UMIN-CTR Clinical Trial

Basic information
Public title	Electroencephalogram analysis to evaluate the influence of light stimulation
Acronym	Electroencephalogram analysis to evaluate the influence of light stimulation
Scientific Title	Electroencephalogram analysis to evaluate the influence of light stimulation
Scientific Title:Acronym	Electroencephalogram analysis to evaluate the influence of light stimulation
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Ophthalmology Laboratory medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the influence of light stimulation (different wavelength and frequency) by electroencephalography
Basic objectives2	Others
Basic objectives -Others	To evaluate the influence of light stimulation (different wavelength and frequency) by electroencephalography
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Electroencephalography
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	Other
Interventions/Control_1	Light stimulation Visit number : Once
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adults over the age of 20 who get agreement.
Key exclusion criteria	1) The subjects with current or past history of diseases that could affect this study (including cardiovascular, hepatic, endocrine, cranial nerve, psychiatric disorders). 2) The subjects with current or past history of alcohol abuse/dependence. 3) The subjects who is usually taking medicines and supplements that may affect sleep. 4) The subjects who are regarded as inadequate by the investigator. 5) The subjects who has either medical or familial histories of photosensitive epilepsy. 6) The subjects whose consent to this clinical trial cannot be obtained.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Motoshi Middle name Last name Hayano
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	Shinanomachi 35 Shinjuku Tokyo Japan
TEL	03-3353-1205
Email	mhayano@keio.jp

Public contact
Name of contact person	1st name Megumi Middle name Last name Shinzawa
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	Shinanomachi 35 Shinjuku Tokyo Japan
TEL	03-3353-1205
Homepage URL
Email	81770153@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University School of Medicine
Address	Shinanomachi 35 Shinjuku Tokyo Japan
Tel	03-5363-3961
Email	med-rinri-jimu@adst.keio.ac.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	2019 Year 09 Month 01 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	2019 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 28 Day
Last modified on	2019 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043130