Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy

This study is not yet open for participant recruitment.
Verified August 2012 by Seoul National University Hospital
Sponsor:
Collaborator:
Soonchunhyang University Hospital
Information provided by (Responsible Party):
YOUNG HO KIM, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01663467
First received: August 8, 2012
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Tinnitus
Drug: Ginkgo biloba
Behavioral: modified tinnitus retraining therapy (TRT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Internet and Smartphone Application-delivered TRT

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Tinnitus Handicap Inventory (THI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    THI will be evaluated 6 months after TRT using smatrphone and web


Estimated Enrollment: 48
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ginkgo biloba only
control group Ginexin-F 80mg tablet will be given twice a day for 6 months.
Drug: Ginkgo biloba
Other Name: 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
Other Name: Ginexin-F
Behavioral: modified tinnitus retraining therapy (TRT)

Detailed Description:

to investigate the effect of TRT with minimized counseling

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic subjective tinnitus

Exclusion Criteria:

  • THI < 18
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663467

Contacts
Contact: YOUNG HO KIM, MD., PhD 82-10-3325-1018 yhkiment@gmail.com
Contact: MOO KYUN PARK, MD., PhD 82-10-5145-3946 aseptic@schmc.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
Soonchunhyang University Hospital
Investigators
Study Chair: YOUNG HO KIM, MD., PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: YOUNG HO KIM, Associate Professor, Department of Otolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul National University Boramae Medical Center, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01663467     History of Changes
Other Study ID Numbers: SNUH_YHK_TRT
Study First Received: August 8, 2012
Last Updated: August 10, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
tinnitus
smartphone
Web

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014