UMIN-CTR Clinical Trial

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