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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 27, 2005

Last Updated Date

February 10, 2009

Start Date ^†

November 2005

Current Primary Outcome Measures ^†

Change in objective measure of tinnitus loudness using psychoacoustic matching task [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Change in subjective handicap rating of tinnitus using a standardized questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original 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

Change History

Complete list of historical versions of study NCT00124800 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Change in subjective ratings of tinnitus loudness, annoyance and awareness [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus

Official Title ^†

The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus

Brief Summary

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.

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Tinnitus

Intervention ^†

Behavioral: Tinnitus retraining therapy
Device: Sound therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

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

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00124800

Responsible Party

Carol Bauer, Professor of Otolaryngology, SIU School of Medicine

Secondary IDs ^††

Study Sponsor ^†

Tinnitus Research Consortium

Collaborators ^††

Investigators ^†

Principal Investigator:

Carol A Bauer, MD

Southern Illinois University School of Medicine

Information Provided By

Tinnitus Research Consortium

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.