<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/NCT04442594</url>
  </required_header>
  <id_info>
    <org_study_id>20-PP-11</org_study_id>
    <nct_id>NCT04442594</nct_id>
  </id_info>
  <brief_title>REMINISCENCES and EMOTIONS : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders</brief_title>
  <acronym>REMINISCENCES</acronym>
  <official_title>REMINISCENCES : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      Presentation &amp; Pre-screening of the control group / reminiscence group Patient/resident&#xD;
      pre-screening team meeting for the study Explanation and proposal of the study to patients&#xD;
      and their families Signature of resident/patient and family consents Audit of inclusion and&#xD;
      non-inclusion criteria Inclusion Medical advice for VR Clinical interview with the family or&#xD;
      legal guardian for an accurate life history + an anamnesis interview (psychologist or doctor)&#xD;
      with the patient or resident.&#xD;
&#xD;
      Creation of video contents Creation of personalized video contents Clinical scales review&#xD;
      Evaluation of the number of psychotropic molecules prescribed (coordinating doctor, general&#xD;
      practitioner, geriatrician)&#xD;
&#xD;
        -  Pre-test phase with the patient for the use of the VR headset&#xD;
&#xD;
        -  Randomisation&#xD;
&#xD;
        -  Session procedure As previously mentioned, the virtual reality sessions will take place&#xD;
           in a quiet setting twice a week in the living or hosting residence. The sessions will be&#xD;
           hold over a period of time of 6 weeks.&#xD;
&#xD;
      Each subject of the reminiscence group will have two personalised virtual surroundings (after&#xD;
      data being collected from team and/or families).&#xD;
&#xD;
      The virtual environment will change every 3 weeks in order to avoid the phenomenon of&#xD;
      habituation.&#xD;
&#xD;
      The subjects of the control group will be exposed to two generic virtual settings (beach,&#xD;
      mountain etc.) with a different virtual environment every 3 weeks.&#xD;
&#xD;
      During the session, note will be taken on the subject's speech. The session will also be&#xD;
      filmed and/or recorded with a prior signed agreement by the patient or his representative.&#xD;
&#xD;
      - Last session (S6) Review of clinical scales (re-testing) Re-evaluation of drug&#xD;
      prescriptions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2020</start_date>
  <completion_date type="Actual">February 1, 2023</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</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>
    <intervention_model_description>The virtual reality sessions will take place twice a week during 6 weeks. Each subject will have two different virtual environment. The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression and anxiety assessment</measure>
    <time_frame>change of Hamilton score between inclusion and 6 weeks (before and after therapy)</time_frame>
    <description>assessment with Hamilton scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>psychotropic drugs consumption</measure>
    <time_frame>change in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy)</time_frame>
    <description>assessment of psychotropic drugs consumption</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Mood Disorders</condition>
  <condition>Virtual Reality</condition>
  <arm_group>
    <arm_group_label>personalized video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>generic vidéo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>virtual reality session</intervention_name>
    <description>The virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks.&#xD;
The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.</description>
    <arm_group_label>generic vidéo</arm_group_label>
    <arm_group_label>personalized video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 65 or older&#xD;
&#xD;
          -  Accompanied in day care or in the geriatric structure of the CHU of Nice (EHPAD-USLD)&#xD;
&#xD;
          -  Mild to moderate cognitive impairment&#xD;
&#xD;
          -  Diagnostic criteria for Alzheimer's disease, NINCDS-ADRDA probably,&#xD;
&#xD;
          -  Positive score on at least one of the following rating scales :&#xD;
&#xD;
          -  NPI-ES depression/dysphoria and anxiety items + GDS 15 Patients&#xD;
&#xD;
          -  IA caregiver = 2 on one of 2 dimensions + IA patient = 2 on one of 2 dimensions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed psychiatric pathology&#xD;
&#xD;
          -  Disabling sensory disorders such as DMLA&#xD;
&#xD;
          -  Significant hearing loss&#xD;
&#xD;
          -  Subjects with risk of photosensitive epilepsy or dizziness. Subjects with Lewy body&#xD;
             dementia&#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>Olivier guerin.o@chu-nice.fr, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nice University Hospital, Gerontology Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EPHAD Ancilla</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EPHAD Clos de Cimiez</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital privé Gériatrique Les Sources</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 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>Alzheimer Disease</mesh_term>
    <mesh_term>Mood Disorders</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/NCT04442594
org study id: 20-PP-11
nct id: NCT04442594
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Presentation & Pre-screening of the control group / reminiscence group Patient/resident
      pre-screening team meeting for the study Explanation and proposal of the study to patients
      and their families Signature of resident/patient and family consents Audit of inclusion and
      non-inclusion criteria Inclusion Medical advice for VR Clinical interview with the family or
      legal guardian for an accurate life history + an anamnesis interview (psychologist or doctor)
      with the patient or resident.

      Creation of video contents Creation of personalized video contents Clinical scales review
      Evaluation of the number of psychotropic molecules prescribed (coordinating doctor, general
      practitioner, geriatrician)

        -  Pre-test phase with the patient for the use of the VR headset

        -  Randomisation

        -  Session procedure As previously mentioned, the virtual reality sessions will take place
           in a quiet setting twice a week in the living or hosting residence. The sessions will be
           hold over a period of time of 6 weeks.

      Each subject of the reminiscence group will have two personalised virtual surroundings (after
      data being collected from team and/or families).

      The virtual environment will change every 3 weeks in order to avoid the phenomenon of
      habituation.

      The subjects of the control group will be exposed to two generic virtual settings (beach,
      mountain etc.) with a different virtual environment every 3 weeks.

      During the session, note will be taken on the subject's speech. The session will also be
      filmed and/or recorded with a prior signed agreement by the patient or his representative.

      - Last session (S6) Review of clinical scales (re-testing) Re-evaluation of drug
      prescriptions
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The virtual reality sessions will take place twice a week during 6 weeks. Each subject will have two different virtual environment. The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Depression and anxiety assessment
time frame: change of Hamilton score between inclusion and 6 weeks (before and after therapy)
description: assessment with Hamilton scale
measure: psychotropic drugs consumption
time frame: change in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy)
description: assessment of psychotropic drugs consumption
arm group label: personalized video
arm group type: Experimental
description: Each subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families).
arm group label: generic vidéo
arm group type: Active Comparator
description: The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.)
intervention type: Procedure
intervention name: virtual reality session
description: The virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks.
The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.
arm group label: generic vidéo
arm group label: personalized video
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier guerin.o@chu-nice.fr, PU-PH
role: Principal Investigator
affiliation: Nice University Hospital, Gerontology Department
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Mood Disorders
sharing ipd: No