UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038052 |
|---|---|
| Receipt number | R000043373 |
| Scientific Title | Research on impression evaluation and biological reaction when listening to auditory signals with low stress and notice |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2021/09/23 18:05:06 |
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Basic information
Public title
Research on impression evaluation and biological reaction when listening to auditory signals with low stress and notice
Acronym
Research on impression evaluation and biological reaction when listening to auditory signals with low stress and notice
Scientific Title
Research on impression evaluation and biological reaction when listening to auditory signals with low stress and notice
Scientific Title:Acronym
Research on impression evaluation and biological reaction when listening to auditory signals with low stress and notice
Region
| Japan |
Condition
Condition
healthy men
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
impression evaluation for auditory signals
Basic objectives2
Others
Basic objectives -Others
Relationship between impression evaluation for auditory signals and biological reaction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
impression evaluation for auditory signals
Key secondary outcomes
Heart rate variability during listening
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
listening auditory signals with concentration
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
health by CMI
Key exclusion criteria
extremy morningness type and eveningness type
psqi >6.0
shift worker within 1 month
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Wakamura |
Organization
Kyoto university
Division name
graduate school of medicine
Zip code
606-8507
Address
53 Shogoin kawhara-cho,Sakyo-ku,Kyoto
TEL
075-751-3974
wakamura.tomoko.5v@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Wakamura |
Organization
Kyoto university
Division name
graduate school of medicine
Zip code
606-8507
Address
53 Shogoin kawhara-cho,Sakyo-ku,Kyoto
TEL
075-751-3974
Homepage URL
wakamura.tomoko.5v@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kaken
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kyoto university graduate school and faculty of medicine, ethics committe
Address
Konoe-cho, Yoshida, Sakyo-ky, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2019 | Year | 12 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 19 | Day |
Last modified on
| 2021 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043373
