Micronutrients to Prevent Noise-induced Hearing Loss
Completed · Phase 2 · Has a placebo group
Conditions studied: Noise-Induced Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT00808470
- Run by
- University of Michigan
- People needed
- 72
- Starts
- 2008-10-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2017-05-19
Who can join
Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Hearing inclusion criteria are as follows for all studies:
- subjects must have a normal audiologic assessment at baseline consisting of:
- symmetric hearing with air conduction thresholds no worse than 25 dB HL at tested frequencies between .25 - 8 kHz;
- no significant threshold asymmetry (i.e., greater than 15 dB) between the ears at any test frequency;
- no significant air-bone gaps (i.e., greater than 10 dB); and
- 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
You may not qualify if…
- 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
Where it is running
- University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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