<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01727492</url>
  </required_header>
  <id_info>
    <org_study_id>12/18/172</org_study_id>
    <nct_id>NCT01727492</nct_id>
  </id_info>
  <brief_title>Prevention of Noise-induced Damage by Use of Antioxidants</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Antwerp</source>
  <brief_summary>
    <textblock>
      The current study is a dubble-blinde placebo-controlled cross-over study verifying the&#xD;
      preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced&#xD;
      tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which&#xD;
      should be taken 1h before leisure noise above 100dB for at least 30 minutes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Protection against noise-induced tinnitus due to antioxidants</measure>
    <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.&#xD;
A 50% decrease of tinnitus loudness scored on a Visual Analogue Scale (VAS) compared to placebo trials is expected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of tinnitus duration</measure>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Decrease of temporary threshold shift in antioxidant trials compared to placebo trials</measure>
    <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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Noise-induced Tinnitus</condition>
  <condition>Noise-induced Hearing Loss</condition>
  <arm_group>
    <arm_group_label>sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Antioxidantia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antioxidantia</intervention_name>
    <arm_group_label>Antioxidantia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-25 years old&#xD;
&#xD;
          -  Temporary tinnitus after noise exposure: loudness &gt;5 on a VAS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  middle ear problems&#xD;
&#xD;
          -  Allergy for magnesium or n-acetylcystein&#xD;
&#xD;
          -  Use of hearing protection when going out&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Annick Gilles, Master</last_name>
    <phone>32 3 821 52 80</phone>
    <email>annick.gilles@uza.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Antwerp</city>
        <state>Edegem</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annick Gilles, Master</last_name>
      <phone>32 821 32 57</phone>
      <email>annick.gilles@uza.be</email>
    </contact>
    <investigator>
      <last_name>Annick Gilles, Master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 5, 2013</last_update_submitted>
  <last_update_submitted_qc>November 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>Ethisch Comité UZ Antwerpen</investigator_full_name>
    <investigator_title>Ethics Comittee UZ Antwerpen</investigator_title>
  </responsible_party>
  <keyword>prevention</keyword>
  <keyword>noise-induced tinnitus</keyword>
  <keyword>noise-induced hearing loss</keyword>
  <keyword>young population</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Tinnitus</mesh_term>
    <mesh_term>Hearing Loss, Noise-Induced</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01727492
org study id: 12/18/172
nct id: NCT01727492
lead sponsor: 
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: 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.
measure: 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.
measure: 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.
arm group label: sugar pill
arm group type: Placebo Comparator
arm group label: Antioxidantia
arm group type: Active Comparator
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: Antioxidantia
arm group label: Antioxidantia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Annick Gilles, Master
phone: 32 3 821 52 80
email: annick.gilles@uza.be
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: Ethisch Comité UZ Antwerpen
investigator title: Ethics Comittee UZ Antwerpen
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Tinnitus
mesh term: Hearing Loss, Noise-Induced