<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/NCT02216318</url>
  </required_header>
  <id_info>
    <org_study_id>H-3-2013-085</org_study_id>
    <nct_id>NCT02216318</nct_id>
  </id_info>
  <brief_title>Energy-efficient and Health Promoting Light for Elderly People</brief_title>
  <acronym>light-age</acronym>
  <official_title>A Study of Two Different Light Conditions for Healthy Subjects Above 65 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glostrup University Hospital, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Elforsk</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Albertslund Kommune</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gate 21</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DTU Fotonik</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VISO systems</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AF Lightning</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Statens Byggeforskningsinstitut</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Glostrup University Hospital, Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      to investigate the effect of two lightning conditions on sleep hypothesizing that sleep&#xD;
      length is influenced by the color of light during daytime&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lightning conditions seems to be important for the length and quality of sleep, as light have&#xD;
      an influence on the production of the sleep hormone (melatonin) and the the circadian rhythm.&#xD;
      Entrainment of the circadian rhythm to the surroundings is accomplished by light-sensitive&#xD;
      retinal ganglion cells and these cells are sensitive to blue light.&#xD;
&#xD;
      Based on previous research, blue light early in the day and abscence of blue light during&#xD;
      evening is important for the entrainment.&#xD;
&#xD;
      In this study, lightning conditions in the home of healthy subjects are set to either blue&#xD;
      enriched or red enriched from 8 a.m to 1. p.m. The lightning condition is based on a&#xD;
      randomization protocol in a cross-over study for 3 weeks in each condition, separated by a&#xD;
      one week pause.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep length</measure>
    <time_frame>1 week</time_frame>
    <description>The mean of sleep length during the last week of each light period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>actigraphy</measure>
    <time_frame>1 week</time_frame>
    <description>mean sleep efficiency during the last week in each light period</description>
  </secondary_outcome>
  <other_outcome>
    <measure>pupillometry</measure>
    <time_frame>the last day of each light period</time_frame>
    <description>the pupillary response to blue and red light</description>
  </other_outcome>
  <other_outcome>
    <measure>melatonin</measure>
    <time_frame>the last day of each light period</time_frame>
    <description>timing of melatonin onset</description>
  </other_outcome>
  <other_outcome>
    <measure>Questionnaire</measure>
    <time_frame>3 weeks</time_frame>
    <description>Questionnaire count</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>red light</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>red light during the whole day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blue light</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blue light during early day</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blue light</intervention_name>
    <arm_group_label>Blue light</arm_group_label>
    <arm_group_label>red light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 65 to 85 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Conditions which will interfere by the primary endpoint as evaluated by the medical&#xD;
             doctor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Line Kessel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glostrup University Hospital, Copenhagen</affiliation>
  </overall_official>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 3, 2018</last_update_submitted>
  <last_update_submitted_qc>August 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Glostrup University Hospital, Copenhagen</investigator_affiliation>
    <investigator_full_name>Line Kessel</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>sleep</keyword>
  <keyword>circadian</keyword>
  <keyword>melatonine</keyword>
  <keyword>pupil response</keyword>
  <!-- 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/NCT02216318
org study id: H-3-2013-085
nct id: NCT02216318
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
to investigate the effect of two lightning conditions on sleep hypothesizing that sleep
      length is influenced by the color of light during daytime
Lightning conditions seems to be important for the length and quality of sleep, as light have
      an influence on the production of the sleep hormone (melatonin) and the the circadian rhythm.
      Entrainment of the circadian rhythm to the surroundings is accomplished by light-sensitive
      retinal ganglion cells and these cells are sensitive to blue light.

      Based on previous research, blue light early in the day and abscence of blue light during
      evening is important for the entrainment.

      In this study, lightning conditions in the home of healthy subjects are set to either blue
      enriched or red enriched from 8 a.m to 1. p.m. The lightning condition is based on a
      randomization protocol in a cross-over study for 3 weeks in each condition, separated by a
      one week pause.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Sleep length
time frame: 1 week
description: The mean of sleep length during the last week of each light period
measure: actigraphy
time frame: 1 week
description: mean sleep efficiency during the last week in each light period
measure: pupillometry
time frame: the last day of each light period
description: the pupillary response to blue and red light
measure: melatonin
time frame: the last day of each light period
description: timing of melatonin onset
measure: Questionnaire
time frame: 3 weeks
description: Questionnaire count
arm group label: red light
arm group type: Placebo Comparator
description: red light during the whole day
arm group label: Blue light
arm group type: Active Comparator
description: Blue light during early day
intervention type: Other
intervention name: blue light
arm group label: Blue light
arm group label: red light
criteria: 
gender: All
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Line Kessel, MD
role: Principal Investigator
affiliation: Glostrup University Hospital, Copenhagen
responsible party type: Principal Investigator
investigator affiliation: Glostrup University Hospital, Copenhagen
investigator full name: Line Kessel
investigator title: MD