UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053781 |
|---|---|
| Receipt number | R000058860 |
| Scientific Title | Intervention study to develop a technique to detect reversible brain fatigue (electronic screen syndrome) by electronic screen using EEG measurement |
| Date of disclosure of the study information | 2024/03/05 |
| Last modified on | 2024/03/29 15:08:06 |
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Basic information
Public title
Intervention study to develop a technique to detect reversible brain fatigue (electronic screen syndrome) by electronic screen using EEG measurement
Acronym
Intervention study to develop a technique to detect reversible brain fatigue (electronic screen syndrome) by electronic screen using EEG measurement
Scientific Title
Intervention study to develop a technique to detect reversible brain fatigue (electronic screen syndrome) by electronic screen using EEG measurement
Scientific Title:Acronym
Intervention study to develop a technique to detect reversible brain fatigue (electronic screen syndrome) by electronic screen using EEG measurement
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detecting differences in EEG features due to the use of electronic screens using a device
Basic objectives2
Others
Basic objectives -Others
Detection of differences in EEG features depending on the presence or absence of an electronic screen
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection of EEG features with and without electronic screen
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Physically move away from the electronic screen for a certain period of time in daily life
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Adults aged between 18 and 60 at the time of obtaining consent
2) Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, voluntarily apply for participation after understanding it well, and can consent to participate in this research in writing.
3) Those who use smartphones frequently (more than 2 hours a day on average for screen time)
4) Those who can come to the measurement venue 2-3 times in total for the measurement
Key exclusion criteria
1) Those who have changed or newly started using health food habitually taken within the past 4 weeks
2) Those who work night shift or day and night shift system
3) Those who are undergoing treatment (hormone replacement therapy, drug therapy, exercise therapy, diet therapy, etc.) at medical institutions for the treatment or prevention of disease, or those who are judged to be in need of treatment.
4) Subjects with a history of diagnosis of serious diseases of glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system nervous system, or mental disease.
5) Those who have a history of alcohol dependence or drug dependence
6) Those who are pregnant, breastfeeding, or wish to become pregnant while participating in the study
7) Participated in other human studies (human studies using foods, drugs, quasi-drugs, medical devices, etc.) within the past 4 weeks, or other studies during the scheduled period of this study plan to participate in a human trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | ISHII |
Organization
Rohto Pharmaceutical Co., Ltd.
Division name
Diagnostic Drug & Device Division
Zip code
619-0216
Address
6-5-4 Kunimidai, Kizugawa City, Kyoto, Japan
TEL
0774-71-8774
ishii@rohto.co.jp
Public contact
Name of contact person
| 1st name | EIKO |
| Middle name | |
| Last name | UNO |
Organization
Rohto Pharmaceutical Co., Ltd.
Division name
Basic Research and Development Division
Zip code
6190216
Address
6-5-4 Kunimidai, Kizugawa City, Kyoto, Japan
TEL
0774718773
Homepage URL
unoe@rohto.co.jp
Sponsor or person
Institute
Rohto Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Rohto Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rohto Pharmaceutical Co., Ltd. Clinical Research Ethics Review Committee
Address
1-8-1 Tatsumi Nishi, Ikuno , Osaka City
Tel
0774-71-8820
rohtoirb@rohto.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
33
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058860
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
