Status:
COMPLETED
Micronutrients to Prevent Noise-induced Hearing Loss
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Florida
Conditions:
Noise-Induced Hearing Loss
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
Brief Summary
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 tra...
Detailed Description
This study assessed the potential for prevention of the temporary changes in hearing that can occur after use of a music player device for 4 hours. All participants listened to one of two playlists (p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00808470
Start Date
October 1 2008
End Date
December 1 2013
Last Update
May 19 2017
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610