xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015646</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-67719</org_study_id>
      <secondary_id>254764</secondary_id>
      <nct_id>NCT06015646</nct_id>
    </id_info>
    <brief_title>Lifestyle Coaching for Fatigue Mitigation in Emergency Medicine Residents</brief_title>
    <official_title>Lifestyle Education and Personalized Coaching for Fatigue Mitigation in Emergency Medicine Residents: A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to determine whether personalized lifestyle coaching minimizes&#xD;
        the negative impact of circadian disruption on performance and recovery in emergency medicine&#xD;
        physician trainees during night shifts.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this study is to examine whether a brief personalized fatigue-mitigation&#xD;
        lifestyle coaching (PFMLC) for emergency medicine residents on overnight shifts would&#xD;
        minimize the negative effects of circadian rhythm disruptions on performance and recovery&#xD;
        compared to those who receive one-time passive information on lifestyle practices.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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 investigators will randomize the participants who have consented to participate in the study to intervention or control arms at the beginning of each of the 3-week study periods. Participants will wear a Fitbit watch for one week prior and one week after 3-4 night shifts. The baseline online survey will collect data on sex, training year, current satisfaction levels with lifestyle strategies, morning-evening chronotype, Sleep-related Impairment, and Task Load. During the nightshifts, the following outcome measures: psychomotor vigilance test, Stanford Sleepiness Scale, Task Load Index, and Noordsy-Dahle Subjective Experience Scale will be assessed at the beginning of the shift and in the middle of the shift at a time that is most convenient time for each participant, determined by them. A final online survey will assess satisfaction levels with lifestyle strategies, Sleep-related Impairment, Task Load, and satisfaction and feedback about the program at the end of the study.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>One of the two principal investigators and researchers who analyze the data will be blinded to the group assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Mean of the 3 overnight percentage changes (from pre-shift) in Mean reaction time reciprocal of the a psychomotor vigilance test</measure>
      <time_frame>Two time points (beginning and middle of night shifts) on each night for a total of 3 nights</time_frame>
      <description>The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.&#xD;
  Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the Mean reaction time reciprocal (lower is desirable) of the PVT test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean of the 3 overnight percentage changes (from pre-shift) the number of lapses in psychomotor vigilance test</measure>
      <time_frame>Two time points (beginning and middle of night shifts) on each night for a total of 3 nights</time_frame>
      <description>The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.&#xD;
  Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the number of lapses ( lower is desirable) of the PVT test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean of the 3 overnight percentage changes (from pre-shift) in the number of false starts in the psychomotor vigilance test</measure>
      <time_frame>Two time points (beginning and middle of night shifts) on each night for a total of 3 nights</time_frame>
      <description>The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.&#xD;
  Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the number of false starts (lower is desirable) in the PVT test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean of the 3 overnight percentage changes (from pre-shift) the Aggregate Score of the psychomotor vigilance test</measure>
      <time_frame>Two time points (beginning and middle of night shifts) on each night for a total of 3 nights</time_frame>
      <description>The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.&#xD;
  Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the Aggregate Score (0 worst-100 best and derived from the number of lapses and false starts) of the PVT test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean of the 3 overnight percentage changes (from pre-shift) in Stanford Sleepiness Scale</measure>
      <time_frame>Two time points (beginning and middle of night shifts) on each night for a total of 3 nights</time_frame>
      <description>The Sleepiness Symptom Scale (SSS) is a validated subjective measure of sleepiness frequently used for research and clinical purposes. It evaluates sleepiness at specific moments in time using a single-item scale. Respondents select one of seven statements to indicate their level of perceived sleepiness. Score Range: The scale score ranges from 1 to 7, reflecting the varying degrees of sleepiness experienced by respondents. This test takes approximately 15 seconds to complete.&#xD;
  Directionality: Higher scores on the SSS represent higher perceived sleepiness, while lower scores indicate increased alertness and desirable.&#xD;
  Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean of the 3 overnight percentage changes (from pre-shift) in Noordsy-Dahle Subjective Experience Scale (NDSE)</measure>
