UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042654 |
|---|---|
| Receipt number | R000048672 |
| Scientific Title | Evening exposure to differing spectral composition of light on human sleep and energy metabolism |
| Date of disclosure of the study information | 2020/12/04 |
| Last modified on | 2020/12/04 18:13:14 |
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Basic information
Public title
Evening exposure to differing spectral composition of light on human sleep and energy metabolism
Acronym
Evening exposure to differing spectral composition of light on human sleep and energy metabolism
Scientific Title
Evening exposure to differing spectral composition of light on human sleep and energy metabolism
Scientific Title:Acronym
Evening exposure to differing spectral composition of light on human sleep and energy metabolism
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effects of differing spectral composition of light on human sleep and energy metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Electroencephalography
2. Energy metabolism index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Light exposure
4h prior to sleep
Interventions/Control_2
Light exposure
4h prior to sleep
Interventions/Control_3
No light exposure
4h prior to sleep
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
| 18 | years-old | < |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy young males and females
2. PSQI < 6
3. Intermediate chronotypes
Key exclusion criteria
1. Individuals with current or past diagnoses in the following:
a. Heart, liver, kidney, cardiovascular disease, and diabetes
b. Allergic to the equipments in the laboratory
2. Claustrophobic
3. Sleep disorders
4. BMI < 18 or BMI > 25
5. Night shift workers
6. Transmeridian travel 1 month prior to the experiment day
7. Drinks alcoholic beverages on a regular bases
8. Smoking habits
9. Color blindness (Ishihara color blindness test)
10. Pregnant
11. Difficulty hearing in the past
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kumpei |
| Middle name | |
| Last name | Tokuyama |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-8550
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-859-1858
tokuyama.kumpei.gf@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Ishihara |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-8550
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-859-1858
Homepage URL
s1630529@u.tsukuba.ac.jp
Sponsor or person
Institute
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty Health and Sport Sciences, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
029-853-2571
hitorinri@un.tsukuba.ac.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
| 2020 | Year | 12 | Month | 04 | 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
10
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
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048672
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
