari Street, Razi Hospital
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۴۴۴۷۱
Phone
+98 56 3162 6000
Email
saebipour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Reza Saebipour
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
sleep
Street address
South Khorasan Province, Birjand, Ghaffari Blvd,
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۴۴۴۷۱
Phone
+98 56 3162 6000
Email
saebipour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi hospital
Full name of responsible person
Mohammad Reza Saebipour
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Sleep
Street address
Ghaffari Street, Razi Hospital
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۴۴۴۷۱
Phone
+98 56 3162 6000
Email
saebipour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Keshtgar
Position
Ph.D. student
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy, Sleep
Street address
East Azarbaijan Province, Tabriz, Golgasht, Tabriz University of Medical Sciences, Faculty of Modern Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 56 3162 6013
Email
keshtgarz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for the public freely.
Under which criteria data/document could be used
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
From where data/document is obtainable
Mohammad Reza Saebipour: saebipour@gmail.com
Parviz Shahabi: parvizshahabi@gmail.com
Zahra Keshtgar:keshtgarz@gmail.com
What processes are involved for a request to access data/document
By sending an email to one of the mentioned people, if all people agree, the data will be accessible to the applicant.