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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124800
First Posted: July 28, 2005
Last Update Posted: September 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tinnitus Research Consortium
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus

Resource links provided by NLM:


Further study details as provided by Tinnitus Research Consortium:

Primary Outcome Measures:
  • Change in objective measure of tinnitus loudness using psychoacoustic matching task [ Time Frame: 18 months ]
  • Change in subjective handicap rating of tinnitus using a standardized questionnaire [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Change in subjective ratings of tinnitus loudness, annoyance and awareness [ Time Frame: 18 months ]

Enrollment: 41
Study Start Date: November 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Tinnitus retraining therapy
    Sound therapy and counseling
    Device: Sound therapy
    sound therapy and counselling
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124800


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

Additional Information:
Responsible Party: Carol Bauer, Professor of Otolaryngology, SIU School of Medicine
ClinicalTrials.gov Identifier: NCT00124800     History of Changes
Other Study ID Numbers: 05-014
First Submitted: July 27, 2005
First Posted: July 28, 2005
Last Update Posted: September 24, 2009
Last Verified: September 2009

Keywords provided by Tinnitus Research Consortium:
tinnitus

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms