UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048024
Receipt No. R000054738
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 2022/06/20
Last modified on 2022/06/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) Adults aged 20 to under 60 at the time of consent acquisition
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) People using smartphones
4) Priority is given to those who meet the conditions of 1) to 3) and have a high score in the questionnaire results supervised by the instructing doctor.
Key exclusion criteria 1) Persons with mental disorders
2) In addition, those who are judged by the investigator to be inappropriate as subjects by referring to the opinions of technical instructors or industrial physicians.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Ishii
Organization Rohto Pharmaceutical Co., Ltd.
Division name Basic Research and Development Division
Zip code 619-0216
Address 6-5-4 Kunimidai, Kizugawa City, Kyoto, Japan
TEL 0774-71-8774
Email 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 619-0216
Address 6-5-4 Kunimidai, Kizugawa City, Kyoto, Japan
TEL 0774-71-8794
Homepage URL
Email unoe@rohto.co.jp

Sponsor
Institute Rohto Pharmaceutical Co., Ltd.
Institute
Department

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 Clinical Research Ethics Review Board
Address 1-8-1 Tatsuminishi, Ikuno-ku, Osaka
Tel 0774-71-8820
Email 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
2022 Year 06 Month 20 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
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 Preinitiation
Date of protocol fixation
2022 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 20 Day
Last follow-up date
2022 Year 08 Month 01 Day
Date of closure to data entry
2022 Year 11 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 10 Day
Last modified on
2022 Year 06 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.