Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and CaRdiovascular Health InvesTigation
- Conditions
- HypertensionCardiovascular DiseasesArrythmiaInjury TraumaticSleep DisorderSympathetic Nervous System
- Registration Number
- NCT05971433
- 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:
* 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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 arrhythmias 7 days of wear Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of arrhythmias.
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.
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.
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
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.
Heart rate 7 days of wear Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine heart rate.
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.
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.
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.
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.
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
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.
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.
Body Mass Index Baseline Height and weight will be measured during laboratory visit and combined to report BMI in kg/m\^2.
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.
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.
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.
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.
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.
Blood Pressure Baseline Blood pressure (diastolic and systolic) will be recorded at the time of laboratory visit
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.
Hemoglobin A1C (HBA1C) Baseline This laboratory test 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.
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.
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.
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.
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.
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.
Cholesterol, total 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.
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.
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.
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.
Cystatin C with estimated glomerular filtration rate (eGFR) Baseline This laboratory test 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Uniformed Services University of the Health Sciences
🇺🇸Bethesda, Maryland, United States