Noise-Induced Hearing Loss Clinical Trial
Official title:
Micronutrient Intervention to Reduce Noise-Induced Hearing Loss: Prevention of Temporary Threshold Changes Induced by Use of a Digital Music Player
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 antioxidant vitamins (beta-carotene, and vitamins C and
E) and the mineral magnesium (which acts in part as a vasodilator but also as an
antioxidant) 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 70 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 31 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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