Phase 2
Completed N=53
Antioxidation Medication for Noise-induced Hearing Loss
Source: ClinicalTrials.gov NCT00552786 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcomePrimary: 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
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
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 |
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
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. Informational only — not medical advice.