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/NCT05978934</url>
    </required_header>
    <id_info>
      <org_study_id>IRB 22-005400</org_study_id>
      <nct_id>NCT05978934</nct_id>
    </id_info>
    <brief_title>Determining How Indoor Lighting Affects the Brain Health of Older Adults</brief_title>
    <official_title>Determining How Indoor Lighting Affects the Brain Health of Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Well Living Lab, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Well Living Lab, Inc.</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 goal of this randomized, cross-over, single-site trial followed by an exploratory third&#xD;
        intervention is to understand how indoor lighting affects different measures of brain health&#xD;
        in older adults living in independent living residences. This is a community based study&#xD;
        occurring in a local senior living facility. The main question this study aims to answer is:&#xD;
  &#xD;
        - How does the quality of ambient indoor lighting an older adult is exposed to affect&#xD;
        measures of brain health, such as sleep quality, physical activity, cognitive function, and&#xD;
        social engagement?&#xD;
  &#xD;
        Participants will be exposed to three different indoor lighting conditions for 4 weeks each&#xD;
        while performing the following tasks:&#xD;
  &#xD;
          -  Wear a smartwatch throughout the study to measure sleep quality and physical activity&#xD;
  &#xD;
          -  Wear a small, wearable light sensor to measure light exposure during waking hours&#xD;
  &#xD;
          -  Perform cognitive assessments throughout the study to detect any changes between each of&#xD;
             the lighting conditions&#xD;
  &#xD;
          -  Complete self-report of surveys to assess independence, social engagement, sleep&#xD;
             quality, and mood&#xD;
  &#xD;
        Results from these tasks will be compared within and between subjects to assess whether the&#xD;
        different lighting conditions affect these different measures of brain health.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 15, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Total Sleep Time</measure>
      <time_frame>Change in total sleep time per night over the course of each condition of the 16-week study.</time_frame>
      <description>Total sleep time per night in minutes as measured daily by a wearable device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Wake After Sleep Onset</measure>
      <time_frame>Change in wake after sleep onset per night over the course of each condition of the 16-week study.</time_frame>
      <description>Wake after sleep onset per night in minutes as measured daily by a wearable device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep State Duration</measure>
      <time_frame>Change in sleep state duration per night over the course of each condition of the 16-week study.</time_frame>
      <description>Sleep state duration per night in minutes as measured daily by a wearable device.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep Quality</measure>
      <time_frame>Change in self-reported sleep quality over the course of each condition of the 16-week study.</time_frame>
      <description>Self-report measurement of perceived sleep quality made daily via the Groningen Sleep Quality Survey.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Steps Taken</measure>
      <time_frame>Change in physical activity in steps per day over the course of each condition of the 16-week study.</time_frame>
      <description>Physical activity in steps per day as measured daily by a wearable device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity</measure>
      <time_frame>Change in physical activity in minutes per day over the course of each condition of the 16-week study.</time_frame>
      <description>Physical activity in minutes per day as measured daily by a wearable device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Working Memory</measure>
      <time_frame>Change in working memory performance over the course of each condition of the 16-week study.</time_frame>
      <description>Task performance on a working memory assessment taken twice weekly.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Task Switching</measure>
      <time_frame>Change in task switching performance over the course of each condition of the 16-week study.</time_frame>
      <description>Task performance on a task switching assessment taken twice weekly.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Response Inhibition</measure>
      <time_frame>Change in response inhibition performance over the course of each condition of the 16-week study.</time_frame>
      <description>Task performance on a response inhibition assessment taken twice weekly.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sustained-Attention Reaction Time</measure>
      <time_frame>Change in sustain-attention reaction time performance over the course of each condition of the 16-week study.</time_frame>
      <description>Task performance on a sustained-attention reaction time assessment taken twice weekly.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Reported Loneliness</measure>
      <time_frame>Change in self-reported loneliness over the course of each condition of the 16-week study.</time_frame>
      <description>Self-report measurement of loneliness assessed weekly via the UCLA Loneliness Scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Reported Depression</measure>
