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Study Status: Withdrawn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

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.


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