Exploratory Hypothesis Testing Study for Visualization and Quantification of Laughter Using Non-Medical Wearable Devices. -A Single-Arm, Open-label, Observational Study
- Conditions
- Healthy Volunteers
- Registration Number
- JPRN-UMIN000052073
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 200
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method