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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041101
Receipt No. R000046840
Scientific Title Physiological effects of daytime and nighttime sleep manipulation on emotional memory consolidation
Date of disclosure of the study information 2020/07/14
Last modified on 2020/07/14

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Basic information
Public title Effects of daytime and nighttime sleep manipulation on emotional memory stabilization
Acronym Sleep manipulation and emotional memory stabilization
Scientific Title Physiological effects of daytime and nighttime sleep manipulation on emotional memory consolidation
Scientific Title:Acronym Sleep manipulation and emotional memory consolidation
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the physiological effects of total or partial sleep deprivation, or daytime nap on the consolidation of emotional memory
Basic objectives2 Others
Basic objectives -Others To gain insights into the therapeutic strategies for effectively regulating emotional memory
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Valence and arousal of emotional stimuli
Key secondary outcomes Memory retrieval performance, galvanic skin conductance response, sleep EEG variables

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Total sleep deprivation
Interventions/Control_2 Partial sleep deprivation
Interventions/Control_3 Total sleep deprivation followed by daytime nap
Interventions/Control_4 Normal sleep-wake schedule
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 Men aged 20 to 39
Key exclusion criteria 1) taking a sleeping pill, antihistaminic drug, other sedative drugs in the past four weeks
2) shift working or traveling across timezones in the past six months
3) history of sleep disorders or other psychiatric disorders (DSM-5)
4) neurological or other disorders (eg, epilepsy) affecting the assessments of the trial
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Yoshiike
Organization National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name Department of Sleep-Wake Disorders
Zip code 187-8553
Address 4-1-1 Ogawahigashicho, Kodaira
TEL 042-346-2071
Email yoshiike@ncnp.go.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Yoshiike
Organization National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name Department of Sleep-Wake Disorders
Zip code 187-8553
Address 4-1-1 Ogawahigashicho, Kodaira
TEL 042-346-2071
Homepage URL
Email yoshiike@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Ethical Committee of National Center of Neurology and Psychiatry
Address 4-1-1 Ogawahigashicho, Kodaira, Tokyo
Tel 042-341-2712
Email rinri-jimu@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
2020 Year 07 Month 14 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 10 Day
Date of IRB
2019 Year 12 Month 23 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 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 07 Month 14 Day
Last modified on
2020 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046840

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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