UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021920
Receipt No. 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

* 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
Email 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
Email heartrate@sb.ecei.tohoku.ac.jp

Sponsor
Institute Graduate School of Information Sciences, Tohoku University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025277

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.