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

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tinnitus retraining therapy
Sound therapy
Sponsored by
Tinnitus Research Consortium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Southern Illinois University School of Medicine

Outcomes

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

Full Information

First Posted
July 27, 2005
Last Updated
September 23, 2009
Sponsor
Tinnitus Research Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT00124800
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tinnitus Research Consortium

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Tinnitus retraining therapy
Intervention Description
Sound therapy and counseling
Intervention Type
Device
Intervention Name(s)
Sound therapy
Intervention Description
sound therapy and counselling
Primary Outcome Measure Information:
Title
Change in objective measure of tinnitus loudness using psychoacoustic matching task
Time Frame
18 months
Title
Change in subjective handicap rating of tinnitus using a standardized questionnaire
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in subjective ratings of tinnitus loudness, annoyance and awareness
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A Bauer, MD
Organizational Affiliation
Southern Illinois University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States

12. IPD Sharing Statement

Links:
URL
http://siumed.edu/surgery
Description
Related Info

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

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