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/NCT05971433</url>
    </required_header>
    <id_info>
      <org_study_id>USUHS.2022-110</org_study_id>
      <nct_id>NCT05971433</nct_id>
    </id_info>
    <brief_title>Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes</brief_title>
    <acronym>SPIRIT</acronym>
    <official_title>Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes (SPIRIT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uniformed Services University of the Health Sciences</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Naval Health Research Center</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Uniformed Services University of the Health Sciences</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 goal of this observational study is to learn about the long-term health of United States&#xD;
        military service members who were injured during combat. The main questions it aims to&#xD;
        examine are:&#xD;
  &#xD;
          -  How does the severity of a combat injury impact 1) cardiovascular risk, 2) the&#xD;
             sympathetic nervous system and arrhythmias, 3) blood pressure, and 4) sleep disorders?&#xD;
  &#xD;
          -  Are self-reported mental health symptoms related to sympathetic nervous system&#xD;
             hyperactivity, sleep disorders, and cardiovascular risk in combat-injured service&#xD;
             members?&#xD;
  &#xD;
        This study will recruit from a sample of participants in another research study called the&#xD;
        Wounded Warrior Recovery Project (WWRP) who 1) agreed to be contacted about future research&#xD;
        studies and 2) have a record of a combat injury within the Injury Severity Score ranges&#xD;
        required for this study.&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Provide demographic information and a medical history review&#xD;
  &#xD;
          -  Visit a local laboratory for biometrics measurements and to provide blood and urine&#xD;
             samples&#xD;
  &#xD;
          -  Wear an ambulatory electrocardiogram monitor for 24 hours per day for seven consecutive&#xD;
             days&#xD;
  &#xD;
          -  Wear a home sleep test monitoring device for one night&#xD;
  &#xD;
          -  Wear a blood pressure monitor for 24 consecutive hours on the day after the home sleep&#xD;
             test&#xD;
  &#xD;
        At the end of the study, participants will be asked to mail back the home sleep test and&#xD;
        blood pressure monitors. Prepaid package materials will be provided.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Frequency of arrhythmias</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of arrhythmias.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of atrial fibrillation</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial fibrillation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of atrial flutter</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial flutter.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Density of premature ventricular contractions (PVCs)</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the density of PVCs (percentage of total heartbeats that are PVCs).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of ventricular tachycardia</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of ventricular tachycardia.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine heart rate.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Standard deviation of beat-to-beat intervals (SDNN)</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Standard deviation of beat-to-beat intervals (SDNN) is a heart rate variability (HRV) time domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Root mean square of successive differences (RMSSD)</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Root mean square of successive differences (RMSSD) is a heart rate variability (HRV) time domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Low frequency power</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Low frequency power (LF, 0.04 - 0.15 Hz) is a heart rate variability (HRV) frequency domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>High frequency power</measure>
      <time_frame>7 days of wear</time_frame>
      <description>High frequency power (HF, 0.15 - 0.4 Hz) is a heart rate variability (HRV) frequency domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Log-transformed QT variance (logQTv)</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Log-transformed QT variance (logQTv) s a QT variability (QTV) measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beat-to-beat QT variability index (QTVI)</measure>
      <time_frame>7 days of wear</time_frame>
      <description>Beat-to-beat QT variability index (QTVI) is a QT variability (QTV) measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Presence of obstructive sleep apnea</measure>
      <time_frame>One night</time_frame>
      <description>The presence of comorbid obstructive sleep apnea and/or nocturnal hypoxemia, will be evaluated with a home sleep study test device (HST) worn during the second or third study day</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Presence of nocturnal hypoxemia</measure>
      <time_frame>One night</time_frame>
      <description>The presence of comorbid obstructive sleep apnea and/or nocturnal hypoxemia, will be evaluated with a home sleep study test device (HST) worn during the second or third study day</description>
    </primary_outcome>
    <primary_outcome>
      <measure>24-hour ambulatory blood pressure monitor (ABPM)</measure>
      <time_frame>24 hours</time_frame>
      <description>Blood pressure (diastolic and systolic) will be assessed using a 24-hour ABPM worn during the 24-hour period following the HST.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>High sensitivity C-reactive protein (hs-CRP)</measure>
      <time_frame>Baseline</time_frame>
      <description>This inflammatory marker will be measured during laboratory testing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Posttraumatic Stress Disorder Checklist for Diagnostic and Statistics Manual of Mental Disorder 5 (PCL-5)</measure>
      <time_frame>Baseline</time_frame>
      <description>The severity of Posttraumatic Stress Disorder (PTSD) symptoms will be assessed by the PCL-5 20-question survey. Total scores range from 0 - 80, with higher scores indicating greater PTSD symptom severity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>8-item Patient Health Questionnaire depression scale (PHQ-8)</measure>
      <time_frame>Baseline</time_frame>
      <description>The severity of depressive symptoms will be measured by the eight-question PHQ-8 survey. Total scores range from 0 - 24, with with higher scores indicating greater depressive symptom severity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Brief Dissociative Experience Scale (DES-B)</measure>
      <time_frame>Baseline</time_frame>
      <description>Severity of dissociative experiences will be assessed using the 8-item DES-B survey. Total scores range from 0 - 32, with with higher scores indicating greater dissociative experience severity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>Baseline</time_frame>
