<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/NCT02978053</url>
  </required_header>
  <id_info>
    <org_study_id>UiB112016</org_study_id>
    <nct_id>NCT02978053</nct_id>
  </id_info>
  <brief_title>Light Treatment to Shift-working Nurses</brief_title>
  <official_title>The Effects of Bright Light on Adaptation to Night Work Among Nurses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bergen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project examines 1) the effects of appropriately timed bright light on adaptation (in&#xD;
      terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such&#xD;
      bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule&#xD;
      after the night shift period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shift workers frequently experience sleepiness during night shifts, which may have&#xD;
      consequences for performance. Sleep duration is often shortened after a night shift. Properly&#xD;
      timed bright light treatment is efficient in delaying the circadian rhythm and can enhance&#xD;
      alertness, increase performance and prolong sleep after night shifts. There is a lack of&#xD;
      studies on light treatment to rotating shift workers. This study is a randomized controlled&#xD;
      crossover trial evaluating the effect of bright light treatment on sleep and sleepiness in&#xD;
      rotating shift workers with three consecutive night shifts. The aim is to evaluate whether&#xD;
      bright light treatment improves adaptation to three consecutive night shifts (reduces&#xD;
      sleepiness during night shifts and improves sleep after night shifts), as well as whether&#xD;
      such treatment affects re-adaptation to a day-oriented schedule after the night shift period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleepiness during the night shifts</measure>
    <time_frame>3 days</time_frame>
    <description>Self-reported using the Karolinska Sleepiness Scale (KSS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychomotor vigilance during night shifts</measure>
    <time_frame>3 days</time_frame>
    <description>Objective data from a 5 min computer based psychomotor vigilance test (PC-PVT) taken once during each night shift</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep after the night shifts</measure>
    <time_frame>3 days</time_frame>
    <description>Self-reported using a sleep diary; objective data from actigraphs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleepiness during the days after the night shift period</measure>
    <time_frame>3 days</time_frame>
    <description>Self-reported using the Karolinska Sleepiness Scale (KSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep during the days after the night shift period</measure>
    <time_frame>3 days</time_frame>
    <description>Self-reported using a sleep diary; objective data from actigraphs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functioning on each shift, and shift period in total, compared to under normal conditions</measure>
    <time_frame>6 days</time_frame>
    <description>Self-reported perception of effect of intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Shift-Work Sleep Disorder</condition>
  <arm_group>
    <arm_group_label>Bright light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 000 lux</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Red light</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>400 lux</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Bright light</intervention_name>
    <description>Bright light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).</description>
    <arm_group_label>Bright light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Red light</intervention_name>
    <description>Red light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).</description>
    <arm_group_label>Red light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A rotating shift work schedule involving three days without night shifts, followed by&#xD;
             three consecutive night shifts, followed by three days without night shifts&#xD;
&#xD;
          -  Problems with sleepiness during night shifts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#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>Bjørn Bjorvatn, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Bergen</name>
      <address>
        <city>Bergen</city>
        <state>Hordaland</state>
        <zip>5018</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>October 1, 2019</last_update_submitted>
  <last_update_submitted_qc>October 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bergen</investigator_affiliation>
    <investigator_full_name>Bjorn Bjorvatn</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Bright light</keyword>
  <keyword>Sleepiness</keyword>
  <keyword>Sleep</keyword>
  <keyword>Psychomotor vigilance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Sleep Disorders, Circadian Rhythm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02978053
org study id: UiB112016
nct id: NCT02978053
lead sponsor: 
has dmc: No
This project examines 1) the effects of appropriately timed bright light on adaptation (in
      terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such
      bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule
      after the night shift period.
Shift workers frequently experience sleepiness during night shifts, which may have
      consequences for performance. Sleep duration is often shortened after a night shift. Properly
      timed bright light treatment is efficient in delaying the circadian rhythm and can enhance
      alertness, increase performance and prolong sleep after night shifts. There is a lack of
      studies on light treatment to rotating shift workers. This study is a randomized controlled
      crossover trial evaluating the effect of bright light treatment on sleep and sleepiness in
      rotating shift workers with three consecutive night shifts. The aim is to evaluate whether
      bright light treatment improves adaptation to three consecutive night shifts (reduces
      sleepiness during night shifts and improves sleep after night shifts), as well as whether
      such treatment affects re-adaptation to a day-oriented schedule after the night shift period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Sleepiness during the night shifts
time frame: 3 days
description: Self-reported using the Karolinska Sleepiness Scale (KSS)
measure: Psychomotor vigilance during night shifts
time frame: 3 days
description: Objective data from a 5 min computer based psychomotor vigilance test (PC-PVT) taken once during each night shift
measure: Sleep after the night shifts
time frame: 3 days
description: Self-reported using a sleep diary; objective data from actigraphs
measure: Sleepiness during the days after the night shift period
time frame: 3 days
description: Self-reported using the Karolinska Sleepiness Scale (KSS)
measure: Sleep during the days after the night shift period
time frame: 3 days
description: Self-reported using a sleep diary; objective data from actigraphs
measure: Functioning on each shift, and shift period in total, compared to under normal conditions
time frame: 6 days
description: Self-reported perception of effect of intervention
arm group label: Bright light
arm group type: Experimental
description: 10 000 lux
arm group label: Red light
arm group type: Placebo Comparator
description: 400 lux
intervention type: Behavioral
intervention name: Bright light
description: Bright light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).
arm group label: Bright light
intervention type: Behavioral
intervention name: Red light
description: Red light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).
arm group label: Red light
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bjørn Bjorvatn, MD, PhD
role: Principal Investigator
affiliation: University of Bergen
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Bergen
investigator full name: Bjorn Bjorvatn
investigator title: Professor
mesh term: Sleep Wake Disorders
mesh term: Sleep Disorders, Circadian Rhythm
sharing ipd: No