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Prevention of Noise-induced Damage by Use of Antioxidants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01727492
Recruitment Status : Unknown
Verified November 2013 by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp.
Recruitment status was:  Recruiting
First Posted : November 16, 2012
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Noise-induced Tinnitus Noise-induced Hearing Loss Drug: Antioxidantia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : November 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727492


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

Locations
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ethisch Comité UZ Antwerpen, Ethics Comittee UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01727492    
Other Study ID Numbers: 12/18/172
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013
Keywords provided by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp:
prevention
noise-induced tinnitus
noise-induced hearing loss
young population
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Tinnitus
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural