Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and caRdiovascular Health InvesTigation
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Soroosh Solhjoo, PhD · PRINCIPAL_INVESTIGATOR · Uniformed Services University of the Health Sciences
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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What this trial measures
- Frequency of arrhythmias7 days of wear
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of arrhythmias.
- Frequency of atrial fibrillation7 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 flutter7 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 tachycardia7 days of wear
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of ventricular tachycardia.
- Heart rate7 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 power7 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 power7 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 apneaOne 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 hypoxemiaOne 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 QuestionnaireBaseline
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 IndexBaseline
Height and weight will be measured during laboratory visit and combined to report BMI in kg/m\^2.
- Blood PressureBaseline
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) ratioBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Albumin, serumBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Alkaline phosphatase, serumBaseline
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, totalBaseline
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 ratioBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Calcium, serumBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Carbon dioxide, totalBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Chloride, serumBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Creatinine, serumBaseline
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) calculationBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Globulin, totalBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Glucose, serumBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Potassium, serumBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Protein, total, serumBaseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
- Sodium, serumBaseline
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, totalBaseline
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) cholesterolBaseline
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.
- TriglyceridesBaseline
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 urineBaseline
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.