To desired study participants

Participation in "A study of voice-based health status monitoring using a smartphone" (study title)

Recently, stress in places such as home and the workplace, and the accompanying mental health disorders, have become a major problem. Stress will cause a person to become ill, which is then reflected in their voice. Everyone has had the experience of listening to a close friend or family member's voice and noticing, "Hey, you don't sound too good." Additionally, skilled doctors can listen to a patient's voice and guess their physical condition. However, they would probably not notice changes in their own voice.
Therefore, we have considered whether it is possible to automatically analyze one's voice and monitor one's health status while talking on a regular smartphone. Here, we use a privately developed application, identify the emotional components contained in voices, and then measure health status (mood modulation) from patterns in the changes. By using this application, it is possible to know daily health status without being especially conscious of smartphone operation, and by knowing body modulations that one would not notice on one's own, it may be possible to address them on one's own before becoming sick.
Here, we would like everyone to cooperate in using a smartphone application ("MIMOSYS," developed and provided by PST Inc.) for a fixed period of time, and then examine the medical validity of the numerical data provided by the application, the use of the application and other results. In doing so, we would like everyone to participate in an answering a common psychological questionnaire and a questionnaire about changes in physical condition.
We hope that you understand the intent of this study and will agree to participate.

1. Summary of this study

[Name of research institution and name of principal investigator]
The research institution and principal investigator conducting this study are as follows.
◆Research institution:
Verbal Analysis of Pathophysiology, Graduate School of Medicine, The University of Tokyo
◆Principal investigator:
Project Associate Professor Shinichi Tokuno

[Purpose of study]
To verify the medical validity of an application for voice measurement and automatic monitoring of health status.

[Persons asked to participate in study]
◆ Physically and mentally healthy males and females aged 16 and older.
NOTE) Minors should consult with their guardians prior to participating in the study.

[What persons study participants will do]
If you consent to this study, please download the application to your own smartphone (Android OS only), and then freely use the application. 
At the start of using the application and three, six, nine and 12 months after starting use, a questionnaire screen will automatically appear for you to answer. The questionnaire asks your date of birth, sex, number of cohabitants, job or occupation, annual income, birthplace, residence, height, weight, past medical history, history of present illness, oral medication, native language, ethnicity origin and a general psychological questionnaire. It also asks about your most recent three-month history of present illness, oral medication history and a general psychological questionnaire after participating in the study for three, six, nine and 12 months.
We will confirm your intent to continue participating in the study based on the presence of questionnaire responses. If you do not respond to a questionnaire, then the application will not operate.

2. Voluntary study participation and freedom to withdraw

Participation in this study depends upon the free will of all study participants. There are no penalties for not participating in the study. If you consent and call in response to a questionnaire, unlinkable anonymized data is immediately saved. Since individual identification is not possible, retrospective withdrawal cannot be done. However, it is always possible to abandon continued study participation. If study participation is abandoned mid-way, please delete the application yourself. No special notification is necessary.

3. Protection of personal information

We will not directly handle your personal information (name, detailed address, etc.) in this study. Your study information and data will be made unlinkable to your personal information before analysis, and we will carefully store it in our office. Hence, even if you withdraw your consent mid-way, it will not be possible to delete past study data. Additionally, it will not be possible to release individual analysis results to you.
All questionnaires with smartphone responses using this application are unsigned. During the study period, questionnaire results and the results of voice analysis are stored on a server belonging to The University of Tokyo and managed by PST Inc., the provider of the application. We recognize which smartphones data comes from in order to link each piece of data, but this information is anonymized, so we do not know whose smartphone it is. After the end of the study period, information on which smartphone it came from is deleted. Additionally, voice files for data analysis are temporarily stored on your own smartphone, but are automatically deleted after analysis.

4. Announcement of study results

Study results will be announced in conference presentations, academic journals and on our homepage after your name and other personal information has been made unidentifiable.
Individual results are anonymized at time of data collection and thus individuals cannot be identified. Therefore, it is not possible to send data in response to individual inquiries.

5. Advantages and disadvantages of study participation

This study does not guarantee that information will have any immediate advantages for participants. However, the results of this study will be used in the development of devices or software that will be useful in your health management and mental healthcare, which will lead to future progress in health management and mental healthcare, and may benefit your daily health. Additionally, it will contribute to building a better society.
If you participate in the study, you will use the application on your own smartphone to respond to the questionnaire, which requires approximately five to 10 minutes to complete. The questionnaire shall automatically appear on your smartphone when participating in the study and every three months after.
The application used in this study automatically analyzes voices during phone calls, and thus does not require any conscious operation other than the questionnaire. Therefore, we do not expect any mental or physical inconvenience.
The operation of the application has been thoroughly verified, but we cannot rule out the possibility of the smartphone experiencing unexpected failures when downloading or operating the application. Please always back up required data when participating in the study.

6. Handling policy for materials (samples) after the end of the study

Any data from you will be used only for this study. However, we will continue to store it even after the end of the study as a valuable resource for future studies. Since there is no personal information included in data, it is stored with no understanding of whose data it is. Furthermore, in the event that data is used in a new study, it will be used only after being approved again by the Medical Ethics Committee of the University of Tokyo.

7. Your expenses

You are not responsible for any expenses required for the present study. Additionally, you will not be paid any honorarium for participating in the study. There are no special charges required to download the application or perform other actions related to the study.

8. Other

This study will be implemented with the approval of the Medical Ethics Committee of the University of Tokyo. Furthermore, this study will be implemented within the framework of the "Self-Managing Healthy Society - COI Base" COI program implemented by Japan Science and Technology Agency (JST) (core institution: The University of Tokyo), and expenses related to this study are being paid by the JST.
The "MIMOSYS" application used in this study is provided free of charge to the University of Tokyo by PST Inc.
Specially Appointed Researcher Mitsuteru Nakamura of The University of Tokyo Graduate School of Medicine and Faculty of Medicine, who is participating in this study, is former employee of PST Inc. However, he shall not deliberately produce results in this study advantageous to PST Inc., and additionally will handle study results and data management with no leaking, falsification or otherwise of information.

Please do not hesitate to contact the following if you have any questions or opinions.

[Contact] Principal investigator and contact person: Shinichi Tokuno
Verbal Analysis of Pathophysiology,
Graduate School of Medicine and Faculty of Medicine,
The University of Tokyo
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033
Tel: 070-6936-0186

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