<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/NCT01714375</url>
  </required_header>
  <id_info>
    <org_study_id>0509000588</org_study_id>
    <secondary_id>1R01OH008641-01</secondary_id>
    <nct_id>NCT01714375</nct_id>
  </id_info>
  <brief_title>Daily Exposure Monitoring to Prevent Hearing Loss</brief_title>
  <acronym>DEMON</acronym>
  <official_title>Daily Exposure Monitoring of Noise Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to determine whether daily assessment and feedback of workers'&#xD;
      noise exposures leads to more effective use of hearing protection and prevention of&#xD;
      noise-induced hearing loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the existence of an OSHA standard for hearing conservation, noise-induced hearing&#xD;
      loss continues to be one of the most prevalent occupational conditions. Furthermore, hearing&#xD;
      loss rates appear to vary significantly between industrial locations with similar measured&#xD;
      noise exposure levels. The factors that determine an effective hearing conservation program&#xD;
      remain poorly understood. The effective use of hearing protection, believed to be a critical&#xD;
      component of such programs, is felt to be highly variable in real world situations.&#xD;
      Provocative new data by our research group indicate that much of the preventable hearing loss&#xD;
      in a large industrial workforce is occurring not among the workers in the highest ambient&#xD;
      noise areas, but instead among employees working in areas where measured ambient median noise&#xD;
      exposures are close to or even slightly below the current OSHA action level (85dBA for an 8&#xD;
      hour time weighted average). One possible reason could be that the use of hearing protection&#xD;
      is currently less effective in such areas of lower or intermittent noise compared to high&#xD;
      noise areas. Since in many worksites, the majority of workers are exposed to moderate noise&#xD;
      levels, there is an urgent need to better understand how to prevent hearing loss in these&#xD;
      settings. There are also currently no national guidelines for ensuring correct fit and&#xD;
      function of hearing protection, and there is an urgent need to find ways to promote the&#xD;
      correct use of hearing protective devices. This study will assess the impact of hearing&#xD;
      protector fit testing and daily noise exposure monitoring, with major implications for&#xD;
      hearing conservation practice, and the wider prevention of noise-induced hearing loss. It&#xD;
      will also explore the role of hearing protective devices in areas of median noise exposure&#xD;
      less than 85dBA.&#xD;
&#xD;
      This proposed study is a worksite intervention trial of a new technology to reduce&#xD;
      occupational noise-induced hearing loss. The intervention will test the effectiveness of a&#xD;
      noise exposure dosimeter, the QuietDose - essentially a small microphone connected to a noise&#xD;
      logging device about the size of a beeper- that measures a worker's daily noise &quot;dose&quot;, as&#xD;
      well as peak noise exposure, inside of the worker's hearing protectors. Workers and the study&#xD;
      coordinator receive daily feedback about noise exposures (if the device was used outside of&#xD;
      the study it would be safety personnel that received the feedback outside of the workers&#xD;
      themselves). Such feedback will allow steps to be taken to minimize such exposures, such as&#xD;
      behavioral adjustments and improved awarenessThe goal of this study is to determine whether&#xD;
      daily assessment and feedback of workers' noise exposures leads to more effective use of&#xD;
      hearing protection and prevention of noise-induced hearing loss. The proposed study will take&#xD;
      advantage of the unique working relationship between a research institution (the Yale&#xD;
      Occupational and Environmental Medicine Program) and a major industrial corporation (Alcoa,&#xD;
      Inc.) to conduct this intervention trial at several of the company's facilities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2007</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hearing Loss</measure>
    <time_frame>1 year</time_frame>
    <description>Hearing loss will be measured in dB/year for the noise-sensitive audiometric frequency averages of 2, 3, and 4000 Hz and 3, 4, and 6000 Hz averaged across ears .</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">322</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>QuietDose device VOLUNTARY</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group of employees will voluntarily use the &quot;QuietDose&quot; units in place of their regular hearing protection, which may be either ear plugs or ear muffs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No QuietDose device</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group of employees will not use the &quot;QuietDose&quot; units and maintain use of their regular hearing protection which may be either ear plugs or ear muffs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QuietDose Device REQUIRED</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group of employees will be required to use the &quot;QuietDose&quot; units in place of their regular hearing protection, which may be either ear plugs or ear muffs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>QuietDose Device</intervention_name>
    <description>The intervention will test the effectiveness of a noise exposure dosimeter, the QuietDose - that measures a worker's daily noise &quot;dose&quot;, as well as peak noise exposure, inside of the worker's hearing protectors. Workers and the study coordinator receive daily feedback about noise exposures (if the device was used outside of the study it would be safety personnel that received the feedback outside of the workers themselves). Such feedback will allow steps to be taken to minimize such exposures, such as behavioral adjustments and improved awarenessThe goal of this study is to determine whether daily assessment and feedback of workers' noise exposures leads to more effective use of hearing protection and prevention of noise-induced hearing loss.</description>
    <arm_group_label>QuietDose Device REQUIRED</arm_group_label>
    <arm_group_label>QuietDose device VOLUNTARY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The only criterion for inclusion is that the employee is currently working in an area where&#xD;
        there is sufficient noise exposure that the company's policy requires the use of hearing&#xD;
        protection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        There are no exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter M Rabinowitz, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale Occupational and Environmental Medicine Program: Yale University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Occupational and Environmental Medicine Program</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</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/NCT01714375
org study id: 0509000588
secondary id: 1R01OH008641-01
nct id: NCT01714375
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to determine whether daily assessment and feedback of workers'
      noise exposures leads to more effective use of hearing protection and prevention of
      noise-induced hearing loss.
