UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046352 |
|---|---|
| Receipt number | R000051089 |
| Scientific Title | Research on mental and physical conditions detected by heart rate variability analysis |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2024/12/12 14:20:50 |
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Basic information
Public title
Research on mental and physical conditions detected by heart rate variability analysis
Acronym
Research on mental and physical conditions by heart rate variability analysis
Scientific Title
Research on mental and physical conditions detected by heart rate variability analysis
Scientific Title:Acronym
Research on mental and physical conditions by heart rate variability analysis
Region
| Japan |
Condition
Condition
Normal adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find heart rate variability analysis indicators that are useful for monitoring mental health.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Heart rate variability analysis index that changes after psychological stress load
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Caliculation work
Interventions/Control_2
Reading
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
Healthy adult
Key exclusion criteria
1. No arrhythmia
2. Do not take drugs that affect autonomic nervous function (beta-blockers)
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Yoshikawa |
Organization
Kanazawa University
Division name
Health Service Center
Zip code
920-1192
Address
Kakumamachi, Kanazawa, Ishikawa
TEL
076-264-5254
hiroaki@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Yoshikawa |
Organization
Kanazawa University
Division name
Health Service Center
Zip code
920-1154
Address
Kakumamachi, Kanazawa, Ishikawa
TEL
076-264-5254
Homepage URL
hiroaki@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
KYOCERA Corporation
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
Medical ethics Committee of Kanazawa University
Address
13-1 Takaramachi, Kanazawa, Ishikawa
Tel
076-265-2104
rinri@adm.kanazawa-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 20 | 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
| 2021 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 10 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051089
