NCT05971433

Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and caRdiovascular Health InvesTigation

Enrolling by Invitation
Not specifiedAges 18+Observational
Uniformed Services University of the Health Sciences
~200 participants
Updated 2026-05-22 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of arrhythmias
Measured over 7 days of wear
+51 more outcomes measured
Hypertension
Cardiovascular Diseases
Sleep Disorder
Arrythmia
Sympathetic Nervous System
Injury Traumatic
1 sites across 1 states
Maryland1
  • Soroosh Solhjoo, PhD · PRINCIPAL_INVESTIGATOR · Uniformed Services University of the Health Sciences

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Enrolled in the Wounded Warrior Recovery Project (WWRP) and previously agreed to be contacted regarding future research
Able to complete the informed consent process, be mailed study devices, and complete laboratory draws within the United States
Age greater than or equal to 18 years

Exclusion

No Injury Severity Score or 3 \< Injury Severity Score \< 15
Unable to complete the informed consent process, be mailed study devices, and complete laboratory draws within the United States
Not enrolled in the WWRP or enrolled in the WWRP but did not agree to be contacted about future research
  • Frequency of arrhythmias7 days of wear

    Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of arrhythmias.

  • Frequency of atrial fibrillation7 days of wear

    Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial fibrillation.

  • Frequency of atrial flutter7 days of wear

    Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial flutter.

  • Density of premature ventricular contractions (PVCs)7 days of wear

    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).

  • Frequency of ventricular tachycardia7 days of wear

    Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of ventricular tachycardia.

  • Heart rate7 days of wear

    Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine heart rate.

  • Standard deviation of beat-to-beat intervals (SDNN)7 days of wear

    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.

  • Root mean square of successive differences (RMSSD)7 days of wear

    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.

  • Low frequency power7 days of wear

    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.

  • High frequency power7 days of wear

    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.

  • Log-transformed QT variance (logQTv)7 days of wear

    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.

  • Beat-to-beat QT variability index (QTVI)7 days of wear

    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.

  • Presence of obstructive sleep apneaOne night

    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

  • Presence of nocturnal hypoxemiaOne night

    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

  • 24-hour ambulatory blood pressure monitor (ABPM)24 hours

    Blood pressure (diastolic and systolic) will be assessed using a 24-hour ABPM worn during the 24-hour period following the HST.

  • High sensitivity C-reactive protein (hs-CRP)Baseline

    This inflammatory marker will be measured during laboratory testing.

  • Posttraumatic Stress Disorder Checklist for Diagnostic and Statistics Manual of Mental Disorder 5 (PCL-5)Baseline

    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.

  • 8-item Patient Health Questionnaire depression scale (PHQ-8)Baseline

    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.

  • Brief Dissociative Experience Scale (DES-B)Baseline

    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.

  • Pittsburgh Sleep Quality Index (PSQI)Baseline

    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.

  • Epworth Sleepiness Scale (ESS)Baseline

    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.

  • Insomnia Severity Index (ISI)Baseline

    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.

  • Berlin Sleep QuestionnaireBaseline

    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.

  • Body Mass IndexBaseline

    Height and weight will be measured during laboratory visit and combined to report BMI in kg/m\^2.

  • Blood PressureBaseline

    Blood pressure (diastolic and systolic) will be recorded at the time of laboratory visit

  • Hemoglobin A1C (HBA1C)Baseline

    This laboratory test will be used to assess overall health outcomes.

  • Alanine aminotransferase (ALT/SGPT)Baseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Albumin:globulin (A:G) ratioBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Albumin, serumBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Alkaline phosphatase, serumBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Aspartate aminotransferase (AST/SGOT)Baseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Bilirubin, totalBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Blood urea nitrogen (BUN)Baseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Blood urea nitrogen (BUN):creatinine ratioBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Calcium, serumBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Carbon dioxide, totalBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Chloride, serumBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Creatinine, serumBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Estimated glomerular filtration rate (eGFR) calculationBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Globulin, totalBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Glucose, serumBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Potassium, serumBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Protein, total, serumBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Sodium, serumBaseline

    This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.

  • Cystatin C with estimated glomerular filtration rate (eGFR)Baseline

    This laboratory test will be used to assess overall health outcomes.

  • Cholesterol, totalBaseline

    This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.

  • High-density lipoprotein (HDL) cholesterolBaseline

    This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.

  • Low-density lipoprotein (LDL) cholesterol (calculation)Baseline

    This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.

  • TriglyceridesBaseline

    This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.

  • Very low-density lipoprotein (VLDL) cholesterol (calculation)Baseline

    This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.

  • Albumin/creatinine ratio, random urineBaseline

    This laboratory test will be used to assess overall health outcomes.

  • N-terminal pro b-type natriuretic peptide (NT-proBNP)Baseline

    This laboratory test will be used to assess overall health outcomes.