Prevention of Noise-induced Damage by Use of Antioxidants
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by University Hospital, Antwerp.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
First received: September 28, 2012
Last updated: November 5, 2013
Last verified: November 2013
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.
Noise-induced Hearing Loss
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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:
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.
| Estimated Enrollment:
| Study Start Date:
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)
|Ages Eligible for Study:
||18 Years to 25 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age: 18-25 years old
- Temporary tinnitus after noise exposure: loudness >5 on a VAS
- middle ear problems
- Allergy for magnesium or n-acetylcystein
- Use of hearing protection when going out
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01727492
|Antwerp University Hospital
|Antwerp, Edegem, Belgium, 2650 |
University Hospital, Antwerp
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Ethisch Comité UZ Antwerpen, Ethics Comittee UZ Antwerpen, University Hospital, Antwerp
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 28, 2012
||November 5, 2013
||Belgium: Ethics Committee
Keywords provided by University Hospital, Antwerp:
noise-induced hearing loss
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 02, 2016
Hearing Loss, Noise-Induced
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs