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
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
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
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