      <time_frame>Change in self-reported depression over the course of each condition of the 16-week study.</time_frame>
      <description>Self-report measurement of depression assessed weekly via the Positive and Negative Affect Scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Reported Mood</measure>
      <time_frame>Change in self-reported mood over the course of each condition of the 16-week study.</time_frame>
      <description>Self-report measurement of mood assessed weekly via the Depression, Anxiety, and Stress Scale.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Sleep</condition>
    <condition>Physical Activity</condition>
    <condition>Cognitive Function</condition>
    <condition>Social Isolation</condition>
    <arm_group>
      <arm_group_label>L1 then L2 followed by L3 lighting condition</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will first experience a static lighting condition (L1) then a dynamic lighting condition (L2). After, participants will experience another dynamic lighting condition (L3) with increased morning brightness compared to L2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>L2 then L1 followed by L3 lighting condition</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will first experience a dynamic lighting condition (L2) then a static lighting condition (L1). After, participants will experience another dynamic lighting condition (L3) with increased morning brightness compared to L2.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Static Lighting Condition (L1)</intervention_name>
      <description>This indoor lighting condition keeps a constant brightness and correlated color temperature.</description>
      <arm_group_label>L1 then L2 followed by L3 lighting condition</arm_group_label>
      <arm_group_label>L2 then L1 followed by L3 lighting condition</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dynamic Lighting Condition (L2)</intervention_name>
      <description>This indoor lighting condition has increased brightness and more blue correlated color temperature in the morning hours followed by decreased brightness and less blue correlated color temperature in the afternoon and evening hours.</description>
      <arm_group_label>L1 then L2 followed by L3 lighting condition</arm_group_label>
      <arm_group_label>L2 then L1 followed by L3 lighting condition</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dynamic Lighting Condition (L3)</intervention_name>
      <description>This exploratory indoor lighting condition matches the same pattern as L2 except the brightness in the morning hours is increased.</description>
      <arm_group_label>L1 then L2 followed by L3 lighting condition</arm_group_label>
      <arm_group_label>L2 then L1 followed by L3 lighting condition</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. At least age 60;&#xD;
  &#xD;
            2. Able to wear wearable devices throughout the study;&#xD;
  &#xD;
            3. Willing to have their lighting in their kitchen and dining areas changed and&#xD;
               controlled for the study;&#xD;
  &#xD;
            4. Willing to have environmental sensors placed in their residence;&#xD;
  &#xD;
            5. Willing to provide contact information about their primary care provider (PCP); and&#xD;
  &#xD;
            6. Able and has capacity to provide informed consent (score &gt; 14.5 based on UBACC consent&#xD;
               capacity form).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Is legally blind&#xD;
  &#xD;
            2. Previously renovated their living units and no longer have the standard lighting&#xD;
               installation offered by the Senior Living Facility;&#xD;
  &#xD;
            3. Currently spend or plan to spend most of their day outside of their residence during&#xD;
               the study (i.e., would not experience the indoor lighting intervention for the&#xD;
               majority of the study);&#xD;
  &#xD;
            4. Plan to travel to a different time zone during the study; or&#xD;
  &#xD;
            5. Plan to be away from their residence for more than a week during the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Robert Klein, PhD</last_name>
      <phone>507-258-7592</phone>
      <email>robert.klein@delos.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eric Heins</last_name>
      <phone>507-259-0611</phone>
      <email>eric.heins@delos.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Waters on Mayowood</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55901</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tianna Bagley</last_name>
        <phone>507-252-2910</phone>
        <email>wonm@thewaters.com</email>
      </contact>
      <investigator>
        <last_name>Christina Chen, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kevin A Mazurek, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Robert Klein, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05978934
  org study id: IRB 22-005400
  nct id: NCT05978934
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized, cross-over, single-site trial followed by an exploratory third
        intervention is to understand how indoor lighting affects different measures of brain health
        in older adults living in independent living residences. This is a community based study
        occurring in a local senior living facility. The main question this study aims to answer is:
  
