<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/NCT03813654</url>
  </required_header>
  <id_info>
    <org_study_id>2018-P-002341</org_study_id>
    <nct_id>NCT03813654</nct_id>
  </id_info>
  <brief_title>Sleep and Circadian Treatments for Shift Workers</brief_title>
  <official_title>Sleep and Circadian Treatments for Shift Workers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</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>
      There are three components to this study: a Field Trial, a Shift Worker Survey, and Focus&#xD;
      Groups. The Investigators will study the effectiveness, feasibility, and acceptability of an&#xD;
      8-h sleep intervention in older night workers in an operational environment. The overall goal&#xD;
      of the Field Trial is to minimize sleep deficiency and negative outcomes resulting from that,&#xD;
      including sleepiness and performance impairments during night shift work. The Shift Worker&#xD;
      Survey is designed to understand some of the demographic and operational factors that enable&#xD;
      or inhibit the ability of individual shift workers to adopt this intervention. The Focus&#xD;
      Groups are designed to glean in-depth information from older shift workers who indicate that&#xD;
      they are unable or unwilling to adopt an 8-h sleep timing intervention. Understanding these&#xD;
      factors will assist in refining and targeting the intervention to those individuals who will&#xD;
      be most likely to benefit from the intervention sleep timing strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of the Field Trial is to minimize sleep deficiency and negative outcomes&#xD;
      resulting from that, including sleepiness and performance impairments during night shift&#xD;
      work. The experimental protocol is divided into two blocks, the Baseline block and the&#xD;
      Intervention block, where participants will work at least 3 night shifts in a row within each&#xD;
      block. For at least one week prior to the baseline block participants will work their usual&#xD;
      shift schedule (i.e., no vacation/scheduled days off). The investigators will recruit up to&#xD;
      200 health care workers in order to have up to 75 health care workers complete the entire&#xD;
      Field Trial. Potential participants will be employed older health care workers who work a&#xD;
      minimum number of 8-h night shifts per month and who are in the greater Boston area.&#xD;
&#xD;
      The Shift Worker Survey is designed to understand some of the demographic and operational&#xD;
      factors that enable or inhibit the ability of individual shift workers to adopt the sleep&#xD;
      intervention that will be tested in the Field Trial. The investigators will use a web-based&#xD;
      survey consisting of ~70 questions developed and administered using REDCap. The complete&#xD;
      questionnaire will take approximately 20-30 minutes to complete. The study will enroll up to&#xD;
      1,000 employed individuals (20 or more hours per week) whose work includes overnight shifts,&#xD;
      with a minimum criterion of at least 4 night shifts a month. Health Care Workers who complete&#xD;
      the Shift Worker Survey will be given the option to complete an additional Health Care&#xD;
      Worker's Questionnaire at the end of the basic Shift Worker Survey. Those whose responses&#xD;
      meet inclusion/exclusion criteria for the Field Trial will be informed at the end of the&#xD;
      Shift Worker Survey that they may be eligible for the Field Trial.&#xD;
&#xD;
      The goal of the Focus Groups is to gain information on the feasibility and acceptability of&#xD;
      the fixed 8-h sleep schedule from the participants' perspective. Investigators will seek to&#xD;
      learn more information about the current sleep strategies they use on a regular basis, and&#xD;
      both the facilitating and challenging aspects of the fixed-sleep countermeasure (e.g.,&#xD;
      individual, intrapersonal and organizational barriers to implementation of fixed 8-h sleep,&#xD;
      recommended modifications to the fixed 8-h sleep schedule that would make it more&#xD;
      user-friendly while maintaining scientific validity). Each of the focus groups will consist&#xD;
      of 4-6 individuals to stimulate discussion without leaving participants out, and will last&#xD;
      60-90 minutes. The investigators aim to enroll up to 60 individuals in Focus Groups. In&#xD;
      addition to the health care workers who took part in the Field Trial, the investigators will&#xD;
      invite night shift workers who complete the Shift Worker Survey but indicate their inability&#xD;
      to comply with a fixed 8-h sleep schedule to attend a Focus Group discussion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 20, 2020</start_date>
  <completion_date type="Anticipated">June 2024</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>Parallel Assignment</intervention_model>
    <intervention_model_description>The interventional study design describes the Field Trial only.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Sleep Time (TST)</measure>
    <time_frame>The TST averaged for intervention nights 2 and 3 (in minutes) will be compared between groups.</time_frame>
    <description>TST is calculated as minutes of sleep in the main sleep episode between shifts, derived from actigraphy data collected in 60 s epochs. The investigators will use a commercial software package to score the sleep. For control group participants who will sleep ad-lib, TST will be calculated for the major sleep episode but also will be summed across sleep episodes if they sleep in more than one bout.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Fragmentation Index (FI)</measure>
    <time_frame>The FI averaged for intervention nights 2 and 3 will be compared between groups.</time_frame>
    <description>FI will be calculated as the number of times that sleep was terminated after 1 minute, expressed as a percentage of total estimated sleep time, using actigraphy data and commercial software to calculate it.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wake After Sleep Onset (WASO)</measure>
    <time_frame>The WASO averaged for intervention nights 2 and 3 will be compared between groups.</time_frame>
    <description>WASO is an objective sleep quality measure and will be calculated as the duration (in minutes) of all awakenings during the main sleep episode measured with actigraphy, and calculated using commercial software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Sleep Quality</measure>
    <time_frame>Subjective Sleep quality (refreshment) averaged for intervention nights 2 and 3 will be compared between groups.(</time_frame>
    <description>Participants will report their subjective sleep quality daily upon awakening from the main sleep episode. Multiple measures of subjective sleep quality will be assessed, but the investigators will report how refreshed the participant feels after awakening as the outcome. This is rated on a 7-point scale, where 7 is the best and 1 is the worst.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Alertness via Karolinska Sleepiness Scale (KSS)</measure>
    <time_frame>The KSS score taken at the end of the final night shift (night shift 3) during the intervention block will be compared between groups.</time_frame>
    <description>Participants will complete the Karolinska Sleepiness Scale (KSS) as a measure of subjective alertness immediately following each night shift. The KSS is a Likert scale ranging from 1, extremely alert, to 9, extremely sleepy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sustained Attention</measure>
    <time_frame>PVT mean lapses of attention measured at the end of the final night shift (night shift 3) during the intervention block will be compared between groups.</time_frame>
    <description>The psychomotor vigilance task (PVT) is a test of visual reaction time (RT) in which the participant is asked to maintain the fastest possible RTs to a simple visual stimulus for several minutes. The inter-stimulus interval varies randomly between 2-10 seconds. While there are a number of standard performance metrics that can be obtained from each PVT, we will use the number of lapses of attention (RT &gt; 500msec) as our outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Energy</measure>
    <time_frame>Subjective Energy measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.</time_frame>
    <description>A Visual Analogue Scale (VAS) will be used to assess subjective energy level. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. energetic-sluggish. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as subjective energeticness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Stress via Visual Analog Scale (VAS)</measure>
    <time_frame>Subjective Stress via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.</time_frame>
    <description>A Visual Analogue Scale (VAS) will be used to assess subjective stress.The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. relaxed-stressed. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as Subjective Stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Calmness via Visual Analog Scale (VAS)</measure>
    <time_frame>Subjective Calmness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.</time_frame>
    <description>A Visual Analogue Scale (VAS) will be used to assess subjective Calmness. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. calm-excited. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as Subjective Calmness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Health via Visual Analog Scale (VAS)</measure>
    <time_frame>Subjective Health via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.</time_frame>
