Micronutrients to Prevent Noise-induced Hearing Loss
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 1/1/2014 |
| Start Date: | October 2008 |
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.
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.
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
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
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