<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/NCT03285789</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0333</org_study_id>
    <secondary_id>2017-A02525-48</secondary_id>
    <nct_id>NCT03285789</nct_id>
  </id_info>
  <brief_title>Dyslexics' Visual Attention Field</brief_title>
  <official_title>Evaluation of the Visuo-attention Field of Symbols Versus Objects Visual Search in Dyslexic Subjects. DyslexiaSPOTLIGHT</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>
      dyslexia is often considered like a phonological deficit but some researches show that a&#xD;
      visual attention (V-A) deficit can occur in dyslexia. The investigator want to show that some&#xD;
      dyslexics have a reduced V-A field in visual search when the investigator use separable&#xD;
      feature (letter-like).&#xD;
&#xD;
      If the investigator demonstrate that, he will show that V-A deficit can be transpose to an&#xD;
      ability acquired before reading, the visual search. Therefore, the V-A deficit can't be a&#xD;
      consequence of reading problem but a cause of it for some dyslexics.&#xD;
&#xD;
      The investigator could imagine an earlier diagnosis for children at risk to develop dyslexia&#xD;
      and make reeducation more specific for the deficit observed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 25, 2018</start_date>
  <completion_date type="Anticipated">October 21, 2026</completion_date>
  <primary_completion_date type="Anticipated">October 21, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Respond time in visual search in different condition of view (full view or reduced view) with separable feature.</measure>
    <time_frame>Day 0</time_frame>
    <description>The subject will have to find a target among distractors, when he will find it, he will have to push a button and we will have his respond time. We will compare the respond time in two view condition: the participant will see all the visual scene or he will have reduced visible window so he won't see all the scene, the periphery will be hide and he will have to move his sight to show it.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>respond time in function of the distractors' number</measure>
    <time_frame>Day 0</time_frame>
    <description>The subject will have to find a target among distractors, when he will find it, he will have to push a button and we will collect his respond time. We compare the respond time between two number of distractors (24 or 48)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual exploration of the scene</measure>
    <time_frame>Day 0</time_frame>
    <description>with an eye tracker the investigator will analyze the ocular movements during visual search (saccades and fixations) and the equip will compare the visual behavior between the different groups and the different conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visuo-spatial perception</measure>
    <time_frame>Day 0</time_frame>
    <description>the investigator will test with different exercises the elementary visuo spatial perception of the participant and he will compare between groups and also he will make correlation with the respond time in visual search.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual attention span (VAS)</measure>
    <time_frame>Day 0</time_frame>
    <description>the subject have to report orally a 5 letters' string presented during 200 ms, the investigator could see if a correlation exist between VAS and RT, VAS and visual exploration, VAS and visuo spatial perception.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1460</enrollment>
  <condition>Dyslexia</condition>
  <arm_group>
    <arm_group_label>Dyslexics with reduced visual attention span</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>21 subjects diagnosed dyslexics with reduced visual attention span</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dyslexics with normal visual attention span</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Passing tests in dyslexics with reduced eva</intervention_name>
    <description>Visual attention span : the subject see a 5 letters strings during 200 ms and he has to report it orally whatever the order Visual search : the subject has to find a target among distractors (24 or 48) in different conditions of stimuli (conjunction feature or separable feature) and different conditions of view (full view or reduced view with the moving window paradigm) Elementary visuo spatial perception: the subject passes 6 visuo spatial tests to judge his visuo spatial abilities.&#xD;
All of these tests will be made during an unique visit of 1h30.</description>
    <arm_group_label>Dyslexics with normal visual attention span</arm_group_label>
    <arm_group_label>Dyslexics with reduced visual attention span</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Passing tests in controls</intervention_name>
    <description>Visual attention span : the subject see a 5 letters strings during 200 ms and he has to report it verbally whatever the order Visual search : the subject has to find a target among distractors (24 or 48) in different conditions of stimuli (conjunction feature or separable feature) and different conditions of view (full view or reduced view with the moving window paradigm) Elementary visuo spatial perception: the subject passes 6 visuo spatial test to judge his visuo spatial abilities.&#xD;
&quot;test de l'alouette&quot; : reading test during 3 minutes, we note the number of word read and the errors. We obtain lexical age.&#xD;
All of these tests will be made during an unique visit of 1h30.</description>
    <arm_group_label>controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  normal or corrected to normal vision&#xD;
&#xD;
          -  diagnosed dyslexics with a recent &quot;alouette&quot; test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other developmental problem (dysphasia, dyspraxia, ADHD)&#xD;
&#xD;
          -  strabismus, amblyopia, oculomotor paralysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laure PISELLA, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>INSERM U1028 - Impact - CRNL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>U1028 INSERM - CNRS UMR 5292 Equipe ImpAct</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>July 25, 2022</last_update_submitted>
  <last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dyslexia</keyword>
  <keyword>Visual Fields</keyword>
  <keyword>visual attention span</keyword>
  <keyword>visual search</keyword>
  <keyword>visual attention field</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslexia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03285789
org study id: 69HCL17_0333
secondary id: 2017-A02525-48
nct id: NCT03285789
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
dyslexia is often considered like a phonological deficit but some researches show that a
      visual attention (V-A) deficit can occur in dyslexia. The investigator want to show that some
      dyslexics have a reduced V-A field in visual search when the investigator use separable
      feature (letter-like).

      If the investigator demonstrate that, he will show that V-A deficit can be transpose to an
      ability acquired before reading, the visual search. Therefore, the V-A deficit can't be a
      consequence of reading problem but a cause of it for some dyslexics.

      The investigator could imagine an earlier diagnosis for children at risk to develop dyslexia
      and make reeducation more specific for the deficit observed.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Respond time in visual search in different condition of view (full view or reduced view) with separable feature.
time frame: Day 0
description: The subject will have to find a target among distractors, when he will find it, he will have to push a button and we will have his respond time. We will compare the respond time in two view condition: the participant will see all the visual scene or he will have reduced visible window so he won't see all the scene, the periphery will be hide and he will have to move his sight to show it.
measure: respond time in function of the distractors' number
time frame: Day 0
description: The subject will have to find a target among distractors, when he will find it, he will have to push a button and we will collect his respond time. We compare the respond time between two number of distractors (24 or 48)
measure: visual exploration of the scene
time frame: Day 0
description: with an eye tracker the investigator will analyze the ocular movements during visual search (saccades and fixations) and the equip will compare the visual behavior between the different groups and the different conditions.
measure: visuo-spatial perception
time frame: Day 0
description: the investigator will test with different exercises the elementary visuo spatial perception of the participant and he will compare between groups and also he will make correlation with the respond time in visual search.
measure: visual attention span (VAS)
time frame: Day 0
description: the subject have to report orally a 5 letters' string presented during 200 ms, the investigator could see if a correlation exist between VAS and RT, VAS and visual exploration, VAS and visuo spatial perception.
arm group label: Dyslexics with reduced visual attention span
arm group type: Experimental
description: 21 subjects diagnosed dyslexics with reduced visual attention span
arm group label: Dyslexics with normal visual attention span
arm group type: Experimental
arm group label: controls
arm group type: Active Comparator
intervention type: Other
intervention name: Passing tests in dyslexics with reduced eva
description: Visual attention span : the subject see a 5 letters strings during 200 ms and he has to report it orally whatever the order Visual search : the subject has to find a target among distractors (24 or 48) in different conditions of stimuli (conjunction feature or separable feature) and different conditions of view (full view or reduced view with the moving window paradigm) Elementary visuo spatial perception: the subject passes 6 visuo spatial tests to judge his visuo spatial abilities.
All of these tests will be made during an unique visit of 1h30.
arm group label: Dyslexics with normal visual attention span
arm group label: Dyslexics with reduced visual attention span
intervention type: Other
intervention name: Passing tests in controls
description: Visual attention span : the subject see a 5 letters strings during 200 ms and he has to report it verbally whatever the order Visual search : the subject has to find a target among distractors (24 or 48) in different conditions of stimuli (conjunction feature or separable feature) and different conditions of view (full view or reduced view with the moving window paradigm) Elementary visuo spatial perception: the subject passes 6 visuo spatial test to judge his visuo spatial abilities.
"test de l'alouette" : reading test during 3 minutes, we note the number of word read and the errors. We obtain lexical age.
All of these tests will be made during an unique visit of 1h30.
arm group label: controls
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laure PISELLA, PhD
role: Principal Investigator
affiliation: INSERM U1028 - Impact - CRNL
facility: 
country: France
responsible party type: Sponsor
mesh term: Dyslexia