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/NCT05996250</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL22_0203</org_study_id>
      <nct_id>NCT05996250</nct_id>
    </id_info>
    <brief_title>Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects</brief_title>
    <acronym>REVIAGE</acronym>
    <official_title>Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects and the Effects of Age, Gender and Level of Education on Performance</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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>
        Spatial navigation is a high-level cognitive function allowing animals and humans to orient&#xD;
        and move in space by constructing a mental representation of the environment. This function&#xD;
        has been identified as one of the very first to be affected by Alzheimer's disease, including&#xD;
        at the early stages, before the appearance of other mnesic disorders that the latter causes,&#xD;
        such as those of episodic memory. However, the neuropsychological tests currently used in the&#xD;
        diagnosis of cognitive disorders do not allow effective assessment of spatial memory&#xD;
        impairment, in particular because it is impractical to offer spatial orientation tasks in a&#xD;
        consulting room. In this context, virtual reality offers very interesting perspectives: it&#xD;
        makes it possible to create controlled environments to assess spatial memory, without leaving&#xD;
        the place of consultation.&#xD;
  &#xD;
        Before being able to test its possible diagnostic efficacy, it is imperative to test the&#xD;
        feasibility as well as the reliability of this type of task on an elderly population with no&#xD;
        cognitive impairment. The data currently available on immersion tolerance in virtual reality&#xD;
        mainly concern young people aged 18 to 35 and little data is available concerning the elderly&#xD;
        or very old.&#xD;
  &#xD;
        If this task correctly assesses spatial navigation abilities, this study should find the&#xD;
        effects of age and sex usually observed.&#xD;
  &#xD;
        The aim of this study is to assess the tolerance of an immersive virtual reality task&#xD;
        evaluating the spatial memory of elderly subjects and the effects of age, gender and level of&#xD;
        education on performance.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sickness Simulator Questionnaire (SSQ) score</measure>
      <time_frame>The sickness simulator scale is assessed immediately after the immersive virtual reality task.</time_frame>
      <description>This is a questionnaire composed of 16 items covering the potential symptoms of intolerance to a virtual reality tool.&#xD;
  Each item is rated 0 (no symptom), 1 (mild symptom), 2 (moderate symptom) or 3 (severe symptom). The total score is obtained by multiplying the sum of the items by 3.74, and therefore varies from 0 to 180.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to complete the task in immersive virtual reality according to the age of the participants</measure>
      <time_frame>through study completion, 1 year</time_frame>
      <description>Time to complete the task in immersive virtual reality (in seconds) according to the age of participants (in years)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to complete the task in immersive virtual reality (in seconds) according to the gender of participants (male or female)</measure>
      <time_frame>through study completion, 1 year</time_frame>
      <description>Time to complete the task in immersive virtual reality according to the gender of participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to complete the task in immersive virtual reality according to the number of years of study</measure>
      <time_frame>through study completion, 1 year</time_frame>
      <description>Time to complete the task in immersive virtual reality (in seconds) according to the number of years of study (from entry into primary school)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Raw score on the Wechsler Memory Scale-III (MEM III) Spatial Memory subtest</measure>
      <time_frame>through study completion, 1 year</time_frame>
      <description>The test is designed for adults and the elderly to assess the performance of auditory memory, visual memory, memory immediate, delayed and visual working memory.The subtest used is the Spatial Memory subtest, it ranges from 0 to 28 (the higher the score, the better the performance).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Healthy Participants</condition>
    <arm_group>
      <arm_group_label>Immersive virtual reality task</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The immersive virtual reality task, specifically designed for this research, is an adaptation to humans of Morris Pool. The virtual environment is composed of a circular arena 22 virtual meters in diameter, delimited by a low wall. It features two visual landmarks and an invisible object to find. The activity includes a control training sequence, an evaluation sequence and a delayed recall performed approximately 20 minutes after the end of the evaluation sequence.&#xD;
  The immersive reality task is performed once by the participants (the study consists on one visit).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Immersive virtual reality task</intervention_name>
      <description>participants will have to wear a virtual reality headset connected to a remote control and will have to perform submersive virtual reality tasks</description>
      <arm_group_label>Immersive virtual reality task</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant aged 60 to 85&#xD;
  &#xD;
            -  Participant affiliated or entitled to a social security scheme&#xD;
  &#xD;
            -  Recruited participants must have been informed and consented in writing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant with a diagnosis of cognitive impairment&#xD;
  &#xD;
            -  Severe, progressive or unstable pathology whose nature may interfere with the&#xD;
               evaluation variables (epilepsy, psychiatric or psychotic disorders in the acute phase,&#xD;
               visual hallucinations, acute infection, lack of sleep)&#xD;
  &#xD;
            -  Participant equipped with a pacemaker&#xD;
  &#xD;
            -  Burns or sores on the upper part of the face or on the scalp&#xD;
  &#xD;
            -  Consumption of toxic substances that can influence cognitive performance&#xD;
  &#xD;
            -  Deafness or blindness that may compromise participant assessment or completion of&#xD;
               tasks and scales&#xD;
  &#xD;
            -  Participant under guardianship or curatorship or legal safeguard&#xD;
  &#xD;
            -  Participant refusing to use an immersive virtual reality tool&#xD;
  &#xD;
            -  Criterion for stopping the procedure under study: stopping the virtual reality task&#xD;
               due to the participant's simulator sickness.&#xD;
  &#xD;
            -  Montreal Cognitive Assessment (MOCA) score less than 26&#xD;
  &#xD;
            -  MacNair Subjective Complaint Scale score greater than 16&#xD;
  &#xD;
            -  AGGIR score (Autonomy, Gerontology Group Iso Resources) less than 5&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>BACHELET ROMAIN</last_name>
      <phone>+334 72 43 22 25</phone>
      <email>romain.bachelet@chu-lyon.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>VIRICEL Deborah</last_name>
      <phone>+334 72 43 25 01</phone>
      <email>deborah.viricel@chu-lyon.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Charpennes Geriatric Hospital, Lyon University Hospital</name>
        <address>
          <city>Villeurbanne</city>
          <zip>69100</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>BACHELET Romain</last_name>
        <phone>+334 72 43 22 25</phone>
        <email>romain.bachelet@chu-lyon.fr</email>
      </contact>
      <contact_backup>
        <last_name>VIRICEL Deborah</last_name>
        <phone>+334 72 43 25 01</phone>
        <email>deborah.viricel@chu-lyon.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Virtual reality</keyword>
    <keyword>ageing</keyword>
    <keyword>spatial memory</keyword>
    <!-- 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/NCT05996250
  org study id: 69HCL22_0203
  nct id: NCT05996250
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Spatial navigation is a high-level cognitive function allowing animals and humans to orient
        and move in space by constructing a mental representation of the environment. This function
        has been identified as one of the very first to be affected by Alzheimer's disease, including
        at the early stages, before the appearance of other mnesic disorders that the latter causes,
        such as those of episodic memory. However, the neuropsychological tests currently used in the
        diagnosis of cognitive disorders do not allow effective assessment of spatial memory
        impairment, in particular because it is impractical to offer spatial orientation tasks in a
        consulting room. In this context, virtual reality offers very interesting perspectives: it
        makes it possible to create controlled environments to assess spatial memory, without leaving
        the place of consultation.
  
