Back to results

Micronutrients to Prevent Noise-induced Hearing Loss

Primary Purpose

Noise-Induced Hearing Loss

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

beta-carotene, vitamins C and E, magnesium

Placebo

About this trial

This is an interventional prevention trial for Noise-Induced Hearing Loss focused on measuring Noise, Hearing Loss, Tinnitus, Antioxidant, Vasodilator, Beta-Carotene, Vitamin C, Vitamin E, Magnesium

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutrients

Placebo for nutrients

Arm Description

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.

Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.

Outcomes

Primary Outcome Measures

Average Threshold Shift at 4 kHz in Both Ears

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

Tinnitus

Presence of tinnitus was assessed using yes/no question. If tinnitus was reported, perception was assessed using survey.

Full Information

NCT ID

NCT00808470

First Posted

December 11, 2008

Last Updated

April 13, 2017

Sponsor

University of Michigan

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD), University of Florida, Southern Illinois University, Hearing Health Science, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00808470

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD), University of Florida, Southern Illinois University, Hearing Health Science, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Noise-Induced Hearing Loss

Keywords

Noise, Hearing Loss, Tinnitus, Antioxidant, Vasodilator, Beta-Carotene, Vitamin C, Vitamin E, Magnesium

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nutrients

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo for nutrients

Arm Type

Placebo Comparator

Arm Description

Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.

Intervention Type

Drug

Intervention Name(s)

beta-carotene, vitamins C and E, magnesium

Other Intervention Name(s)

Soundbites®

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Average Threshold Shift at 4 kHz in Both Ears

Description

Time Frame

15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.

Secondary Outcome Measure Information:

Title

Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music

Description

Time Frame

15 min

Title

Tinnitus

Description

Presence of tinnitus was assessed using yes/no question. If tinnitus was reported, perception was assessed using survey.

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.

Other Pre-specified Outcome Measures:

Title

Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes

Description

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).

Time Frame

15 min

Title

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.

Title

Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Time Measures

Description

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.

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.

Title

Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Pairs

Description

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).

Time Frame

15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Josef M Miller, PhD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Colleen G Le Prell, PhD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27990155

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.

Results Reference

background

PubMed Identifier

22122960

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.

Results Reference

result

PubMed Identifier

24975234

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.

Results Reference

derived

PubMed Identifier

21974483

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.

Results Reference

derived

Learn more about this trial

Micronutrients to Prevent Noise-induced Hearing Loss

We'll reach out to this number within 24 hrs