UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041115 |
|---|---|
| Receipt number | 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 | 2024/01/06 17:17:10 |
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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
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
abe.takashi.gp@u.tsukuba.ac.jp
Sponsor or person
Institute
International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2024 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046950
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
