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Strategies for Evaluating Antioxidant Efficacy in Clinical Trials Assessing Prevention of Noise-Induced Hearing Loss

  • Chapter
Free Radicals in ENT Pathology

Abstract

Outcomes in studies assessing the prevention of acquired hearing loss have been encouraging, particularly with respect to the prevention of noise-induced hearing loss (NIHL) in animal models. Data from human subjects are more limited, but several small-scale studies suggest potential benefit from several different agents with antioxidant properties. Our own research efforts have evaluated additional compounds with potential benefits for the prevention of NIHL (NCT00808470; NCT01444846). A number of other agents are entering human clinical trials, and this chapter provides a review of the test measures that are commonly used, as well as other emerging metrics that may have utility in the future. While we review current and completed clinical trials as part of this chapter, the field continues to advance at a rapid pace, and the information provided in this chapter will surely become quickly dated. Readers are encouraged to visit the National Institutes of Health online Clinical Trials Registry (http://clinicaltrials.gov/) for easy access to up-to-date clinical trial information. At the time of writing this chapter, there are no therapeutics approved by the US Food and Drug Administration (FDA) for the prevention of NIHL or hearing loss acquired secondary to other insults such as aminoglycoside antibiotic exposure or cisplatin treatment.

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Abbreviations

ABR:

Auditory brainstem response

ASHA:

American Speech–Language–Hearing Association

BKB:

Bamford-Kowal-Bench sentences

CST:

Connected Speech Test

CHABA:

Committee on Hearing, Bioacoustics, and Biomechanics

dB:

Decibel

DoD:

Department of Defense

DPOAE:

Distortion product otoacoustic emission

EHF:

Extended high frequency

FDA:

Food and Drug Administration

HCoE:

Department of Defense Hearing Center of Excellence

HINT:

Hearing in noise test

HPD:

Hearing Protection Device

Hz:

Hertz

kHz:

Kilohertz

NIHL:

Noise-induced hearing loss

NIOSH:

National institute of occupational safety and health

NIPTS:

Noise-induced permanent threshold shift

NU-6:

Northwestern University Auditory Test No. 6

OHC:

Outer hair cell

OSHA:

Occupational safety and health administration

PRO:

Patient reported observation

PTS:

Permanent threshold shift

RSIR:

Revised Speech intelligibility rating test

R-SPIN:

Revised speech perception in noise test

SIR:

Speech intelligibility rating test

SNR:

Signal to noise ratio

SPIN:

Speech perception in noise test

SPRINT:

Speech recognition in noise test

sSRT:

Sentence-based speech reception threshold

STS:

Standard threshold shift (OSHA), significant threshold shift (NIOSH)

TFI:

Tinnitus functional index

TTS:

Temporary threshold shift

TTS2:

Temporary threshold shift measured 2 min after noise exposure ends

QuickSIN:

Quick sentence in noise test

WIN:

Words in noise test

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Authors and Affiliations

  1. Department of Speech, Language, and Hearing Sciences, University of Florida, 100174, Gainesville, FL, 32610, USA

    Colleen G. Le Prell Ph.D. & Edward Lobarinas Ph.D.

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  1. Colleen G. Le Prell Ph.D.
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  2. Edward Lobarinas Ph.D.
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Correspondence to Colleen G. Le Prell Ph.D. .

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Editors and Affiliations

  1. Cochlear Signaling & Tissue Engin., University of Michigan Kresge Hearing Research Institute, Ann Arbor, Michigan, USA

    Josef Miller

  2. Dept of Speech , Lang & Hearing Sci, Univ of Florida Health Sciences Center, Gainesville, Florida, USA

    Colleen G. Le Prell

  3. Div . of Otolaryngology Head & Neck Surgery, SIU School of Medicine, Springfield, Illinois, USA

    Leonard Rybak

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Le Prell, C.G., Lobarinas, E. (2015). Strategies for Evaluating Antioxidant Efficacy in Clinical Trials Assessing Prevention of Noise-Induced Hearing Loss. In: Miller, J., Le Prell, C., Rybak, L. (eds) Free Radicals in ENT Pathology. Oxidative Stress in Applied Basic Research and Clinical Practice. Humana Press, Cham. https://doi.org/10.1007/978-3-319-13473-4_9

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