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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124800
• Other study ID #: 05-014
• Status: Completed
• Phase: Phase 1
• First received: July 27, 2005
• Last updated: September 23, 2009
• Start date: November 2005
• Est. completion date: June 2009

Study information

• Verified date: September 2009
• Source: Tinnitus Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• Tinnitus retraining therapy
Sound therapy and counseling

Device:
• Sound therapy
sound therapy and counselling

Locations

Country	Name	City	State
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Tinnitus Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in objective measure of tinnitus loudness using psychoacoustic matching task		18 months	No
Primary	Change in subjective handicap rating of tinnitus using a standardized questionnaire		18 months	No
Secondary	Change in subjective ratings of tinnitus loudness, annoyance and awareness		18 months	No

External Links

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