<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/NCT03834714</url>
  </required_header>
  <id_info>
    <org_study_id>20181214</org_study_id>
    <secondary_id>GR014085</secondary_id>
    <nct_id>NCT03834714</nct_id>
  </id_info>
  <brief_title>Noise Exposure and Near-Infrared Light</brief_title>
  <official_title>Effects of Noise Exposure and Near Infrared Light (NIL) on Auditory Health and Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Office of Naval Research (ONR)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this work is to determine the effect noise has on the auditory&#xD;
      system (both auditory health and performance) and also the degree to which the effect of&#xD;
      pre-noise therapy such as Near Infrared (NIR) light can mitigate the effects of noise&#xD;
      exposure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2020</start_date>
  <completion_date type="Actual">December 23, 2021</completion_date>
  <primary_completion_date type="Actual">December 23, 2021</primary_completion_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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in auditory threshold</measure>
    <time_frame>Baseline, up to 365 days</time_frame>
    <description>Auditory function tests will be measured through the change in air conduction threshold measurements from 500 up to 8000 Hz</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in otoacoustic emissions (OAE)</measure>
    <time_frame>Baseline, up to 365 days</time_frame>
    <description>Auditory performance will be measured through OAE testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in central auditory performance (CAP)</measure>
    <time_frame>Baseline, up to 365 days</time_frame>
    <description>Auditory performance will be measured through central auditory processing assessments</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Hearing Loss, Noise-Induced</condition>
  <arm_group>
    <arm_group_label>Noise Stimulus and Infrared Light</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive infrared light therapy for 2 out of the 4 visits and sham infrared light therapy for the other 2 visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Noise Stimulus and Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive sham infrared light therapy for 2 out of the 4 visits and infrared light therapy for the other 2 visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Near Infrared Light</intervention_name>
    <description>NIR Light Therapy will be administered with the Earlight Generation 1.4 device during 2 out of the 4 sessions. It will be administered to each ear individually for 30 minutes per ear.</description>
    <arm_group_label>Noise Stimulus and Infrared Light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Noise Stimulus</intervention_name>
    <description>Noise stimulus will be administered, open ear, to continuous broadband noise up to 25% of the allowable daily dose of noise per the AFI 48-127 Occupational Noise and Hearing Conservation Program.</description>
    <arm_group_label>Noise Stimulus and Infrared Light</arm_group_label>
    <arm_group_label>Noise Stimulus and Sham</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Near Infrared Light</intervention_name>
    <description>Sham NIR Light Therapy will be administered with the Earlight Generation 1.4 device during 2 out of the 4 sessions. It will be administered to each ear individually for 30 minutes per ear.</description>
    <arm_group_label>Noise Stimulus and Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45 years old, male or female&#xD;
&#xD;
          -  Pass hearing exam with a threshold of 25 decibels (dB) hearing or less, for each ear,&#xD;
             for all frequencies tested from 500 Hz to 8000 Hz&#xD;
&#xD;
          -  Normal otoscopic exam, otoacoustic emissions (OAEs), and middle ear function as&#xD;
             demonstrated by a normal tympanogram&#xD;
&#xD;
          -  Completion of a hearing history questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Screening hearing test failure&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Adults unable to provide consent&#xD;
&#xD;
          -  History of significant ear surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael E Hoffer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>U.S. Army Aeromedical Research Laboratory</name>
      <address>
        <city>Fort Rucker</city>
        <state>Alabama</state>
        <zip>36362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wright-Patterson Air Force Base</name>
      <address>
        <city>Wright-Patterson Air Force Base</city>
        <state>Ohio</state>
        <zip>45433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>April 15, 2022</last_update_submitted>
  <last_update_submitted_qc>April 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Michael E. Hoffer</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Noise induced hearing loss</keyword>
  <keyword>Near infrared energy</keyword>
  <keyword>Hering test</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>Hearing Loss, Noise-Induced</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03834714
org study id: 20181214
secondary id: GR014085
nct id: NCT03834714
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The primary objective of this work is to determine the effect noise has on the auditory
      system (both auditory health and performance) and also the degree to which the effect of
      pre-noise therapy such as Near Infrared (NIR) light can mitigate the effects of noise
      exposure.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Change in auditory threshold
time frame: Baseline, up to 365 days
description: Auditory function tests will be measured through the change in air conduction threshold measurements from 500 up to 8000 Hz
measure: Change in otoacoustic emissions (OAE)
time frame: Baseline, up to 365 days
description: Auditory performance will be measured through OAE testing
measure: Change in central auditory performance (CAP)
time frame: Baseline, up to 365 days
description: Auditory performance will be measured through central auditory processing assessments
arm group label: Noise Stimulus and Infrared Light
arm group type: Active Comparator
description: All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive infrared light therapy for 2 out of the 4 visits and sham infrared light therapy for the other 2 visits.
arm group label: Noise Stimulus and Sham
arm group type: Sham Comparator
description: All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive sham infrared light therapy for 2 out of the 4 visits and infrared light therapy for the other 2 visits.
intervention type: Device
intervention name: Near Infrared Light
description: NIR Light Therapy will be administered with the Earlight Generation 1.4 device during 2 out of the 4 sessions. It will be administered to each ear individually for 30 minutes per ear.
arm group label: Noise Stimulus and Infrared Light
intervention type: Other
intervention name: Noise Stimulus
description: Noise stimulus will be administered, open ear, to continuous broadband noise up to 25% of the allowable daily dose of noise per the AFI 48-127 Occupational Noise and Hearing Conservation Program.
arm group label: Noise Stimulus and Infrared Light
arm group label: Noise Stimulus and Sham
intervention type: Device
intervention name: Sham Near Infrared Light
description: Sham NIR Light Therapy will be administered with the Earlight Generation 1.4 device during 2 out of the 4 sessions. It will be administered to each ear individually for 30 minutes per ear.
arm group label: Noise Stimulus and Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael E Hoffer, MD
role: Principal Investigator
affiliation: University of Miami
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Michael E. Hoffer
investigator title: Professor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Noise-Induced
sharing ipd: No