Tinnitus Retraining Therapy Trial

Summary

The primary purpose of the Tinnitus Retraining Therapy Trial (TRTT) is to assess the efficacy of tinnitus retraining therapy (TRT) as a treatment for severe debilitating tinnitus. TRT is a non-medical intervention that uses directive counseling (DC) and sound therapy (ST)to habituate the patient's associated negative emotional reactions to tinnitus, its perception, and ultimately, its impact on the patient's life.

Conditions

• Subjective Tinnitus

Interventions

DEVICE

Conventional sound generator (SG)

Conventional SGs: Tranquil model sound generators (General Hearing Instruments, Inc.) are either inside or outside-the-ear devices that generate low-level noise, which is set at or just below the patient's mixing point (i.e., the noise level that just blends with the study participant's tinnitus)

DEVICE

Placebo sound generator (placebo SG)

Tranquil model placebo sound generators (General Hearing Instruments, Inc.) are either inside or outside-the-ear devices that generate a sound different from the active devices.

BEHAVIORAL

Standard of Care (SC)

The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.

BEHAVIORAL

Directive Counseling (DC)

Directive Counseling (DC): two-hour educational session during which the patient is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, provide instruction on anatomy and physiology of hearing and tinnitus, introduce the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and describe and recommend the use of ST and environmental sound in the habituation process.

BEHAVIORAL

Directive Counseling (DC)

Directive Counseling (DC): two-hour educational session during which the patient is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, provide instruction on anatomy and physiology of hearing and tinnitus, introduce the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and describe and recommend the use of ST and environmental sound in the habituation process.

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• University of Alabama, Tuscaloosa

  collaborator OTHER

• David Grant U.S. Air Force Medical Center

  collaborator FED

• 59th Medical Wing

  collaborator FED

• United States Naval Medical Center, San Diego

  collaborator FED

• United States Naval Medical Center, Portsmouth

  collaborator FED

• Naval Hospital Camp Pendleton

  collaborator FED

• Walter Reed National Military Medical Center

  collaborator FED

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• C. Craig Formby, PhD · The University of Alabama, Tuscaloosa

• Roberta W Scherer, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2017-02-28

Completion

2017-02-28

Countries

• United States

Study Locations