UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013148 |
|---|---|
| Receipt number | 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 12:52:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
k-miki@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
