UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046374 |
|---|---|
| Receipt number | R000052920 |
| Scientific Title | Optimization of vital monitoring using UWB radar to children |
| Date of disclosure of the study information | 2022/01/10 |
| Last modified on | 2023/05/15 16:20:46 |
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Basic information
Public title
Optimization of remote and non-contact vital monitoring using UWB radar to children
Acronym
Optimization of remote and non-contact vital monitoring using UWB radar to children
Scientific Title
Optimization of vital monitoring using UWB radar to children
Scientific Title:Acronym
Optimization of vital monitoring using UWB radar to children
Region
| Japan |
Condition
Condition
Healthy children
Classification by specialty
| Cardiology | Pneumology | Pediatrics |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To optimize an analytic algorithm of vital monitoring device using UWB radar to children.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory rate observed by UWB radar and polysomnography
Key secondary outcomes
1. Respiratory curve observed by UWB radar and polysomnography
2. Heart rate observed by UWB radar and polysomnography
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
| 1 | days-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children before entering elementary school.
Key exclusion criteria
1. Children who could not accept nasal canula of polysomnography and ECG leads due to skin diseases etc.
2. Children whose body weight < 2500g
3. Children who have cardiac pacemakers.
4. Children who are judged inappropriate to participate in the study by the investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Watanabe |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
6068507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto-city, Kyoto
TEL
075-751-3111
wshin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Imamura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
6068507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto-city, Kyoto
TEL
075-751-3196
Homepage URL
t_imamura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
MEXT, Center of Innovation Science and Technology-Based Radical Innovation and Entrepreneurship (COI STREAM) "Last 5X innovation for a Smart, Happy, and Resilient Society"
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyoto University Graduate School of Engineering, Department of Electrical Engineering
Name of secondary funder(s)
Mari Co.,Ltd.
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4642
ethcom@kuhp.kyoto-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
京都大学医学部附属病院 （京都府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The respiratory rate and heart rate of children will be measured using UWB radar and polysomnography, which is a standard measurement method. We will adjust the analytic algorithm of the UWB radar so that the results are close to those measured by polysomnography.
Management information
Registered date
| 2021 | Year | 12 | Month | 14 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052920
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
