Noise-induced hearing loss (NIHL) is a significant clinical, social, and economic issue;resolving this important health issue is central to the mission of the NIDCD. Our long-term strategic program of """"""""bedside to laboratory bench to bedside"""""""" directly leads to the current proposal to translate an intervention from """"""""bench to bedside"""""""". Ten years of NIDCD funding for studies in animals have allowed us to identify mechanisms contributing to NIHL, including direct mechanical trauma, free radicals formed in association with metabolic stress, and reduced blood flow. We have now identified a combination of micronutrients (antioxidants and other agents) as highly effective in preventing NIHL in animals. This treatment significantly attenuates sensory cell death in the inner ear and corresponding threshold deficits. The proposed studies, conducted by an international team including basic scientists, otolaryngologists, and audiologists, will demonstrate efficacy of this therapeutic intervention in humans during carefully-controlled clinical trials with real-world noise insults.
Specific Aim 1 will verify therapeutic efficacy with real-world noise insults that induce temporary threshold shifts;these studies will focus on loud music under laboratory conditions, and military urban warfare training exercises.
Specific Aim 2 will verify therapeutic efficacy in humans exposed to occupational noise on a daily basis, including aircraft noise experienced by pilots and ground crew, and machine noise experienced by cutlery workers. Availability of an effective treatment will reduce development of hearing loss in at-risk human populations, thereby improving quality of life for millions and decreasing healthcare costs for individuals, businesses, and government agencies. Funds are therefore requested to initiate a series of Phase II clinical trials to demonstrate for the first time the effectiveness of this intervention in man. This program is intended to be the first translational research step to eliminate NIHL in the 21st century. Noise-induced hearing loss is an important medical, social, and economic issue. We have identified a treatment that reduces inner ear cell death and hearing loss in animals. These studies will demonstrate efficacy of this treatment in humans. This prevention will improve quality of life for the millions exposed to noise, and decrease healthcare costs for individuals, businesses, and government agencies.

Agency
National Institute of Health (NIH)
Institute
National Institute on Deafness and Other Communication Disorders (NIDCD)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DC008423-03
Application #
7766912
Study Section
National Institute of Neurological Disorders and Stroke Initial Review Group (NSD)
Program Officer
Donahue, Amy
Project Start
2008-02-01
Project End
2012-01-31
Budget Start
2010-02-01
Budget End
2011-01-31
Support Year
3
Fiscal Year
2010
Total Cost
$711,176
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Otolaryngology
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
Le Prell, C G; Fulbright, A; Spankovich, C et al. (2016) Dietary supplement comprised of ?-carotene, vitamin C, vitamin E, and magnesium: failure to prevent music-induced temporary threshold shift. Audiol Neurotol Extra 6:20-39
Spankovich, C; Le Prell, C G (2014) Associations between dietary quality, noise, and hearing: data from the National Health and Nutrition Examination Survey, 1999-2002. Int J Audiol 53:796-809
Le Prell, Colleen G; Spankovich, Christopher; LobariƱas, Edward et al. (2013) Extended high-frequency thresholds in college students: effects of music player use and other recreational noise. J Am Acad Audiol 24:725-39
Spankovich, C; Le Prell, C G (2013) Healthy diets, healthy hearing: National Health and Nutrition Examination Survey, 1999-2002. Int J Audiol 52:369-76
Le Prell, Colleen G; Dell, Shawna; Hensley, Brittany et al. (2012) Digital music exposure reliably induces temporary threshold shift in normal-hearing human subjects. Ear Hear 33:e44-58
Watanabe, Reiko; Morell, Maria H; Miller, Josef M et al. (2012) Nestin-expressing cells in the developing, mature and noise-exposed cochlear epithelium. Mol Cell Neurosci 49:104-9
Le Prell, C G; Johnson, A C; Lindblad, A C et al. (2011) Increased vitamin plasma levels in Swedish military personnel treated with nutrients prior to automatic weapon training. Noise Health 13:432-43
Le Prell, C G; Yang, Q; Harris, J G (2011) Modification of digital music files for use in human temporary threshold shift studies. J Acoust Soc Am 130:EL142-6
Le Prell, C G; Hensley, B N; Campbell, K C M et al. (2011) Evidence of hearing loss in a 'normally-hearing' college-student population. Int J Audiol 50 Suppl 1:S21-31