UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037336 |
|---|---|
| Receipt number | R000039257 |
| Scientific Title | R-R interval prediction by a reflection light sensor. |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2019/07/11 11:28:40 |
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Basic information
Public title
R-R interval prediction by a reflection light sensor.
Acronym
R-R interval prediction by a reflection light sensor.
Scientific Title
R-R interval prediction by a reflection light sensor.
Scientific Title:Acronym
R-R interval prediction by a reflection light sensor.
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the absence of arrhythmia, the heart beat is reflected in the pulse in the periphery and can be measured with a transmission type pulse oximeter. However, most of these devices are somewhat wired and limited, so they are not suitable for measurement during work and exercise. It is a reflection type photoelectric pulse wave sensor module and verifies whether the pulse wave interval (PPI) measured by AGVS that can be recorded wirelessly reflects the electrocardiogram RRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Peak-to-peak interval at rest and after exercise.
Key secondary outcomes
Pulse rate at rest and after exercise.
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
Key inclusion criteria
Healthy
Key exclusion criteria
Those whom can not apply the instruments.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Soh |
| Middle name | |
| Last name | Nishimoto |
Organization
Hyogo College of Medicine
Division name
Department of Plastic Surgery
Zip code
663-8131
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6753
nishimot@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Soh |
| Middle name | |
| Last name | Nishimoto |
Organization
Hyogo College of Medicine
Division name
Department of Plastic Surgery
Zip code
663-8131
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6753
Homepage URL
nishimot@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Genial Light Co.Ltd.
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
The Ethics Review Board of Genial Light
Address
145-1 Tokiwa-cho, Naka-ku, Hamamatsu, Shizuoka
Tel
053-456-3630
info@geniallight.co.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
| 2019 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.geniallight.co.jp
Publication of results
Published
Result
URL related to results and publications
https://www.geniallight.co.jp
Number of participants that the trial has enrolled
5
Results
In linear regression, PPI=0.99991xRRI+0.00012, R=0.99939 at fingertip. PPI=0.99896xRRI+0.00087, R=0.99933 at forehead.
Results date posted
| 2019 | Year | 07 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
4 healthy men.
Participant flow
no problem
Adverse events
none
Outcome measures
R-R intervals and EKG intervals
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In linear regression, PPI=0.99991xRRI+0.00012,R=0.99939 at finger tip. At forehead, PPI=0.99896xRRI+0.00087,R=0.99933.
Management information
Registered date
| 2019 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039257
| 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 |