        Before being able to test its possible diagnostic efficacy, it is imperative to test the
        feasibility as well as the reliability of this type of task on an elderly population with no
        cognitive impairment. The data currently available on immersion tolerance in virtual reality
        mainly concern young people aged 18 to 35 and little data is available concerning the elderly
        or very old.
  
        If this task correctly assesses spatial navigation abilities, this study should find the
        effects of age and sex usually observed.
  
        The aim of this study is to assess the tolerance of an immersive virtual reality task
        evaluating the spatial memory of elderly subjects and the effects of age, gender and level of
        education on performance.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Sickness Simulator Questionnaire (SSQ) score
  time frame: The sickness simulator scale is assessed immediately after the immersive virtual reality task.
  description: This is a questionnaire composed of 16 items covering the potential symptoms of intolerance to a virtual reality tool.
  Each item is rated 0 (no symptom), 1 (mild symptom), 2 (moderate symptom) or 3 (severe symptom). The total score is obtained by multiplying the sum of the items by 3.74, and therefore varies from 0 to 180.
  measure: Time to complete the task in immersive virtual reality according to the age of the participants
  time frame: through study completion, 1 year
  description: Time to complete the task in immersive virtual reality (in seconds) according to the age of participants (in years)
  measure: Time to complete the task in immersive virtual reality (in seconds) according to the gender of participants (male or female)
  time frame: through study completion, 1 year
  description: Time to complete the task in immersive virtual reality according to the gender of participants
  measure: Time to complete the task in immersive virtual reality according to the number of years of study
  time frame: through study completion, 1 year
  description: Time to complete the task in immersive virtual reality (in seconds) according to the number of years of study (from entry into primary school)
  measure: Raw score on the Wechsler Memory Scale-III (MEM III) Spatial Memory subtest
  time frame: through study completion, 1 year
  description: The test is designed for adults and the elderly to assess the performance of auditory memory, visual memory, memory immediate, delayed and visual working memory.The subtest used is the Spatial Memory subtest, it ranges from 0 to 28 (the higher the score, the better the performance).
  arm group label: Immersive virtual reality task
  arm group type: Other
  description: The immersive virtual reality task, specifically designed for this research, is an adaptation to humans of Morris Pool. The virtual environment is composed of a circular arena 22 virtual meters in diameter, delimited by a low wall. It features two visual landmarks and an invisible object to find. The activity includes a control training sequence, an evaluation sequence and a delayed recall performed approximately 20 minutes after the end of the evaluation sequence.
  The immersive reality task is performed once by the participants (the study consists on one visit).
  intervention type: Other
  intervention name: Immersive virtual reality task
  description: participants will have to wear a virtual reality headset connected to a remote control and will have to perform submersive virtual reality tasks
  arm group label: Immersive virtual reality task
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: BACHELET ROMAIN
  phone: +334 72 43 22 25
  email: romain.bachelet@chu-lyon.fr
  last name: VIRICEL Deborah
  phone: +334 72 43 25 01
  email: deborah.viricel@chu-lyon.fr
  facility: 
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor