Antioxidation Medication for Noise-induced Hearing Loss

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00552786
Study type	Interventional
Source	National Taiwan University Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	November 2007
Completion date	March 2008

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04696835` - fNIRS in Pediatric Hearing Aids	N/A
Completed	`NCT03662256` - Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine	N/A
Completed	`NCT04602780` - Evaluating the Revised WORQ in CI Users
Completed	`NCT03723161` - Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Completed	`NCT05086809` - Investigation of an Updated Bone-anchored Sound Processor	N/A
Active, not recruiting	`NCT03548779` - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2	N/A
Completed	`NCT03428841` - Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients	N/A
Completed	`NCT04559282` - Home Test of New Sound Processor	N/A
Enrolling by invitation	`NCT03345654` - Individually-guided Hearing Aid Fitting
Completed	`NCT06016335` - MRI-based Synthetic CT Images of the Head and Neck	N/A
Completed	`NCT05165121` - Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids	N/A
Recruiting	`NCT05533840` - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Terminated	`NCT02294812` - Effects of Cognitive Training on Speech Perception	N/A
Completed	`NCT04622059` - AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis	N/A
Recruiting	`NCT02558478` - Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing	N/A
Withdrawn	`NCT02740322` - Validating the Hum Test	N/A
Completed	`NCT01963104` - Community-Based Kiosks for Hearing Screening and Education	N/A
Completed	`NCT01857661` - The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial	N/A
Completed	`NCT01892007` - Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users	N/A
Withdrawn	`NCT01223638` - The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.