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

This study has been completed.
Sponsor:
Information provided by:
Tinnitus Research Consortium
ClinicalTrials.gov Identifier:
NCT00124800
First received: July 27, 2005
Last updated: September 23, 2009
Last verified: September 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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 ]

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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Carol Bauer, Professor of Otolaryngology, SIU School of Medicine
ClinicalTrials.gov Identifier: NCT00124800     History of Changes
Other Study ID Numbers: 05-014
Study First Received: July 27, 2005
Last Updated: September 23, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014