Noise-induced Hearing Loss, Noise-induced Tinnitus
Conditions
Keywords
prevention, noise-induced tinnitus, noise-induced hearing loss, young population
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.
Interventions
DRUGAntioxidantia
Sponsors
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium
Contacts
Primary ContactAnnick Gilles, Master
Outcome results
None listed