Despite the existence of an OSHA standard for hearing conservation, noise-induced hearing
      loss continues to be one of the most prevalent occupational conditions. Furthermore, hearing
      loss rates appear to vary significantly between industrial locations with similar measured
      noise exposure levels. The factors that determine an effective hearing conservation program
      remain poorly understood. The effective use of hearing protection, believed to be a critical
      component of such programs, is felt to be highly variable in real world situations.
      Provocative new data by our research group indicate that much of the preventable hearing loss
      in a large industrial workforce is occurring not among the workers in the highest ambient
      noise areas, but instead among employees working in areas where measured ambient median noise
      exposures are close to or even slightly below the current OSHA action level (85dBA for an 8
      hour time weighted average). One possible reason could be that the use of hearing protection
      is currently less effective in such areas of lower or intermittent noise compared to high
      noise areas. Since in many worksites, the majority of workers are exposed to moderate noise
      levels, there is an urgent need to better understand how to prevent hearing loss in these
      settings. There are also currently no national guidelines for ensuring correct fit and
      function of hearing protection, and there is an urgent need to find ways to promote the
      correct use of hearing protective devices. This study will assess the impact of hearing
      protector fit testing and daily noise exposure monitoring, with major implications for
      hearing conservation practice, and the wider prevention of noise-induced hearing loss. It
      will also explore the role of hearing protective devices in areas of median noise exposure
      less than 85dBA.

      This proposed study is a worksite intervention trial of a new technology to reduce
      occupational noise-induced hearing loss. The intervention will test the effectiveness of a
      noise exposure dosimeter, the QuietDose - essentially a small microphone connected to a noise
      logging device about the size of a beeper- that measures a worker's daily noise "dose", as
      well as peak noise exposure, inside of the worker's hearing protectors. Workers and the study
      coordinator receive daily feedback about noise exposures (if the device was used outside of
      the study it would be safety personnel that received the feedback outside of the workers
      themselves). Such feedback will allow steps to be taken to minimize such exposures, such as
      behavioral adjustments and improved awarenessThe goal of this study is to determine whether
      daily assessment and feedback of workers' noise exposures leads to more effective use of
      hearing protection and prevention of noise-induced hearing loss. The proposed study will take
      advantage of the unique working relationship between a research institution (the Yale
      Occupational and Environmental Medicine Program) and a major industrial corporation (Alcoa,
      Inc.) to conduct this intervention trial at several of the company's facilities.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Hearing Loss
time frame: 1 year
description: Hearing loss will be measured in dB/year for the noise-sensitive audiometric frequency averages of 2, 3, and 4000 Hz and 3, 4, and 6000 Hz averaged across ears .
arm group label: QuietDose device VOLUNTARY
arm group type: Active Comparator
description: This group of employees will voluntarily use the "QuietDose" units in place of their regular hearing protection, which may be either ear plugs or ear muffs.
arm group label: No QuietDose device
arm group type: No Intervention
description: This group of employees will not use the "QuietDose" units and maintain use of their regular hearing protection which may be either ear plugs or ear muffs.
arm group label: QuietDose Device REQUIRED
arm group type: Active Comparator
description: This group of employees will be required to use the "QuietDose" units in place of their regular hearing protection, which may be either ear plugs or ear muffs.
intervention type: Device
intervention name: QuietDose Device
description: The intervention will test the effectiveness of a noise exposure dosimeter, the QuietDose - that measures a worker's daily noise "dose", as well as peak noise exposure, inside of the worker's hearing protectors. Workers and the study coordinator receive daily feedback about noise exposures (if the device was used outside of the study it would be safety personnel that received the feedback outside of the workers themselves). Such feedback will allow steps to be taken to minimize such exposures, such as behavioral adjustments and improved awarenessThe goal of this study is to determine whether daily assessment and feedback of workers' noise exposures leads to more effective use of hearing protection and prevention of noise-induced hearing loss.
arm group label: QuietDose Device REQUIRED
arm group label: QuietDose device VOLUNTARY
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter M Rabinowitz, MD MPH
role: Principal Investigator
affiliation: Yale Occupational and Environmental Medicine Program: Yale University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness