<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/NCT01672489</url>
  </required_header>
  <id_info>
    <org_study_id>2011P000370</org_study_id>
    <nct_id>NCT01672489</nct_id>
  </id_info>
  <brief_title>Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff</brief_title>
  <official_title>Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute for Breathing and Sleep, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liberty Mutual</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this protocol is to assess the risk of drowsy driving amongst shift workers&#xD;
      using objective measures of drowsiness and driving performance in an instrumented research&#xD;
      vehicle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim 1. To test the hypothesis that on road (track) driving performance will&#xD;
      deteriorate (variation in lateral lane position and the rate of out of lane driving events)&#xD;
      and the frequency of episodes of severe sleepiness will increase (&quot;microsleeps&quot; on EEG and&#xD;
      Johns' Drowsiness Score &gt;4) in shift workers following an extended work shift or night shift&#xD;
      compared to a rested state, following day shifts.&#xD;
&#xD;
      Specific Aim 2. To test the hypothesis that ocular measures of alertness (percent of time&#xD;
      with eyes closed, eye tracking and Johns' Drowsiness Score) are related to abnormal driving&#xD;
      performance (driving out of the lane) and &quot;microsleeps&quot; during on road (track) driving.&#xD;
&#xD;
      Specific Aim 2a. To test the hypothesis that autonomic measures, ECG, respiration (measured&#xD;
      with the Bioharness), skin conductance level and peripheral blood flow (measured with the Q&#xD;
      sensor), are related to abnormal driving performance (driving out of the lane) and&#xD;
      &quot;microsleeps&quot; during on road (track) driving&#xD;
&#xD;
      Specific Aim 3. To test the hypothesis that self-reported sleepiness is related to on road&#xD;
      (track) driving performance and episodes of severe sleepiness following extended working&#xD;
      shifts or night shifts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2011</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Brain activity including &quot;microsleeps&quot; using electroencephalography (EEG).</measure>
    <time_frame>Up to 3 hours per session for each participant.</time_frame>
    <description>Continuous EEG recordings are made during each track driving session using a portable Vitaport 4 system (Temec ®).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants' fatigue and drowsiness level while driving using Optalert.</measure>
    <time_frame>Up to 3 hours per session for each participant.</time_frame>
    <description>Optalert is a portable device, worn like sunglasses, designed to detect drowsiness, particularly when driving.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Driving performance measured by an instrumented vehicle.</measure>
    <time_frame>Up to 3 hours per session for each participant.</time_frame>
    <description>A dual control instrumented vehicle, owned by Liberty Mutual, has been used for each driving session with each subject. This vehicle is fitted with a lane tracking system, as well as the capability to instruct and record responses from the driver. Lane position is monitored and recorded continuously with lateral and rear facing cameras. Data is logged to on-board computers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alertness level and level of fatigue measured by a composite of variables from a Zephyr Bioharness device worn by each participant.</measure>
    <time_frame>Up to 3 hours per session for each participant.</time_frame>
    <description>The Zephyr Bioharness uses smart fabric sensors (non-adhesive) to measure electrocardiography (ecg), respiratory wave form, chest skin temperature, posture and activity (3-axis accelerometer).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alertness level and level of fatigue from a composite of variables measured by an Affectiva Q-Sensor worn by each participant.</measure>
    <time_frame>Up to 3 hours per session for each participant.</time_frame>
    <description>Additional autonomic nervous systems measures are obtained from a wrist-worn sensor (Affectiva Q-Sensor).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants' fatigue and drowsiness level measured by an eye tracker device.</measure>
    <time_frame>Up to 3 hours per session for each participant.</time_frame>
    <description>An eye tracking device, owned by Liberty Mutual, is used to measure eye activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant's awareness of their fatigue level using a composite of survey data taken by each participant.</measure>
    <time_frame>Surveys are taken by the participant every 15 minutes during regular stops during each session.</time_frame>
    <description>Questionnaires include: Karolinska Sleepiness Scale, Likelihood of Falling Asleep Questionnaire, and the Sleepiness Symptoms Questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep and wake times using an Actiwatch device.</measure>
    <time_frame>Up to 7 weeks per subject worn continuously during enrollment in the study.</time_frame>
    <description>The Actiwatch-L recorder is a small wrist worn device (17 grams) that measures activity and ambient light exposure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep and wake times using a 'sleep and work' diary completed by each subject.</measure>
    <time_frame>Up to 7 weeks per participant completed daily.</time_frame>
    <description>Subjects maintain a sleep/work diary to provide a self-assessment of their sleep quantity and quality, work periods, as well as caffeine, medication, and alcohol intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' view of their health and well-being using a composite of surveys administered during subject enrollment.</measure>
    <time_frame>Up to 2 hours per subject during the start of their participation in the study.</time_frame>
    <description>Participants are given the Berlin Apnea questionnaire, the MASLACH burnout inventory, and the Owl and Lark Questionnaire during enrollment. The data from these questionnaires will be used for analysis purposes.</description>
  </secondary_outcome>
  <enrollment type="Actual">19</enrollment>
  <condition>Impaired Driving</condition>
  <condition>Sleep Driving</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Participants in this study include shift workers who undertake extended duration shifts (16&#xD;
        hours or longer) or night shifts (e.g. resident physicians, nursing staff and allied health&#xD;
        staff, police, firefighters, etc.).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must be a shift worker who undertakes extended duration shifts (16 hours&#xD;
             or longer) or overnight shifts&#xD;
&#xD;
          -  Participant must be between the ages of 18-65y&#xD;
&#xD;
          -  Participant needs to have held a US driving license for two years previously or an&#xD;
             International Driving license for two years with 6-months regular (&gt;2/week) US driving&#xD;
             experience&#xD;
&#xD;
          -  Participants who wear corrective eye wear (i.e., glasses) are ONLY eligible to&#xD;
             participate if they have a valid prescription so we can fit the Optalert glasses with&#xD;
             their prescription lenses&#xD;
&#xD;
          -  Resident physicians are only recruited if the combination of their time involvement in&#xD;
             the study (i.e., any additional time beyond the time that it would ordinarily take&#xD;
             them to commute home from work), together with their scheduled work hours, would fall&#xD;
             within ACGME standards for duty hours for resident physicians.&#xD;
&#xD;
        Exclusion Criteria: Exclusion criteria includes all parameters outside the inclusion&#xD;
        criteria above.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Czeisler, PH.D., M.D.</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>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>August 6, 2015</last_update_submitted>
  <last_update_submitted_qc>August 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2015</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>Charles Andrew Czeisler, MD, PhD</investigator_full_name>
    <investigator_title>Charles A. Czeisler PH.D., M.D.</investigator_title>
  </responsible_party>
  <keyword>Drowsy</keyword>
  <keyword>Drive</keyword>
  <keyword>Driving</keyword>
  <keyword>Shift Work Disorder</keyword>
  <keyword>SWD</keyword>
  <keyword>EEG</keyword>
  <keyword>ECG</keyword>
  <keyword>Actiwatch</keyword>
  <keyword>Diary</keyword>
  <keyword>Bioharness</keyword>
  <keyword>Q-Sensor</keyword>
  <keyword>Q Sensor</keyword>
  <keyword>Liberty Mutual</keyword>
  <keyword>sleep</keyword>
  <keyword>impaired</keyword>
  <keyword>Optalert</keyword>
  <keyword>tracker</keyword>
  <keyword>vehicle</keyword>
  <keyword>questionnaire</keyword>
  <keyword>survey</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleepiness</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/NCT01672489
org study id: 2011P000370
nct id: NCT01672489
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this protocol is to assess the risk of drowsy driving amongst shift workers
      using objective measures of drowsiness and driving performance in an instrumented research
      vehicle.
Specific Aim 1. To test the hypothesis that on road (track) driving performance will
      deteriorate (variation in lateral lane position and the rate of out of lane driving events)
      and the frequency of episodes of severe sleepiness will increase ("microsleeps" on EEG and
      Johns' Drowsiness Score >4) in shift workers following an extended work shift or night shift
      compared to a rested state, following day shifts.

      Specific Aim 2. To test the hypothesis that ocular measures of alertness (percent of time
      with eyes closed, eye tracking and Johns' Drowsiness Score) are related to abnormal driving
      performance (driving out of the lane) and "microsleeps" during on road (track) driving.

      Specific Aim 2a. To test the hypothesis that autonomic measures, ECG, respiration (measured
      with the Bioharness), skin conductance level and peripheral blood flow (measured with the Q
      sensor), are related to abnormal driving performance (driving out of the lane) and
      "microsleeps" during on road (track) driving

      Specific Aim 3. To test the hypothesis that self-reported sleepiness is related to on road
      (track) driving performance and episodes of severe sleepiness following extended working
      shifts or night shifts.
observational model: Cohort
measure: Brain activity including "microsleeps" using electroencephalography (EEG).
time frame: Up to 3 hours per session for each participant.
description: Continuous EEG recordings are made during each track driving session using a portable Vitaport 4 system (Temec ®).
measure: Participants' fatigue and drowsiness level while driving using Optalert.
time frame: Up to 3 hours per session for each participant.
description: Optalert is a portable device, worn like sunglasses, designed to detect drowsiness, particularly when driving.
measure: Driving performance measured by an instrumented vehicle.
time frame: Up to 3 hours per session for each participant.
description: A dual control instrumented vehicle, owned by Liberty Mutual, has been used for each driving session with each subject. This vehicle is fitted with a lane tracking system, as well as the capability to instruct and record responses from the driver. Lane position is monitored and recorded continuously with lateral and rear facing cameras. Data is logged to on-board computers.
measure: Alertness level and level of fatigue measured by a composite of variables from a Zephyr Bioharness device worn by each participant.
time frame: Up to 3 hours per session for each participant.
description: The Zephyr Bioharness uses smart fabric sensors (non-adhesive) to measure electrocardiography (ecg), respiratory wave form, chest skin temperature, posture and activity (3-axis accelerometer).
measure: Alertness level and level of fatigue from a composite of variables measured by an Affectiva Q-Sensor worn by each participant.
time frame: Up to 3 hours per session for each participant.
description: Additional autonomic nervous systems measures are obtained from a wrist-worn sensor (Affectiva Q-Sensor).
measure: Participants' fatigue and drowsiness level measured by an eye tracker device.
time frame: Up to 3 hours per session for each participant.
description: An eye tracking device, owned by Liberty Mutual, is used to measure eye activity.
measure: Participant's awareness of their fatigue level using a composite of survey data taken by each participant.
time frame: Surveys are taken by the participant every 15 minutes during regular stops during each session.
description: Questionnaires include: Karolinska Sleepiness Scale, Likelihood of Falling Asleep Questionnaire, and the Sleepiness Symptoms Questionnaire.
measure: Sleep and wake times using an Actiwatch device.
time frame: Up to 7 weeks per subject worn continuously during enrollment in the study.
description: The Actiwatch-L recorder is a small wrist worn device (17 grams) that measures activity and ambient light exposure.
measure: Sleep and wake times using a 'sleep and work' diary completed by each subject.
time frame: Up to 7 weeks per participant completed daily.
description: Subjects maintain a sleep/work diary to provide a self-assessment of their sleep quantity and quality, work periods, as well as caffeine, medication, and alcohol intake.
measure: Participants' view of their health and well-being using a composite of surveys administered during subject enrollment.
time frame: Up to 2 hours per subject during the start of their participation in the study.
description: Participants are given the Berlin Apnea questionnaire, the MASLACH burnout inventory, and the Owl and Lark Questionnaire during enrollment. The data from these questionnaires will be used for analysis purposes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Czeisler, PH.D., M.D.
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: Charles Andrew Czeisler, MD, PhD
investigator title: Charles A. Czeisler PH.D., M.D.
mesh term: Sleepiness