        - How does the quality of ambient indoor lighting an older adult is exposed to affect
        measures of brain health, such as sleep quality, physical activity, cognitive function, and
        social engagement?
  
        Participants will be exposed to three different indoor lighting conditions for 4 weeks each
        while performing the following tasks:
  
          -  Wear a smartwatch throughout the study to measure sleep quality and physical activity
  
          -  Wear a small, wearable light sensor to measure light exposure during waking hours
  
          -  Perform cognitive assessments throughout the study to detect any changes between each of
             the lighting conditions
  
          -  Complete self-report of surveys to assess independence, social engagement, sleep
             quality, and mood
  
        Results from these tasks will be compared within and between subjects to assess whether the
        different lighting conditions affect these different measures of brain health.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Total Sleep Time
  time frame: Change in total sleep time per night over the course of each condition of the 16-week study.
  description: Total sleep time per night in minutes as measured daily by a wearable device.
  measure: Wake After Sleep Onset
  time frame: Change in wake after sleep onset per night over the course of each condition of the 16-week study.
  description: Wake after sleep onset per night in minutes as measured daily by a wearable device.
  measure: Sleep State Duration
  time frame: Change in sleep state duration per night over the course of each condition of the 16-week study.
  description: Sleep state duration per night in minutes as measured daily by a wearable device.
  measure: Sleep Quality
  time frame: Change in self-reported sleep quality over the course of each condition of the 16-week study.
  description: Self-report measurement of perceived sleep quality made daily via the Groningen Sleep Quality Survey.
  measure: Steps Taken
  time frame: Change in physical activity in steps per day over the course of each condition of the 16-week study.
  description: Physical activity in steps per day as measured daily by a wearable device.
  measure: Physical Activity
  time frame: Change in physical activity in minutes per day over the course of each condition of the 16-week study.
  description: Physical activity in minutes per day as measured daily by a wearable device.
  measure: Working Memory
  time frame: Change in working memory performance over the course of each condition of the 16-week study.
  description: Task performance on a working memory assessment taken twice weekly.
  measure: Task Switching
  time frame: Change in task switching performance over the course of each condition of the 16-week study.
  description: Task performance on a task switching assessment taken twice weekly.
  measure: Response Inhibition
  time frame: Change in response inhibition performance over the course of each condition of the 16-week study.
  description: Task performance on a response inhibition assessment taken twice weekly.
  measure: Sustained-Attention Reaction Time
  time frame: Change in sustain-attention reaction time performance over the course of each condition of the 16-week study.
  description: Task performance on a sustained-attention reaction time assessment taken twice weekly.
  measure: Self-Reported Loneliness
  time frame: Change in self-reported loneliness over the course of each condition of the 16-week study.
  description: Self-report measurement of loneliness assessed weekly via the UCLA Loneliness Scale.
  measure: Self-Reported Depression
  time frame: Change in self-reported depression over the course of each condition of the 16-week study.
  description: Self-report measurement of depression assessed weekly via the Positive and Negative Affect Scale.
  measure: Self-Reported Mood
  time frame: Change in self-reported mood over the course of each condition of the 16-week study.
  description: Self-report measurement of mood assessed weekly via the Depression, Anxiety, and Stress Scale.
  arm group label: L1 then L2 followed by L3 lighting condition
  arm group type: Active Comparator
  description: Participants will first experience a static lighting condition (L1) then a dynamic lighting condition (L2). After, participants will experience another dynamic lighting condition (L3) with increased morning brightness compared to L2.
  arm group label: L2 then L1 followed by L3 lighting condition
  arm group type: Active Comparator
  description: Participants will first experience a dynamic lighting condition (L2) then a static lighting condition (L1). After, participants will experience another dynamic lighting condition (L3) with increased morning brightness compared to L2.
  intervention type: Behavioral
  intervention name: Static Lighting Condition (L1)
  description: This indoor lighting condition keeps a constant brightness and correlated color temperature.
  arm group label: L1 then L2 followed by L3 lighting condition
  arm group label: L2 then L1 followed by L3 lighting condition
  intervention type: Behavioral
  intervention name: Dynamic Lighting Condition (L2)
  description: This indoor lighting condition has increased brightness and more blue correlated color temperature in the morning hours followed by decreased brightness and less blue correlated color temperature in the afternoon and evening hours.
  arm group label: L1 then L2 followed by L3 lighting condition
  arm group label: L2 then L1 followed by L3 lighting condition
  intervention type: Behavioral
  intervention name: Dynamic Lighting Condition (L3)
  description: This exploratory indoor lighting condition matches the same pattern as L2 except the brightness in the morning hours is increased.
  arm group label: L1 then L2 followed by L3 lighting condition
  arm group label: L2 then L1 followed by L3 lighting condition
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Robert Klein, PhD
  phone: 507-258-7592
  email: robert.klein@delos.com
  last name: Eric Heins
  phone: 507-259-0611
  email: eric.heins@delos.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No