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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01727492
Other study ID # 12/18/172
Secondary ID
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
Est. completion date
Est. primary completion date
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


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.
See also
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Withdrawn NCT02049073 - Prevention of Noise-induced Hearing Loss Phase 1/Phase 2
Completed NCT02257983 - Protective Effects of EPI-743 on Noise-Induced Hearing Loss Phase 2
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Completed NCT00808470 - Micronutrients to Prevent Noise-induced Hearing Loss Phase 2
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Completed NCT02472821 - Test of Hearing Health Education Programs for Farm and Rural Youth N/A