    <description>Visual Analogue Scales (VAS) will be used to assess subjective health. VAS consist of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. healthy-sick. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as Subjective Health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Alertness via Visual Analog Scale (VAS)</measure>
    <time_frame>Subjective Alertness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.</time_frame>
    <description>Participants will complete the Visual Analog Scale (VAS) as a measure of subjective alertness three times per night shift: Once just before the night shift, once during their shift break, and once immediately following the night shift. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. sleepy-alert. Participants will indicate a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as Subjective Alertness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue and Inter-Shift Recovery</measure>
    <time_frame>OFER15 scores from the end of the third night shift in the Intervention block will be compared between groups.</time_frame>
    <description>The Occupational Fatigue Exhaustion Recovery Scale (OFER 15), which consists of 15 questions about acute fatigue and recovery between shifts, will be used. Each of the 15 questions is answered on a Likert scale which ranges from 0 (Strongly Disagree) to 6 (Strongly Agree). The OFER15 will be completed immediately after the third night shift in the Baseline block and at the end of the third night shift in the Intervention block.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Stress</measure>
    <time_frame>Subjective stress will be assessed immediately after the third night shift in the Intervention block and will be compared between groups.</time_frame>
    <description>The investigators will collect subjective measures of daily stress using a validated questionnaire, the Daily Stress Inventory (DSI), a 58-item self-report measure that allows a person to indicate events that they have experienced in the past 24 hours.&#xD;
After indicating which events occurred, individuals rate the stressfulness of those events on a Likert scale ranging from 1 (occurred but was not stressful) to 7 (caused me to panic).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Quality of Life: WHOQOLBref</measure>
    <time_frame>WHOQOL-Bref will be taken immediately after the third night shift in the Intervention block and will be compared between groups.</time_frame>
    <description>The investigators will use a validated questionnaire, the WHOQOLBref, a 26 item questionnaire suitable for field studies, which asks a series of questions about life, health, energy, and personal satisfaction, to assess Quality of Life. The questionnaire contains 4 separately scored domains: Physical Health, Psychological, Social Relationships, and Environment. Each domain contains several questions and ask participants to provide a response on a Likert Scale ranging from 1 to 5, with higher numbers indicating a higher quality of life (aside from 3 negatively phrased items).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary Cortisol Level</measure>
    <time_frame>Salivary Cortisol will be assessed immediately after the third night shift in the Intervention block and levels will be compared between groups.</time_frame>
    <description>The investigators will collect a single saliva sample at the end of the final night shift in the Baseline block and the Intervention block. The sample will be frozen and later assayed to assess cortisol level (in micrograms per deciliter, μg/dL). Higher cortisol levels will be indicative of greater stress.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Shift-Work Sleep Disorder</condition>
  <condition>Shift-Work Related Sleep Disturbance</condition>
  <arm_group>
    <arm_group_label>Control (Group A)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During the intervention block of the Field Trial, at the end of the first night shift, the participant will be told about their randomization group. In the control group (Group A), participants will not be given any instructions about the timing or duration of their sleep, but will be instructed to follow their usual night shift sleep routine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8-h Afternoon-Evening Sleep (Group B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the 8-h afternoon-evening sleep intervention group (Group B), participants will be instructed to go to bed between 13:00 and 14:00 (depending on their individual commute time) and to remain in bed attempting to sleep for 8 hours (until 21:00-22:00) before the next two night shifts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8-h Free Sleep (Group C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the 8-h free sleep group (Group C), participants will be instructed to remain in bed for 8 continuous hours before the next two night shifts, but will not be given any instruction regarding which 8 hours they should sleep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>8-h Afternoon-Evening Sleep</intervention_name>
