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/NCT06009289</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-71788</org_study_id>
      <nct_id>NCT06009289</nct_id>
    </id_info>
    <brief_title>Light and Sleep Fragmentation</brief_title>
    <official_title>Application of Precision Medicine to Phototherapy: a Stepped Care Approach to Consolidate Sleep and Slow Cognitive Decline in Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>VA Palo Alto Health Care System</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>
        This trial will examine scheduled exposure to bright light in the morning and afternoon as a&#xD;
        countermeasure to sleep fragmentation in older individuals with mild cognitive impairment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">June 1, 2026</start_date>
    <completion_date type="Anticipated">May 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2028</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sleep fragmentation</measure>
      <time_frame>4 weeks</time_frame>
      <description>24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cognition</measure>
      <time_frame>6 months</time_frame>
      <description>Performance on the WAIS-4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood</measure>
      <time_frame>6 months</time_frame>
      <description>Geriatric Depression Scale, range: 0-15 with higher scores being associated with greater depressive symptomatology</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Sleep</condition>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Mood Disorders</condition>
    <arm_group>
      <arm_group_label>Standard of care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>One hour of daily bright light exposure beginning one hour after wake time.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Stepped care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One hour of daily bright light exposure in the afternoon</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Light therapy</intervention_name>
      <description>One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor</description>
      <arm_group_label>Standard of care</arm_group_label>
      <arm_group_label>Stepped care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Mild Cognitive Impairment&#xD;
  &#xD;
            -  Age &gt;65&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe depression&#xD;
  &#xD;
            -  Unstable psychiatric or medical disease&#xD;
  &#xD;
            -  Acute infection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Renske Lok, PhD</last_name>
      <email>rlok@stanford.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Stanford University</name>
        <address>
          <city>Redwood City</city>
          <state>California</state>
          <zip>94063</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Renske Lok, PhD</last_name>
        <email>rlok@stanford.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Jamie M. Zeitzer, Ph.D.</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
      <mesh_term>Mood Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>After completion of study and publication of data, deidentified IPD will be uploaded to Dryad with documentation. Analytic code will be shared with Github</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>within six months after publication; no restrictions on duration of availability</ipd_time_frame>
      <ipd_url>https://laneguides.stanford.edu/DataManagement/Sharing</ipd_url>
    </patient_data>
    <!-- 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/NCT06009289
  org study id: IRB-71788
  nct id: NCT06009289
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This trial will examine scheduled exposure to bright light in the morning and afternoon as a
        countermeasure to sleep fragmentation in older individuals with mild cognitive impairment.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Sleep fragmentation
  time frame: 4 weeks
  description: 24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation
  measure: Cognition
  time frame: 6 months
  description: Performance on the WAIS-4
  measure: Mood
  time frame: 6 months
  description: Geriatric Depression Scale, range: 0-15 with higher scores being associated with greater depressive symptomatology
  arm group label: Standard of care
  arm group type: Active Comparator
  description: One hour of daily bright light exposure beginning one hour after wake time.
  arm group label: Stepped care
  arm group type: Experimental
  description: One hour of daily bright light exposure in the afternoon
  intervention type: Behavioral
  intervention name: Light therapy
  description: One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor
  arm group label: Standard of care
  arm group label: Stepped care
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 99 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Renske Lok, PhD
  email: rlok@stanford.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Jamie M. Zeitzer, Ph.D.
  investigator title: Professor
  mesh term: Cognitive Dysfunction
  mesh term: Mood Disorders
  sharing ipd: Yes
  ipd description: After completion of study and publication of data, deidentified IPD will be uploaded to Dryad with documentation. Analytic code will be shared with Github
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code
  ipd time frame: within six months after publication; no restrictions on duration of availability
  ipd url: https://laneguides.stanford.edu/DataManagement/Sharing