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Antioxidation Medication for Noise-induced Hearing Loss

This study has been completed.
Sponsor:
Collaborators:
Institute of Occupational Safety and Health, Taiwan
Municipal Hospital of Tainan, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00552786
First received: November 1, 2007
Last updated: July 1, 2010
Last verified: November 2009
History of Changes
Results First Received: March 29, 2009  
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
Condition: Hearing Loss
Interventions: Drug: N-acetylcysteine (NAC)
Drug: glucose

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruited between November 2007 and January 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 60 workers voluntarily participated in this study. However, 6 workers had preexisting hearing loss of >50 dBA at high frequency and 1 worker accidentally turned off the noise monitoring device. These 7 participants were excluded from the analysis. The 53 workers who satisfactorily completed the study.

Reporting Groups
  Description
N-acetylcysteine (NAC) First, Then Placebo Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
Placebo First, Then N-acetylcysteine (NAC) Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).

Participant Flow for 3 periods

 Period 1:   First Intervention
    N-acetylcysteine (NAC) First, Then Placebo     Placebo First, Then N-acetylcysteine (NAC)  
STARTED     25     28  
Medication and Hearing Evaluation     25     28  
COMPLETED     25     28  
NOT COMPLETED     0     0  

Period 2:   Washout Period of 2 Weeks
    N-acetylcysteine (NAC) First, Then Placebo     Placebo First, Then N-acetylcysteine (NAC)  
STARTED     25     28  
COMPLETED     25     28  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    N-acetylcysteine (NAC) First, Then Placebo     Placebo First, Then N-acetylcysteine (NAC)  
STARTED     25     28  
COMPLETED     25     28  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
N-acetylcysteine (NAC) First, Then Placebo Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
Placebo First, Then N-acetylcysteine (NAC) Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
Total Total of all reporting groups

Baseline Measures
    N-acetylcysteine (NAC) First, Then Placebo     Placebo First, Then N-acetylcysteine (NAC)     Total  
Number of Participants  
[units: participants]
 		  25     28     53  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     25     28     53  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  40.0  ± 11.6     42.1  ± 9.6     41.1  ± 10.5  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     25     28     53  
Region of Enrollment  
[units: participants]
 		     
Taiwan     25     28     53  



  Outcome Measures
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1.  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)   [ Time Frame: 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 ]
  Show Outcome Measure 1

2.  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)   [ Time Frame: 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 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
N-acetylcysteine (NAC) Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
Placebo Placebo administered once daily in either first intervention period or second intervention period.

Other Adverse Events
    N-acetylcysteine (NAC)     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     0/53     0/53  



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Yue-Liang Guo
Organization: National Taiwan University
phone: +886-2-33228216
e-mail: leonguo@ntu.edu.tw


Publications:

Publications automatically indexed to this study:


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