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Micronutrients to Prevent Noise-induced Hearing Loss

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00808470
First Posted: December 15, 2008
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Florida
Southern Illinois University
Hearing Health Science, Inc.
Information provided by (Responsible Party):
Glenn Green, University of Michigan
  Purpose

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.


Condition Intervention Phase
Noise-Induced Hearing Loss Drug: beta-carotene, vitamins C and E, magnesium Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Micronutrient Intervention to Reduce Noise-Induced Hearing Loss: Prevention of Temporary Threshold Changes Induced by Use of a Digital Music Player

Resource links provided by NLM:


Further study details as provided by Glenn Green, University of Michigan:

Primary Outcome Measures:
  • Average Threshold Shift at 4 kHz in Both Ears [ Time Frame: 15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ]
    The study measures the quietest decibel level the participants can hear before the 4 hour music exposure The first post-music test to measure shift is 15 minutes after the music exposure is completed and again at 1 hour intervals. The shift represents the mean change in quietest decibel volume detected between baseline (pre-music) and post music.


Secondary Outcome Measures:
  • Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music [ Time Frame: 15 min ]
    The study measures the quietest decibel level the participants can hear before the 4 hour music exposure The first post-music test to measure shift is 15 minutes after the music exposure is completed and again at 1 hour intervals. The shift represents the mean change in quietest decibel volume detected between baseline (pre-music) and post music.

  • Tinnitus [ Time Frame: immediate, repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ]
    Presence of tinnitus was assessed using yes/no question. If tinnitus was reported, perception was assessed using survey.


Other Outcome Measures:
  • Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes [ Time Frame: 15 min ]
    DPOAE amplitude was measured following the audiometric testing completion at approximately 30 minutes post music. Test time was approximate as DPOAE tests began as soon as threshold testing was completed. F1 and F2 frequency pairs included 3328 and 3984 Hz, F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10 dB lower than F1 levels. Threshold tests began precisely at 15 min, 1 hr 15 min, 2 hr 15 min, 3 hr 15 min. Threshold tests take approximately 15 min, but the exact duration of testing varies from subject to subject. The OAE testing began as soon as threshold testing completed. Thus, OAE tests began approx. 30 min, 1 hr 30 min, 2 hr 30 min, and 3 hr 30 min post music, but for some it may have been a little bit earlier or a little bit later (i.e., the test may have begun as early as 25 min or as late as 35 min post music, depending on how quickly the subject completed threshold testing).

  • Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, 8, kHz [ Time Frame: repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ]
  • Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Time Measures [ Time Frame: repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ]
    DPOAE amplitude was measured following the audiometric testing completion at each of the post-music test times. F1 and F2 frequency pairs included 6656 and 8015 Hz, 5016 and 6000 Hz, 3328 and 3984 Hz, 2484 and 3000 Hz, and 1687 and 2015 Hz. F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10 dB lower than F1 levels.

  • Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Pairs [ Time Frame: 15 minutes ]
    Distortion Product Otoacoustic Emission (DPOAE) Amplitude was measured following the audiometric testing completion at approximately 30 minutes post music. F1 and F2 frequency pairs included 6656 and 8015 Hz, 5016 and 6000 Hz, 2484 and 3000 Hz, and 1687 and 2015 Hz. F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10dB lower than F1 Levels. Threshold tests began precisely at 15 min, 1 hr 15 min, 2 hr 15 min, 3 hr 15 min. The OAE testing began as soon as threshold testing completed. Threshold tests take approximately 15 min, but the exact duration of testing varies among subjects. Thus, OAE tests began approx. 30 min, 1 hr 30 min, 2 hr 30 min, and 3 hr 30 min post music, but for some it may have been a little bit earlier than for others (i.e., the test may have begun as early as 25 min or as late as 35 min post music, depending on how quickly the subject completed threshold testing).


Enrollment: 72
Study Start Date: October 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutrients
Subjects in University of Florida music player study who are assigned to nutrient condition(beta-carotene, vitamins C and E, magnesium). Nutrient tablets are consumed for 4 days.
Drug: beta-carotene, vitamins C and E, magnesium

6 mint-flavored tablets per day, taken once daily

total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene.

Other Name: Soundbites®
Placebo Comparator: Placebo for nutrients
Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.
Other: Placebo
6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808470


Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Michigan
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Florida
Southern Illinois University
Hearing Health Science, Inc.
Investigators
Principal Investigator: Josef M Miller, PhD University of Michigan
Principal Investigator: Colleen G Le Prell, PhD University of Florida
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Glenn Green, Associate Professor of Otolaryngology, University of Michigan
ClinicalTrials.gov Identifier: NCT00808470     History of Changes
Other Study ID Numbers: U01DC008423 ( U.S. NIH Grant/Contract )
U01DC008423-02S1 ( U.S. NIH Grant/Contract )
U01DC008423-03 ( U.S. NIH Grant/Contract )
First Submitted: December 11, 2008
First Posted: December 15, 2008
Results First Submitted: May 8, 2015
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017
Last Verified: April 2017

Keywords provided by Glenn Green, University of Michigan:
Noise
Hearing Loss
Tinnitus
Antioxidant
Vasodilator
Beta-Carotene
Vitamin C
Vitamin E
Magnesium

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural
Vitamins
Ascorbic Acid
Beta Carotene
Carotenoids
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Provitamins