      <time_frame>Two time points (beginning and middle of night shifts) on each night for a total of 3 nights</time_frame>
      <description>Modified version of Noordsy-Dahle Subjective Experience Scale (NDSE) for healthy adults includes 8 sub-domains:&#xD;
  Global well-being, Delighted 1 to Terrible 7, Lower score better Anxiety: None 1 to Extreme 7, Lower score better Depression: None 1 to Extreme 7, Lower score better Energy: Tired 1 to Energized 7, Higher score better Motivation: None 1 to Strong 7, Higher score better Clarity of thought: Clouded 1 to Totally Clear 7, Higher score better Concentration: Poor 1 to Excellent 7, Higher score better Social interest: Alone 1 to With Others 7, Higher score better&#xD;
  This test takes approximately 90 seconds to complete. Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean of total sleep hours</measure>
      <time_frame>3 weeks</time_frame>
      <description>Investigators will compare total sleep hours per 24-hour period during a baseline week, a night float week, and a recovery week using FitBit Versa 4, between the two groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean of heartrate variability</measure>
      <time_frame>3 weeks</time_frame>
      <description>Investigators will compare the heart rate variability per 24-hour period during a baseline week, a night float week, and a recovery week using Fitbit Versa 4, between the two groups.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Percentage change from baseline in NIH PROMIS Short Form Sleep-Related Impairment</measure>
      <time_frame>3 weeks</time_frame>
      <description>The NIH PROMIS Short Form Sleep-Related Impairment Scale is included as an exploratory outcome measure in this study. The Sleep-Related Impairment is designed to assess the impact of sleep-related impairment on various aspects of daily functioning and overall quality of life. Higher scores indicate greater sleep-related impairment. It takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study. Investigators will compare the percentage change from baseline between the two groups. The minimum score is 8 and the maximum is 40 and linked to T-scores ranging from 30 to 80.1. With lower scores being more favorable.</description>
    </other_outcome>
    <other_outcome>
      <measure>Percentage change from baseline in Task Load Index</measure>
      <time_frame>3 weeks</time_frame>
      <description>The National Aeronautics and Space Administration (NASA) Task Load Index (TLX) is included as an exploratory outcome measure in this study. The TLX is a measure of perceived workload and is used to measure cognitive load. Lower scores are more desirable. It takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study. Investigators will compare the percentage change from baseline between the two groups. The score ranges from 0 to 600 with lower scores being more favorable.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Lifestyle, Healthy</condition>
    <condition>Sleepiness</condition>
    <condition>Alertness</condition>
    <condition>Shift-Work Related Sleep Disturbance</condition>
    <condition>Work Related Stress</condition>
    <condition>Self Efficacy</condition>
    <condition>Self-Compassion</condition>
    <arm_group>
      <arm_group_label>Lifestyle Coaching and Educational Handout</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Lifestyle coach-led 30-minute focused, personalized session in addition to educational handout containing lifestyle tips for fatigue mitigation in night shift workers, which will be given to all participants at the beginning of the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Educational Handout Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>An educational handout containing lifestyle tips for fatigue mitigation in night shift workers will be given to all participants at the beginning of the study. Personalized coaching will not be offered to participants in this arm.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Personalized lifestyle coaching and educational handout</intervention_name>
      <description>Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study. Participants will also receive a 30-minute focused, personalized lifestyle coaching within a week of the initial overnight shift. The lifestyle coach will be in close contact during the night shifts.</description>
      <arm_group_label>Lifestyle Coaching and Educational Handout</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Handout</intervention_name>
      <description>Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study</description>
      <arm_group_label>Educational Handout Control</arm_group_label>
      <arm_group_label>Lifestyle Coaching and Educational Handout</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Stanford Health Care (SHC) Emergency Medicine residents (PGY 1 to 4)&#xD;
  &#xD;
            -  Scheduled to work at least 3 consecutive overnight shifts at SHC Emergency Department.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-Stanford Health Care (SHC) Emergency Medicine residents&#xD;
  &#xD;
            -  Stanford Health Care (SHC) Emergency Medicine residents who are not rotating in&#xD;
               Stanford Emergency Medicine Department&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Al'ai Alvarez, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Maryam S Makowski, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maryam S Makowski, PhD</last_name>
