UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037456 |
|---|---|
| Receipt number | 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 | 2020/07/07 13:42:28 |
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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)
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
s-kita@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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)
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
Open public recruiting
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
| 2020 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042694
