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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035962
Receipt No. R000040957
Scientific Title Preliminary study on the relationship between stress/well-being and sensing data obtained from wearable devices in a life in a long-term enclosed environment of a simulated spaceship in preparation for manned Mars mission
Date of disclosure of the study information 2019/02/21
Last modified on 2019/02/20

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Basic information
Public title Preliminary study on the relationship between stress/well-being and sensing data obtained from wearable devices in a life in a long-term enclosed environment of a simulated spaceship in preparation for manned Mars mission
Acronym SHIRASE-001 Study
Scientific Title Preliminary study on the relationship between stress/well-being and sensing data obtained from wearable devices in a life in a long-term enclosed environment of a simulated spaceship in preparation for manned Mars mission
Scientific Title:Acronym SHIRASE-001 Study
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study aims at elucidating the relationship between stress/well-being and sensing/recording data such as data obtained from wearable devices among the crews and mission controllers who will join simulated spaceship experiment taking place in an inactive Antarctic research vessel, "SHIRASE" in preparation for a long-term life in an enclosed environment of future manned Mars missions.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between stress/well-being and sensing/recording data.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria Adult crews and mission controllers who will join simulated spaceship experiment taking place in an inactive Antarctic research vessel, "SHIRASE 5002".
Key exclusion criteria (1)Those who are under treatment for psychiatric diseases such as depression.
(2)Those who have a disease which may affect acquisition of physical data (eg. facial palsy, limb palsy, involuntary movement, cardiovascular diseases, difficulty speaking, etc.).
(3)Those who have difficulties in operating personal computers such as sending and receiving e-mails, entering information on websites.
(4)Those who have difficulties obtaining physical data for any work-related reason.
(5) Those who are considered to be ineligible by the PI or investigators.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Izumi
Organization Specified Non-profit Organization FIELD ASSISTANT
Division name N.A.
Zip code
Address B1F 2-7 Yoshidacho, Naka-ku, Yokohama, Kanagawa, JAPAN
TEL 03-3421-8008
Email npofieldassistant@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Izumi
Organization Specified Non-profit Organization FIELD ASSISTANT
Division name N.A.
Zip code
Address B1F 2-7 Yoshidacho, Naka-ku, Yokohama, Kanagawa, JAPAN
TEL 03-3421-8008
Homepage URL
Email npofieldassistant@gmail.com

Sponsor
Institute Specified Non-profit Organization FIELD ASSISTANT
Institute
Department

Funding Source
Organization Specified Non-profit Organization FIELD ASSISTANT
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 21 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 Enrolling by invitation
Date of protocol fixation
2019 Year 02 Month 21 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information METHODS
Written informed consents from the participants will be obtained with explanatory documents.

Assessments:
A)Collecting demographic characteristics
The following information will be collected from the subjects after informed consent:
-Sex, age, occupation, business contents, duration of employment, position, family composition, commute, etc.
-Results of past medical checks and stress checks at their workplace if the participants allow.
-Past medical history/comorbidities and prescriptions.

B)Data collection with sensing devices
The following data will be recorded in the ship during an observation period.
Sensing data such as body motion and pulse data will be obtained with wrist-type wearable devices.

C) Assessment of the levels of stress, well-being, depression and daily condition
The subjects will answer questionnaires in electronic files or on paper filling anonymous user-IDs.

D) Video-camera records
Video-camera recordings are scheduled in the interest of safety of the simulated spaceship experiment. The copy of the video records will be analyzed for the details of events, conversation time, etc.

Management information
Registered date
2019 Year 02 Month 20 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040957

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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