    <description>8 consecutive hours time in bed during the afternoon/evening.</description>
    <arm_group_label>8-h Afternoon-Evening Sleep (Group B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>8-h Free Sleep</intervention_name>
    <description>8 consecutive hours time in bed at any time.</description>
    <arm_group_label>8-h Free Sleep (Group C)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Field Trial -&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 50-65 years&#xD;
&#xD;
          -  Health care workers who work a minimum of 4 night shifts (8-4) per month&#xD;
&#xD;
          -  Must live in the greater Boston area&#xD;
&#xD;
          -  Must report an ability to work three successive 8-h night shifts during two weeks&#xD;
&#xD;
          -  Must report an ability to spend 8 consecutive hours in bed attempting to sleep prior&#xD;
             to the final two successive night shifts in the second study week&#xD;
&#xD;
          -  Must have a typical commute time between home and place of work of less than one hour&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-optional activities that would interfere with the participant's ability to remain&#xD;
             in bed attempting to sleep if randomized to an 8-h sleep group&#xD;
&#xD;
          -  Prescription or over-the-counter medication(s) known to affect sleep [e.g., hypnotics]&#xD;
             or alertness [e.g., antihistamines]&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeanne F Duffy, MBA, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Jeanne Duffy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sleep</keyword>
  <keyword>attention</keyword>
  <keyword>vigilance</keyword>
  <keyword>aging</keyword>
  <keyword>shift work</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Dyssomnias</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/NCT03813654
org study id: 2018-P-002341
nct id: NCT03813654
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There are three components to this study: a Field Trial, a Shift Worker Survey, and Focus
      Groups. The Investigators will study the effectiveness, feasibility, and acceptability of an
      8-h sleep intervention in older night workers in an operational environment. The overall goal
      of the Field Trial is to minimize sleep deficiency and negative outcomes resulting from that,
      including sleepiness and performance impairments during night shift work. The Shift Worker
      Survey is designed to understand some of the demographic and operational factors that enable
      or inhibit the ability of individual shift workers to adopt this intervention. The Focus
      Groups are designed to glean in-depth information from older shift workers who indicate that
      they are unable or unwilling to adopt an 8-h sleep timing intervention. Understanding these
      factors will assist in refining and targeting the intervention to those individuals who will
      be most likely to benefit from the intervention sleep timing strategy.
The overall goal of the Field Trial is to minimize sleep deficiency and negative outcomes
      resulting from that, including sleepiness and performance impairments during night shift
      work. The experimental protocol is divided into two blocks, the Baseline block and the
      Intervention block, where participants will work at least 3 night shifts in a row within each
      block. For at least one week prior to the baseline block participants will work their usual
      shift schedule (i.e., no vacation/scheduled days off). The investigators will recruit up to
      200 health care workers in order to have up to 75 health care workers complete the entire
      Field Trial. Potential participants will be employed older health care workers who work a
      minimum number of 8-h night shifts per month and who are in the greater Boston area.

      The Shift Worker Survey is designed to understand some of the demographic and operational
      factors that enable or inhibit the ability of individual shift workers to adopt the sleep
      intervention that will be tested in the Field Trial. The investigators will use a web-based
      survey consisting of ~70 questions developed and administered using REDCap. The complete
      questionnaire will take approximately 20-30 minutes to complete. The study will enroll up to
      1,000 employed individuals (20 or more hours per week) whose work includes overnight shifts,
      with a minimum criterion of at least 4 night shifts a month. Health Care Workers who complete
      the Shift Worker Survey will be given the option to complete an additional Health Care
      Worker's Questionnaire at the end of the basic Shift Worker Survey. Those whose responses
      meet inclusion/exclusion criteria for the Field Trial will be informed at the end of the
      Shift Worker Survey that they may be eligible for the Field Trial.

