The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus - Full Text View

Sponsored by:	Tinnitus Research Consortium
Information provided by:	Tinnitus Research Consortium
ClinicalTrials.gov Identifier:	NCT00124800

Purpose

The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. The null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard TRT and subjects treated with sham TRT.

Condition	Intervention	Phase
Tinnitus	Behavioral: Tinnitus retraining therapy Device: Sound therapy	Phase I

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus

Further study details as provided by Tinnitus Research Consortium:

Primary Outcome Measures:

Change in objective measure of tinnitus loudness using psychoacoustic matching task
Change in subjective handicap rating of tinnitus using a standardized questionnaire

Secondary Outcome Measures:

Change in subjective ratings of tinnitus loudness, annoyance and awareness

Estimated Enrollment:	40
Study Start Date:	September 2005
Estimated Study Completion Date:	June 2008

Detailed Description:

The specific aims of the study are to:

Evaluate the efficacy of TRT in reducing the objective magnitude of tinnitus.
Evaluate the efficacy of TRT in reducing the subjective awareness and impact of tinnitus.
Determine the therapeutic time course of improvement in tinnitus.
Determine the long-term improvement in tinnitus derived from TRT.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Chronic non-pulsatile tinnitus

Exclusion Criteria:

Hyperacusis
Subjective hearing loss
Objective hearing loss with pure tone average greater than 35 dB sound pressure level (SPL)
Evidence of significant depression or suicidal ideation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124800

Contacts

Contact: David Pence, BA	217-545-7579	dpence@siumed.edu
Contact: Carol Bauer, MD	217-545-5140	cbauer@siumed.edu

Locations

United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794

Sponsors and Collaborators

Tinnitus Research Consortium

Investigators

Principal Investigator:

Carol A Bauer, MD

Southern Illinois University School of Medicine

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	05-014
Study First Received:	July 27, 2005
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00124800
Health Authority:	United States: Institutional Review Board

Keywords provided by Tinnitus Research Consortium:

tinnitus

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Neurologic Manifestations
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009