xml: <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/NCT05970211</url>
    </required_header>
    <id_info>
      <org_study_id>005599</org_study_id>
      <nct_id>NCT05970211</nct_id>
    </id_info>
    <brief_title>Early Age-Related Hearing Loss Investigation Pilot Study</brief_title>
    <acronym>P-EARLHI</acronym>
    <official_title>Early Age-Related Hearing Loss Investigation Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of South Florida</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of South Florida</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>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this clinical trial pilot is to obtain feasibility and pilot data necessary to&#xD;
        inform the hearing intervention being designed for a larger R01 clinical trial that seeks to&#xD;
        determine whether best practice hearing aid intervention impacts hearing-related outcomes in&#xD;
        adults with hearing loss aged 55 to 75 years.&#xD;
  &#xD;
        Secondary purposes include: To determine what effects best practice hearing aid intervention&#xD;
        has on physical, social, and quality of life outcomes in adults with hearing loss aged 55 to&#xD;
        75 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an observational pre-post intervention feasibility study. In addition to the&#xD;
        objective finding that adults with hearing loss experience higher rates of cognitive decline,&#xD;
        they also tend to report lesser degrees of physical activity and increased cognitive fatigue,&#xD;
        which is the feeling of tiredness or having a lack of energy. Unfortunately, the mechanism by&#xD;
        which hearing loss relates to physical activity and fatigue, and the effect of hearing aids&#xD;
        as an intervention to improve these factors, is unclear. Thus, the purpose of this study is&#xD;
        twofold: First, we will establish the feasibility of administering a best practices hearing&#xD;
        aid intervention to a sample of adults from the target age range of 55 - 75 years old to&#xD;
        inform the larger clinical trial; Second, we will collect pilot data to explore the&#xD;
        relationships between hearing loss, physical activity, socialization, fatigue and&#xD;
        hearing-related outcomes before and after hearing aid intervention.&#xD;
  &#xD;
        There are no experimental or investigational devices or agents used in this study. We are&#xD;
        providing best-practices standard of care hearing intervention including hearing aids. We are&#xD;
        additionally tracking activity using the ActiGraph wGT3X-BT, an FDA-approved Class II medical&#xD;
        device that tracks continuous, high resolution physical activity and sleep/wake information.&#xD;
  &#xD;
        Participation involves a minimum of 6 in-office study visits. Intervention sessions occur&#xD;
        approximately 2 weeks apart, with a final long-term outcome session occurring approximately&#xD;
        6-months post the baseline intervention session.&#xD;
  &#xD;
        Significant others of participants are invited to join the study and contribute data related&#xD;
        to their own quality of life and their observations of the effects of the hearing&#xD;
        intervention on the participant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 19, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Objective Physical Activity</measure>
      <time_frame>2-week measurement taken between 4- and 6- months post study enrollment</time_frame>
      <description>Activity level as measured by research-grade accelerometer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Words in Noise Test</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Measures speech perception in noise performance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>International Outcome Inventory for Comprehensive Hearing Intervention</measure>
      <time_frame>Measured at 6-months post study enrollment</time_frame>
      <description>Self-reported hearing aid benefit measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Client Oriented Scale of Improvement</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported hearing aid benefit measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hearing Handicap Inventory for Adults</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported hearing handicap</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Center for Epidemiological Studies Depression and Hopelessness Scale</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Speech, Spatial and Qualities of Hearing Scale</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported hearing difficulties</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social Network Index</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported social network information</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>UCLA Loneliness Scale</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported loneliness</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Positive and Negative Affect Schedule</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported positive and negative affect/mood</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The World Health Organization Well-Being Index</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported well being</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Vanderbilt Fatigue Scale for Adults</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported fatigue</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Research &amp; Development Short Form Survey (RAND36)</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Single-item sedentary questionnaire</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported physical activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified four-square step test</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Measures physical function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Expanded short physical performance battery</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Measures lower extremity function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baecke Physical Activity Questionnaire</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported physical activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROMIS v2.0 Mobility Questionnaire</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported mobility</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>User Experience Questionnaire+</measure>
      <time_frame>Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment</time_frame>
      <description>Self-reported hearing device user experience</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hearing Loss</condition>
    <arm_group>
      <arm_group_label>Hearing Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Adults aged 55-75 with hearing loss who have little/no prior experience with hearing aids will be enrolled in the hearing intervention group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Phonak Audeo Lumity Receiver in Canal Hearing Aid</intervention_name>
      <description>bilateral receiver in canal hearing aids provided as part of a best practices hearing loss intervention including devices, hearing centered counseling, and self management skills training for hearing loss</description>
      <arm_group_label>Hearing Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults aged 55 to 75 years old with little or no experience with hearing aids&#xD;
  &#xD;
            -  English or Spanish speakers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to complete written questionnaires on a tablet without assistance&#xD;
  &#xD;
            -  Refer for cognitive screening score based on criteria using the Mini Mental State&#xD;
               Examination&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Michelle Arnold, PhD</last_name>
      <phone>8139741262</phone>
      <email>mlarnold@usf.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of South Florida</name>
        <address>
          <city>Tampa</city>
          <state>Florida</state>
          <zip>33620</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michelle Arnold, PhD</last_name>
        <phone>813-974-1262</phone>
        <email>arctlab@usf.edu</email>
      </contact>
      <contact_backup>
        <last_name>Sarah Bochat, AuD</last_name>
        <phone>8139741262</phone>
        <email>arctlab@usf.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of South Florida</investigator_affiliation>
      <investigator_full_name>Michelle Arnold</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </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>
      <mesh_term>Presbycusis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970211
  org study id: 005599
  nct id: NCT05970211
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The purpose of this clinical trial pilot is to obtain feasibility and pilot data necessary to
        inform the hearing intervention being designed for a larger R01 clinical trial that seeks to
        determine whether best practice hearing aid intervention impacts hearing-related outcomes in
        adults with hearing loss aged 55 to 75 years.
  
        Secondary purposes include: To determine what effects best practice hearing aid intervention
        has on physical, social, and quality of life outcomes in adults with hearing loss aged 55 to
        75 years.
  This is an observational pre-post intervention feasibility study. In addition to the
        objective finding that adults with hearing loss experience higher rates of cognitive decline,
        they also tend to report lesser degrees of physical activity and increased cognitive fatigue,
        which is the feeling of tiredness or having a lack of energy. Unfortunately, the mechanism by
        which hearing loss relates to physical activity and fatigue, and the effect of hearing aids
        as an intervention to improve these factors, is unclear. Thus, the purpose of this study is
        twofold: First, we will establish the feasibility of administering a best practices hearing
        aid intervention to a sample of adults from the target age range of 55 - 75 years old to
        inform the larger clinical trial; Second, we will collect pilot data to explore the
        relationships between hearing loss, physical activity, socialization, fatigue and
        hearing-related outcomes before and after hearing aid intervention.
  
        There are no experimental or investigational devices or agents used in this study. We are
        providing best-practices standard of care hearing intervention including hearing aids. We are
        additionally tracking activity using the ActiGraph wGT3X-BT, an FDA-approved Class II medical
        device that tracks continuous, high resolution physical activity and sleep/wake information.
  
        Participation involves a minimum of 6 in-office study visits. Intervention sessions occur
        approximately 2 weeks apart, with a final long-term outcome session occurring approximately
        6-months post the baseline intervention session.
  
        Significant others of participants are invited to join the study and contribute data related
        to their own quality of life and their observations of the effects of the hearing
        intervention on the participant.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective Physical Activity
  time frame: 2-week measurement taken between 4- and 6- months post study enrollment
  description: Activity level as measured by research-grade accelerometer
  measure: Words in Noise Test
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Measures speech perception in noise performance
  measure: International Outcome Inventory for Comprehensive Hearing Intervention
  time frame: Measured at 6-months post study enrollment
  description: Self-reported hearing aid benefit measure
  measure: Client Oriented Scale of Improvement
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported hearing aid benefit measure
  measure: Hearing Handicap Inventory for Adults
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported hearing handicap
  measure: Center for Epidemiological Studies Depression and Hopelessness Scale
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported depression
  measure: Speech, Spatial and Qualities of Hearing Scale
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported hearing difficulties
  measure: Social Network Index
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported social network information
  measure: UCLA Loneliness Scale
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported loneliness
  measure: The Positive and Negative Affect Schedule
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported positive and negative affect/mood
  measure: The World Health Organization Well-Being Index
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported well being
  measure: The Vanderbilt Fatigue Scale for Adults
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported fatigue
  measure: Research & Development Short Form Survey (RAND36)
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported quality of life
  measure: Single-item sedentary questionnaire
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported physical activity
  measure: Modified four-square step test
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Measures physical function
  measure: Expanded short physical performance battery
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Measures lower extremity function
  measure: Baecke Physical Activity Questionnaire
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported physical activity
  measure: PROMIS v2.0 Mobility Questionnaire
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported mobility
  measure: User Experience Questionnaire+
  time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
  description: Self-reported hearing device user experience
  arm group label: Hearing Intervention Group
  arm group type: Experimental
  description: Adults aged 55-75 with hearing loss who have little/no prior experience with hearing aids will be enrolled in the hearing intervention group.
  intervention type: Device
  intervention name: Phonak Audeo Lumity Receiver in Canal Hearing Aid
  description: bilateral receiver in canal hearing aids provided as part of a best practices hearing loss intervention including devices, hearing centered counseling, and self management skills training for hearing loss
  arm group label: Hearing Intervention Group
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Michelle Arnold, PhD
  phone: 8139741262
  email: mlarnold@usf.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of South Florida
  investigator full name: Michelle Arnold
  investigator title: Assistant Professor
  mesh term: Hearing Loss
  mesh term: Deafness
  mesh term: Presbycusis