      The goal of the Focus Groups is to gain information on the feasibility and acceptability of
      the fixed 8-h sleep schedule from the participants' perspective. Investigators will seek to
      learn more information about the current sleep strategies they use on a regular basis, and
      both the facilitating and challenging aspects of the fixed-sleep countermeasure (e.g.,
      individual, intrapersonal and organizational barriers to implementation of fixed 8-h sleep,
      recommended modifications to the fixed 8-h sleep schedule that would make it more
      user-friendly while maintaining scientific validity). Each of the focus groups will consist
      of 4-6 individuals to stimulate discussion without leaving participants out, and will last
      60-90 minutes. The investigators aim to enroll up to 60 individuals in Focus Groups. In
      addition to the health care workers who took part in the Field Trial, the investigators will
      invite night shift workers who complete the Shift Worker Survey but indicate their inability
      to comply with a fixed 8-h sleep schedule to attend a Focus Group discussion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The interventional study design describes the Field Trial only.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Total Sleep Time (TST)
time frame: The TST averaged for intervention nights 2 and 3 (in minutes) will be compared between groups.
description: TST is calculated as minutes of sleep in the main sleep episode between shifts, derived from actigraphy data collected in 60 s epochs. The investigators will use a commercial software package to score the sleep. For control group participants who will sleep ad-lib, TST will be calculated for the major sleep episode but also will be summed across sleep episodes if they sleep in more than one bout.
measure: Sleep Fragmentation Index (FI)
time frame: The FI averaged for intervention nights 2 and 3 will be compared between groups.
description: FI will be calculated as the number of times that sleep was terminated after 1 minute, expressed as a percentage of total estimated sleep time, using actigraphy data and commercial software to calculate it.
measure: Wake After Sleep Onset (WASO)
time frame: The WASO averaged for intervention nights 2 and 3 will be compared between groups.
description: WASO is an objective sleep quality measure and will be calculated as the duration (in minutes) of all awakenings during the main sleep episode measured with actigraphy, and calculated using commercial software.
measure: Subjective Sleep Quality
time frame: Subjective Sleep quality (refreshment) averaged for intervention nights 2 and 3 will be compared between groups.(
description: Participants will report their subjective sleep quality daily upon awakening from the main sleep episode. Multiple measures of subjective sleep quality will be assessed, but the investigators will report how refreshed the participant feels after awakening as the outcome. This is rated on a 7-point scale, where 7 is the best and 1 is the worst.
measure: Subjective Alertness via Karolinska Sleepiness Scale (KSS)
time frame: The KSS score taken at the end of the final night shift (night shift 3) during the intervention block will be compared between groups.
description: Participants will complete the Karolinska Sleepiness Scale (KSS) as a measure of subjective alertness immediately following each night shift. The KSS is a Likert scale ranging from 1, extremely alert, to 9, extremely sleepy.
measure: Sustained Attention
time frame: PVT mean lapses of attention measured at the end of the final night shift (night shift 3) during the intervention block will be compared between groups.
description: The psychomotor vigilance task (PVT) is a test of visual reaction time (RT) in which the participant is asked to maintain the fastest possible RTs to a simple visual stimulus for several minutes. The inter-stimulus interval varies randomly between 2-10 seconds. While there are a number of standard performance metrics that can be obtained from each PVT, we will use the number of lapses of attention (RT > 500msec) as our outcome.
measure: Subjective Energy
time frame: Subjective Energy measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
description: A Visual Analogue Scale (VAS) will be used to assess subjective energy level. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. energetic-sluggish. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as subjective energeticness.
measure: Subjective Stress via Visual Analog Scale (VAS)
time frame: Subjective Stress via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
description: A Visual Analogue Scale (VAS) will be used to assess subjective stress.The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. relaxed-stressed. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as Subjective Stress.
measure: Subjective Calmness via Visual Analog Scale (VAS)
time frame: Subjective Calmness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
description: A Visual Analogue Scale (VAS) will be used to assess subjective Calmness. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. calm-excited. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as Subjective Calmness.
measure: Subjective Health via Visual Analog Scale (VAS)
time frame: Subjective Health via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
description: Visual Analogue Scales (VAS) will be used to assess subjective health. VAS consist of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. healthy-sick. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as Subjective Health.
measure: Subjective Alertness via Visual Analog Scale (VAS)
time frame: Subjective Alertness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
description: Participants will complete the Visual Analog Scale (VAS) as a measure of subjective alertness three times per night shift: Once just before the night shift, once during their shift break, and once immediately following the night shift. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. sleepy-alert. Participants will indicate a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as Subjective Alertness.
measure: Fatigue and Inter-Shift Recovery
time frame: OFER15 scores from the end of the third night shift in the Intervention block will be compared between groups.
description: The Occupational Fatigue Exhaustion Recovery Scale (OFER 15), which consists of 15 questions about acute fatigue and recovery between shifts, will be used. Each of the 15 questions is answered on a Likert scale which ranges from 0 (Strongly Disagree) to 6 (Strongly Agree). The OFER15 will be completed immediately after the third night shift in the Baseline block and at the end of the third night shift in the Intervention block.
measure: Subjective Stress
time frame: Subjective stress will be assessed immediately after the third night shift in the Intervention block and will be compared between groups.
description: The investigators will collect subjective measures of daily stress using a validated questionnaire, the Daily Stress Inventory (DSI), a 58-item self-report measure that allows a person to indicate events that they have experienced in the past 24 hours.
After indicating which events occurred, individuals rate the stressfulness of those events on a Likert scale ranging from 1 (occurred but was not stressful) to 7 (caused me to panic).
measure: Subjective Quality of Life: WHOQOLBref
time frame: WHOQOL-Bref will be taken immediately after the third night shift in the Intervention block and will be compared between groups.
description: The investigators will use a validated questionnaire, the WHOQOLBref, a 26 item questionnaire suitable for field studies, which asks a series of questions about life, health, energy, and personal satisfaction, to assess Quality of Life. The questionnaire contains 4 separately scored domains: Physical Health, Psychological, Social Relationships, and Environment. Each domain contains several questions and ask participants to provide a response on a Likert Scale ranging from 1 to 5, with higher numbers indicating a higher quality of life (aside from 3 negatively phrased items).
measure: Salivary Cortisol Level
time frame: Salivary Cortisol will be assessed immediately after the third night shift in the Intervention block and levels will be compared between groups.
description: The investigators will collect a single saliva sample at the end of the final night shift in the Baseline block and the Intervention block. The sample will be frozen and later assayed to assess cortisol level (in micrograms per deciliter, μg/dL). Higher cortisol levels will be indicative of greater stress.
arm group label: Control (Group A)
arm group type: No Intervention
description: During the intervention block of the Field Trial, at the end of the first night shift, the participant will be told about their randomization group. In the control group (Group A), participants will not be given any instructions about the timing or duration of their sleep, but will be instructed to follow their usual night shift sleep routine.
arm group label: 8-h Afternoon-Evening Sleep (Group B)
arm group type: Experimental
description: In the 8-h afternoon-evening sleep intervention group (Group B), participants will be instructed to go to bed between 13:00 and 14:00 (depending on their individual commute time) and to remain in bed attempting to sleep for 8 hours (until 21:00-22:00) before the next two night shifts.
arm group label: 8-h Free Sleep (Group C)
arm group type: Experimental
description: In the 8-h free sleep group (Group C), participants will be instructed to remain in bed for 8 continuous hours before the next two night shifts, but will not be given any instruction regarding which 8 hours they should sleep.
intervention type: Behavioral
intervention name: 8-h Afternoon-Evening Sleep
description: 8 consecutive hours time in bed during the afternoon/evening.
arm group label: 8-h Afternoon-Evening Sleep (Group B)
intervention type: Behavioral
intervention name: 8-h Free Sleep
description: 8 consecutive hours time in bed at any time.
arm group label: 8-h Free Sleep (Group C)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeanne F Duffy, MBA, PhD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Jeanne Duffy
investigator title: Principal Investigator
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Dyssomnias
mesh term: Sleep Disorders, Circadian Rhythm
sharing ipd: No