UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046673 |
|---|---|
| Receipt number | R000053188 |
| Scientific Title | Exploratory observational study on the measurement accuracy of wearable devices (Wearable Device study) |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/02/08 19:09:00 |
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Basic information
Public title
Exploratory observational study on the measurement accuracy of wearable devices (Wearable Device study)
Acronym
Wearable Device study
Scientific Title
Exploratory observational study on the measurement accuracy of wearable devices (Wearable Device study)
Scientific Title:Acronym
Wearable Device study
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the measurement accuracy of the newly developed wearable devices
Basic objectives2
Others
Basic objectives -Others
measurement accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The measurement accuracy of the newly developed wearable devices will be verified by comparing the values measured or calculated by the new device with the respective control values for the following measurement items.
1.Activity type
2.Step Count
3.Heart Rate
4.Energy Consumption
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) male and female who are aged of 20 years or older and younger than 65 years
(2) Subjects who have not regularly visited a medical institution in the last year before giving their consent
(3) Subjects who give written consent to participate in this study
Key exclusion criteria
(1) Subjects who take medicines on a daily basis
(2) Subjects with sarcopenia, frailty, or difficulty in walking independently
(3) Subjects with dementia
(4) Subjects with other reasons that the investigator in this study judged to be inappropriate to participate in this study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Sakata |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3640
yasushisk@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shozo |
| Middle name | |
| Last name | Konishi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
03-3295-1350
Homepage URL
konisho7332@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Sony Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology-JAPAN
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Suita, Osaka , Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.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
| 2022 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, indoor and outdoor measurements will be conducted separately.
<Indoor measurement>
Description: Walking at multiple speeds, multiple activities of daily living
Measurement/calculation items: energy consumption, step count, heart rate
<Outdoor measurement>
Description: Moving activities in accordance with a scenario simulating daily life
Recorded/calculated items: Activity type
Management information
Registered date
| 2022 | Year | 01 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053188
