Clinical Trial: Prevention of Noise-induced Damage by Use of Antioxidants
Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional
Official Title:
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.
Detailed Summary:
Sponsor: University Hospital, Antwerp
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: Change of tinnitus duration
Original Secondary Outcome: Same as current
Information By: University Hospital, Antwerp
Dates:
Date Received: September 28, 2012
Date Started: November 2012
Date Completion:
Last Updated: November 5, 2013
Last Verified: November 2013