      <phone>6504975950</phone>
      <email>nnaryann@stanford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nikitha Menon, BA</last_name>
      <phone>6504978741</phone>
      <email>nkmenon@stanford.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Stanford Medicine</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94303</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nikitha K Menon, BA</last_name>
      </contact>
      <investigator>
        <last_name>Maryam S Makowski, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Al'ai Alvarez, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Maryam S Makowski, PhD</investigator_full_name>
      <investigator_title>Clinical Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>physician well-being</keyword>
    <keyword>occupational well-being</keyword>
    <keyword>resident well-being</keyword>
    <keyword>physician coaching</keyword>
    <keyword>lifestyle coaching</keyword>
    <keyword>night shifts</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyssomnias</mesh_term>
      <mesh_term>Parasomnias</mesh_term>
      <mesh_term>Emergencies</mesh_term>
      <mesh_term>Sleepiness</mesh_term>
      <mesh_term>Occupational Stress</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015646
  org study id: IRB-67719
  secondary id: 254764
  nct id: NCT06015646
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine whether personalized lifestyle coaching minimizes
        the negative impact of circadian disruption on performance and recovery in emergency medicine
        physician trainees during night shifts.
  The goal of this study is to examine whether a brief personalized fatigue-mitigation
        lifestyle coaching (PFMLC) for emergency medicine residents on overnight shifts would
        minimize the negative effects of circadian rhythm disruptions on performance and recovery
        compared to those who receive one-time passive information on lifestyle practices.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The investigators will randomize the participants who have consented to participate in the study to intervention or control arms at the beginning of each of the 3-week study periods. Participants will wear a Fitbit watch for one week prior and one week after 3-4 night shifts. The baseline online survey will collect data on sex, training year, current satisfaction levels with lifestyle strategies, morning-evening chronotype, Sleep-related Impairment, and Task Load. During the nightshifts, the following outcome measures: psychomotor vigilance test, Stanford Sleepiness Scale, Task Load Index, and Noordsy-Dahle Subjective Experience Scale will be assessed at the beginning of the shift and in the middle of the shift at a time that is most convenient time for each participant, determined by them. A final online survey will assess satisfaction levels with lifestyle strategies, Sleep-related Impairment, Task Load, and satisfaction and feedback about the program at the end of the study.
  primary purpose: Health Services Research
  masking: Double (Investigator, Outcomes Assessor)
  masking description: One of the two principal investigators and researchers who analyze the data will be blinded to the group assignment.
  measure: Mean of the 3 overnight percentage changes (from pre-shift) in Mean reaction time reciprocal of the a psychomotor vigilance test
  time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights
  description: The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.
  Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the Mean reaction time reciprocal (lower is desirable) of the PVT test.
  measure: Mean of the 3 overnight percentage changes (from pre-shift) the number of lapses in psychomotor vigilance test
  time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights
  description: The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.
  Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the number of lapses ( lower is desirable) of the PVT test.
  measure: Mean of the 3 overnight percentage changes (from pre-shift) in the number of false starts in the psychomotor vigilance test
  time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights
  description: The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.
  Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the number of false starts (lower is desirable) in the PVT test.
  measure: Mean of the 3 overnight percentage changes (from pre-shift) the Aggregate Score of the psychomotor vigilance test
  time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights
  description: The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.
  Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the Aggregate Score (0 worst-100 best and derived from the number of lapses and false starts) of the PVT test.
  measure: Mean of the 3 overnight percentage changes (from pre-shift) in Stanford Sleepiness Scale
  time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights
  description: The Sleepiness Symptom Scale (SSS) is a validated subjective measure of sleepiness frequently used for research and clinical purposes. It evaluates sleepiness at specific moments in time using a single-item scale. Respondents select one of seven statements to indicate their level of perceived sleepiness. Score Range: The scale score ranges from 1 to 7, reflecting the varying degrees of sleepiness experienced by respondents. This test takes approximately 15 seconds to complete.
