Prevention of Noise-induced Damage by Use of Antioxidants

November 5, 2013 updated by: Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Edegem
      • Antwerp, Edegem, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
        • Contact:
        • Sub-Investigator:
          • Annick Gilles, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Outcome Measure
Measure Description
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

Outcome Measure
Measure Description
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (ESTIMATE)

November 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/18/172

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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