Prevention of Noise-induced Damage by Use of Antioxidants

NCT ID: NCT01727492

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Noise-induced Tinnitus Noise-induced Hearing Loss

Keywords

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prevention noise-induced tinnitus noise-induced hearing loss young population

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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sugar pill

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

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)

Group Type ACTIVE_COMPARATOR

Antioxidantia

Intervention Type DRUG

Interventions

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Antioxidantia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Ethisch Comité UZ Antwerpen

Ethics Comittee UZ Antwerpen

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Antwerp University Hospital

Antwerp, Edegem, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Annick Gilles, Master

Role: CONTACT

Phone: 32 3 821 52 80

Email: [email protected]

Facility Contacts

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Annick Gilles, Master

Role: primary

References

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Gilles A, Ihtijarevic B, Wouters K, Van de Heyning P. Using prophylactic antioxidants to prevent noise-induced hearing damage in young adults: a protocol for a double-blind, randomized controlled trial. Trials. 2014 Apr 5;15:110. doi: 10.1186/1745-6215-15-110.

Reference Type DERIVED
PMID: 24708640 (View on PubMed)

Other Identifiers

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12/18/172

Identifier Type: -

Identifier Source: org_study_id