Prevention of Noise-induced Damage by Use of Antioxidants

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Antwerp
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01727492
First received: September 28, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

The current study is a dubble-blinde placebo-controlled cross-over study verifying the preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which should be taken 1h before leisure noise above 100dB for at least 30 minutes.


Condition Intervention
Noise-induced Tinnitus
Noise-induced Hearing Loss
Drug: Antioxidantia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Protection against noise-induced tinnitus due to antioxidants

    Antioxidants protect against temporary threshold shift. The most prevalent cause of noise-induced tinnitus is noise-induced hearing loss. Therefore, it is assumed that the preventive intake of antioxidants prior to a loud event, might protect against threshold shift as well as noise-induced tinnitus.

    A 50% decrease of tinnitus loudness scored on a Visual Analogue Scale (VAS) compared to placebo trials is expected.



Secondary Outcome Measures:
  • Change of tinnitus duration
    It is expected that with the intake of antioxidants noise-induced tinnitus is prevented or reduced after loud music exposure. In addition, it is expected that the tinnitus persistence is shortened compared to the placebo arm.


Other Outcome Measures:
  • Decrease of temporary threshold shift in antioxidant trials compared to placebo trials
    A limited number of participants will have audiological testing (audiometry including high frequency audiometry, speech-in-noise testing and otoacoustic emissions) prior to the musical event as well as the morning after noise exposure in order to measure the effects of antioxidants on the hearing thresholds and hearing performance.


Estimated Enrollment: 30
Study Start Date: November 2012
Arms Assigned Interventions
Placebo Comparator: sugar pill
Active Comparator: Antioxidantia
Dosage: 600mg n-acetylcystein and 200mg magnesium intake: 1 hour before leisure noise exposure above 100dB of at least 30 minutes frequency: 4 separate events (2x placebo, 2x antioxidants)
Drug: Antioxidantia

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 18-25 years old
  • Temporary tinnitus after noise exposure: loudness >5 on a VAS

Exclusion Criteria:

  • middle ear problems
  • Allergy for magnesium or n-acetylcystein
  • Use of hearing protection when going out
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727492

Contacts
Contact: Annick Gilles, Master 32 3 821 52 80 annick.gilles@uza.be

Locations
Belgium
Antwerp University Hospital Recruiting
Antwerp, Edegem, Belgium, 2650
Contact: Annick Gilles, Master    32 821 32 57    annick.gilles@uza.be   
Sub-Investigator: Annick Gilles, Master         
Sponsors and Collaborators
University Hospital, Antwerp
  More Information

No publications provided by University Hospital, Antwerp

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ethisch Comité UZ Antwerpen, Ethics Comittee UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01727492     History of Changes
Other Study ID Numbers: 12/18/172
Study First Received: September 28, 2012
Last Updated: November 5, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Antwerp:
prevention
noise-induced tinnitus
noise-induced hearing loss
young population

Additional relevant MeSH terms:
Tinnitus
Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014