Prevention of Noise-induced Damage by Use of Antioxidants
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|ClinicalTrials.gov Identifier: NCT01727492|
Recruitment Status : Unknown
Verified November 2013 by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp.
Recruitment status was: Recruiting
First Posted : November 16, 2012
Last Update Posted : November 6, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Noise-induced Tinnitus Noise-induced Hearing Loss||Drug: Antioxidantia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||November 2012|
|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)
- 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.
- Change of tinnitus durationIt 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.
- Decrease of temporary threshold shift in antioxidant trials compared to placebo trialsA 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.
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|Ages Eligible for Study:||18 Years to 25 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727492
|Contact: Annick Gilles, Master||32 3 821 52 email@example.com|
|Antwerp University Hospital||Recruiting|
|Antwerp, Edegem, Belgium, 2650|
|Contact: Annick Gilles, Master 32 821 32 57 firstname.lastname@example.org|
|Sub-Investigator: Annick Gilles, Master|
|Responsible Party:||Ethisch Comité UZ Antwerpen, Ethics Comittee UZ Antwerpen, University Hospital, Antwerp|
|Other Study ID Numbers:||
|First Posted:||November 16, 2012 Key Record Dates|
|Last Update Posted:||November 6, 2013|
|Last Verified:||November 2013|
noise-induced hearing loss
Hearing Loss, Noise-Induced
Nervous System Diseases
Hearing Loss, Sensorineural