Prevention of Noise-induced Damage by Use of Antioxidants

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Unknown status

CT.gov ID

NCT01727492

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Noise-induced Tinnitus Noise-induced Hearing Loss	Drug: Antioxidantia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Study Start Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: sugar pill
Active Comparator: 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)	Drug: Antioxidantia

Arm

Intervention/Treatment

Placebo Comparator: sugar pill

Active Comparator: 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)

Drug: Antioxidantia

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

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.