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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034415
Receipt No. 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

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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
Email 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/
Email s-kita@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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)
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038585

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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