UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040118 |
|---|---|
| Receipt number | R000045743 |
| Scientific Title | Effects of sleep deprivation on the wake state instability |
| Date of disclosure of the study information | 2020/04/09 |
| Last modified on | 2023/04/12 10:47:51 |
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Basic information
Public title
Effects of sleep deprivation on the wake state instability
Acronym
Effects of sleep deprivation on the wake state instability
Scientific Title
Effects of sleep deprivation on the wake state instability
Scientific Title:Acronym
Effects of sleep deprivation on the wake state instability
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the effects of sleep deprivation on the wake state instability
Basic objectives2
Others
Basic objectives -Others
To understand the effects of sleep deprivation on the cognitive performance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Psychomotor vigilance task
2. Time production task
Key secondary outcomes
1. Wakefulness
2. Subjective sleepiness / fatigue
3. Sleep architecture during sleep and sleep deprivation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A. normal sleep
B. sleep deprivation
The order of laboratory is (A, B).
Interventions/Control_2
A. normal sleep
B. sleep deprivation
The order of laboratory is (B, A).
Interventions/Control_3
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
| 60 | 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 currently have no symptoms to be treated
5. Those who can visit the lab or return home by walking, public transportation, or pick-up by others
Driving by themselves (including bicycles) after the experiment is not allowed.
Key exclusion criteria
. 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 least 40 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 150 mL 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
30
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
Clinical Research Ethics Review Committee, University of Tsukuba Hospital
Address
2-1-1 AmakuboTsukuba, Ibaraki 305-0005
Tel
029-853-3914
jisedai@md.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 | 04 | Month | 09 | 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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | 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 | 04 | Month | 09 | Day |
Last modified on
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045743
