UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021920 |
|---|---|
| Receipt number | R000025277 |
| Scientific Title | Reliability evaluation of an optical heart rate activity tracker |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2018/02/20 09:28:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Reliability evaluation of an optical heart rate activity tracker
Acronym
Comparative experiments of an optical heart rate activity tracker
Scientific Title
Reliability evaluation of an optical heart rate activity tracker
Scientific Title:Acronym
Comparative experiments of an optical heart rate activity tracker
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate reliability of an optical heart rate activity tracker during various activities.
Basic objectives2
Others
Basic objectives -Others
Reliability evaluation of an optical heart rate activity tracker
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
reliability of heart rate tracking ability of an optical heart rate activity tracker
it evaluates reliability by using optical heart rate monitors and ECG at the same time, and as a additional experiment, it examines possibility of estimating HRV using optical heart rate monitors.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Polar H7,
Optical heart rate activity tracker(Polar A360),smartphone(iphone),ECG
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults in 20s whose BMI is around 18.5 - 25 (also members of national health insurance). The additional experiment only requires age criteria.
Key exclusion criteria
People who have following disease or condition
1. high blood pressure
2. diabetes
3. whistling
4. other underlying disease
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kengo Kinoshita |
Organization
Graduate School of Information Sciences, Tohoku University
Division name
Applied Information Sciences Systems Bioinformatics
Zip code
Address
Sendaishi Aobaku Aramakiji Aoba 6-3-09 Graduate School of Information Sciences, Tohoku University Applied Information Sciences Systems Bioinformatics
TEL
022-795-7179
kengo@ecei.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Tagawa |
Organization
Graduate School of Information Sciences, Tohoku University
Division name
Applied Information Sciences Systems Bioinformatics
Zip code
Address
Sendaishi Aobaku Aramakiji Aoba 6-3-09 Graduate School of Information Sciences, Tohoku University Ap
TEL
022-795-7179
Homepage URL
heartrate@sb.ecei.tohoku.ac.jp
Sponsor or person
Institute
Graduate School of Information Sciences, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
広瀬川澱緑地（宮城県）
追加実験は東北大学医学系研究科５号館８階行動医学 生理検査室(宮城県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 18 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 15 | Day |
Last modified on
| 2018 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025277
