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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041115
Receipt No. R000046950
Scientific Title The effect of REM sleep on emotional memory based decision-making
Date of disclosure of the study information 2020/07/15
Last modified on 2020/07/15

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Basic information
Public title The effect of REM sleep on emotional memory based decision-making
Acronym The effect of REM sleep on emotional memory based decision-making
Scientific Title The effect of REM sleep on emotional memory based decision-making
Scientific Title:Acronym The effect of REM sleep on emotional memory based decision-making
Region
Japan

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

Objectives
Narrative objectives1 Understanding the effect of REM sleep on decision making under uncertain situation task
Basic objectives2 Others
Basic objectives -Others Understanding the effect of REM sleep on skin conductance response during decision making under uncertain situation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Iowa Gambling Task(IGT)
Key secondary outcomes Psychomotor Vigilance Task
Cambridge Gambling Task
Wakefulness
Subjective sleepiness/fatigue
Cognitive understanding of IGT

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Phenylethyl alcohol

Presents an odor during a task before sleep during REM sleep.
Interventions/Control_2 Phenylethyl alcohol

Presents distilled water during a task before sleep and an odor (Phenylethyl alcohol) during REM sleep.
Interventions/Control_3 Phenylethyl alcohol

Presents an odor (Phenylethyl alcohol) during a task before sleep and distilled water during REM sleep.
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
30 years-old >=
Gender Male and Female
Key inclusion criteria 1. Those who do not have difficulty in filling out Japanese explanatory documents, consent forms, and survey forms
2. Those who can stay in the examination room on the 5th floor of the Innovation Medical Research Institute, University of Tsukuba
3. Those who have never been treated for mental illness or sleep disorder
4. Those who do not have sleep disorders, olfactory and taste disorders, and their history
Key exclusion criteria 1. Those who are living irregular lives (Regular life: 21: 00 ~ 1: 00 going to bed, getting up from 6: 00 ~ 9: 00, sleeping 7 ~ 9 hours)
2. Thin (below BMI18.5) or obese (over BMI25) physique
3. Those who worked night shift (after 22:00) within the last 3 months
4. Those who have traveled to a country with a time difference of 3 hours or more within the last 3 months
5. Those who drink alcohol regularly (at least40 g of pure alcohol [approximate: 2 cans of beer] twice a week or more)
6. Those who have a smoking habit
7. Those who have a daily caffeine intake of 300 mg or more (approximate: 5 cups of 150mL coffee)
8. Those who may fall under 1. -7. above during the experiment period
9. Extreme eveningness type or extreme morningness type (Morningness-Eveningness Questionnaire score 30 points or less or 70 points or above)
10. Those whose Pittsburgh Sleep Questionnaire scores more than 5.5
11. Those whose Epworth sleepiness scale score of 11 or higher
12. Those who have a disease that may change suddenly or have a history
13. Those who have claustrophobic
14. Those who are pregnant or may be pregnant
15. Those who are under lactation
16. Those who are judged by the investigator to be inappropriate
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Abe
Organization University of Tsukuba
Division name International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code 305-0821
Address Innovation Medical Research Institute 502, 1-2 Kasuga, Tsukuba, Ibaraki
TEL 029-859-1858
Email abe.takashi.gp@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Abe
Organization University of Tsukuba
Division name International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code 305-0821
Address Innovation Medical Research Institute 502, 1-2 Kasuga, Tsukuba, Ibaraki
TEL 029-859-1858
Homepage URL
Email abe.takashi.gp@u.tsukuba.ac.jp

Sponsor
Institute International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Human Sciences, University of Tsukuba
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577
Tel 029-853-5605
Email hitorinri@u.tsukuba.ac.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 筑波大学国際統合睡眠医科学研究機構
International Institute for Integrative Sleep Medicine, University of Tsukuba (WPI-IIIS)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 15 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 25 Day
Date of IRB
2020 Year 01 Month 09 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2022 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 15 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046950

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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