September 16, 2013
Federal grant boosts hearing loss study
CARBONDALE, Ill. -- A Southern Illinois University School of Medicine patented drug aimed at preventing noise-induced hearing loss is in the final stages of research. A $2.5 million grant from the U.S. Department of Defense U.S. Army Research and Materiel Command Branch will support a Phase 3 clinical trial to determine if D-methionine (D-met) can prevent noise-induced hearing loss in soldiers.
Kathleen C.M. Campbell, Ph.D., SIU professor of otolaryngology head and neck surgery and director of the division’s audiology research, is the principal investigator for the five-year project and inventor of the D-met drug. The study is a collaboration among SIU, the U.S. Army and Yale University.
The clinical trial is a prospective double-blind, placebo-controlled trial being conducted at Ft. Jackson, S.C. It involves 600 drill sergeant instructor trainees during their two weeks of M-16 weapons training, firing 500 rounds during a period of 11 days.
The soldiers will take either the D-met formulation or a placebo for a total of 18 days before, during and after the training. They will be assessed for hearing thresholds and tinnitus (ringing in the ears) before and two weeks after the noise exposure. The clinical trials are approved by the Food and Drug Administration and military institutional review boards. Data will be collected over a period of two years.
“As a former clinician who worked to rehabilitate patients with hearing loss and tinnitus, I am pleased to collaborate with the military to hopefully prevent this life-altering problem,” said Campbell. “To possibly bring the research from bench to bedside is very gratifying.” Campbell did her research at SIU, which owns the patents on the D-met drug.
Although the Department of Defense has had hearing conservation programs since the 1970s, including universal hearing protection (muffs and/or plugs) as well as monitoring and tracking, disability claims are increasing. The U.S. military receives more than 22,000 new claims per year for noise induced hearing loss (NIHL), which is the most common reason that U.S. troops cannot be redeployed.
“Noise-induced hearing loss and tinnitus comprise the top two injuries in terms of incidence and compensation not only Army-wide, but Department of Defense-wide. The Fort Jackson Hearing Program is committed to reducing these disabling conditions in our troops,” said Captain Rebecca Ludwig, chief of the Fort Jackson Hearing Program.
Hearing disability increases the risk of death not only for the soldiers with hearing loss but also for fellow troops because of impaired ability to communicate quickly, detect hazards or locate the enemy. NIHL is estimated to cost the Veterans Administration more than one billion dollars annually and noise-induced tinnitus (ringing in the ears) costs another one billion dollars per year. Permanent NIHL affects more than ten million Americans and work-related noise exposure affects close to 30 million. Campbell’s studies have been shown that D-Met protects against NIHL.
Campbell’s noise-induced hearing loss research previously has received $8.3 million in funding from the National Institutes of Health, DOD, and other national and international funding organizations as well as industry contracts and patent income. She has served as principal investigator for more than 60 state and federal research grants, focused primarily on ototoxicity and otoprotective agents.
Campbell joined SIU’s faculty in 1989. Previously, she was in charge of electrophysiologic measures for the otolaryngology department at the University of Iowa (1982-88), where she also completed her doctoral degree (1989). She began her career as a full-time clinician in British Columbia, starting the first audiology clinic in the Canadian Rockies for BC Public Health (1977-82). Campbell earned her master’s at the University of South Dakota (1977) and her bachelor’s at South Dakota State University (1973).