UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037829 |
|---|---|
| Receipt number | R000043130 |
| Scientific Title | Electroencephalogram analysis to evaluate the influence of light stimulation |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/08/28 11:25:18 |
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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
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
81770153@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043130
