Clinical trial NCT00808470: Micronutrients to Prevent Noise-induced Hearing Loss
Official title: Micronutrient Intervention to Reduce Noise-Induced Hearing Loss: Prevention of Temporary Threshold Changes Induced by Use of a Digital Music Player
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Noise-Induced Hearing Loss
Keywords: Noise
Hearing Loss
Tinnitus
Antioxidant
Vasodilator
Beta-Carotene
Vitamin C
Vitamin E
Magnesium
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: University of Florida
name: Southern Illinois University
name: Hearing Health Science, Inc.
First posted: 2008-12-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 (pop or rock) set at the same volumes to provide equivalent and consistent exposures across participants. Participants received either a dietary supplement or a placebo once/daily for three days prior to the day of music exposure, and also on the day of music exposure. The fourth and final dose was consumed immediately prior to music listening and consumption was observed by a member of the study team. Changes in hearing were assessed 15-min post-music, and then 1, 2, and 3 hours later, as well as the following day and 1 week later.

Eligibility 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

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

Primary outcomes:
measure: Average Threshold Shift at 4 kHz in Both Ears
timeFrame: 15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.
Secondary outcomes:
measure: Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music
timeFrame: 15 min
measure: Tinnitus
timeFrame: immediate, repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.
Other outcomes:
measure: Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes
timeFrame: 15 min
measure: Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, 8, kHz
timeFrame: repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.
measure: Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Time Measures
timeFrame: repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.
measure: Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Pairs
timeFrame: 15 minutes
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Michigan
name: Josef M Miller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Colleen G Le Prell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Prell CG, Fulbright A, Spankovich C, Griffiths SK, Lobarinas E, Campbell KC, Antonelli PJ, Green GE, Guire K, Miller JM. Dietary supplement comprised of beta-carotene, vitamin C, vitamin E, and magnesium: failure to prevent music-induced temporary threshold shift. Audiol Neurotol Extra. 2016 May-Aug;6(2):20-39. doi: 10.1159/000446600. Epub 2016 Jul 5.
citation: Le Prell CG, Johnson AC, Lindblad AC, Skjonsberg A, Ulfendahl M, Guire K, Green GE, Campbell KC, Miller JM. Increased vitamin plasma levels in Swedish military personnel treated with nutrients prior to automatic weapon training. Noise Health. 2011 Nov-Dec;13(55):432-43. doi: 10.4103/1463-1741.90317.
citation: Spankovich C, Le Prell CG. Associations between dietary quality, noise, and hearing: data from the National Health and Nutrition Examination Survey, 1999-2002. Int J Audiol. 2014 Nov;53(11):796-809. doi: 10.3109/14992027.2014.921340. Epub 2014 Jun 30.
citation: Le Prell CG, Yang Q, Harris JG. Modification of digital music files for use in human temporary threshold shift studies. J Acoust Soc Am. 2011 Oct;130(4):EL142-6. doi: 10.1121/1.3630017.