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Trials

, 15:110

First Online: 05 April 2014Received: 20 November 2013Accepted: 21 March 2014DOI: 10.1186-1745-6215-15-110

Cite this article as: Gilles, A., Ihtijarevic, B., Wouters, K. et al. Trials 2014 15: 110. doi:10.1186-1745-6215-15-110

Abstract

BackgroundDuring leisure activities young people are often exposed to excessive noise levels resulting in an increase of noise-induced symptoms such as hearing loss, tinnitus and hyperacusis. Noise-induced tinnitus is often perceived after loud music exposure and provides an important marker for overexposure as a temporary threshold shift that is often not experienced by the individual itself. As oxidative stress plays an important role in the pathogenesis of noise-induced hearing loss, the use of antioxidants to prevent hearing damage has recently become the subject of research.

MethodsThis study proposes a randomized, double-blind, placebo-controlled crossover trial to assess the effects of a prophylactic combination of N-acetylcysteine 600 mg and magnesium 200 mg prior to leisure noise exposure in young adults. The primary outcome measure is the tinnitus loudness scored by a visual analogue scale VAS. Secondary outcome measures are the differences in audiological measurements for the antioxidant treatments compared to placebo intake. Audiological testing comprising of pure tone audiometry including frequencies up to 16 kHz, distortion product otoacoustic emissions, transient-evoked otoacoustic emissions and speech-in-noise testing will be performed prior to and within 7 hours after noise exposure. By use of a mixed effects statistical model, the effects of antioxidants compared to placebo intake will be assessed.

DiscussionAs adolescents and young adults often do not use hearing protection while being exposed to loud music, the use of preventive antioxidant intake may provide a useful and harmless way to prevent noise-induced hearing damage in this population. Furthermore, when exposed to hazardous noise levels the protection provided by hearing protectors might not be sufficient to prevent hearing damage and antioxidants may provide additive otoprotective effects. Previous research mainly focused on occupational noise exposure. The present study provides a protocol to assess the usefulness of antioxidants during leisure noise activities.

Trial registrationThe present protocol is registered at ClinicalTrials.gov: NCT01727492.

KeywordsNoise-induced hearing loss Antioxidants N-acetylcysteine Magnesium Adolescents ROS RNS Prevention Noise damage Randomized controlled trial AbbreviationsANOVAAnalysis of variance

CONSORTConsolidated Standards of Reporting Trials

DPOAEDistortion-product otoacoustic emission

LISTLeuven intelligibility sentence test

Mg2+Magnesium

NACN-acetylcysteine

NIHLNoise-induced hearing loss

NITNoise-induced tinnitus

RNSReactive nitrogen species

ROSReactive oxygen species

SNRSignal-to-noise ratio

SPIRITStandard Protocol Items: Recommendations for Interventional Trials

SRTSpeech reception threshold

TEOAETransient-evoked otoacoustic emission

VASVisual analogue scale.

Annick Gilles, Berina Ihtijarevic contributed equally to this work.

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Author: Annick Gilles - Berina Ihtijarevic - Kristien Wouters - Paul Van de Heyning

Source: https://link.springer.com/







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