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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035963
Receipt No. 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 2019/02/20

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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
Middle name
Last name Katsumasa Goto
Organization Graduate School of Health Sciences, Toyohashi SOZO University
Division name Department of Physiology
Zip code
Address 20-1 Matsushita, Ushikawa, Toyohashi, Aichi
TEL 050-2017-2272
Email goto@sozo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsumasa Goto
Organization Graduate School of Health Sciences, Toyohashi SOZO University
Division name Department of Physiology
Zip code
Address 20-1 Matsushita, Ushikawa, Toyohashi, Aichi
TEL 050-2017-2272
Homepage URL
Email goto@sozo.ac.jp

Sponsor
Institute Department of Physiology, Graduate School of Health Sciences, Toyohashi SOZO University
Institute
Department

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
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 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
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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 25 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
2019 Year 02 Month 20 Day
Last modified on
2019 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=R000040943

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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