Using prophylactic antioxidants to prevent noise-induced hearing damage in young adults: a protocol for a double-blind, randomized controlled trial.
BACKGROUND
During 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.


METHODS
This 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.


CONCLUSIONS
As 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.


BACKGROUND
The present protocol is registered at ClinicalTrials.gov: NCT01727492.
Department of Translational Neuroscience, Faculty of Medicine, University of Antwerp, Antwerp, Belgium. annick.gilles@uza.be.
Annick
A
Gilles
Berina
B
Ihtijarevic
Kristien
K
Wouters
Paul
P
Van de Heyning
D000111:Acetylcysteine / Q000008:administration & dosage*; D000161:Acoustic Stimulation; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000975:Antioxidants / Q000008:administration & dosage*; D001301:Audiometry, Pure-Tone; D001302:Audiometry, Speech; D001530:Belgium; D002985:Clinical Protocols; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006317:Hearing Loss, Noise-Induced / Q000175:diagnosis / Q000378:metabolism / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D006801:Humans; D008274:Magnesium / Q000008:administration & dosage*; D008297:Male; D009146:Music; D009622:Noise / Q000009:adverse effects*; D017084:Otoacoustic Emissions, Spontaneous / Q000187:drug effects; D018384:Oxidative Stress / Q000187:drug effects; D010470:Perceptual Masking; D011322:Primary Prevention / Q000379:methods*; D012107:Research Design; D012307:Risk Factors; D013067:Speech Perception; D013997:Time Factors; D014012:Tinnitus / Q000175:diagnosis / Q000378:metabolism / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D016896:Treatment Outcome; D055815:Young Adult
D000975:Antioxidants; D004338:Drug Combinations; D008274:Magnesium; D000111:Acetylcysteine