A University of Alabama researcher is embarking on a $5.6 million phase-three, randomized, controlled clinical trial to evaluate the effectiveness of an innovative treatment that uses a noise-generating device, along with counseling, to alleviate the debilitating effects of tinnitus - that ringing in the ears that drives some people to distraction.
The non-medical habituation-based treatment being studied is known as Tinnitus Retraining Therapy or TRT. The investigational study of TRT will involve tinnitus sufferers drawn from the U.S. Navy, Marines and Air Force, and will be conducted in Navy and Air Force flagship hospitals in California, Texas, Maryland and Virginia. Researchers expect to recruit 228 participants for the study.
Dr. Craig Formby, UA distinguished graduate research professor in the department of communicative disorders, leads the NIH-sponsored study. Formby's team at UA leads the clinical part of the study, which is funded by a $3.2 million award from the National Institute of Deafness and Other Communication Disorders. Researchers at Johns Hopkins University have received a $2.4 million award to manage and analyze the study data. The project will be spread over five years, including four years for recruiting study participants and conducting the treatment and follow-up measurements.
Tinnitus is the No. 1 service-connected disability among veterans returning from the Middle East conflicts. In 2008, compensation for tinnitus disability in the VA medical system alone exceeded $500 million and is projected to exceed $1.1 billion and affect more that 800,000 veterans by 2011.
"Tinnitus is a noise inside the ear or head in the absence of any sound that could account for it," Formby says. "We don't know what happens. In some cases, it's related to an acoustic insult or gunfire. However, there may be no obvious cause for the tinnitus for many sufferers. It's some sort of over-stimulation of the auditory system that produces hyperactivity either at a peripheral or central level."
Most people who have tinnitus ignore it, Formby says, but for some it's torture. As many as 50 million Americans experience tinnitus. Estimates are that for about 2 to 5 million people, the problem is incapacitating.
"We know of reports of sufferers who have chronic debilitating tinnitus that is so troublesome that they would elect to cut the auditory nerve to get rid of the persistent ringing," Formby says.
The current standard of care involves counseling people with debilitating tinnitus. The counselors typically try to help the tinnitus sufferer to manage the problem by suggesting coping strategies and by providing information about tinnitus.
"The standard of care historically has included reassurance that the patient's condition is not life threatening nor an indicator of imminent hearing loss," he says.
Formby will compare the current standard of care for management of tinnitus in the military with TRT and with a placebo condition that will control for the treatment effects of the noise-generator component of the TRT treatment. After specialized TRT counseling to start the habituation process, each of the affected military personnel will use a pair of ear-worn noise-generator devices produced by General Hearing Instruments that produce a "soft seashell-like noise," which blends with the tinnitus.