      <description>Participant-reported sleep characteristics will be assessed using the 19-item Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 - 21, with higher scores indicating worse sleep quality.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Epworth Sleepiness Scale (ESS)</measure>
      <time_frame>Baseline</time_frame>
      <description>Participant-reported sleep characteristics will be assessed using the 8-item Epworth Sleepiness Scale (ESS). Total scores range from 0 - 24, with higher scores indicating increased daytime sleepiness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>Baseline</time_frame>
      <description>Participant-reported sleep characteristics will be assessed using the 7-item Insomnia Severity Index (ISI). Total scores range from 0 - 28, with higher scores indicating increased insomnia symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berlin Sleep Questionnaire</measure>
      <time_frame>Baseline</time_frame>
      <description>Participant-reported sleep characteristics will be assessed using the 11-item Berlin Sleep Questionnaire. Scores will be calculated to determine if participants are &quot;High Risk&quot; or &quot;Low Risk&quot; for sleep apnea.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>Baseline</time_frame>
      <description>Height and weight will be measured during laboratory visit and combined to report BMI in kg/m^2.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood Pressure</measure>
      <time_frame>Baseline</time_frame>
      <description>Blood pressure (diastolic and systolic) will be recorded at the time of laboratory visit</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hemoglobin A1C (HBA1C)</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Alanine aminotransferase (ALT/SGPT)</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Albumin:globulin (A:G) ratio</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Albumin, serum</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Alkaline phosphatase, serum</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Aspartate aminotransferase (AST/SGOT)</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bilirubin, total</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood urea nitrogen (BUN)</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood urea nitrogen (BUN):creatinine ratio</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Calcium, serum</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Carbon dioxide, total</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chloride, serum</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Creatinine, serum</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Estimated glomerular filtration rate (eGFR) calculation</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Globulin, total</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glucose, serum</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Potassium, serum</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Protein, total, serum</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sodium, serum</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cystatin C with estimated glomerular filtration rate (eGFR)</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cholesterol, total</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>High-density lipoprotein (HDL) cholesterol</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Low-density lipoprotein (LDL) cholesterol (calculation)</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Triglycerides</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Very low-density lipoprotein (VLDL) cholesterol (calculation)</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Albumin/creatinine ratio, random urine</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>N-terminal pro b-type natriuretic peptide (NT-proBNP)</measure>
      <time_frame>Baseline</time_frame>
      <description>This laboratory test will be used to assess overall health outcomes.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Hypertension</condition>
    <condition>Cardiovascular Diseases</condition>
    <condition>Sleep Disorder</condition>
    <condition>Arrythmia</condition>
    <condition>Sympathetic Nervous System</condition>
    <condition>Injury Traumatic</condition>
    <arm_group>
      <arm_group_label>Injury severity scored as &quot;severe&quot;</arm_group_label>
      <description>This group will include participants whose injury was scored as &quot;severe&quot; based on the recorded Injury Severity Score (ISS). Both cohorts will complete the same course of testing in this study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Injury severity scored as &quot;minimal&quot;</arm_group_label>
      <description>This group will include participants whose injury was scored as &quot;minimal&quot; based on the recorded Injury Severity Score (ISS). Both cohorts will complete the same course of testing in this study.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Wounded Warrior Recovery Project participants who 1) agreed to be contacted about future&#xD;
          research studies and 2) have a record of injury within the established Injury Severity&#xD;
          Score cutoffs for this study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Enrolled in the Wounded Warrior Recovery Project (WWRP) and previously agreed to be&#xD;
               contacted regarding future research&#xD;
  &#xD;
            -  Able to complete the informed consent process, be mailed study devices, and complete&#xD;
               laboratory draws within the United States&#xD;
  &#xD;
            -  Age greater than or equal to 18 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No Injury Severity Score or 3 &lt; Injury Severity Score &lt; 15&#xD;
  &#xD;
            -  Unable to complete the informed consent process, be mailed study devices, and complete&#xD;
               laboratory draws within the United States&#xD;
  &#xD;
            -  Not enrolled in the WWRP or enrolled in the WWRP but did not agree to be contacted&#xD;
               about future research&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Ian Stewart, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Uniformed Services University of the Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lauren Walker, MSSW</last_name>
      <phone>301-385-1328</phone>
      <email>lauren.walker.ctr@usuhs.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Autumn Mains, MSN, RN</last_name>
      <phone>301-400-4391</phone>
      <email>autumn.mains.ctr@usuhs.edu</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uniformed Services University of the Health Sciences</investigator_affiliation>
      <investigator_full_name>Ian Stewart</investigator_full_name>
      <investigator_title>Professor of Medicine; Director, Division of Nephrology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Wake Disorders</mesh_term>
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Wounds and Injuries</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/NCT05971433
  org study id: USUHS.2022-110
  nct id: NCT05971433
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the long-term health of United States
        military service members who were injured during combat. The main questions it aims to
        examine are:
  