  Directionality: Higher scores on the SSS represent higher perceived sleepiness, while lower scores indicate increased alertness and desirable.
  Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups
  measure: Mean of the 3 overnight percentage changes (from pre-shift) in Noordsy-Dahle Subjective Experience Scale (NDSE)
  time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights
  description: Modified version of Noordsy-Dahle Subjective Experience Scale (NDSE) for healthy adults includes 8 sub-domains:
  Global well-being, Delighted 1 to Terrible 7, Lower score better Anxiety: None 1 to Extreme 7, Lower score better Depression: None 1 to Extreme 7, Lower score better Energy: Tired 1 to Energized 7, Higher score better Motivation: None 1 to Strong 7, Higher score better Clarity of thought: Clouded 1 to Totally Clear 7, Higher score better Concentration: Poor 1 to Excellent 7, Higher score better Social interest: Alone 1 to With Others 7, Higher score better
  This test takes approximately 90 seconds to complete. Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups.
  measure: Mean of total sleep hours
  time frame: 3 weeks
  description: Investigators will compare total sleep hours per 24-hour period during a baseline week, a night float week, and a recovery week using FitBit Versa 4, between the two groups.
  measure: Mean of heartrate variability
  time frame: 3 weeks
  description: Investigators will compare the heart rate variability per 24-hour period during a baseline week, a night float week, and a recovery week using Fitbit Versa 4, between the two groups.
  measure: Percentage change from baseline in NIH PROMIS Short Form Sleep-Related Impairment
  time frame: 3 weeks
  description: The NIH PROMIS Short Form Sleep-Related Impairment Scale is included as an exploratory outcome measure in this study. The Sleep-Related Impairment is designed to assess the impact of sleep-related impairment on various aspects of daily functioning and overall quality of life. Higher scores indicate greater sleep-related impairment. It takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study. Investigators will compare the percentage change from baseline between the two groups. The minimum score is 8 and the maximum is 40 and linked to T-scores ranging from 30 to 80.1. With lower scores being more favorable.
  measure: Percentage change from baseline in Task Load Index
  time frame: 3 weeks
  description: The National Aeronautics and Space Administration (NASA) Task Load Index (TLX) is included as an exploratory outcome measure in this study. The TLX is a measure of perceived workload and is used to measure cognitive load. Lower scores are more desirable. It takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study. Investigators will compare the percentage change from baseline between the two groups. The score ranges from 0 to 600 with lower scores being more favorable.
  arm group label: Lifestyle Coaching and Educational Handout
  arm group type: Experimental
  description: Lifestyle coach-led 30-minute focused, personalized session in addition to educational handout containing lifestyle tips for fatigue mitigation in night shift workers, which will be given to all participants at the beginning of the study.
  arm group label: Educational Handout Control
  arm group type: Active Comparator
  description: An educational handout containing lifestyle tips for fatigue mitigation in night shift workers will be given to all participants at the beginning of the study. Personalized coaching will not be offered to participants in this arm.
  intervention type: Behavioral
  intervention name: Personalized lifestyle coaching and educational handout
  description: Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study. Participants will also receive a 30-minute focused, personalized lifestyle coaching within a week of the initial overnight shift. The lifestyle coach will be in close contact during the night shifts.
  arm group label: Lifestyle Coaching and Educational Handout
  intervention type: Behavioral
  intervention name: Handout
  description: Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study
  arm group label: Educational Handout Control
  arm group label: Lifestyle Coaching and Educational Handout
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Al'ai Alvarez, MD
  role: Principal Investigator
  affiliation: Stanford University
  last name: Maryam S Makowski, PhD
  role: Principal Investigator
  affiliation: Stanford University
  last name: Maryam S Makowski, PhD
  phone: 6504975950
  email: nnaryann@stanford.edu
  last name: Nikitha Menon, BA
  phone: 6504978741
  email: nkmenon@stanford.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Maryam S Makowski, PhD
  investigator title: Clinical Assistant Professor
  mesh term: Dyssomnias
  mesh term: Parasomnias
  mesh term: Emergencies
  mesh term: Sleepiness
  mesh term: Occupational Stress
  sharing ipd: No