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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Tinnitus retraining therapy

Sound therapy and counseling

Intervention Type BEHAVIORAL

Sound therapy

sound therapy and counselling

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes