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)

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 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)

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name