UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052073 |
|---|---|
| Receipt number | R000059404 |
| Scientific Title | Exploratory Hypothesis Testing Study for Visualization and Quantification of Laughter Using Non-Medical Wearable Devices. -A Single-Arm, Open-label, Observational Study- |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/03/01 09:17:09 |
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Basic information
Public title
Exploratory Hypothesis Testing Study for Visualization and Quantification of Laughter Using Non-Medical Wearable Devices.
-A Single-Arm, Open-label, Observational Study-
Acronym
Exploratory Hypothesis Testing Study for Visualization and Quantification of Laughter Using Non-Medical Wearable Devices.
-A Single-Arm, Open-label, Observational Study-
Scientific Title
Exploratory Hypothesis Testing Study for Visualization and Quantification of Laughter Using Non-Medical Wearable Devices.
-A Single-Arm, Open-label, Observational Study-
Scientific Title:Acronym
Exploratory Hypothesis Testing Study for Visualization and Quantification of Laughter Using Non-Medical Wearable Devices.
-A Single-Arm, Open-label, Observational Study-
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Constructing a Machine Learning Model to Distinguish Between Laughter and Non-Laughter States Using Demographic Information and Vital Data Extractable from Wearable Devices, and Leveraging it for Solution Development
Basic objectives2
Others
Basic objectives -Others
Constructing a Machine Learning Model
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy of laughing state discrimination using a machine learning model created using feature value such as demographic information and changes in stress-related values (heart rate variability) obtained by non-medical wearable devices
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy individuals who are aged 18-60
2)Individuals who voluntarily give written informed consent
3)Individuals who own a smartphone device capable of installing applications, do not plan to change their device model during the study period, and agree to the terms of use for wearable device and application used in this study
4)Individuals with regular work schedules and working hours (office workers)
5)Individuals who can visit designated facilities regularly according to the schedule instructed by the research personnel
Key exclusion criteria
1)Individuals with a history of cardiovascular disease or a medical history involving physician treatment for a duration of one month or more, whom the lead principal investigator has deemed ineligible for inclusion in this study
2)Individuals for whom health management is challenging due to perioperative conditions, infectious disease, or similar factors
3)Individuals deemed unable to use wearable devices
4)Individuals with implanted devices affecting heart rate, such as a pacemaker
5)Individuals using drugs that may affect heart rate
6)Individuals with hypothyroidism or suspected hypothyroidism
7)Individuals currently participating in other clinical trials or planning to participate in other clinical trials during the study period
8)Individuals in the breastfeeding period, pregnant or potentially pregnant, and those wishing to become pregnant during the study period
9)Any other individuals deemed ineligible for this study participation by lead principal investigator and study manager
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inoue |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga
TEL
+81-77-521-8835
Inoue.Shoichiro@otsuka.jp
Public contact
Name of contact person
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inoue |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga
TEL
+81-77-521-8835
Homepage URL
Inoue.Shoichiro@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
TechDoctor, Inc.
FANY Co., Ltd.
Yoshimoto Kogyo Co., Ltd.
Dentsu Inc.
Dentsu Live Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
Tel
03-6717-1499
shimizu_se@otsuka.jp
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
| 2023 | Year | 09 | Month | 01 | 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
| 2023 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Constructing a Machine Learning Model to Distinguish Between Laughter and Non-Laughter States Using Demographic Information and Vital Data Extractable from Wearable Devices
Management information
Registered date
| 2023 | Year | 08 | Month | 31 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059404
