UMIN-CTR Clinical Trial

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

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio University School of Medicine

Division name

Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes

Zip code

106-0032

Address

Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan

TEL

03-5786-0006

Email

tkishimoto@keio.jp

Name of contact person

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio University School of Medicine

Division name

Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes

Zip code

106-0032

Address

Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan

TEL

03-5786-0006

Homepage URL

Email

tkishimoto@keio.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN

Tel

03-3353-1211

Email

@

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学医学部（東京都）

Date of disclosure of the study information

2018

Year

11

Month

05

Day

URL releasing protocol

http

Publication of results

Unpublished

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

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 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

Registered date

2018

Year

10

Month

31

Day

Last modified on

2021

Year

10

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039554