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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037456
Receipt No. R000042694
Scientific Title Effects of gamma-band flickering violet lights on sleep and cognitive functions
Date of disclosure of the study information 2019/07/23
Last modified on 2019/07/23

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Basic information
Public title Study on effects of flickering violet light on sleep and cognitive functions
Acronym Study on flickering violet light and sleep/cognitive functions
Scientific Title Effects of gamma-band flickering violet lights on sleep and cognitive functions
Scientific Title:Acronym Gamma-band flickering violet light and sleep/cognitive functions
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We would like to evaluate the effects of the gamma-band flickering violet light exposure during daytime on nocturnal sleep and cognitive functions exploratorily.
Basic objectives2 Others
Basic objectives -Others Using the crossover design with healthy adults, we will perform gamma-band (40 Hz) flickering violet light (365 nm) exposure during the day, and evaluate subsequent changes in sleep and cognitive function by comparison with control (no additional light) and alpha-band (10 Hz) light conditions. In addition, the existence of synchronization of electroencephalogram during the exposure of flicker light will also be evaluated.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sleep structure using polysomnography
Key secondary outcomes Sleep parameters(sleep onset latency, sleep efficiency, total sleep time, wake after sleep onset)
Cognitive functions (Psychomotor vigilance task, n-back, Digit-Symbol Substitution test, Trail making test)
Alertness(Subjective sleepiness, Karolinska drawsiness test)
Electroencephalogram during light exposure

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Exposure of flickering violet light (365nm) (40 Hz) will be exposed for 3 hours during daytime
Interventions/Control_2 Exposure of flickering violet light (365nm) (10 Hz) will be exposed for 3 hours during daytime
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
50 years-old >
Gender Male and Female
Key inclusion criteria Healthy adults (male and female) aged from 20 to 49 years old
Key exclusion criteria History of major disorder which possibly affect results
History of alcohol and substance use disorder and/or habits of binge drinking.
History of drugs which possibly affect results
Pregnant, Breastfeeding, or having a plan for pregnancy
Others who the researcher judged inappropriate
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Kitamura
Organization National Center of Neurology and Psychiatry
Division name Department of Sleep-Wake Disorders
Zip code 185-8553
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2712(6267)
Email s-kita@ncnp.go.jp

Public contact
Name of contact person
1st name Shingo
Middle name
Last name Kitamura
Organization National Center of Neurology and Psychiatry
Division name Sleep-Wake Disorders
Zip code 187-8553
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2712(6267)
Homepage URL
Email s-kita@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Tsubota Laboratory, Inc.
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 Ethics Committee of the National Center of Neurology and Psychiatry
Address 4-1-1, Ogawa-higashi, Kodaira, Tokyo
Tel 042-341-2712(7828)
Email ml_rinrijimu@ncnp.go.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 07 Month 23 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 06 Month 13 Day
Date of IRB
2019 Year 06 Month 13 Day
Anticipated trial start date
2019 Year 08 Month 13 Day
Last follow-up date
2020 Year 02 Month 29 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 07 Month 23 Day
Last modified on
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042694

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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