Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy

October 23, 2016 updated by: YOUNG HO KIM, Seoul National University Hospital

Efficacy of Internet and Smartphone Application-delivered TRT

The purpose of this study is to prove the efficacy of the internet and smartphone application-delivered tinnitus retraining therapy (TRT).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

to investigate the effect of TRT with minimized counseling

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-707
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic subjective tinnitus

Exclusion Criteria:

  • THI < 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ginkgo biloba only
control group Ginexin-F 80mg tablet will be given twice a day for 6 months.
Drug: Ginkgo biloba
Ginexin-F 80mg tablet will be given twice a day for 6 months.
Other Names:
  • Ginexin-F
Experimental: Ginkgo biloba + modified TRT

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.
Drug: Ginkgo biloba
Ginexin-F 80mg tablet will be given twice a day for 6 months.
Other Names:
  • Ginexin-F
Behavioral: modified TRT

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Inventory (THI)
Time Frame: 6 months
THI will be evaluated 6 months after TRT using smatrphone and web
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Soonchunhyang University Hospital

Investigators

  • Study Chair: YOUNG HO KIM, MD., PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 23, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH_YHK_TRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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