UMIN-CTR Clinical Trial

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

Healthy adult male only, or healthy adult male and female

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

YES

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan Aerospace Exploration Agency

Institute

Department

Personal name

Organization

Japan Aerospace Exploration Agency

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

University of Tsukuba, University of Tokyo, National Defense Medical College, Shiseido, Yakult, Cellspect, KAKENHI'Living In Space'

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

筑波宇宙センター（茨城県）

Date of disclosure of the study information

2016

Year

01

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Observe using video camera

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