151
Participants
Start Date
July 31, 2011
Primary Completion Date
February 28, 2017
Study Completion Date
February 28, 2017
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)
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.
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.
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.
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.
Walter Reed National Military Medical Center, Bethesda
Naval Medical Center, San Diego
David Grant Medical Center, Travis Air Force Base
Naval Hospital Camp Pendleton, Camp Pendleton
Wilford Hall Medical Center, Lackland Air Force Base
Portsmouth Naval Medical Center, Portsmouth
Collaborators (1)
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
University of Alabama, Tuscaloosa
OTHER
David Grant U.S. Air Force Medical Center
FED
59th Medical Wing
FED
United States Naval Medical Center, San Diego
FED
United States Naval Medical Center, Portsmouth
FED
Naval Hospital Camp Pendleton
FED
Walter Reed National Military Medical Center
FED
Johns Hopkins Bloomberg School of Public Health
OTHER