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Enrolling by invitationNCT05971433SPIRITUpdated May 22, 2026

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

An observational study in Hypertension, Cardiovascular Diseases and Sleep Disorder, sponsored by Uniformed Services University of the Health Sciences. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Uniformed Services University of the Health Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypertension
  • Cardiovascular Diseases
  • Sleep Disorder
  • Arrythmia
  • Sympathetic Nervous System
  • Injury Traumatic
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 200 is close to the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Uniformed Services University of the Health Sciences is the lead sponsor of 45 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Wounded Warrior Recovery Project participants who 1) agreed to be contacted about future research studies and 2) have a record of injury within the established Injury Severity Score cutoffs for this study

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Injury severity scored as "severe"

    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.

  • Injury severity scored as "minimal"

    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.

06

What researchers measure

Primary outcomes

  1. Frequency of arrhythmias

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

    Time frame: 7 days of wear

  2. Frequency of atrial fibrillation

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

    Time frame: 7 days of wear

  3. Frequency of atrial flutter

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

    Time frame: 7 days of wear

  4. Density of premature ventricular contractions (PVCs)

    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).

    Time frame: 7 days of wear

  5. Frequency of ventricular tachycardia

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

    Time frame: 7 days of wear

  6. Heart rate

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

    Time frame: 7 days of wear

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

    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.

    Time frame: 7 days of wear

  8. Root mean square of successive differences (RMSSD)

    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.

    Time frame: 7 days of wear

  9. Low frequency power

    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.

    Time frame: 7 days of wear

  10. High frequency power

    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.

    Time frame: 7 days of wear

  11. Log-transformed QT variance (logQTv)

    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.

    Time frame: 7 days of wear

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

    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.

    Time frame: 7 days of wear

  13. Presence of obstructive sleep apnea

    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

    Time frame: One night

  14. Presence of nocturnal hypoxemia

    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

    Time frame: One night

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

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

    Time frame: 24 hours

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

    This inflammatory marker will be measured during laboratory testing.

    Time frame: Baseline

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

    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.

    Time frame: Baseline

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

    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.

    Time frame: Baseline

  19. Brief Dissociative Experience Scale (DES-B)

    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.

    Time frame: Baseline

  20. Pittsburgh Sleep Quality Index (PSQI)

    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.

    Time frame: Baseline

  21. Epworth Sleepiness Scale (ESS)

    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.

    Time frame: Baseline

  22. Insomnia Severity Index (ISI)

    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.

    Time frame: Baseline

  23. Berlin Sleep Questionnaire

    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.

    Time frame: Baseline

  24. Body Mass Index

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

    Time frame: Baseline

  25. Blood Pressure

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

    Time frame: Baseline

  26. Hemoglobin A1C (HBA1C)

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

    Time frame: Baseline

  27. Alanine aminotransferase (ALT/SGPT)

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

    Time frame: Baseline

  28. Albumin:globulin (A:G) ratio

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

    Time frame: Baseline

  29. Albumin, serum

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

    Time frame: Baseline

  30. Alkaline phosphatase, serum

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

    Time frame: Baseline

  31. Aspartate aminotransferase (AST/SGOT)

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

    Time frame: Baseline

  32. Bilirubin, total

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

    Time frame: Baseline

  33. Blood urea nitrogen (BUN)

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

    Time frame: Baseline

  34. Blood urea nitrogen (BUN):creatinine ratio

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

    Time frame: Baseline

  35. Calcium, serum

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

    Time frame: Baseline

  36. Carbon dioxide, total

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

    Time frame: Baseline

  37. Chloride, serum

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

    Time frame: Baseline

  38. Creatinine, serum

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

    Time frame: Baseline

  39. Estimated glomerular filtration rate (eGFR) calculation

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

    Time frame: Baseline

  40. Globulin, total

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

    Time frame: Baseline

  41. Glucose, serum

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

    Time frame: Baseline

  42. Potassium, serum

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

    Time frame: Baseline

  43. Protein, total, serum

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

    Time frame: Baseline

  44. Sodium, serum

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

    Time frame: Baseline

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

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

    Time frame: Baseline

  46. Cholesterol, total

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

    Time frame: Baseline

  47. High-density lipoprotein (HDL) cholesterol

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

    Time frame: Baseline

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

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

    Time frame: Baseline

  49. Triglycerides

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

    Time frame: Baseline

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

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

    Time frame: Baseline

  51. Albumin/creatinine ratio, random urine

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

    Time frame: Baseline

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

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

    Time frame: Baseline

07

Study locations

1 site
  • Uniformed Services University of the Health Sciences
    Bethesda, Maryland 20814, United States
08

References and documents

Publications

  • Walker LE, Jurick SM, Thomas V, Arnold T, Elisman K, Kalra S, Mains A, Rioux S, Galarneau M, McCabe C, Lavender JM, Collen J, Haigney MC, Solhjoo S, Stewart IJ. A study protocol for determining the role of Sympathetic activity in Post-injury outcomes: Impact on sleep and caRdiovascular health InvesTigation (SPIRIT). PLoS One. 2025 Jul 17;20(7):e0321035. doi: 10.1371/journal.pone.0321035. eCollection 2025. PubMed 40674309 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05971433
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborators
Naval Health Research Center
Responsible party
Soroosh Solhjoo, PhD (Senior Principal Scientist, Assistant Professor of Medicine, Uniformed Services University of the Health Sciences) — Principal investigator
First posted
Aug 2, 2023
Start date
Apr 1, 2024
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
May 22, 2026

Study contacts

Soroosh Solhjoo, PhD
principal investigator · Uniformed Services University of the Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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