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/NCT06008782</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00218068</org_study_id>
      <secondary_id>K23AG059900</secondary_id>
      <nct_id>NCT06008782</nct_id>
    </id_info>
    <brief_title>HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment</brief_title>
    <official_title>HEARS-SLP: Providing Speech Language Pathologist-Delivered Hearing Health Care to Individuals With Cognitive Impairment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Johns Hopkins University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Building upon the HEARS audiologist-community health worker (CHW) model, this study&#xD;
        intervention will be delivered by a speech-language pathologist (SLP). The primary objective&#xD;
        of the study is to develop and test an affordable and accessible hearing rehabilitative&#xD;
        intervention that will be delivered by a SLP to individuals with cognitive impairment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)</measure>
      <time_frame>Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)</time_frame>
      <description>Scoring: Each of the 12 NPI-Q domains contains a survey question that reflects symptoms of that domain. Initial responses to each domain question are &quot;Yes&quot; or &quot;No&quot;. If the response to the question is &quot;No&quot;, the informant goes to the next question. If &quot;Yes&quot;, the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores. Total NPI-Q severity score is the sum of individual symptom scores, ranges from 0 to 36.&#xD;
  SEVERITY of the symptom (how it affects the patient):&#xD;
  = Mild (noticeable, but not a significant change)&#xD;
  = Moderate (significant, but not a dramatic change)&#xD;
  = Severe</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale</measure>
      <time_frame>Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)</time_frame>
      <description>Scoring for QOL-AD:&#xD;
  Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.&#xD;
  The total score is the sum of all 13 items. Total scores range from 13 to 52.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S)</measure>
      <time_frame>Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)</time_frame>
      <description>Higher scores indicate increased hearing handicap.&#xD;
  Scoring:&#xD;
  0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Hearing Loss</condition>
    <condition>Dementia</condition>
    <condition>Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>Immediate treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>immediate treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Delayed treatment</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>1 month delayed treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>HEARS-SLP device</intervention_name>
      <description>Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.</description>
      <arm_group_label>Delayed treatment</arm_group_label>
      <arm_group_label>Immediate treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>HEARS-SLP program</intervention_name>
      <description>Tailored aural rehabilitation for participant and communication partner</description>
      <arm_group_label>Delayed treatment</arm_group_label>
      <arm_group_label>Immediate treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 60 - 100 years old&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
            -  Lives at home&#xD;
  &#xD;
            -  Diagnosis of probable Alzheimer's Disease or other related dementia according to the&#xD;
               core clinical criteria outlined in the National Institute on Aging (NIA) and&#xD;
               Alzheimer's Association Guidelines&#xD;
  &#xD;
            -  Availability of caregiver/study partner to participate in all study-related visits and&#xD;
               who provides ≥8 hours of weekly oversight/care&#xD;
  &#xD;
            -  Speech frequency pure tone average (0.5- 4 kHz) &gt;25 db in the better-hearing ear;&#xD;
               adult onset hearing loss&#xD;
  &#xD;
            -  Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants,&#xD;
               antipsychotics) for neuropsychiatric symptoms&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current self-reported use of hearing aid or amplification device&#xD;
  &#xD;
            -  Medical contraindication to use hearing aids ( e.g. draining ears)&#xD;
  &#xD;
            -  Inability to participate in the 1-month follow up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Esther Oh, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carrie L Nieman, MD, MPH</last_name>
      <phone>410-502-6965</phone>
      <email>cnieman1@jhmi.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Roxanne Clement-Rorick, MPH</last_name>
      <phone>410-955-0920</phone>
      <email>rcleme10@jh.edu</email>
    </overall_contact_backup>
    <reference>
      <citation>Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.</citation>
      <PMID>6626295</PMID>
    </reference>
    <reference>
      <citation>Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61. doi: 10.1097/00003446-199002000-00011.</citation>
      <PMID>2307305</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</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>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06008782
  org study id: IRB00218068
  secondary id: K23AG059900
  nct id: NCT06008782
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Building upon the HEARS audiologist-community health worker (CHW) model, this study
        intervention will be delivered by a speech-language pathologist (SLP). The primary objective
        of the study is to develop and test an affordable and accessible hearing rehabilitative
        intervention that will be delivered by a SLP to individuals with cognitive impairment.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)
  time frame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
  description: Scoring: Each of the 12 NPI-Q domains contains a survey question that reflects symptoms of that domain. Initial responses to each domain question are "Yes" or "No". If the response to the question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores. Total NPI-Q severity score is the sum of individual symptom scores, ranges from 0 to 36.
  SEVERITY of the symptom (how it affects the patient):
  = Mild (noticeable, but not a significant change)
  = Moderate (significant, but not a dramatic change)
  = Severe
  measure: Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale
  time frame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
  description: Scoring for QOL-AD:
  Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.
  The total score is the sum of all 13 items. Total scores range from 13 to 52.
  measure: Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S)
  time frame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
  description: Higher scores indicate increased hearing handicap.
  Scoring:
  0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
  arm group label: Immediate treatment
  arm group type: Experimental
  description: immediate treatment
  arm group label: Delayed treatment
  arm group type: Placebo Comparator
  description: 1 month delayed treatment
  intervention type: Device
  intervention name: HEARS-SLP device
  description: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
  arm group label: Delayed treatment
  arm group label: Immediate treatment
  intervention type: Behavioral
  intervention name: HEARS-SLP program
  description: Tailored aural rehabilitation for participant and communication partner
  arm group label: Delayed treatment
  arm group label: Immediate treatment
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Esther Oh, MD, PhD
  role: Principal Investigator
  affiliation: Johns Hopkins School of Medicine
  last name: Carrie L Nieman, MD, MPH
  phone: 410-502-6965
  email: cnieman1@jhmi.edu
  last name: Roxanne Clement-Rorick, MPH
  phone: 410-955-0920
  email: rcleme10@jh.edu
  citation: Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
  PMID: 6626295
  citation: Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61. doi: 10.1097/00003446-199002000-00011.
  PMID: 2307305
  responsible party type: Sponsor
  mesh term: Hearing Loss
  mesh term: Cognitive Dysfunction
  sharing ipd: No