Prevention of Noise-induced Damage by Use of Antioxidants

Noise-induced Hearing Loss Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01727492
• Other study ID #: 12/18/172
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2012
• Last updated: November 5, 2013
• Start date: November 2012

Study information

• Verified date: November 2013
• Source: University Hospital, Antwerp
• Contact: Annick Gilles, Master
• Phone: 32 3 821 52 80
• Email: annick.gilles[@]uza.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced
• Noise-induced Hearing Loss
• Noise-induced Tinnitus
• Tinnitus

Intervention

Drug:
• Antioxidantia

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Antwerp	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decrease of temporary threshold shift in antioxidant trials compared to placebo trials	A limited number of participants will have audiological testing (audiometry including high frequency audiometry, speech-in-noise testing and otoacoustic emissions) prior to the musical event as well as the morning after noise exposure in order to measure the effects of antioxidants on the hearing thresholds and hearing performance.
Primary	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	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.