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| Sponsor: | National Taiwan University Hospital |
|---|---|
| Collaborators: |
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-acetylcysteine (NAC) Drug: glucose |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Antioxidation Medication for Noise-induced Hearing Loss |
| Enrollment: | 53 |
| Study Start Date: | November 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Acetin |
Drug: N-acetylcysteine (NAC)
600mg twice daily for 2 weeks
Other Name: acetin (600mg)
|
| Placebo Comparator: Glucose |
Drug: glucose
1 gm glucose capsule
Other Name: Sugar
|
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 53 noise-exposed workers from steel industries in Taiwan will be recruited, and divided into N-Acetylcysteine (NAC)(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 (PTA) and distortion product otoacoustic emissions (DPOAE) 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 Glutathione S-transferase (GST)T1 and GSTM1 genes will be determined. Statistical analysis will be performed to evaluate the relation between intake of anti-oxidant medicine and noise-induced temporal threshold shift (TTS).
The expected results of this study are to determine whether anti-oxidant supplements protect workers from noise-induced TTS.
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Taiwan | |
| Environmental and Occupational Medicine, National Taiwan University Hospital | |
| Taipei, Taiwan, 100 | |
| 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
| Responsible Party: | Dr. Yue-Liang Guo, National Taiwan University |
| ClinicalTrials.gov Identifier: | NCT00552786 History of Changes |
| Other Study ID Numbers: | 200704018M |
| Study First Received: | November 1, 2007 |
| Results First Received: | March 29, 2009 |
| Last Updated: | July 1, 2010 |
| Health Authority: | Taiwan: Department of Health |
|
noise hearing loss temporary threshold shift |
|
Hearing Loss Deafness Hearing Loss, Noise-Induced Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Hearing Loss, Sensorineural Acetylcysteine N-monoacetylcystine |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |