UMIN-CTR Clinical Trial

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
Email	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
Email	keisuke.suzuki.334@nec.com

Sponsor
Institute	NEC Corporation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048644