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Micronutrients to Prevent Noise-induced Hearing Loss

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ClinicalTrials.gov Identifier: NCT00808470
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE December 11, 2008
First Posted Date  ICMJE December 15, 2008
Results First Submitted Date  ICMJE May 8, 2015
Results First Posted Date  ICMJE May 19, 2017
Last Update Posted Date May 19, 2017
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
Maximum threshold shift at 3, 4, or 6 kHz in either ear [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes. Tests at 1 year and 2 years to measure permanent changes in Spanish studies. ]
Change History Complete list of historical versions of study NCT00808470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
  • Threshold shift at individual frequencies, including 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12.5, 14 and 16 kHz [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes. Tests at 1 year and 2 years to measure permanent changes in Spanish studies. ]
  • Distortion Product Otoacoustic Emission (DPOAE) amplitude [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes. Tests at 1 year and 2 years to measure permanent changes in Spanish studies. ]
  • Tinnitus [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes. Tests at 1 year and 2 years to measure permanent changes in Spanish studies. ]
Current Other Pre-specified Outcome Measures
 (submitted: April 13, 2017)
  • 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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Micronutrients to Prevent Noise-induced Hearing Loss
Official Title  ICMJE Micronutrient Intervention to Reduce Noise-Induced Hearing Loss: Prevention of Temporary Threshold Changes Induced by Use of a Digital Music Player
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Noise-Induced Hearing Loss
Intervention  ICMJE
  • 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®
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: beta-carotene, vitamins C and E, magnesium
  • 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.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2017)
72
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2008)
324
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Spain,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT00808470
Other Study ID Numbers  ICMJE U01DC008423( U.S. NIH Grant/Contract )
U01DC008423-02S1 ( U.S. NIH Grant/Contract )
U01DC008423-03 ( U.S. NIH Grant/Contract )
U01DC008423 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Glenn Green, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • University of Florida
  • Southern Illinois University
  • Hearing Health Science, Inc.
Investigators  ICMJE
Principal Investigator: Josef M Miller, PhD University of Michigan
Principal Investigator: Colleen G Le Prell, PhD University of Florida
PRS Account University of Michigan
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP