<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/NCT04469803</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19120222</org_study_id>
    <nct_id>NCT04469803</nct_id>
  </id_info>
  <brief_title>Impact of Intra-Shift Napping on EMS Cardiovascular Health</brief_title>
  <official_title>The Impact of Napping During Night Shifts on Indicators of Cardiovascular Health Among EMS Clinicians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZOLL Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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>
      Cardiovascular disease (CVD) exerts a significant health burden among shift workers,&#xD;
      including police, firefighters, and emergency medical services (EMS). The unique occupational&#xD;
      demands inherent to these professions--sleep loss, circadian misalignment, high stress, and&#xD;
      sustained hyper-vigilance--confer increased risk for both on and off-duty cardiovascular&#xD;
      events. Mitigating cardiovascular risks in these professions requires that we first identify&#xD;
      robust markers and potential mechanisms of risk. Previous work suggest shift work has a&#xD;
      negative impact on blood pressure (BP) and heart rate variability (HRV). Blunted BP dipping&#xD;
      at night and during sleep, and reduced HRV are powerful markers of increased CVD risk. Both&#xD;
      are linked to preclinical indicators of cardiac damage, such as presence of coronary artery&#xD;
      calcium, left atrial enlargement, and cardiovascular-related mortality. This study will use&#xD;
      an experimental crossover study design with three intervention conditions to test the impact&#xD;
      of a 30 minute brief nap and a 2-hour longer nap versus no nap on BP and HRV. Outcomes of&#xD;
      interest include blunted dipping of BP during nighttime hours and during sleep and HRV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease (CVD) exerts a significant health burden among shift workers,&#xD;
      including police, firefighters, and emergency medical services (EMS). The unique occupational&#xD;
      demands inherent to these professions--sleep loss, circadian misalignment, high stress, and&#xD;
      sustained hyper-vigilance--confer increased risk for both on and off-duty cardiovascular&#xD;
      events. Mitigating cardiovascular risks in these professions requires that we first identify&#xD;
      robust markers and potential mechanisms of risk. Previous work suggest shift work has a&#xD;
      negative impact on blood pressure (BP) and heart rate variability (HRV). Blunted BP dipping&#xD;
      at night and during sleep, and reduced HRV are powerful markers of increased CVD risk. Both&#xD;
      are linked to preclinical indicators of cardiac damage, such as presence of coronary artery&#xD;
      calcium, left atrial enlargement, and cardiovascular-related mortality.&#xD;
&#xD;
      Critical questions remain:&#xD;
&#xD;
      Are BP dipping and HRV impacted by napping during night shift work? Compared to those who do&#xD;
      not nap, does napping during night shifts help BP and HRV to normalize quicker in the hours&#xD;
      immediately post night shift work? What is the impact of brief naps (e.g., 30 minutes) versus&#xD;
      longer naps (e.g., 2 hours)?&#xD;
&#xD;
      This study will use a randomized crossover experimental design of EMS workers and be based in&#xD;
      the laboratory environment. Participants will complete three intervention conditions. All&#xD;
      study arms will involve a 12-hour simulated night shift. The intervention of interest is&#xD;
      napping (no nap vs. a 30 minute nap vs. a two-hour nap) in a randomized crossover study&#xD;
      design. The primary outcome of interest is BP dipping (&gt;10% drop) and Heart Rate Variability&#xD;
      (HRV) measured as the standard deviation of inter-beat intervals of the sinus beats in&#xD;
      milliseconds (SDNN). All outcomes will be measured serially before the simulation, during&#xD;
      simulated night shifts, during the intra-shift napping period, and during recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2021</start_date>
  <completion_date type="Actual">October 2, 2022</completion_date>
  <primary_completion_date type="Actual">October 2, 2022</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>
    <intervention_model_description>Randomized crossover study design</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with blunted dipping of blood pressure via the sleep based method</measure>
    <time_frame>Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours</time_frame>
    <description>Blood pressure is created by the heart muscle contractions and is measured using two numbers: The Systolic Blood Pressure (SBP) and the Diastolic Blood Pressure (DBP). Normal patterns in BP include elevations in SBP and DBP during the daylight and waking hours followed by a drop (dip) during nighttime hours and during sleep. A dip of 10% to 20% during nighttime or sleep is considered normal, whereas a dip &lt;10% is defined as blunted BP dipping. Blunted BP dipping will be quantified as: [(mean BP during waking hours - mean BP during sleep) / mean BP during waking hours] X 100 - the &quot;sleep-based method.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with blunted dipping of blood pressure via the wide fixed time method</measure>
    <time_frame>Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours</time_frame>
    <description>Blood pressure is created by the heart muscle contractions and is measured using two numbers: The Systolic Blood Pressure (SBP) and the Diastolic Blood Pressure (DBP). Normal patterns in BP include elevations in SBP and DBP during the daylight and waking hours followed by a drop (dip) during nighttime hours and during sleep. A dip of 10% to 20% during nighttime or sleep is considered normal, whereas a dip &lt;10% is defined as blunted BP dipping. Blunted BP dipping during nighttime hours (2300 to 0659 hours) vs. daytime hours (0700 to 2259 hours) will be quantified as: [(mean daytime BP - mean nighttime BP) / mean daytime hours BP] X 100 - the &quot;wide-fixed time method.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of participants with unhealthy Heart Rate Variability (HRV) measured via the standard deviation of the inter-beat intervals of normal sinus beats (SDNN)</measure>
    <time_frame>HRV will be monitored with a holter monitor continuously over 72 total hours</time_frame>
    <description>A healthy heart oscillates and beat-to-beat fluctuations are variable. Greater variability in heart rate is associated with better health, the capacity to respond and cope, and better performance. The Heart Rate Variability (HRV) measure standard deviation of the inter-beat intervals of normal sinus beats (SDNN) is considered standard and is calculated in milliseconds (ms) over short-term (e.g., 60 seconds) and long-term intervals (24 hours). Values of SDNN &lt;50ms are considered unhealthy for medical risk stratification.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Heart Rate Variability</condition>
  <arm_group>
    <arm_group_label>No nap, brief nap, then longer nap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with no nap first, undergo a 1-week minimum washout, then complete the protocol again with a brief nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a longer nap opportunity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No nap, longer nap, then brief nap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with no nap first, undergo a 1-week minimum washout, then complete the protocol again with a longer nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a brief nap opportunity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brief nap, no nap, then longer nap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with brief nap first, undergo a 1-week minimum washout, then complete the protocol again with no nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a longer nap opportunity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brief nap, longer nap, then no nap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with brief nap first, undergo a 1-week minimum washout, then complete the protocol again with longer nap, then undergo a minimum 1-week washout, then return to complete the protocol again with no nap opportunity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Longer nap, brief nap, then no nap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with a longer nap first, undergo a 1-week minimum washout, then complete the protocol again with a brief nap, then undergo a minimum 1-week washout, then return to complete the protocol again with no nap opportunity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Longer nap, no nap, then brief nap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with a longer nap first, undergo a 1-week minimum washout, then complete the protocol again with no nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a brief nap opportunity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intra-Shift Napping</intervention_name>
    <description>The Brief Nap opportunity will allow for a 30-minute nap between the hours of 0200 and 0400 during the 12-hour simulated night shift. The Longer Nap opportunity will allow for a 2-hour nap between the hours of 0200 and 0400 during the 12-hour simulated night shift.</description>
    <arm_group_label>Brief nap, longer nap, then no nap</arm_group_label>
    <arm_group_label>Brief nap, no nap, then longer nap</arm_group_label>
    <arm_group_label>Longer nap, brief nap, then no nap</arm_group_label>
    <arm_group_label>Longer nap, no nap, then brief nap</arm_group_label>
    <arm_group_label>No nap, brief nap, then longer nap</arm_group_label>
    <arm_group_label>No nap, longer nap, then brief nap</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 18 years or older;&#xD;
&#xD;
          2. current / active certification as an EMS clinician at the EMT-Basic, Advanced,&#xD;
             Paramedic, Flight Paramedic, or Flight Nurse level, or healthcare shift worker;&#xD;
&#xD;
          3. has not ever been diagnosed with any of the following: hypertension, cardiovascular&#xD;
             disease, myocardial infarction, stroke/TIA, chronic kidney disease, adrenal disease,&#xD;
             thyroid disease, rheumatologic disease, hematologic disease, cancer of any type,&#xD;
             dementia/memory loss, organ transplantation; insomnia or other major sleep problem;&#xD;
             sleep apnea or other diagnosis that is related to problems with breathing or the&#xD;
             airway; and&#xD;
&#xD;
          4. is not currently pregnant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. 17 years of age or younger;&#xD;
&#xD;
          2. not an EMS clinician or inactive as an EMS clinician or not a healthcare shift worker;&#xD;
&#xD;
          3. has ever been diagnosed with hypertension, cardiovascular disease, myocardial&#xD;
             infarction, stroke/TIA, chronic kidney disease, adrenal disease, thyroid disease,&#xD;
             rheumatologic disease, hematologic disease, cancer of any type, dementia/memory loss,&#xD;
             organ transplantation; insomnia or other major sleep problem; sleep apnea or other&#xD;
             diagnosis that is related to problems with breathing or the airway;&#xD;
&#xD;
          4. is currently pregnant;&#xD;
&#xD;
          5. is unwilling to wear multiple monitoring devices (e.g., automated blood pressure&#xD;
             monitoring device, holter monitor for HRV measurement, wrist actigraphy) for the&#xD;
             duration of the study protocol.&#xD;
&#xD;
          6. is unwilling to refrain from caffeine during the study protocol; or&#xD;
&#xD;
          7. is unwilling to adhere to sleep / wake times outlined in the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leonard Weiss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>P. Daniel Patterson, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Patterson PD, Weiss LS, Weaver MD, Salcido DD, Opitz SE, Okerman TS, Smida TT, Martin SE, Guyette FX, Martin-Gill C, Callaway CW. Napping on the night shift and its impact on blood pressure and heart rate variability among emergency medical services workers: study protocol for a randomized crossover trial. Trials. 2021 Mar 16;22(1):212. doi: 10.1186/s13063-021-05161-4.</citation>
    <PMID>33726840</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Leonard Weiss</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators will work with the ZOLL Foundation and share de-identified research data if requested and if approved by the University of Pittsburgh. The study team will develop a process to receive requests from outside the study team for de-identified datasets.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>One year after the main results are reported in peer-reviewed manuscripts.</ipd_time_frame>
    <ipd_access_criteria>The study team will develop a process to receive requests from outside the study team for de-identified datasets.</ipd_access_criteria>
  </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/NCT04469803
org study id: STUDY19120222
nct id: NCT04469803
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular disease (CVD) exerts a significant health burden among shift workers,
      including police, firefighters, and emergency medical services (EMS). The unique occupational
      demands inherent to these professions--sleep loss, circadian misalignment, high stress, and
      sustained hyper-vigilance--confer increased risk for both on and off-duty cardiovascular
      events. Mitigating cardiovascular risks in these professions requires that we first identify
      robust markers and potential mechanisms of risk. Previous work suggest shift work has a
      negative impact on blood pressure (BP) and heart rate variability (HRV). Blunted BP dipping
      at night and during sleep, and reduced HRV are powerful markers of increased CVD risk. Both
      are linked to preclinical indicators of cardiac damage, such as presence of coronary artery
      calcium, left atrial enlargement, and cardiovascular-related mortality. This study will use
      an experimental crossover study design with three intervention conditions to test the impact
      of a 30 minute brief nap and a 2-hour longer nap versus no nap on BP and HRV. Outcomes of
      interest include blunted dipping of BP during nighttime hours and during sleep and HRV.
Cardiovascular disease (CVD) exerts a significant health burden among shift workers,
      including police, firefighters, and emergency medical services (EMS). The unique occupational
      demands inherent to these professions--sleep loss, circadian misalignment, high stress, and
      sustained hyper-vigilance--confer increased risk for both on and off-duty cardiovascular
      events. Mitigating cardiovascular risks in these professions requires that we first identify
      robust markers and potential mechanisms of risk. Previous work suggest shift work has a
      negative impact on blood pressure (BP) and heart rate variability (HRV). Blunted BP dipping
      at night and during sleep, and reduced HRV are powerful markers of increased CVD risk. Both
      are linked to preclinical indicators of cardiac damage, such as presence of coronary artery
      calcium, left atrial enlargement, and cardiovascular-related mortality.

      Critical questions remain:

      Are BP dipping and HRV impacted by napping during night shift work? Compared to those who do
      not nap, does napping during night shifts help BP and HRV to normalize quicker in the hours
      immediately post night shift work? What is the impact of brief naps (e.g., 30 minutes) versus
      longer naps (e.g., 2 hours)?

      This study will use a randomized crossover experimental design of EMS workers and be based in
      the laboratory environment. Participants will complete three intervention conditions. All
      study arms will involve a 12-hour simulated night shift. The intervention of interest is
      napping (no nap vs. a 30 minute nap vs. a two-hour nap) in a randomized crossover study
      design. The primary outcome of interest is BP dipping (>10% drop) and Heart Rate Variability
      (HRV) measured as the standard deviation of inter-beat intervals of the sinus beats in
      milliseconds (SDNN). All outcomes will be measured serially before the simulation, during
      simulated night shifts, during the intra-shift napping period, and during recovery.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized crossover study design
primary purpose: Other
masking: None (Open Label)
masking description: No masking
measure: Number of participants with blunted dipping of blood pressure via the sleep based method
time frame: Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours
description: Blood pressure is created by the heart muscle contractions and is measured using two numbers: The Systolic Blood Pressure (SBP) and the Diastolic Blood Pressure (DBP). Normal patterns in BP include elevations in SBP and DBP during the daylight and waking hours followed by a drop (dip) during nighttime hours and during sleep. A dip of 10% to 20% during nighttime or sleep is considered normal, whereas a dip <10% is defined as blunted BP dipping. Blunted BP dipping will be quantified as: [(mean BP during waking hours - mean BP during sleep) / mean BP during waking hours] X 100 - the "sleep-based method."
measure: Number of participants with blunted dipping of blood pressure via the wide fixed time method
time frame: Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours
description: Blood pressure is created by the heart muscle contractions and is measured using two numbers: The Systolic Blood Pressure (SBP) and the Diastolic Blood Pressure (DBP). Normal patterns in BP include elevations in SBP and DBP during the daylight and waking hours followed by a drop (dip) during nighttime hours and during sleep. A dip of 10% to 20% during nighttime or sleep is considered normal, whereas a dip <10% is defined as blunted BP dipping. Blunted BP dipping during nighttime hours (2300 to 0659 hours) vs. daytime hours (0700 to 2259 hours) will be quantified as: [(mean daytime BP - mean nighttime BP) / mean daytime hours BP] X 100 - the "wide-fixed time method."
measure: The number of participants with unhealthy Heart Rate Variability (HRV) measured via the standard deviation of the inter-beat intervals of normal sinus beats (SDNN)
time frame: HRV will be monitored with a holter monitor continuously over 72 total hours
description: A healthy heart oscillates and beat-to-beat fluctuations are variable. Greater variability in heart rate is associated with better health, the capacity to respond and cope, and better performance. The Heart Rate Variability (HRV) measure standard deviation of the inter-beat intervals of normal sinus beats (SDNN) is considered standard and is calculated in milliseconds (ms) over short-term (e.g., 60 seconds) and long-term intervals (24 hours). Values of SDNN <50ms are considered unhealthy for medical risk stratification.
arm group label: No nap, brief nap, then longer nap
arm group type: Experimental
description: Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with no nap first, undergo a 1-week minimum washout, then complete the protocol again with a brief nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a longer nap opportunity.
arm group label: No nap, longer nap, then brief nap
arm group type: Experimental
description: Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with no nap first, undergo a 1-week minimum washout, then complete the protocol again with a longer nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a brief nap opportunity.
arm group label: Brief nap, no nap, then longer nap
arm group type: Experimental
description: Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with brief nap first, undergo a 1-week minimum washout, then complete the protocol again with no nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a longer nap opportunity.
arm group label: Brief nap, longer nap, then no nap
arm group type: Experimental
description: Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with brief nap first, undergo a 1-week minimum washout, then complete the protocol again with longer nap, then undergo a minimum 1-week washout, then return to complete the protocol again with no nap opportunity.
arm group label: Longer nap, brief nap, then no nap
arm group type: Experimental
description: Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with a longer nap first, undergo a 1-week minimum washout, then complete the protocol again with a brief nap, then undergo a minimum 1-week washout, then return to complete the protocol again with no nap opportunity.
arm group label: Longer nap, no nap, then brief nap
arm group type: Experimental
description: Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with a longer nap first, undergo a 1-week minimum washout, then complete the protocol again with no nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a brief nap opportunity.
intervention type: Behavioral
intervention name: Intra-Shift Napping
description: The Brief Nap opportunity will allow for a 30-minute nap between the hours of 0200 and 0400 during the 12-hour simulated night shift. The Longer Nap opportunity will allow for a 2-hour nap between the hours of 0200 and 0400 during the 12-hour simulated night shift.
arm group label: Brief nap, longer nap, then no nap
arm group label: Brief nap, no nap, then longer nap
arm group label: Longer nap, brief nap, then no nap
arm group label: Longer nap, no nap, then brief nap
arm group label: No nap, brief nap, then longer nap
arm group label: No nap, longer nap, then brief nap
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leonard Weiss, MD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: P. Daniel Patterson, PhD
role: Study Director
affiliation: University of Pittsburgh
facility: 
country: United States
citation: Patterson PD, Weiss LS, Weaver MD, Salcido DD, Opitz SE, Okerman TS, Smida TT, Martin SE, Guyette FX, Martin-Gill C, Callaway CW. Napping on the night shift and its impact on blood pressure and heart rate variability among emergency medical services workers: study protocol for a randomized crossover trial. Trials. 2021 Mar 16;22(1):212. doi: 10.1186/s13063-021-05161-4.
PMID: 33726840
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Leonard Weiss
investigator title: Assistant Professor
sharing ipd: Yes
ipd description: The investigators will work with the ZOLL Foundation and share de-identified research data if requested and if approved by the University of Pittsburgh. The study team will develop a process to receive requests from outside the study team for de-identified datasets.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: One year after the main results are reported in peer-reviewed manuscripts.
ipd access criteria: The study team will develop a process to receive requests from outside the study team for de-identified datasets.