UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037830 |
|---|---|
| Receipt number | R000042230 |
| Scientific Title | Human vital monitoring using UWB radar |
| Date of disclosure of the study information | 2019/08/28 |
| Last modified on | 2025/03/03 10:35:48 |
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Basic information
Public title
Human vital monitoring using UWB radar
Acronym
Human vital monitoring using UWB radar
Scientific Title
Human vital monitoring using UWB radar
Scientific Title:Acronym
Human vital monitoring using UWB radar
Region
| Japan |
Condition
Condition
sleep disordered breathing
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate ultra-wideband (UWB) radar technology against polysomnography (PSG)
Basic objectives2
Others
Basic objectives -Others
To compare the apnea hypopnea index measured by UWB radar and by PSG
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of the apnea hypopnea index measured by UWB radar and that measured by PSG
Key secondary outcomes
1. Correlation of the apnea index measured by UWB radar and that measured by PSG
2. Correlation of the hypopnea index measured by UWB radar and that measured by PSG
3. Correlation of the respiratory rate measured by UWB radar and that measured by PSG
4. Correlation of the heart rate measured by UWB radar and that measured by PSG
5. Correlation of the body position measured by UWB radar and that measured by PSG
6. Correlation of the sleep time and sleep efficacy measured by UWB radar and those measured by PSG
7. Correlation of the periodic limb movement index measured by UWB radar and that measured by PSG
8. Correlation of the apnea hypopnea index measured by audio data and that measured by PSG
9. Correlation of the apnea index measured by audio data and that measured by PSG
10. Correlation of the hypopnea index measured by audio data and that measured by PSG
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suspected to have sleep-related breathing disorders including obstructive sleep apnea by the examination with screening test including overnight pulse oximetryin the setting of outpatient clinic
Key exclusion criteria
1. patients implanted with pacemakers
2. Inappropriate patients considered by the research director and research co-workers
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Chin |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Care and Sleep Control Medicine
Zip code
606-8507
Address
Shogoin 54, Kawahara-cho, Kyoto
TEL
075-751-3852
chink@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hamada |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Advanced Medicine for Respiratory Failure
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7689
Homepage URL
sh1124@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Care and Sleep Control Medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
The Last 5X innovation R and D Center for a Smart, Happy, and a Resilient Society
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
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
| 2019 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
https://kukonai.com/respiratory_failure
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished.
Number of participants that the trial has enrolled
38
Results
The respiratory rate measured using the UWB radar demonstrated a high degree of agreement with the respiratory rate recorded by PSG. During epochs of normal breathing, the measurement accuracy was significantly higher when the radar was directed at the chest or back compared to the supine position. However, in epochs with apnea or hypopnea, the measurement accuracy declined, and the radar tended to overcount the respiratory rate.
Results date posted
| 2025 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent PSG testing at Kyoto University Hospital due to suspected sleep apnea.
Participant flow
Patients who received an explanation of the study using a research information sheet at the time of their PSG admission and from whom written consent to participate was obtained were included in the study.
Adverse events
No specific remarks.
Outcome measures
Comparison of respiratory rates measured by radar and PSG.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study in patients with suspected sleep disordered breathing.
Management information
Registered date
| 2019 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042230
