<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/NCT03811964</url>
  </required_header>
  <id_info>
    <org_study_id>6791</org_study_id>
    <nct_id>NCT03811964</nct_id>
  </id_info>
  <brief_title>Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies</brief_title>
  <official_title>Study of the Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      The light has visual and non-visual effects on organism and can act on the behavior, the&#xD;
      mood, the cognition and the sleep. These effects are mediated by &quot;classical&quot; retina&#xD;
      photoreceptors which allow vision (rods, cones) but also melanopsin cells. The non-visual&#xD;
      effects of light seems to be altered in many neurological, psychiatric or ophtalmological&#xD;
      conditions but their exact role in the pathogenesis remains poorly understand. The purpose of&#xD;
      the study is to increase our knowledge of the non-visual effects of light and establish new&#xD;
      therapeutic applications&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 22, 2020</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PIPR : Post-Illumination Pupil Response</measure>
    <time_frame>1 day</time_frame>
    <description>1 measurement per subject is performed after exposure to monochromatic light exposure</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">726</enrollment>
  <condition>Sleep Disorders</condition>
  <condition>Neurological Pathologies</condition>
  <condition>Psychiatric Pathologies</condition>
  <condition>Ophthalmological Pathologies</condition>
  <arm_group>
    <arm_group_label>primary sleep-wake disorder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects with primary sleep-wake disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>neurological pathology</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>subjects presenting a neurological pathology with disorder of the controls of the wake and the sleep</description>
  </arm_group>
  <arm_group>
    <arm_group_label>psychiatric pathology</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>subject presenting a psychiatric pathology with disorder of the controls of the wake and the sleep</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ophthalmological pathology</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>subject presenting an ophthalmological pathology with possible alteration of the photoreception and / or phototransduction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>photosensitivity</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>subjects with photosensitivity with regulation disorder of sleep and wake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>healthy subject</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Specific light exposures</intervention_name>
    <description>Specific light exposures using light in a wide range of intensities or different light/dark regimens</description>
    <arm_group_label>group control</arm_group_label>
    <arm_group_label>neurological pathology</arm_group_label>
    <arm_group_label>ophthalmological pathology</arm_group_label>
    <arm_group_label>photosensitivity</arm_group_label>
    <arm_group_label>primary sleep-wake disorder</arm_group_label>
    <arm_group_label>psychiatric pathology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  Subject having signed a free and informed consent&#xD;
&#xD;
          -  Subject affiliated to a social protection scheme Arm 1 :Subjects with primary&#xD;
             sleep-wake disorder Arm 2 : subjects presenting a neurological pathology with disorder&#xD;
             of the controls of the wake and the sleep Arm 3 : subject presenting a psychiatric&#xD;
             pathology pathology with disorder of the controls of the wake and the sleep Arm 4 :&#xD;
             subject presenting an ophthalmological pathology with possible alteration of the&#xD;
             photoreception and / or phototransduction Arm 5 : subjects with photosensitivity with&#xD;
             regulation disorder of sleep and wake Arm 6 : healthy subject&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Age-Related Macular Degeneration (AMD) and all maculopathies (retinopathies pigmentosa,&#xD;
        macular involvement of diabetes)&#xD;
&#xD;
          -  Cataract with significant vision loss &lt;5/10&#xD;
&#xD;
          -  Chorioretinal neovascularization&#xD;
&#xD;
          -  Subject in exclusion period determined by previous or current study&#xD;
&#xD;
          -  Impossibility to give the subject information enlightened (subject in emergency&#xD;
             situation, difficulties of understanding the subject, ...)&#xD;
&#xD;
          -  Subject under the protection of justice&#xD;
&#xD;
          -  Subject under guardianship or curatorship&#xD;
&#xD;
          -  Pregnancy / Breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bourgin Patrice, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Strasbourg, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bourgin Patrice, MD</last_name>
    <phone>03 88 11 64 30</phone>
    <phone_ext>0033</phone_ext>
    <email>pbourgin@unistra.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital, Strasbourg, France</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bourgin Patrice, MD</last_name>
      <phone>03 88 11 64 30</phone>
      <phone_ext>0033</phone_ext>
      <email>pbourgin@unistra.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 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>Sleep Wake Disorders</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/NCT03811964
org study id: 6791
nct id: NCT03811964
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The light has visual and non-visual effects on organism and can act on the behavior, the
      mood, the cognition and the sleep. These effects are mediated by "classical" retina
      photoreceptors which allow vision (rods, cones) but also melanopsin cells. The non-visual
      effects of light seems to be altered in many neurological, psychiatric or ophtalmological
      conditions but their exact role in the pathogenesis remains poorly understand. The purpose of
      the study is to increase our knowledge of the non-visual effects of light and establish new
      therapeutic applications
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: PIPR : Post-Illumination Pupil Response
time frame: 1 day
description: 1 measurement per subject is performed after exposure to monochromatic light exposure
arm group label: primary sleep-wake disorder
arm group type: Other
description: Subjects with primary sleep-wake disorder
arm group label: neurological pathology
arm group type: Other
description: subjects presenting a neurological pathology with disorder of the controls of the wake and the sleep
arm group label: psychiatric pathology
arm group type: Other
description: subject presenting a psychiatric pathology with disorder of the controls of the wake and the sleep
arm group label: ophthalmological pathology
arm group type: Other
description: subject presenting an ophthalmological pathology with possible alteration of the photoreception and / or phototransduction
arm group label: photosensitivity
arm group type: Other
description: subjects with photosensitivity with regulation disorder of sleep and wake
arm group label: group control
arm group type: Other
description: healthy subject
intervention type: Other
intervention name: Specific light exposures
description: Specific light exposures using light in a wide range of intensities or different light/dark regimens
arm group label: group control
arm group label: neurological pathology
arm group label: ophthalmological pathology
arm group label: photosensitivity
arm group label: primary sleep-wake disorder
arm group label: psychiatric pathology
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bourgin Patrice, MD
role: Principal Investigator
affiliation: University Hospital, Strasbourg, France
last name: Bourgin Patrice, MD
phone: 03 88 11 64 30
phone ext: 0033
email: pbourgin@unistra.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Sleep Wake Disorders