UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031391
Receipt number R000035838
Scientific Title Association between light sensitivity and circadian rhythm in children
Date of disclosure of the study information 2018/02/21
Last modified on 2018/02/20 17:06:48

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Basic information

Public title

Association between light sensitivity and circadian rhythm in children

Acronym

Association between light sensitivity and circadian rhythm in children

Scientific Title

Association between light sensitivity and circadian rhythm in children

Scientific Title:Acronym

Association between light sensitivity and circadian rhythm in children

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Not applicable Adult Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the effects of different color temperatures of LED lighting on children's melatonin secretion and sleepiness before bedtime

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Salivary melatonin concentration

Key secondary outcomes

Karolinska. Sleepiness Scale (KSS)
Psychomotor Vigilance Task (PVT)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Adult group I
First night: Dim lighting (<30 lx)
Second night: LED lighting (color temperature: 3000 K, illumination: approximately 270 lx)

Interventions/Control_2

Adult group II
First night: Dim lighting (<30 lx)
Second night: LED lighting (color temperature: 6200 K, illumination: 270 lx)

Interventions/Control_3

Child group I
First night: Dim lighting (<30 lx)
Second night: LED lighting (color temperature: 3000 K, illumination: approximately 270 lx)

Interventions/Control_4

Child group II
First night: Dim lighting (<30 lx)
Second night: LED lighting (color temperature: 6200 K, illumination: 270 lx)

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

5 years-old <=

Age-upper limit

50 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy Male or female children (elementry school students) and their parents

Key exclusion criteria

1)Subjects who take hyponotics and sedatives
2)Subjects who are shift worker or night worker

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigekazu Higuchi

Organization

Kyushu University

Division name

Department of Human Science

Zip code


Address

4-9-1, Shiobaru, Minami-ku, Fukuoka

TEL

092-553-4542

Email

higu-s@design.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sang-il Lee

Organization

Hokkaido University

Division name

Division of Human Environmental Systems

Zip code


Address

Kita 13, Nishi 8, Kita-ku, Sapporo, 060-8628, Japan

TEL

011-706-6282

Homepage URL


Email

si.lee@eng.hokudai.ac.jp


Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science (JSPS)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

九州大学(福岡県)


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 21 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

Completed

Date of protocol fixation

2016 Year 07 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 20 Day

Last modified on

2018 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035838


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name