search
Back to results

Prevention of Noise-induced Damage by Use of Antioxidants

Primary Purpose

Noise-induced Tinnitus, Noise-induced Hearing Loss

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Antioxidantia
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Noise-induced Tinnitus focused on measuring prevention, noise-induced tinnitus, noise-induced hearing loss, young population

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Antwerp University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

sugar pill

Antioxidantia

Arm Description

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)

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

First Posted
September 28, 2012
Last Updated
November 5, 2013
Sponsor
University Hospital, Antwerp
search

1. Study Identification

Unique Protocol Identification Number
NCT01727492
Brief Title
Prevention of Noise-induced Damage by Use of Antioxidants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noise-induced Tinnitus, Noise-induced Hearing Loss
Keywords
prevention, noise-induced tinnitus, noise-induced hearing loss, young population

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Title
Antioxidantia
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Antioxidantia
Primary Outcome Measure Information:
Title
Protection against noise-induced tinnitus due to antioxidants
Description
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 Outcome Measure Information:
Title
Change of tinnitus duration
Description
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 Pre-specified Outcome Measures:
Title
Decrease of temporary threshold shift in antioxidant trials compared to placebo trials
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annick Gilles, Master
Phone
32 3 821 52 80
Email
annick.gilles@uza.be
Facility Information:
Facility Name
Antwerp University Hospital
City
Antwerp
State/Province
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annick Gilles, Master
Phone
32 821 32 57
Email
annick.gilles@uza.be
First Name & Middle Initial & Last Name & Degree
Annick Gilles, Master

12. IPD Sharing Statement

Citations:
PubMed Identifier
24708640
Citation
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.
Results Reference
derived

Learn more about this trial

Prevention of Noise-induced Damage by Use of Antioxidants

We'll reach out to this number within 24 hrs