UMIN-CTR Clinical Trial

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 Keisuke Middle name Last name 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 Keisuke Middle name Last name 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	NPO Field Assistant IRB
Address	2-7 Yoshidacho Nakaku Yokohamashi
Tel	03-3421-8008
Email	faethicsboard(at mark)gmail.com

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	No longer recruiting
Date of protocol fixation	2019 Year 02 Month 21 Day
Date of IRB	2019 Year 02 Month 21 Day
Anticipated trial start date	2019 Year 02 Month 21 Day
Last follow-up date	2019 Year 03 Month 31 Day
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	2022 Year 02 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040957