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Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy

Primary Purpose

Tinnitus

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ginkgo biloba
modified TRT
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, smartphone, Web

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic subjective tinnitus

Exclusion Criteria:

  • THI < 18

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ginkgo biloba only

Ginkgo biloba + modified TRT

Arm Description

control group Ginexin-F 80mg tablet will be given twice a day for 6 months.

experimental group modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba. Ginexin-F 80mg tablet will be given twice a day for 6 months.

Outcomes

Primary Outcome Measures

Tinnitus Handicap Inventory (THI)
THI will be evaluated 6 months after TRT using smatrphone and web

Secondary Outcome Measures

Full Information

First Posted
August 8, 2012
Last Updated
October 23, 2016
Sponsor
Seoul National University Hospital
Collaborators
Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01663467
Brief Title
Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy
Official Title
Efficacy of Internet and Smartphone Application-delivered TRT
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
there was no participants who were enrolled in this study
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Soonchunhyang University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to prove the efficacy of the internet and smartphone application-delivered tinnitus retraining therapy (TRT).
Detailed Description
to investigate the effect of TRT with minimized counseling

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, smartphone, Web

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginkgo biloba only
Arm Type
Active Comparator
Arm Description
control group Ginexin-F 80mg tablet will be given twice a day for 6 months.
Arm Title
Ginkgo biloba + modified TRT
Arm Type
Experimental
Arm Description
experimental group modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba. Ginexin-F 80mg tablet will be given twice a day for 6 months.
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba
Other Intervention Name(s)
Ginexin-F
Intervention Description
Ginexin-F 80mg tablet will be given twice a day for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
modified TRT
Intervention Description
modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba. Ginexin-F 80mg tablet will be given twice a day for 6 months.
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI)
Description
THI will be evaluated 6 months after TRT using smatrphone and web
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic subjective tinnitus Exclusion Criteria: THI < 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YOUNG HO KIM, MD., PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy

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