Prevention of Noise-induced Damage by Use of Antioxidants
Overview
- Phase
- Not Applicable
- Intervention
- Antioxidantia
- Conditions
- Noise-induced Tinnitus
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Protection against noise-induced tinnitus due to antioxidants
- Last Updated
- 12 years ago
Overview
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.
Investigators
Ethisch Comité UZ Antwerpen
Ethics Comittee UZ Antwerpen
University Hospital, Antwerp
Eligibility 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
Arms & Interventions
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)
Intervention: Antioxidantia
Outcomes
Primary Outcomes
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 Outcomes
- Change of tinnitus duration