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Enrolling by Invitation

NCT Number: NCT05971433

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

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.

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Key information

Conditions

Hypertension Arrhythmias, Cardiac Arrythmia Cardiovascular Diseases Heart Diseases Injury Traumatic Mental Disorders Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders Sympathetic Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Frequency of arrhythmias

    Time frame: 7 days of wear

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

  2. Frequency of atrial fibrillation

    Time frame: 7 days of wear

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

  3. Frequency of atrial flutter

    Time frame: 7 days of wear

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

  4. Density of premature ventricular contractions (PVCs)

    Time frame: 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).

  5. Frequency of ventricular tachycardia

    Time frame: 7 days of wear

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

  6. Heart rate

    Time frame: 7 days of wear

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

  7. Standard deviation of beat-to-beat intervals (SDNN)

    Time frame: 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.

  8. Root mean square of successive differences (RMSSD)

    Time frame: 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.

  9. Low frequency power

    Time frame: 7 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.

  10. High frequency power

    Time frame: 7 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.

  11. Log-transformed QT variance (logQTv)

    Time frame: 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.

  12. Beat-to-beat QT variability index (QTVI)

    Time frame: 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.

  13. Presence of obstructive sleep apnea

    Time frame: One 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

  14. Presence of nocturnal hypoxemia

    Time frame: One 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

  15. 24-hour ambulatory blood pressure monitor (ABPM)

    Time frame: 24 hours

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

  16. High sensitivity C-reactive protein (hs-CRP)

    Time frame: Baseline

    This inflammatory marker will be measured during laboratory testing.

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

    Time frame: 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.

  18. 8-item Patient Health Questionnaire depression scale (PHQ-8)

    Time frame: 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.

  19. Brief Dissociative Experience Scale (DES-B)

    Time frame: 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.

  20. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  21. Epworth Sleepiness Scale (ESS)

    Time frame: 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.

  22. Insomnia Severity Index (ISI)

    Time frame: 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.

  23. Berlin Sleep Questionnaire

    Time frame: Baseline

    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.

  24. Body Mass Index

    Time frame: Baseline

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

  25. Blood Pressure

    Time frame: Baseline

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

  26. Hemoglobin A1C (HBA1C)

    Time frame: Baseline

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

  27. Alanine aminotransferase (ALT/SGPT)

    Time frame: Baseline

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

  28. Albumin:globulin (A:G) ratio

    Time frame: Baseline

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

  29. Albumin, serum

    Time frame: Baseline

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

  30. Alkaline phosphatase, serum

    Time frame: Baseline

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

  31. Aspartate aminotransferase (AST/SGOT)

    Time frame: Baseline

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

  32. Bilirubin, total

    Time frame: Baseline

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

  33. Blood urea nitrogen (BUN)

    Time frame: Baseline

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

  34. Blood urea nitrogen (BUN):creatinine ratio

    Time frame: Baseline

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

  35. Calcium, serum

    Time frame: Baseline

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

  36. Carbon dioxide, total

    Time frame: Baseline

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

  37. Chloride, serum

    Time frame: Baseline

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

  38. Creatinine, serum

    Time frame: Baseline

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

  39. Estimated glomerular filtration rate (eGFR) calculation

    Time frame: Baseline

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

  40. Globulin, total

    Time frame: Baseline

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

  41. Glucose, serum

    Time frame: Baseline

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

  42. Potassium, serum

    Time frame: Baseline

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

  43. Protein, total, serum

    Time frame: Baseline

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

  44. Sodium, serum

    Time frame: Baseline

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

  45. Cystatin C with estimated glomerular filtration rate (eGFR)

    Time frame: Baseline

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

  46. Cholesterol, total

    Time frame: Baseline

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

  47. High-density lipoprotein (HDL) cholesterol

    Time frame: Baseline

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

  48. Low-density lipoprotein (LDL) cholesterol (calculation)

    Time frame: Baseline

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

  49. Triglycerides

    Time frame: Baseline

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

  50. Very low-density lipoprotein (VLDL) cholesterol (calculation)

    Time frame: Baseline

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

  51. Albumin/creatinine ratio, random urine

    Time frame: Baseline

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

  52. N-terminal pro b-type natriuretic peptide (NT-proBNP)

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Uniformed Services University of the Health Sciences

Fed

Collaborators

  • Naval Health Research Center

Registry information

Official study title

Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes (SPIRIT)

Acronym: SPIRIT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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