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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046374
Receipt No. 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 2021/12/14

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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
Email 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
Email t_imamura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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 Preinitiation
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
2024 Year 12 Month 08 Day
Date of closure to data entry
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
2021 Year 12 Month 14 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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