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

History of Changes

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:

MedlinePlus related topics: Tinnitus

Drug Information available for: Ginkgo biloba

U.S. FDA Resources

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 May 19, 2013

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