Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 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: May 13, 2014
Last verified: May 2014
  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 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 13, 2014
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 September 22, 2014