Formby Begins $5.6 Million Study of Treatment for Tinnitus Among Military Personnel

February 1st, 2010 - Filed under: Cover Story

tinnitusDr. Craig Formby, distinguished graduate research professor in the department of communicative disorders, 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 – the ringing in the ears that drives some people to distraction.

The non-medical, habituation-based treatment being studied is known as Tinnitus Retraining Therapy (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.

Formby’s team at UA leads the clinical part of the NIH-sponsored study, 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.

Dr. Craig Formby

Dr. Craig Formby

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. It’s projected to exceed $1.1 billion and affect more than 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. For an estimated 2 to 5 million, 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.

Under the current standard of care, counselors typically try to help tinnitus sufferers manage the problem by suggesting coping strategies and by providing information about tinnitus. Formby will compare this standard 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 devices produced by General Hearing Instruments that generate a “soft seashell-like noise,” which blends with the tinnitus.

“In TRT theory, the soft noise throughout the day from the noise generators helps to facilitate the habituation process, which is initiated by the counseling,” Formby says. “Patients are encouraged to use their devices from the time they start their day until the end of the day or at least for eight hours a day. The patients are told to forget the devices are on. Don’t worry about the tinnitus, don’t keep a log, and don’t worry about how bad their tinnitus is from hour to hour or day to day; just go on with their lives.”

They are also taught about their auditory system and how it is believed to work together with parts of the brain and central nervous system to give rise to their debilitating tinnitus conditions.

“If successful, then most patients receiving the full TRT treatment will likely report the tinnitus is no longer troublesome for them at the conclusion of the study,” Formby says. “If you make a measurement of the tinnitus in terms of its pitch and loudness characteristics at the start of the study and at the end of the study, then the perceived tinnitus properties will likely be similar. But the patient’s perception of the annoyance and awareness of the tinnitus will be reduced, and the tinnitus will not be bothersome to them in the way it was at the start of the study.”

Formby has been working with the U.S. military since 1999 to develop the study protocol for this pioneering investigation, which is the first definitive phase-three clinical trial of TRT sponsored by NIH. The clinical trial will take place at the Naval Hospital Camp Pendleton in Irvine, Calif.; the National Naval Medical Center in Bethesda, Md.; the Portsmouth Naval Hospital in Portsmouth, Va.; the San Diego Naval Hospital; the David Grant Medical Center at Travis Air Force Base in Fairfield, Calif.; and the Wilford Hall Medical Center at Lackland Air Force Base in San Antonio, Texas.

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