Prevention of Noise-induced Damage by Use of Antioxidants

Not Applicable

• Conditions: Noise-induced Hearing Loss; Noise-induced Tinnitus
• Interventions: Drug: Antioxidantia

• Registration Number: NCT01727492
• Lead Sponsor: University Hospital, Antwerp

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 Description

Not available

Study Timeline

• Study First Submitted: 2012-09-28
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Antioxidantia	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Antwerp, Edegem, Belgium