UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013150 |
|---|---|
| Receipt number | R000015332 |
| Scientific Title | Whether Gentle skin stimulation modulating Tinnitus Distress among Tinnitus Patients or not? |
| Date of disclosure of the study information | 2014/02/13 |
| Last modified on | 2018/03/30 09:00:14 |
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Basic information
Public title
Whether Gentle skin stimulation modulating Tinnitus Distress among Tinnitus Patients or not?
Acronym
Whether Gentle skin stimulation modulating Tinnitus Distress among Tinnitus Patients or not?
Scientific Title
Whether Gentle skin stimulation modulating Tinnitus Distress among Tinnitus Patients or not?
Scientific Title:Acronym
Whether Gentle skin stimulation modulating Tinnitus Distress among Tinnitus Patients or not?
Region
| Japan |
Condition
Condition
tinnitus
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether vagal nerve stimulation via gentle skin stimulation method is effective for tinnitus patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To confirm whether vagal nerve stimulation via gentle skin stimulation method is effective for tinnitus patients.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Somacept that is skin plaster with micro cones to
modulate the autonomic function was used for the intervention device.
Interventions/Control_2
Sham patch will be applied as for the sham.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Tinnitus patients who were suffering more than 3 month and indicated the score of THI-12 at least more than 9 point.
Key exclusion criteria
Meniere's disease, sudden deafness, acoustic tumor, pulsatile tinnitus, and middle ear disease
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumi Tanuma |
Organization
International University of Health and Welfare Shioya Hospital
Division name
Ear Nose Throat
Zip code
Address
Tomita 77, Yaita, Tochigi
TEL
0287-44-1155
fum-tan4@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）、国際医療福祉大学塩谷病院（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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | 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
| 2018 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015332
