Tinnitus Retraining Therapy Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

February 28, 2017

Study Completion Date

February 28, 2017

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.

Trial Locations (6)

20889

Walter Reed National Military Medical Center, Bethesda

92134

Naval Medical Center, San Diego

94535

David Grant Medical Center, Travis Air Force Base

92055-5191

Naval Hospital Camp Pendleton, Camp Pendleton

78236-5300

Wilford Hall Medical Center, Lackland Air Force Base

23705-2103

Portsmouth Naval Medical Center, Portsmouth

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

collaborator

University of Alabama, Tuscaloosa

OTHER

collaborator

David Grant U.S. Air Force Medical Center

FED

collaborator

59th Medical Wing

FED

collaborator

United States Naval Medical Center, San Diego

FED

collaborator

United States Naval Medical Center, Portsmouth

FED

collaborator

Naval Hospital Camp Pendleton

FED

collaborator

Walter Reed National Military Medical Center

FED

lead

Johns Hopkins Bloomberg School of Public Health

OTHER