UMIN-CTR Clinical Trial

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
Email	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
Email	inoue.natsuhiko@jaxa.jp

Sponsor
Institute	Japan Aerospace Exploration Agency
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023883