UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057325 |
|---|---|
| Receipt number | R000065487 |
| Scientific Title | PHR Utilizing a Longitudinal Study with Wearables in Japan (PULSE-J Study) |
| Date of disclosure of the study information | 2025/03/19 |
| Last modified on | 2025/04/02 09:59:52 |
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Basic information
Public title
PHR Utilizing a Longitudinal Study with Wearables in Japan (PULSE-J Study)
Acronym
PHR Utilizing a Longitudinal Study with Wearables in Japan (PULSE-J Study)
Scientific Title
PHR Utilizing a Longitudinal Study with Wearables in Japan (PULSE-J Study)
Scientific Title:Acronym
PHR Utilizing a Longitudinal Study with Wearables in Japan (PULSE-J Study)
Region
| Japan |
Condition
Condition
Users of health care services
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop and validate biomarkers useful for disease prediction and early detection by integrating and analyzing health data obtained from health care services and biological data obtained from wearable devices in each cohort of users, and by calculating the statistics of biological data. This is to develop and verify biomarkers that are useful for new disease prediction and early detection.
Basic objectives2
Others
Basic objectives -Others
Application to personalized medicine and preventive medicine.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Time-series exploration of changes in the subject's health status based on health data obtained from healthcare services and biometric data (heart rate, sleep, step count, etc.) from wearable devices
Key secondary outcomes
(1)Data acquisition status
(2)Relevance of wearable device biometric data to data or questionnaire data obtainable from health care services
(3)Quantification of health data or questionnaire data from health care services by biometric data of wearable devices
(4)Other exploratory evaluation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)You are 18 years of age or older at the time of obtaining consent
(2)You are a person who regularly records your symptoms in a health care application.
(3)Own a smartphone device on which the wearable device application can be installed, and agree to the terms of use for the wearable device and application used in the study.
(4)Have given appropriate written consent to participate in this study.
Key exclusion criteria
(1)Those who use devices or medications that can affect the heartbeat, such as pacemakers or drugs
(2)Those who have eczema, allergies, asthma, sensitive skin, or other conditions that could easily cause dermatitis due to wearable devices
(3)Other individuals who are deemed by the principal investigator to be inappropriate to participate in this study.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Kazumichi |
| Middle name | |
| Last name | Minato |
Organization
TechDoctor, Inc.
Division name
Board Member
Zip code
104-0031
Address
2-2-1 Kyobashi, Chuo-ku, Tokyo
TEL
03-5476-8889
minato@technology-doctor.com
Public contact
Name of contact person
| 1st name | Kosaku |
| Middle name | |
| Last name | Kawada |
Organization
TechDoctor, Inc.
Division name
Business Development
Zip code
104-0031
Address
2-2-1 Kyobashi, Chuo-ku, Tokyo
TEL
03-5476-8889
Homepage URL
kawada@technology-doctor.com
Sponsor or person
Institute
TechDoctor, Inc.
Institute
Department
Personal name
Funding Source
Organization
TechDoctor, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yoyogi Mental Clinic Research Ethics Committee
Address
4-26-11 Sendagaya, Shibuya-ku, Tokyo
Tel
03-6804-2227
cns_jimu(a)triad-j.co.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
| 2025 | Year | 03 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Time-series exploration of changes in the subject's health status based on health data obtained from healthcare services and biometric data (heart rate, sleep, step count, etc.) from wearable devices
Management information
Registered date
| 2025 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065487
