Prevention of Noise-induced Damage by Use of Antioxidants

Antwerp University Hospital (UZA)

Status: Unknown

Conditions: Noise-induced Hearing Loss; Noise-induced Tinnitus

Treatments: Drug: Antioxidantia

Study type: Interventional

Funder types: Other

Identifiers

NCT01727492

12/18/172

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

sugar pill

Placebo Comparator group

Antioxidantia

Active Comparator group

Description:

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)

Treatment:

Drug: Antioxidantia