UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025744 |
|---|---|
| Receipt number | R000029620 |
| Scientific Title | Understanding the health effects and susceptibility factors of circadian misaligngment |
| Date of disclosure of the study information | 2017/01/19 |
| Last modified on | 2019/07/23 11:42:15 |
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Basic information
Public title
Understanding the health effects and susceptibility factors of circadian misaligngment
Acronym
Understanding the health effects and susceptibility factors of circadian misaligngment
Scientific Title
Understanding the health effects and susceptibility factors of circadian misaligngment
Scientific Title:Acronym
Understanding the health effects and susceptibility factors of circadian misaligngment
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of internal desynchrony during a stay in the dim light environment and reveal the vulnerable factors (light sensitivity, circadian preferences) and health effects (stress response, mood, alertness, and psychomotor performance).
Basic objectives2
Others
Basic objectives -Others
Differences of circadian rhythm phase (The onset of melatonin secretion and nadir of rectal temperature)
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The magnitude of Internal desynchrony will be calculated by the discrepancy of the circadian phases between on first experimental day and second experimental day during a stay in the temporal isolation laboratory under dim light environments.
Key secondary outcomes
The level of a stress response, mood, alertness, and psychomotor performance will be calculated by cortisol awakening response and salivary stress hormone, questionnaire, electroencephalography, and test battery on the second and third day, respectively, and compared to those on the first day. The correlation analyses with the magnitude of internal desynchrony will also be performed.
Participants will be stratified by eligible vulnerable factors (light sensitivity and circadian preferences), and group differences of the magnitude of internal desynchrony will be evaluated.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Staying at dim light environment (<150lux) for 3 days
Interventions/Control_2
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
Male with eligible age (>=20, <=49 years old)
Key exclusion criteria
Affected with sleep, physical, or psychiatric disorders
Using drugs which may affect sleep
Affected with disease of the rectum
Worked night shifts or traveled across time zones in the previous 6 months
Difficulty for staying laboratory
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kitamura |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health, Department of psychophysiology
Zip code
187-8553
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2712(6266)
s-kita@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kitamura |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health, Department of psychophysiology
Zip code
187-8553
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2712(6266)
Homepage URL
s-kita@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the National Center of Neurology and Psychiatry
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2712(7828)
ml_rinrijimu@ncnp.go.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
| 2017 | Year | 01 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 19 | Day |
Last modified on
| 2019 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029620
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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