Phase 2 N=53 Randomized Double-blind Prevention

Antioxidation Medication for Noise-induced Hearing Loss

Hearing Loss

Bottom Line

View on ClinicalTrials.gov: NCT00552786 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2010

Primary outcome: Primary: Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift) — 3.4; 2.7 decibels — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: N-acetylcysteine (NAC) (Drug); glucose (Drug)
Age: Adult, Older Adult · 25+ yrs
Sex: Male
Sponsor: National Taiwan University Hospital
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)	3.4; 2.7	<0.05 sig
SECONDARY Temporary Threshold Changes Measurement by Distortion Product Otoacoustic Emissions (DPOAE) (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)	-0.85; -0.89	<0.05 sig

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00552786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.