UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051885 |
|---|---|
| Receipt number | R000059197 |
| Scientific Title | Research on Accuracy Verification and Improvement of Wristwatch-type Wearable IoT Devices |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2025/02/09 10:37:25 |
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Basic information
Public title
Research on Accuracy Verification and Improvement of Wristwatch-type Wearable IoT Devices
Acronym
Research on Accuracy Verification and Improvement of Wristwatch-type Wearable IoT Devices
Scientific Title
Research on Accuracy Verification and Improvement of Wristwatch-type Wearable IoT Devices
Scientific Title:Acronym
Accuracy Verification and Improvement of Wristwatch-type Wearable IoT Devices
Region
| Japan |
Condition
Condition
Patients who, for any reason, measure any vital data with a pulse oximeter, blood pressure monitor, heart rate monitor, respiratory rate monitor, thermometer, or bladder thermometer.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Wrist-worn wearable IoT (Internet of things) devices are intended to provide a simple method of measuring vital signs and other data in daily life and are expected to be used in the stage between health and disease, before a patient is hospitalized for close monitoring. The objectives of this study are (1) to confirm the accuracy of the vital signs obtained by the wristwatch wearable IoT devices by comparing the vital sign data measured by the medical device with the vital sign data measured by the wristwatch wearable IoT device (the validity of the current product), and (2) to improve the accuracy of vital sign data obtained by the wristwatch wearable IoT device by having AI learn the vital sign data measured by the medical device.
Basic objectives2
Others
Basic objectives -Others
Verification and improvement of device functions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare age, gender, and vital data collected by a wristwatch wearable IoT device with transcutaneous arterial blood oxygen saturation, blood pressure, heart rate, respiratory rate, skin temperature, and bladder temperature measured by a medical device.
Key secondary outcomes
Training AI with Information from Transcutaneous Arterial Oxygen Saturation, Blood Pressure, Heart Rate, Respiration Rate, Skin Temperature, and Bladder Temperature Measurements in Medical Devices
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing measurement of any vital data including pulse oximetry, blood pressure, heart rate monitoring, respiration rate monitoring, body temperature, and bladder temperature using pulse oximeters, blood pressure monitors, heart rate monitors, respiration rate monitors, thermometers, and bladder thermometers for various reasons at medical facilities such as Fujii Cardiovascular Internal Medicine and Prefectural Hiroshima Hospital.
Patients who have received explanations and have provided their informed consent.
Key exclusion criteria
Patients for whom obtaining consent through written explanation is challenging.
Patients with unstable conditions.
Patients deemed inappropriate by their attending physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yukihito |
| Middle name | |
| Last name | Higashi |
Organization
Hiroshima University Hospital
Division name
Division of Regeneration and Medicine,
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5831
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Maruhashi |
Organization
Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name
Department of Regenerative Medicine
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku
TEL
082-257-5831
Homepage URL
maru0512@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
adodice
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
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3, Minami-ku, Hiroshima
Tel
082-257-5555
iryo-sinsa@office.hiroshima-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
| 2023 | Year | 08 | Month | 10 | 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
Suspended
Date of protocol fixation
| 2022 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no
Management information
Registered date
| 2023 | Year | 08 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059197
