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Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy

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ClinicalTrials.gov Identifier: NCT01663467
Recruitment Status : Withdrawn (there was no participants who were enrolled in this study)
First Posted : August 13, 2012
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
Soonchunhyang University Hospital
Information provided by (Responsible Party):
YOUNG HO KIM, Seoul National University Hospital

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

Condition or disease Intervention/treatment
Tinnitus Drug: Ginkgo biloba Behavioral: modified TRT

Detailed Description:
to investigate the effect of TRT with minimized counseling

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Internet and Smartphone Application-delivered TRT
Study Start Date : September 2014
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

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 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
Ginexin-F 80mg tablet will be given twice a day for 6 months.
Other Name: 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.




Primary Outcome Measures :
  1. Tinnitus Handicap Inventory (THI) [ Time Frame: 6 months ]
    THI will be evaluated 6 months after TRT using smatrphone and web



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic subjective tinnitus

Exclusion Criteria:

  • THI < 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663467


Locations
Korea, Republic of
Seoul National University Hospital
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

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
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by YOUNG HO KIM, 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