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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014802
Receipt No. R000017215
Scientific Title Usefulness of the autonomic nervous system evaluation by real-time heart rate variability analysis
Date of disclosure of the study information 2014/08/09
Last modified on 2018/08/13

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Basic information
Public title Usefulness of the autonomic nervous system evaluation by real-time heart rate variability analysis
Acronym Autonomic nervous system evaluation by real-time heart rate variability
Scientific Title Usefulness of the autonomic nervous system evaluation by real-time heart rate variability analysis
Scientific Title:Acronym Autonomic nervous system evaluation by real-time heart rate variability
Region
Japan

Condition
Condition healthy Volunteer
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will evaluate the sympathetic activity by simultaneously performing for healthy volunteer "heart rate variability analysis method real-time" and the general analysis of muscle sympathetic nerve activity(MSNA).
Consequently, we can evaluate the autonomic nervous activity over time and instantaneous by the real-time heart rate variability analysis and demonstrate usefullness of its method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the correlation between the number of times excitement and excitement frequency by (MSNA) muscle sympathetic and LF / HF rate of change by real-time heart rate variability analysis over time due to various stress or loads
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 evaluate the sympathetic nerve activity between MSNA and real-time heart rate valiability for healthy volinteer
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
65 years-old >
Gender Male and Female
Key inclusion criteria participants (healthy volunteer), who could fully understand and agree all the contents of presenst study
Key exclusion criteria Those whom the doctor or research investigator has determined to be inappropriate as a subject of the present study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Tsutsui
Organization Hokkaido University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL 011-706-6970
Email htsutsui@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamoru Sakakibara
Organization Hokkaido University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL 011-706-6973
Homepage URL
Email mike.s@ninus.ocn.ne.jp

Sponsor
Institute Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 09 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
recruited 8 paitients and analyize the data about autonomic nerve activity   
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
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 09 Day
Last modified on
2018 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017215

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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