UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020703 |
|---|---|
| Receipt number | R000023883 |
| Scientific Title | Research on Evaluating Stress Accumulation in an Isolation Environment that Simulate a Long Duration Space Mission |
| Date of disclosure of the study information | 2016/01/22 |
| Last modified on | 2021/06/24 16:35:47 |
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Basic information
Public title
Research on Evaluating Stress Accumulation in an Isolation Environment
that Simulate a Long Duration Space Mission
Acronym
Research on Evaluating Stress Accumulation in an Isolation Environment
that Simulate a Long Duration Space Mission
Scientific Title
Research on Evaluating Stress Accumulation in an Isolation Environment
that Simulate a Long Duration Space Mission
Scientific Title:Acronym
Research on Evaluating Stress Accumulation in an Isolation Environment
that Simulate a Long Duration Space Mission
Region
| Japan |
Condition
Condition
Healthy adult male only, or healthy adult male and female
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To narrow down stress markers that reflect a level of the stress objectively when placing a workload on participants in an isolated environment
Basic objectives2
Others
Basic objectives -Others
To narrow down stress markers that reflect a level of the stress objectively when placing a workload on participants in an isolated environment
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Narrowing down stress markers that reflect a level of the stress objectively
Key secondary outcomes
Changes in stress marker candidate levels when placing a workload on participants in an isolated environment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1)Prohibition on leaving the Isolation Chamber for 14 days, 2)Following the designated plan (to sleep/wake up at designated time, to perform tasks according to schedule), 3)Personal space available only in each sleeping compartment and bathroom/restroom, 4)No information and communication equipment, no internet usage, no game machines, no smoking, 5)Restriction on meals (only preserved foods simulating space foods being provided, and no caffeinated drinks or alcohol beverages allowed), 6)Restriction on hygiene (allowing for only short-time showers), 7)Restriction on exercise (First 8 subjects-muscle training permitted, second 8 subjects-exercise prohibited, third 8 subjects-50% VO2max bike exercise conducted for 15 min every day with other exercise prohibited)
Interventions/Control_2
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. adult male only, or adult male and female
2. would like to participate closed chamber study as a subject.
3. agree with informed consent
Key exclusion criteria
1. have presence of chronic illness or medication
2. smoker
3. alcoholic, drug abuse
4. claustrophobia
5. food allergy
6. in the caused ill feelings by blood collection.
7. serious medical history (cerebrovascular disease, heart disease)
8. positive for tuberculosis test
9. are prohibited to participate in trail by safety manager
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Furukawa, M.D., Ph.D. |
Organization
Japan Aerospace Exploration Agency
Division name
Human Spaceflight Technology Directorate
Zip code
Address
2-1-1, Sengen, Tsukuba, Ibaraki, 305-8505, Japan
TEL
+81-50-3362-7648
furukawa.satoshi@jaxa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuhiko Inoue, Ph.D. |
Organization
Japan Aerospace Exploration Agency
Division name
Human Spaceflight Technology Directorate
Zip code
Address
2-1-1, Sengen, Tsukuba, Ibaraki, 305-8505, Japan
TEL
+81-50-3362-3528
Homepage URL
inoue.natsuhiko@jaxa.jp
Sponsor or person
Institute
Japan Aerospace Exploration Agency
Institute
Department
Personal name
Funding Source
Organization
Japan Aerospace Exploration Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Tsukuba, University of Tokyo, National Defense Medical College, Shiseido, Yakult, Cellspect, KAKENHI'Living In Space'
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
筑波宇宙センター（茨城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 22 | 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
Submitted for publication
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
| 2016 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe using video camera
Management information
Registered date
| 2016 | Year | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023883
