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| ID | Type | Description | Link |
|---|---|---|---|
| U01DC008423-02S1 | U.S. NIH Grant/Contract | View source | |
| U01DC008423-03 | U.S. NIH Grant/Contract | View source | |
| U01DC008423 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| University of Florida | OTHER |
| Southern Illinois University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrients | Experimental | 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. |
|
| Placebo for nutrients | Placebo Comparator | Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beta-carotene, vitamins C and E, magnesium | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes | 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). |
Inclusion Criteria:
Hearing inclusion criteria are as follows for all studies:
subjects must have a normal audiologic assessment at baseline consisting of:
Additional criteria are as follows:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josef M Miller, PhD | University of Michigan | Principal Investigator |
| Colleen G Le Prell, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27990155 | Background | 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. | |
| 22122960 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nutrients | Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days. Dietary supplement consisting of 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. |
| FG001 | 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. Placebo Control: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
healthy young adults that meet audiometric enrollment criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | Nutrients | Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days. Dietary supplement consisting of 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects that completed music exposure were analyzed; two subjects withdrew from study prior to music exposure. | Posted | Mean | Standard Deviation | decibels | 15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. |
|
one week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nutrients | Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days. Dietary supplement consisting of 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach ache | Gastrointestinal disorders | Systematic Assessment | includes any report of stomach ache, upset stomach, |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Colleen Le Prell | University of Texas at Dallas | 214-905-3018 | colleen.leprell@utdallas.edu |
| ID | Term |
|---|---|
| D006317 | Hearing Loss, Noise-Induced |
| D034381 | Hearing Loss |
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D019207 | beta Carotene |
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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| Hearing Health Science, Inc. |
| UNKNOWN |
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Not provided
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|
|
| Placebo | Other | 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. |
|
| 15 min |
| Tinnitus | Presence of tinnitus was assessed using yes/no question. If tinnitus was reported, perception was assessed using survey. | immediate, repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. |
| 15 min |
| Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, 8, kHz | 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 | 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. | 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 Pairs | 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). | 15 minutes |
| 24975234 | Derived | 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. |
| 21974483 | Derived | 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. |
| BG001 | 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. Placebo Control: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. Placebo Control: 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. |
|
|
|
| Secondary | Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music | 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. | all participants that completed music exposure were assessed; two participants withdrew prior to music exposure. | Posted | Mean | Standard Deviation | decibels | 15 min |
|
|
|
| Secondary | Tinnitus | Presence of tinnitus was assessed using yes/no question. If tinnitus was reported, perception was assessed using survey. | all participants completing music exposure completed tinnitus surveys. | Posted | Number | participants | 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 | Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes | 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). | Data for one participant in the placebo group is incomplete. | Posted | Mean | Standard Deviation | decibels (dB) | 15 min |
|
|
|
| Other Pre-specified | Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, 8, kHz | Not Posted | repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. | Participants |
| Other Pre-specified | Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Time Measures | 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. | Not Posted | repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. | Participants |
| Other Pre-specified | Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Pairs | 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). | Not Posted | 15 minutes | Participants |
| 0 |
| 37 |
| 2 |
| 37 |
| EG001 | Placebo for Nutrients | Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days. Placebo Control: 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. | 0 | 35 | 5 | 35 |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| 1000 Hz |
|
| 2000 Hz |
|
| 3000 Hz |
|
| 6000 Hz |
|
| 8000 Hz |
|
| f2=3984Hz,f1=55dB,right |
|
| f2=3984Hz,f1=50dB,right |
|
| f2=3984Hz,f1=45dB,right |
|
| f2=3984Hz,f1=40dB,right |
|
| f2=3984Hz,f1=35dB,right |
|
| f2=3984Hz,f1=30dB,right |
|
| f2=3984Hz,f1=25dB,right |
|
| f2=3984Hz,f1=65dB,left |
|
| f2=3984Hz,f1=60dB,left |
|
| f2=3984Hz,f1=55dB,left |
|
| f2=3984Hz,f1=50dB,left |
|
| f2=3984Hz,f1=45dB,left |
|
| f2=3984Hz,f1=40dB,left |
|
| f2=3984Hz,f1=35dB,left |
|
| f2=3984Hz,f1=30dB,left |
|
| f2=3984Hz,f1=25dB,left |
|