<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/NCT03002142</url>
  </required_header>
  <id_info>
    <org_study_id>PHRI15-DB/RACO-MA</org_study_id>
    <nct_id>NCT03002142</nct_id>
  </id_info>
  <brief_title>Auditory Rehabilitation and Cognition in Alzheimer Patients</brief_title>
  <acronym>RACO-MA</acronym>
  <official_title>Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with&#xD;
      hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive&#xD;
      to presbycusis and/or to central auditory dysfunction.&#xD;
&#xD;
      Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis&#xD;
      of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric&#xD;
      tests as noisy and/or dichotic tests, are needed.&#xD;
&#xD;
      Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease;&#xD;
      therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now,&#xD;
      investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored&#xD;
      the hearing ability of the patient. However, the major part of care management and&#xD;
      investigations implies the patient's communication ability with caregivers. Hearing loss may&#xD;
      be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory&#xD;
      rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline&#xD;
      but this management must be investigate during longitudinal studies in order to demonstrate&#xD;
      their efficiency and need to be compared with a placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2017</start_date>
  <completion_date type="Actual">May 3, 2020</completion_date>
  <primary_completion_date type="Actual">March 3, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale</measure>
    <time_frame>Change before and one year after the fitting with device</time_frame>
    <description>French scale validated by the french society of geriatry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>Tonal audiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech recognition threshold (dB HL) measured by speech audiometry</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>Speech audiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Discrimination Test (%) measured by speech audiometry</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>Speech audiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dichotic test measured with audiometry</measure>
    <time_frame>From 1 to 90 days prior the fitting with device</time_frame>
    <description>Speech audiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)</measure>
    <time_frame>6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>Audiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Devices tolerance measured with number of hours per day with hearing aids</measure>
    <time_frame>6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>Audiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective auditory thresholds measured with auditory brainstem responses (ms)</measure>
    <time_frame>6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>in case of uncooperative patients or to confirm tonal audiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>in case of uncooperative patients or to confirm tonal audiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini Mental State Examination (30 items, total score from 0-30)</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>French validated version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>French validated version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing loss impact scale in adults measured by 2 questionnaire (Abbreviated Profile of Hearing Aid Benefit, 24 items) and Impact of hearing loss in adults (20 items, total score from 0-200)</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>French validated version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>French validated version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>French validated version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>French validated version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive functions measured by trail making test</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>French validated version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working memory and processing speed measured by Wechsler Adult Intelligence Scale</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>French validated version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech comprehension measured by Beauregard tests</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>French validated version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire</measure>
    <time_frame>From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device</time_frame>
    <description>French validated version</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Alzheimer's Disease</condition>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Patients treated with hearing aids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients fitted with functional hearing aids (Phonak Audéo BR)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients treated with placebo device</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients fitted with non-functional hearing aids</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hearing aids</intervention_name>
    <description>Phonak Audéo B-R (Target V 5.0)</description>
    <arm_group_label>Patients treated with hearing aids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Phonak Audéo B-R (Target V 5.0) without amplification</description>
    <arm_group_label>Patients treated with placebo device</arm_group_label>
    <other_name>Non functional hearing aids</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Alzheimer patient&#xD;
&#xD;
          -  Mini Mental state examination= 15-25 or mild cognitive impairment&#xD;
&#xD;
          -  Over 65 yo&#xD;
&#xD;
          -  Sensorineural hearing loss with pure tone average over 30 dB&#xD;
&#xD;
          -  Language: French&#xD;
&#xD;
          -  Able to sign the consent&#xD;
&#xD;
          -  Affiliated to the French social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Conductive hearing loss&#xD;
&#xD;
          -  Retrocochlear hearing loss&#xD;
&#xD;
          -  History of neurological disorders with consequences in hearing loss (vascular&#xD;
             accident; brain surgery, cerebral tumors, head trauma with loss consciousness)&#xD;
&#xD;
          -  patient included in another study&#xD;
&#xD;
          -  French no spoken&#xD;
&#xD;
          -  chronic used of drugs or alcohol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>DAVID BAKHOS, MCU-PU</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Tours</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>March 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer</keyword>
  <keyword>Hearing loss</keyword>
  <keyword>Cognition</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Hearing aids</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>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03002142
org study id: PHRI15-DB/RACO-MA
nct id: NCT03002142
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with
      hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive
      to presbycusis and/or to central auditory dysfunction.

      Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis
      of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric
      tests as noisy and/or dichotic tests, are needed.

      Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease;
      therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now,
      investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored
      the hearing ability of the patient. However, the major part of care management and
      investigations implies the patient's communication ability with caregivers. Hearing loss may
      be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory
      rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline
      but this management must be investigate during longitudinal studies in order to demonstrate
      their efficiency and need to be compared with a placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale
time frame: Change before and one year after the fitting with device
description: French scale validated by the french society of geriatry
measure: air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: Tonal audiometry
measure: Speech recognition threshold (dB HL) measured by speech audiometry
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: Speech audiometry
measure: Speech Discrimination Test (%) measured by speech audiometry
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: Speech audiometry
measure: Dichotic test measured with audiometry
time frame: From 1 to 90 days prior the fitting with device
description: Speech audiometry
measure: Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)
time frame: 6 months after the fitting with device, 12 months after the fitting with device
description: Audiometry
measure: Devices tolerance measured with number of hours per day with hearing aids
time frame: 6 months after the fitting with device, 12 months after the fitting with device
description: Audiometry
measure: Objective auditory thresholds measured with auditory brainstem responses (ms)
time frame: 6 months after the fitting with device, 12 months after the fitting with device
description: in case of uncooperative patients or to confirm tonal audiometry
measure: Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: in case of uncooperative patients or to confirm tonal audiometry
measure: Mini Mental State Examination (30 items, total score from 0-30)
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: French validated version
measure: Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: French validated version
measure: Hearing loss impact scale in adults measured by 2 questionnaire (Abbreviated Profile of Hearing Aid Benefit, 24 items) and Impact of hearing loss in adults (20 items, total score from 0-200)
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: French validated version
measure: Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: French validated version
measure: Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: French validated version
measure: Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: French validated version
measure: Executive functions measured by trail making test
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: French validated version
measure: Working memory and processing speed measured by Wechsler Adult Intelligence Scale
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: French validated version
measure: Speech comprehension measured by Beauregard tests
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: French validated version
measure: Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire
time frame: From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device
description: French validated version
arm group label: Patients treated with hearing aids
arm group type: Experimental
description: Patients fitted with functional hearing aids (Phonak Audéo BR)
arm group label: Patients treated with placebo device
arm group type: Placebo Comparator
description: Patients fitted with non-functional hearing aids
intervention type: Device
intervention name: Hearing aids
description: Phonak Audéo B-R (Target V 5.0)
arm group label: Patients treated with hearing aids
intervention type: Device
intervention name: Placebo
description: Phonak Audéo B-R (Target V 5.0) without amplification
arm group label: Patients treated with placebo device
other name: Non functional hearing aids
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: DAVID BAKHOS, MCU-PU
role: Principal Investigator
affiliation: University Hospital, Tours
facility: 
country: France
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Alzheimer Disease
sharing ipd: Undecided