SPIRIT: Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes
Study Details
Study Description
Brief 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:
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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?
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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:
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Provide demographic information and a medical history review
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Visit a local laboratory for biometrics measurements and to provide blood and urine samples
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Wear an ambulatory electrocardiogram monitor for 24 hours per day for seven consecutive days
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Wear a home sleep test monitoring device for one night
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Frequency of arrhythmias [7 days of wear]
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of arrhythmias.
- Frequency of atrial fibrillation [7 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 flutter [7 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 tachycardia [7 days of wear]
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of ventricular tachycardia.
- Heart rate [7 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 power [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.
- High frequency power [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.
- 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 apnea [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
- Presence of nocturnal hypoxemia [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
- 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 Questionnaire [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.
- Body Mass Index [Baseline]
Height and weight will be measured during laboratory visit and combined to report BMI in kg/m^2.
- Blood Pressure [Baseline]
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) ratio [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Albumin, serum [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Alkaline phosphatase, serum [Baseline]
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, total [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) [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 ratio [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Calcium, serum [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Carbon dioxide, total [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Chloride, serum [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Creatinine, serum [Baseline]
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) calculation [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Globulin, total [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Glucose, serum [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Potassium, serum [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Protein, total, serum [Baseline]
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Sodium, serum [Baseline]
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, total [Baseline]
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) cholesterol [Baseline]
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.
- Triglycerides [Baseline]
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 urine [Baseline]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Enrolled in the Wounded Warrior Recovery Project (WWRP) and previously agreed to be contacted regarding future research
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Able to complete the informed consent process, be mailed study devices, and complete laboratory draws within the United States
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Age greater than or equal to 18 years
Exclusion Criteria:
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No Injury Severity Score or 3 < Injury Severity Score < 15
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Unable to complete the informed consent process, be mailed study devices, and complete laboratory draws within the United States
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Not enrolled in the WWRP or enrolled in the WWRP but did not agree to be contacted about future research
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Uniformed Services University of the Health Sciences
- Naval Health Research Center
Investigators
- Principal Investigator: Ian Stewart, MD, Uniformed Services University of the Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- USUHS.2022-110