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Antioxidation Medication for Noise-induced Hearing Loss

Primary Purpose

Hearing Loss

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
N-acetylcysteine (NAC)
glucose
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hearing Loss focused on measuring noise, hearing loss, temporary threshold shift

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Environmental and Occupational Medicine, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acetin

Glucose

Arm Description

Outcomes

Primary Outcome Measures

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)
The hearing threshold level (HL) at high frequency (HF) by pure-tone audiometry (PTA) was defined as the average of HLs at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by PTA were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of temporary threshold change was calculated by subtracting the pre-shift hearing threshold from the post-shift hearing threshold at each frequency.

Secondary Outcome Measures

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)
Distortion product otoacoustic emissions (DPOAE) is an objective measure to assess the cochlear changes. DPOAE response threshold at high frequency (HF) was defined as the average of response levels (dB SPL) at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by DPOAE were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of DPOAE temporary threshold change was calculated by subtracting the pre-shift DPOAE response threshold from the post-shift DPOAE response threshold at each frequency.

Full Information

First Posted
November 1, 2007
Last Updated
July 1, 2010
Sponsor
National Taiwan University Hospital
Collaborators
Institute of Occupational Safety and Health, Taiwan, Municipal Hospital of Tainan, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00552786
Brief Title
Antioxidation Medication for Noise-induced Hearing Loss
Official Title
Antioxidation Medication for Noise-induced Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital
Collaborators
Institute of Occupational Safety and Health, Taiwan, Municipal Hospital of Tainan, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
noise, hearing loss, temporary threshold shift

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetin
Arm Type
Experimental
Arm Title
Glucose
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine (NAC)
Other Intervention Name(s)
acetin (600mg)
Intervention Description
600mg twice daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
glucose
Other Intervention Name(s)
Sugar
Intervention Description
1 gm glucose capsule
Primary Outcome Measure Information:
Title
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)
Description
The hearing threshold level (HL) at high frequency (HF) by pure-tone audiometry (PTA) was defined as the average of HLs at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by PTA were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of temporary threshold change was calculated by subtracting the pre-shift hearing threshold from the post-shift hearing threshold at each frequency.
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
Secondary Outcome Measure Information:
Title
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)
Description
Distortion product otoacoustic emissions (DPOAE) is an objective measure to assess the cochlear changes. DPOAE response threshold at high frequency (HF) was defined as the average of response levels (dB SPL) at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by DPOAE were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of DPOAE temporary threshold change was calculated by subtracting the pre-shift DPOAE response threshold from the post-shift DPOAE response threshold at each frequency.
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue-Liang L Guo, MD, MPH, PHD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tung-Sheng Shih, PHD
Organizational Affiliation
Institute of Occupational Safety and Health, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Environmental and Occupational Medicine, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17023129
Citation
Coleman JK, Kopke RD, Liu J, Ge X, Harper EA, Jones GE, Cater TL, Jackson RL. Pharmacological rescue of noise induced hearing loss using N-acetylcysteine and acetyl-L-carnitine. Hear Res. 2007 Apr;226(1-2):104-13. doi: 10.1016/j.heares.2006.08.008. Epub 2006 Oct 4.
Results Reference
background
PubMed Identifier
15966690
Citation
Kopke R, Bielefeld E, Liu J, Zheng J, Jackson R, Henderson D, Coleman JK. Prevention of impulse noise-induced hearing loss with antioxidants. Acta Otolaryngol. 2005 Mar;125(3):235-43. doi: 10.1080/00016480410023038.
Results Reference
background
PubMed Identifier
15157958
Citation
Duan M, Qiu J, Laurell G, Olofsson A, Counter SA, Borg E. Dose and time-dependent protection of the antioxidant N-L-acetylcysteine against impulse noise trauma. Hear Res. 2004 Jun;192(1-2):1-9. doi: 10.1016/j.heares.2004.02.005.
Results Reference
background
PubMed Identifier
17184943
Citation
Kopke RD, Jackson RL, Coleman JK, Liu J, Bielefeld EC, Balough BJ. NAC for noise: from the bench top to the clinic. Hear Res. 2007 Apr;226(1-2):114-25. doi: 10.1016/j.heares.2006.10.008. Epub 2006 Dec 20.
Results Reference
background
PubMed Identifier
20638463
Citation
Lin CY, Wu JL, Shih TS, Tsai PJ, Sun YM, Ma MC, Guo YL. N-Acetyl-cysteine against noise-induced temporary threshold shift in male workers. Hear Res. 2010 Oct 1;269(1-2):42-7. doi: 10.1016/j.heares.2010.07.005. Epub 2010 Jul 16.
Results Reference
derived

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Antioxidation Medication for Noise-induced Hearing Loss

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