Antioxidation Medication for Noise-induced Hearing Loss

NCT00552786 | Completed Phase 2 Results

• 1 other identifier: 200704018M
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Hearing Loss

Keywords

noise; hearing loss; temporary threshold shift

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• 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)

  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

Study Arms (2)

Acetin

EXPERIMENTAL

Drug: N-acetylcysteine (NAC)

Glucose

PLACEBO COMPARATOR

Drug: glucose

Interventions

N-acetylcysteine (NAC) DRUG

600mg twice daily for 2 weeks

Also known as: acetin (600mg)

Acetin

glucose DRUG

1 gm glucose capsule

Also known as: Sugar

Glucose

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• workers in steel industry
• known exposure to noise at work

You may not qualify if:

• ever diagnosed as having diabetes mellitus
• fasting glucose of 120 or greater

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Institute of Occupational Safety and Health, Taiwan: collaborator
• Municipal Hospital of Tainan, Taiwan: collaborator

Study Sites (1)

Environmental and Occupational Medicine, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 17023129 BACKGROUND

• 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.

  PMID: 15966690 BACKGROUND

• 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.

  PMID: 15157958 BACKGROUND

• 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.

  PMID: 17184943 BACKGROUND

• 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.

  PMID: 20638463 DERIVED

MeSH Terms

Conditions

Hearing Loss

Interventions

Acetylcysteine; Glucose; Sugars

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Hexoses; Monosaccharides; Carbohydrates

Limitations and Caveats

No text entered.

Results Point of Contact

• Title: Dr. Yue-Liang Guo
• Organization: National Taiwan University

leonguo@ntu.edu.tw

+886-2-33228216

Study Officials

• Yue-Liang L Guo, MD, MPH, PHD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Tung-Sheng Shih, PHD

  Institute of Occupational Safety and Health, Taiwan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 2, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 27, 2010
• Results First Posted: July 27, 2010

Record last verified: 2009-11

Locations

TW (1)