          -  How does the severity of a combat injury impact 1) cardiovascular risk, 2) the
             sympathetic nervous system and arrhythmias, 3) blood pressure, and 4) sleep disorders?
  
          -  Are self-reported mental health symptoms related to sympathetic nervous system
             hyperactivity, sleep disorders, and cardiovascular risk in combat-injured service
             members?
  
        This study will recruit from a sample of participants in another research study called the
        Wounded Warrior Recovery Project (WWRP) who 1) agreed to be contacted about future research
        studies and 2) have a record of a combat injury within the Injury Severity Score ranges
        required for this study.
  
        Participants will:
  
          -  Provide demographic information and a medical history review
  
          -  Visit a local laboratory for biometrics measurements and to provide blood and urine
             samples
  
          -  Wear an ambulatory electrocardiogram monitor for 24 hours per day for seven consecutive
             days
  
          -  Wear a home sleep test monitoring device for one night
  
          -  Wear a blood pressure monitor for 24 consecutive hours on the day after the home sleep
             test
  
        At the end of the study, participants will be asked to mail back the home sleep test and
        blood pressure monitors. Prepaid package materials will be provided.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Frequency of arrhythmias
  time frame: 7 days of wear
  description: Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of arrhythmias.
  measure: Frequency of atrial fibrillation
  time frame: 7 days of wear
  description: Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial fibrillation.
  measure: Frequency of atrial flutter
  time frame: 7 days of wear
  description: Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial flutter.
  measure: Density of premature ventricular contractions (PVCs)
  time frame: 7 days of wear
  description: Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the density of PVCs (percentage of total heartbeats that are PVCs).
  measure: Frequency of ventricular tachycardia
  time frame: 7 days of wear
  description: Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of ventricular tachycardia.
  measure: Heart rate
  time frame: 7 days of wear
  description: Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine heart rate.
  measure: Standard deviation of beat-to-beat intervals (SDNN)
  time frame: 7 days of wear
  description: Standard deviation of beat-to-beat intervals (SDNN) is a heart rate variability (HRV) time domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
  measure: Root mean square of successive differences (RMSSD)
  time frame: 7 days of wear
  description: Root mean square of successive differences (RMSSD) is a heart rate variability (HRV) time domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
  measure: Low frequency power
  time frame: 7 days of wear
  description: Low frequency power (LF, 0.04 - 0.15 Hz) is a heart rate variability (HRV) frequency domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
  measure: High frequency power
  time frame: 7 days of wear
  description: High frequency power (HF, 0.15 - 0.4 Hz) is a heart rate variability (HRV) frequency domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
  measure: Log-transformed QT variance (logQTv)
  time frame: 7 days of wear
  description: Log-transformed QT variance (logQTv) s a QT variability (QTV) measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
  measure: Beat-to-beat QT variability index (QTVI)
  time frame: 7 days of wear
  description: Beat-to-beat QT variability index (QTVI) is a QT variability (QTV) measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
  measure: Presence of obstructive sleep apnea
  time frame: One night
  description: The presence of comorbid obstructive sleep apnea and/or nocturnal hypoxemia, will be evaluated with a home sleep study test device (HST) worn during the second or third study day
  measure: Presence of nocturnal hypoxemia
  time frame: One night
  description: The presence of comorbid obstructive sleep apnea and/or nocturnal hypoxemia, will be evaluated with a home sleep study test device (HST) worn during the second or third study day
  measure: 24-hour ambulatory blood pressure monitor (ABPM)
  time frame: 24 hours
  description: Blood pressure (diastolic and systolic) will be assessed using a 24-hour ABPM worn during the 24-hour period following the HST.
  measure: High sensitivity C-reactive protein (hs-CRP)
  time frame: Baseline
  description: This inflammatory marker will be measured during laboratory testing.
  measure: Posttraumatic Stress Disorder Checklist for Diagnostic and Statistics Manual of Mental Disorder 5 (PCL-5)
  time frame: Baseline
  description: The severity of Posttraumatic Stress Disorder (PTSD) symptoms will be assessed by the PCL-5 20-question survey. Total scores range from 0 - 80, with higher scores indicating greater PTSD symptom severity.
  measure: 8-item Patient Health Questionnaire depression scale (PHQ-8)
  time frame: Baseline
  description: The severity of depressive symptoms will be measured by the eight-question PHQ-8 survey. Total scores range from 0 - 24, with with higher scores indicating greater depressive symptom severity.
  measure: Brief Dissociative Experience Scale (DES-B)
  time frame: Baseline
