UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041101 |
|---|---|
| Receipt number | 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 13:33:14 |
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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
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
yoshiike@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046840
