Prevention of Noise-induced Damage by Use of Antioxidants

NCT01727492 | Unknown

• 1 other identifier: 12/18/172
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Noise-induced Tinnitus; Noise-induced Hearing Loss

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of tinnitus duration

Other Outcomes (1)

• Decrease of temporary threshold shift in antioxidant trials compared to placebo trials

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

Antioxidantia

ACTIVE COMPARATOR

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)

Drug: Antioxidantia

Interventions

Antioxidantia DRUG

Antioxidantia

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-25 years old
• Temporary tinnitus after noise exposure: loudness \>5 on a VAS

You may not qualify if:

• middle ear problems
• Allergy for magnesium or n-acetylcystein
• Use of hearing protection when going out

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Antwerp, Edegem, 2650, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 24708640 DERIVED

MeSH Terms

Conditions

Tinnitus; Hearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Loss, Sensorineural; Hearing Loss

Central Study Contacts

Annick Gilles, Master

CONTACT

32 3 821 52 80; annick.gilles@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ethics Comittee UZ Antwerpen

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: November 16, 2012
• Study Start: November 1, 2012
• Last Updated: November 6, 2013

Record last verified: 2013-11

Locations

BE (1)