Exploratory Hypothesis Testing Study for Visualization and Quantification of Laughter Using Non-Medical Wearable Devices. -A Single-Arm, Open-label, Observational Study-

Exploratory Hypothesis Testing Study for Visualization and Quantification of Laughter Using Non-Medical Wearable Devices. -A Single-Arm, Open-label, Observational Study- - Exploratory Hypothesis Testing Study for Visualization and Quantification of Laughter Using Non-Medical Wearable Devices. -A Single-Arm, Open-label, Observational Study-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052073

Enrollment

200

Registered

2023-09-01

Start date

2023-09-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactShoichiro Inoue

Otsuka Pharmaceutical Co., Ltd. Otsu Nutraceuticals Research Institute

Inoue.Shoichiro@otsuka.jp+81-77-521-8835

Outcome results