Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes (SPIRIT)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cholesterol, total
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Cholesterol, total
时间窗: Baseline
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Frequency of atrial flutter
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: Baseline
This inflammatory marker will be measured during laboratory testing.
Frequency of atrial fibrillation
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 7 days of wear
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine heart rate.
High frequency power
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: Baseline
Height and weight will be measured during laboratory visit and combined to report BMI in kg/m\^2.
Alanine aminotransferase (ALT/SGPT)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Blood Pressure
时间窗: Baseline
Blood pressure (diastolic and systolic) will be recorded at the time of laboratory visit
Bilirubin, total
时间窗: 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)
时间窗: Baseline
This laboratory test will be used to assess overall health outcomes.
Calcium, serum
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Low-density lipoprotein (LDL) cholesterol (calculation)
时间窗: Baseline
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Triglycerides
时间窗: 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
时间窗: Baseline
This laboratory test will be used to assess overall health outcomes.
N-terminal pro b-type natriuretic peptide (NT-proBNP)
时间窗: Baseline
This laboratory test will be used to assess overall health outcomes.
Hemoglobin A1C (HBA1C)
时间窗: Baseline
This laboratory test will be used to assess overall health outcomes.
Albumin, serum
时间窗: 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
时间窗: 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.
Protein, total, serum
时间窗: 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
时间窗: 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)
时间窗: Baseline
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
次要结局
未报告次要终点
研究者
Soroosh Solhjoo, PhD
Senior Principal Scientist, Assistant Professor of Medicine
Uniformed Services University of the Health Sciences