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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031391
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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