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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013150
Receipt No. 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

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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
Email 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
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)、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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015332

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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