<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/NCT01712243</url>
  </required_header>
  <id_info>
    <org_study_id>1I21RX000773-01A2</org_study_id>
    <nct_id>NCT01712243</nct_id>
  </id_info>
  <brief_title>Light to Maximize Vision, Minimize Insomnia</brief_title>
  <official_title>Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Palo Alto Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Palo Alto Health Care System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether specific wavelengths of light at night can&#xD;
      be used to improve mobile balance while simultaneously not increasing alertness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mobile balance</measure>
    <time_frame>15 minutes</time_frame>
    <description>Mobile balance as determined using a GaitRite walkway</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alertness</measure>
    <time_frame>15 minutes</time_frame>
    <description>Alertness as determined by electroencephalographic power density</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Postural Balance</condition>
  <arm_group>
    <arm_group_label>Dim light</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 minutes of very dim (&lt;1 lux) light during the night</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Room light</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 minutes of normal room light (~100 lux) during the night</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colored light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 minutes of colored light during the night</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Light</intervention_name>
    <arm_group_label>Colored light</arm_group_label>
    <arm_group_label>Dim light</arm_group_label>
    <arm_group_label>Room light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 55-85&#xD;
&#xD;
          -  At least 20/200 corrected visual acuity&#xD;
&#xD;
          -  Greater than 20° visual field with no lower visual field loss&#xD;
&#xD;
          -  Stable health&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Normal color vision&#xD;
&#xD;
          -  Normal hearing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Extreme chronotype&#xD;
&#xD;
          -  Sleep disorders&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Depression&#xD;
&#xD;
          -  Alcohol abuse&#xD;
&#xD;
          -  Use of illegal drugs&#xD;
&#xD;
          -  Use of sleep/wake altering drugs on an acute or as needed basis (including&#xD;
             nutraceuticals, antihistamines)&#xD;
&#xD;
          -  Use of light sensitizing drugs&#xD;
&#xD;
          -  Self-reported history of nocturia (&gt;3 times per night)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA Palo Alto Health Care System</investigator_affiliation>
    <investigator_full_name>Jamie M. Zeitzer, Ph.D.</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance 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/NCT01712243
org study id: 1I21RX000773-01A2
nct id: NCT01712243
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether specific wavelengths of light at night can
      be used to improve mobile balance while simultaneously not increasing alertness.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Mobile balance
time frame: 15 minutes
description: Mobile balance as determined using a GaitRite walkway
measure: Alertness
time frame: 15 minutes
description: Alertness as determined by electroencephalographic power density
arm group label: Dim light
arm group type: Active Comparator
description: 15 minutes of very dim (<1 lux) light during the night
arm group label: Room light
arm group type: Active Comparator
description: 15 minutes of normal room light (~100 lux) during the night
arm group label: Colored light
arm group type: Experimental
description: 15 minutes of colored light during the night
intervention type: Other
intervention name: Light
arm group label: Colored light
arm group label: Dim light
arm group label: Room light
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA Palo Alto Health Care System
investigator full name: Jamie M. Zeitzer, Ph.D.
investigator title: Assistant Professor
mesh term: Sleep Initiation and Maintenance Disorders