UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between light sensitivity and circadian rhythm in children
Title of the study (Brief title)	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	Shigekazu Higuchi
Organization	Kyushu University
Division name	Department of Human Science
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	Sang-il Lee
Organization	Hokkaido University
Division name	Division of Human Environmental Systems
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
Institute	Kyushu University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035838