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Micronutrients to Prevent Noise-induced Hearing Loss - NCT00808470-32610(Clinical Trial 259549)



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City:  Gainesville
State:  
FL
Zip Code: 32610
Conditions: Noise-Induced Hearing Loss
Purpose: Noise-induced hearing loss (NIHL) is a significant clinical, social, and economic issue. 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. A combination of antioxidants (beta-carotene, and vitamins C and E) and the mineral magnesium (which acts in part as a vasodilator) is highly effective in preventing NIHL in animals. These studies evaluate efficacy of this intervention in humans. Hypothesis: Treatment with these micronutrients provides safe, effective attenuation of acute hearing changes induced by exposure to real-world sounds producing temporary (non-permanent) or permanent hearing changes induced by exposure to real-world sounds. Experiment 1: "Digital Audio Player" studies (University of Florida, Gainesville). Prevention of *temporary* elevations in hearing thresholds, induced by exposure to moderately loud music, will be measured. Subjects will be 60 young adults with equal numbers of male and female participants. Experiment 2: "Urban warfare" military studies (Karolinska Institutet, Sweden). Prevention of *temporary* elevations in hearing thresholds, induced by automatic gunfire sound inside a concrete bunker, will be measured. Subjects will be 24 adult male or female officers in the Swedish army required to participate in urban combat training regardless of study participation. All subjects are required to wear standard hearing protection during combat exercises. Experiment 3: "NATO airbase" studies (Universidad de Castilla-La Mancha, Spain). Prevention of permanent hearing loss, induced by daily exposure to aircraft engine noise, will be measured over two-years. Subjects will be 120 adult male or female Spanish NATO soldiers. All subjects are required to wear standard hearing protection regardless of study participation. Experiment 4: "Stamping Factory" studies (Universidad de Castilla-La Mancha, Spain). Prevention of permanent hearing loss, induced by daily exposure to industrial noise, will be will be measured over two-years. Subjects will be 120 adult male or female personnel at a Spanish stamping factory hired within the past 5 years. All subjects are required to wear standard hearing protection regardless of study participation.
Study summary:
Criteria: Inclusion Criteria: Hearing inclusion criteria are as follows for all studies: - subjects must have a normal audiologic assessment at baseline consisting of: 1. symmetric hearing with air conduction thresholds no worse than 25 dB HL at tested frequencies between .25 - 8 kHz; 2. no significant threshold asymmetry (i.e., greater than 15 dB) between the ears at any test frequency; 3. no significant air-bone gaps (i.e., greater than 10 dB); and 4. Type A tympanograms bilaterally, defined as a range of -140 to +40 daPa based on the 90% range for adults (Margolis & Hunter 2000). Additional criteria are as follows: - No history of ear disease, able to provide informed consent, agree to follow study procedures, normal health screening at study entry - To participate in two-year studies, subjects must be non-smoking individuals, and must have normal electrolytes, BUN, creatinine, hematocrit, and liver enzymes Exclusion Criteria: - Pregnant or trying to become pregnant within study period females), - subjects belonging to vulnerable populations - subjects with any history of chronic disease - hearing loss that exceeds limits specified above - inability or failure to provide informed consent - medical conditions that require treatment with drugs including anticoagulants - diuretics - digoxin - aspirin/salicylate - barbiturates - minocycline
Study is available at: University of Florida
Gainesville, FL 32610
United States

Primary Contact:
Colleen G Le Prell, PhD
Email: colleeng@phhp.ufl.edu
Phone: 352-271-6163
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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