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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034725
Receipt No. R000039554
Scientific Title Development of technology for the quantification of stress and well-being using pulse, voice, and electrodermal data: A pilot study
Date of disclosure of the study information 2018/11/05
Last modified on 2021/05/10

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Basic information
Public title Development of technology for the quantification of stress and well-being using pulse, voice, and electrodermal data: A pilot study
Acronym Development of technology for the quantification of stress and well-being using pulse, voice, and electrodermal data: A pilot study
Scientific Title Development of technology for the quantification of stress and well-being using pulse, voice, and electrodermal data: A pilot study
Scientific Title:Acronym Development of technology for the quantification of stress and well-being using pulse, voice, and electrodermal data: A pilot study
Region
Japan

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

Objectives
Narrative objectives1 The study targets desk workers and measures their pulse, voice, and electrodermal data with a technology that extracts pulse from an image, a technology that extracts the emotional component from voice, and a wearable device. By labeling those data with the subjects' stress and well-being levels, as measured by several assessment scales, we try to develop a machine learning algorithm that predicts a person's stress/well-being level based on his/her pulse, voice, and electrodermal data.
This study serves as a pilot study to examine feasibility and determine the optimal sample size before collecting and analyzing large-scale data.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To see if data collection is feasible under the protocols and to identify any problems that arise during the course of the study.
Key secondary outcomes 1. Retention rate of using sensing device and wearable device
2. Change in vital data along with any environmental changes/activities

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 Desk workers who sit in front of their personal computers for 3.5 hours or more a day
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 30

Research contact person
Name of lead principal investigator
1st name Taishiro
Middle name
Last name Kishimoto
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 1608582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3492
Email tkishimoto@keio.jp

Public contact
Name of contact person
1st name Taishiro
Middle name
Last name Kishimoto
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 1608582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3492
Homepage URL
Email tkishimoto@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel 03-3353-1211
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 慶應義塾大学医学部(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 05 Day

Related information
URL releasing protocol http
Publication of results Unpublished

Result
URL related to results and publications http
Number of participants that the trial has enrolled 28
Results under analysis
Results date posted
2020 Year 11 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics under analysis
Participant flow 28 participants
Adverse events None.
Outcome measures under analysis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 11 Month 05 Day
Date of IRB
2018 Year 11 Month 05 Day
Anticipated trial start date
2018 Year 11 Month 05 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
Subject recruitment:
The study will be publicized through advertising documents and explanatory meetings at the target companies. Written informed consent 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, business department, job description, duration of employment, position, family composition, commute, household income, 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 physical data (B-1 to B-3) will be recorded in participants' offices during a one-month observation period.
B-1) Heart rate data
Heart rates will be extracted from face images with video cameras built in or connected to personal computers (PCs) at their offices. The subjects will install software on their PCs and start the software at the beginning of their work.
B-2) Voice data
Affective components will be extracted from voices with microphones built in or connected to PCs. The subjects will install software on their PCs and start the software at the beginning of their work.
B-3) Electrodermal activity (EDA) data
Physical data such as EDA data, heart rate, body motion, and body temperature will be obtained with a wrist-type wearable sensor.

C) Assessment of the levels of stress, well-being, depression and daily condition
Emails containing URLs will be sent to the subjects, who will answer questionnaires online by entering anonymous user IDs. Assessment scales are as follows:
-New occupational stress questionnaires (modified)
-Perceived Stress Scale: PSS
-Satisfaction With Life Scale: SWLS
-Japanese Positive and Negative Affect Schedule (PANAS)
-Japanese Flourishing Scale (FS-J)
-Patient Health Questionnaire-9 Japanese version
-Daily well-being

Management information
Registered date
2018 Year 10 Month 31 Day
Last modified on
2021 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039554

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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