Antioxidation Medication for Noise-Induced Hearing Loss - Full Text View

Sponsors and Collaborators:	National Taiwan University Hospital Institute of Occupational Safety and Health, Taiwan Municipal Hospital of Tainan, Taiwan
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00552786

Purpose

This study will examine whether oral intake of 1200mg N-Acetylcysteine/day will prevent temporary threshold shift in hearing among workers exposed to noise

Condition	Intervention	Phase
Hearing Loss	Drug: N-acetyl cysteine Other: glucose	Phase II

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness Noise

Drug Information available for: Cysteine Dextrose Acetylcysteine Cysteine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Antioxidation Medication for Noise-Induced Hearing Loss

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

pure tone audiometry measured temporary threshold shift [ Time Frame: 1 month ]

Secondary Outcome Measures:

Distortion product otoacoustic emissions [ Time Frame: 1 month ]

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	January 2008

Arms	Assigned Interventions
1: Experimental	Drug: N-acetyl cysteine 600mg twice daily for 2 weeks
2: Placebo Comparator	Other: glucose 1 gm glucose capsule

Detailed Description:

Both genetic and environmental factors contribute to noise-induced hearing loss (NIHL). The cellular antioxidant system appears to protect cochlear hair cells from oxidative stress due to noise. Previous animal studies showed protective effects of anti-oxidant medicines against NIHL.The objective of this study is to test the hypothesis that preventive medication of antioxidation is related to susceptibility to NIHL.

The 60 noise-exposed workers from steel industries in Taiwan will be recruited, and divided into N-Acetylcysteine (Acetine, 1200mg/day) group and placebo one. The duration of medication is 2 weeks initially. After washout for 2 weeks, the kinds of medications in these 2 groups will be crossover and used for 2 weeks. Firstly, questionnaires interview about noise exposure, smoking, alcohol drinking, drug habit history and calculation of Body Mass Index (BMI) will be done. The following methods would be performed individually after medication. With detailed local examination with otoscope, these subjects receive hearing tests by pure-tone audiometry and distortion product otoacoustic emissions before and after their daily works. The possible confounding factors including background noise, solvent, heavy metals, carbon monoxide and temperature in the workplaces will be assessed. The amount of noise exposure is evaluated by personal dosimeter. Early morning, Blood samples will be collected. Deletion polymorphisms in the GSTT1 and GSTM1 genes, and single nucleotide polymorphisms (SNPs) in GSTP1 will be determined. Statistical analysis will be performed to evaluate the relation between intake of anti-oxidant medicine and noise-induced temporal threshold shift. The expected results of this study are to determine whether anti-oxidant supplements protect workers from noise-induced temporal threshold shift.

We anticipate that these human studies might help elucidate the relative importance of anti-oxidant enzymes as risk factors for NIHL.

Eligibility

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

workers in steel industry
known exposure to noise at work

Exclusion Criteria:

ever diagnosed as having diabetes mellitus
fasting glucose of 120 or greater

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552786

Locations

Taiwan
Environmental and Occupational Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100

Sponsors and Collaborators

National Taiwan University Hospital

Institute of Occupational Safety and Health, Taiwan

Municipal Hospital of Tainan, Taiwan

Investigators

Principal Investigator:	Yue-Liang L Guo, MD, MPH, PHD	National Taiwan University Hospital
Study Director:	Tung-Sheng Shih, PHD	Institute of Occupational Safety and Health, Taiwan

More Information

Publications:

Coleman JK, Kopke RD, Liu J, Ge X, Harper EA, Jones GE, Cater TL, Jackson RL. Pharmacological rescue of noise induced hearing loss using N-acetylcysteine and acetyl-L-carnitine. Hear Res. 2007 Apr;226(1-2):104-13. Epub 2006 Oct 4.

Kopke R, Bielefeld E, Liu J, Zheng J, Jackson R, Henderson D, Coleman JK. Prevention of impulse noise-induced hearing loss with antioxidants. Acta Otolaryngol. 2005 Mar;125(3):235-43.

Duan M, Qiu J, Laurell G, Olofsson A, Counter SA, Borg E. Dose and time-dependent protection of the antioxidant N-L-acetylcysteine against impulse noise trauma. Hear Res. 2004 Jun;192(1-2):1-9.

Kopke RD, Jackson RL, Coleman JK, Liu J, Bielefeld EC, Balough BJ. NAC for noise: from the bench top to the clinic. Hear Res. 2007 Apr;226(1-2):114-25. Epub 2006 Dec 20. Review.

Study ID Numbers:	200704018M
Study First Received:	November 1, 2007
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00552786 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

noise
hearing loss
temporary threshold shift

Study placed in the following topic categories:

Sensation Disorders
Antioxidants
Otorhinolaryngologic Diseases
Retrocochlear Diseases
Hearing Loss, Sensorineural
Sensorineural Hearing Loss
Antiviral Agents
Ear Diseases
Signs and Symptoms

Deafness
Hearing Loss, Noise-Induced
Hearing Disorders
Expectorants
Neurologic Manifestations
Acetylcysteine
Hearing Loss
N-monoacetylcystine

Additional relevant MeSH terms:

Sensation Disorders
Respiratory System Agents
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Retrocochlear Diseases
Physiological Effects of Drugs
Hearing Loss, Sensorineural
Ear Diseases
Signs and Symptoms
Hearing Disorders
Hearing Loss, Noise-Induced
Deafness

Therapeutic Uses
Free Radical Scavengers
Acetylcysteine
Hearing Loss
Antidotes
Otorhinolaryngologic Diseases
Nervous System Diseases
Antiviral Agents
Protective Agents
Pharmacologic Actions
Expectorants
Neurologic Manifestations
N-monoacetylcystine

ClinicalTrials.gov processed this record on May 06, 2009