UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035963 |
|---|---|
| Receipt number | R000040943 |
| Scientific Title | Effects ofacoustic columnar diffuser-associated environment on the activity of autonomic nervous system in healthy human subjects |
| Date of disclosure of the study information | 2019/02/25 |
| Last modified on | 2019/08/22 09:27:19 |
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Basic information
Public title
Effects ofacoustic columnar diffuser-associated environment on the activity of autonomic nervous system in healthy human subjects
Acronym
Effects ofacoustic columnar diffuse on the activity of autonomic nervous system in healthy human subjects
Scientific Title
Effects ofacoustic columnar diffuser-associated environment on the activity of autonomic nervous system in healthy human subjects
Scientific Title:Acronym
Effects ofacoustic columnar diffuse on the activity of autonomic nervous system in healthy human subjects
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of acoustic columnar diffuser-associated environment on the recovery rate of the cold stimulation-induced activation of sympathetic nerves in healthy human subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Acute responses in the activity of autonomic nervous system evaluated by heart rate variability (HRV) to clod stimulation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
sham control (cold stimulation on a hand under normal acoustic environment for 30 s)
Cold stimulation is induced by immersion of the hand in ice water (4 oC) for 30 s.
Two trials with 45-60-min interval.
Interventions/Control_2
cold stimulation on a hand under acoustic columnar diffuser-associated environment for 30 s
Cold stimulation is induced by immersion of the hand in ice water (4 oC for 30 s.
Two trials with 45-60-min interval.
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
Key inclusion criteria
healthy male
Age 20-30 years
Key exclusion criteria
having any diseases or injuries under medical treatment(s)
having any medications
earing hearing aid(s)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsumasa |
| Middle name | |
| Last name | Goto |
Organization
Graduate School of Health Sciences, Toyohashi SOZO University
Division name
Department of Physiology
Zip code
440-8511
Address
20-1 Matsushita, Ushikawa, Toyohashi, Aichi
TEL
050-2017-2272
goto@sozo.ac.jp
Public contact
Name of contact person
| 1st name | Katsumasa |
| Middle name | |
| Last name | Goto |
Organization
Graduate School of Health Sciences, Toyohashi SOZO University
Division name
Department of Physiology
Zip code
440-8511
Address
20-1 Matsushita, Ushikawa, Toyohashi, Aichi
TEL
050-2017-2272
Homepage URL
goto@sozo.ac.jp
Sponsor or person
Institute
Department of Physiology, Graduate School of Health Sciences, Toyohashi SOZO University
Institute
Department
Personal name
Funding Source
Organization
Department of Physiology, Graduate School of Health Sciences, Toyohashi SOZO University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nihon Onkyo Engineering Co., Ltd.
Name of secondary funder(s)
Nihon Onkyo Engineering Co., Ltd.
IRB Contact (For public release)
Organization
Toyohashi SOZO University
Address
20-1 Matsushita, Ushikawa, Toyohashi, Aichi
Tel
0532-55-2111
yass@sozo.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
日本音響エンジニアリング株式会社 音響ラボ（千葉県）
日本音響エンジニアリング株式会社 本社試聴室（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 25 | 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
30
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 | 02 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 20 | Day |
Last modified on
| 2019 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040943
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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