UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034415 |
|---|---|
| Receipt number | R000038585 |
| Scientific Title | Implicit mood changes according to the degree of sleep pressure between the chronotypes. |
| Date of disclosure of the study information | 2019/06/18 |
| Last modified on | 2019/06/17 12:19:29 |
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Basic information
Public title
Implicit mood changes according to the degree of sleep pressure between the chronotypes.
Acronym
Implicit mood changes according to chronotype
Scientific Title
Implicit mood changes according to the degree of sleep pressure between the chronotypes.
Scientific Title:Acronym
Implicit mood changes according to chronotype
Region
| Japan |
Condition
Condition
Observational study with minimal intervention.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We would like to check the circadian rhythm and implicit mood changes during the sleep deprivation condition.
Basic objectives2
Others
Basic objectives -Others
exploratory objectives for the variables associated with the circadian rhythm
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
implicit mood
Key secondary outcomes
core body temperature, melatonin level, polysomnography, sleepiness scale, CES-D, subjective mood scale, Karolinska drowsiness scale, psychomotor vigilance test
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
healthy male adult
Key exclusion criteria
history of major psychiatric illness including schizophrenia, bipolar disorder, mood disorder, and anxiety disorder.
history of major head trauma.
history of alcohol and substance use disorder.
Target sample size
38
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
Department of Sleep-Wake Disorders
Zip code
1878553
Address
4-1-1, Ogawa-higashi, Kodaira, Tokyo
TEL
042-346-2014
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
Department of Sleep-Wake Disorders
Zip code
1878553
Address
4-1-1, Ogawa-higashi, Kodaira, Tokyo
TEL
042-346-2014
Homepage URL
http://www.ncnp.go.jp/nimh/sleep/
s-kita@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science(JSPS)
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
| 2019 | Year | 06 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
recruiting
Management information
Registered date
| 2018 | Year | 10 | Month | 09 | Day |
Last modified on
| 2019 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038585
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
