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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013148
Receipt No. R000015331
Scientific Title Gentle Skin Stimulation modulates the Balance between the sympathetic nerve and the vagal nerve among Normal adult.
Date of disclosure of the study information 2014/02/13
Last modified on 2014/08/13

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Basic information
Public title Gentle Skin Stimulation modulates the Balance between the sympathetic nerve and the vagal nerve among Normal adult.
Acronym Gentle Skin Stimulation modulates the Balance between the sympathetic nerve and the vagal nerve among Normal adult.
Scientific Title Gentle Skin Stimulation modulates the Balance between the sympathetic nerve and the vagal nerve among Normal adult.
Scientific Title:Acronym Gentle Skin Stimulation modulates the Balance between the sympathetic nerve and the vagal nerve among Normal adult.
Region
Japan

Condition
Condition Normal adults
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Gentle Skin Stimulation modulates the Balance between the sympathetic nerve and the vagal nerve among Normal adult.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparing the difference of the value of pNN50 which is is calculated from RR interval of plethysmography under Sham control double blind condition.
Key secondary outcomes

Base
Study type

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 A soft elastomer brushed disc that is named Somacept type II (Toyo Resin Co., Japan) has 11 mm in diameter and with 417 micro cones was used for the skin stimulation.
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
21 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria normal adults
Key exclusion criteria person who undergo some medical treatment(s).
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Nakagawa
Organization International University of Health and Welfare Hospital
Division name Ear nose throat
Zip code
Address Iguchi 537-3, Nasushiobara, Tochigi
TEL 0287-39-3060
Email m.nakagawa@iuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miki Kurokawa
Organization International University of Health and Welfare Hospital
Division name general affairs
Zip code
Address Iguchi 537-3, Nasushiobara, Tochigi
TEL 0287-39-3060
Homepage URL
Email k-miki@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare Hospital
Institute
Department

Funding Source
Organization International University of Health and Welfare Hospital
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 国際医療福祉大学病院(栃木県)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 13 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
2014 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 27 Day
Last follow-up date
2014 Year 07 Month 31 Day
Date of closure to data entry
2014 Year 07 Month 31 Day
Date trial data considered complete
2014 Year 07 Month 31 Day
Date analysis concluded
2014 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 13 Day
Last modified on
2014 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=R000015331

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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