UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035962 |
|---|---|
| Receipt number | 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 | 2022/02/22 18:21:20 |
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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 | 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
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
npofieldassistant@gmail.com
Sponsor or person
Institute
Specified Non-profit Organization FIELD ASSISTANT
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
