UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042630 |
|---|---|
| Receipt number | R000048644 |
| Scientific Title | Development of stress relief detection system using wearable sensors |
| Date of disclosure of the study information | 2020/12/11 |
| Last modified on | 2021/01/05 09:20:19 |
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Basic information
Public title
Development of stress relief detection system using wearable sensors
Acronym
Development of stress relief detection system using wearable sensors
Scientific Title
Development of stress relief detection system using wearable sensors
Scientific Title:Acronym
Development of stress relief detection system using wearable sensors
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate tendencies of biological information when stress relief occurs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biological information of each subjects when they try stress relieving activity
Key secondary outcomes
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Subjects try mental arithmetic test as an acute stress before stress relieving activity
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Recruit participants, agreeing with the purpose of the study, whose ages are between 20 and 49 and select subjects randomly from them to make their job categories, ages and genders be unbiased. Inform all participants that they are free to participate in the study and to quit their participation during the study and that refusals in such will carry no negative consequences to them.
Key exclusion criteria
1.Persons who have mental or physical disorders which concern biological information such as autonomic ataxia.
2.Persons who have some difficulties to listen music or to do aerobic exercise.
3.Persons who are judged as unsuitable for the study by the principal investigator or members of this project for other reason.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Tsujikawa |
Organization
NEC Corporation
Division name
Biometrics Research Laboratories
Zip code
211-8666
Address
1753, Shimonumabe, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
080-8879-2402
tujikawa@nec.com
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Suzuki |
Organization
NEC Corporation
Division name
Biometrics Research Laboratories
Zip code
211-8666
Address
1753, Shimonumabe, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
080-8868-2603
Homepage URL
keisuke.suzuki.334@nec.com
Sponsor or person
Institute
NEC Corporation
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NEC Ethical Review Committee for the Life Sciences
Address
Shiba 5-chome Minato-ku, Tokyo 108-8001 Japan
Tel
03-3798-9520
rinri-shinsa@quality.jp.nec.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
| 2020 | Year | 12 | Month | 11 | 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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 02 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048644