  description: Severity of dissociative experiences will be assessed using the 8-item DES-B survey. Total scores range from 0 - 32, with with higher scores indicating greater dissociative experience severity.
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: Baseline
  description: Participant-reported sleep characteristics will be assessed using the 19-item Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 - 21, with higher scores indicating worse sleep quality.
  measure: Epworth Sleepiness Scale (ESS)
  time frame: Baseline
  description: Participant-reported sleep characteristics will be assessed using the 8-item Epworth Sleepiness Scale (ESS). Total scores range from 0 - 24, with higher scores indicating increased daytime sleepiness.
  measure: Insomnia Severity Index (ISI)
  time frame: Baseline
  description: Participant-reported sleep characteristics will be assessed using the 7-item Insomnia Severity Index (ISI). Total scores range from 0 - 28, with higher scores indicating increased insomnia symptoms.
  measure: Berlin Sleep Questionnaire
  time frame: Baseline
  description: Participant-reported sleep characteristics will be assessed using the 11-item Berlin Sleep Questionnaire. Scores will be calculated to determine if participants are "High Risk" or "Low Risk" for sleep apnea.
  measure: Body Mass Index
  time frame: Baseline
  description: Height and weight will be measured during laboratory visit and combined to report BMI in kg/m^2.
  measure: Blood Pressure
  time frame: Baseline
  description: Blood pressure (diastolic and systolic) will be recorded at the time of laboratory visit
  measure: Hemoglobin A1C (HBA1C)
  time frame: Baseline
  description: This laboratory test will be used to assess overall health outcomes.
  measure: Alanine aminotransferase (ALT/SGPT)
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Albumin:globulin (A:G) ratio
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Albumin, serum
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Alkaline phosphatase, serum
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Aspartate aminotransferase (AST/SGOT)
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Bilirubin, total
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Blood urea nitrogen (BUN)
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Blood urea nitrogen (BUN):creatinine ratio
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Calcium, serum
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Carbon dioxide, total
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Chloride, serum
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Creatinine, serum
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Estimated glomerular filtration rate (eGFR) calculation
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Globulin, total
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Glucose, serum
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Potassium, serum
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Protein, total, serum
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Sodium, serum
  time frame: Baseline
  description: This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
  measure: Cystatin C with estimated glomerular filtration rate (eGFR)
  time frame: Baseline
  description: This laboratory test will be used to assess overall health outcomes.
  measure: Cholesterol, total
  time frame: Baseline
  description: This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
  measure: High-density lipoprotein (HDL) cholesterol
  time frame: Baseline
  description: This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
  measure: Low-density lipoprotein (LDL) cholesterol (calculation)
  time frame: Baseline
  description: This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
  measure: Triglycerides
  time frame: Baseline
  description: This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
  measure: Very low-density lipoprotein (VLDL) cholesterol (calculation)
  time frame: Baseline
  description: This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
  measure: Albumin/creatinine ratio, random urine
  time frame: Baseline
  description: This laboratory test will be used to assess overall health outcomes.
  measure: N-terminal pro b-type natriuretic peptide (NT-proBNP)
  time frame: Baseline
  description: This laboratory test will be used to assess overall health outcomes.
  arm group label: Injury severity scored as "severe"
  description: This group will include participants whose injury was scored as "severe" based on the recorded Injury Severity Score (ISS). Both cohorts will complete the same course of testing in this study.
  arm group label: Injury severity scored as "minimal"
  description: This group will include participants whose injury was scored as "minimal" based on the recorded Injury Severity Score (ISS). Both cohorts will complete the same course of testing in this study.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Ian Stewart, MD
  role: Principal Investigator
  affiliation: Uniformed Services University of the Health Sciences
  last name: Lauren Walker, MSSW
  phone: 301-385-1328
  email: lauren.walker.ctr@usuhs.edu
  last name: Autumn Mains, MSN, RN
  phone: 301-400-4391
  email: autumn.mains.ctr@usuhs.edu
  responsible party type: Principal Investigator
  investigator affiliation: Uniformed Services University of the Health Sciences
  investigator full name: Ian Stewart
  investigator title: Professor of Medicine; Director, Division of Nephrology
  mesh term: Sleep Wake Disorders
  mesh term: Cardiovascular Diseases
  mesh term: Wounds and Injuries
  sharing ipd: No