Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes

Hypertension Clinical Trial

— SPIRIT  

Official title:

Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes (SPIRIT)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05971433
• Other study ID #: USUHS.2022-110
• Status: Enrolling by invitation
• Start date: April 1, 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Uniformed Services University of the Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Arrythmia
• Cardiovascular Diseases
• Hypertension
• Injury Traumatic
• Sleep Disorder
• Sleep Wake Disorders
• Sympathetic Nervous System
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Uniformed Services University of the Health Sciences	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Uniformed Services University of the Health Sciences	Naval Health Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of arrhythmias	Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of arrhythmias.	7 days of wear
Primary	Frequency of atrial fibrillation	Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial fibrillation.	7 days of wear
Primary	Frequency of atrial flutter	Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial flutter.	7 days of wear
Primary	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).	7 days of wear
Primary	Frequency of ventricular tachycardia	Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of ventricular tachycardia.	7 days of wear
Primary	Heart rate	Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine heart rate.	7 days of wear
Primary	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.	7 days of wear
Primary	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.	7 days of wear
Primary	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.	7 days of wear
Primary	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.	7 days of wear
Primary	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.	7 days of wear
Primary	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.	7 days of wear
Primary	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	One night
Primary	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	One night
Primary	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.	24 hours
Primary	High sensitivity C-reactive protein (hs-CRP)	This inflammatory marker will be measured during laboratory testing.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	Body Mass Index	Height and weight will be measured during laboratory visit and combined to report BMI in kg/m^2.	Baseline
Primary	Blood Pressure	Blood pressure (diastolic and systolic) will be recorded at the time of laboratory visit	Baseline
Primary	Hemoglobin A1C (HBA1C)	This laboratory test will be used to assess overall health outcomes.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	Albumin, serum	This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	Bilirubin, total	This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	Calcium, serum	This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.	Baseline
Primary	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.	Baseline
Primary	Chloride, serum	This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.	Baseline
Primary	Creatinine, serum	This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.	Baseline
Primary	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.	Baseline
Primary	Globulin, total	This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.	Baseline
Primary	Glucose, serum	This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.	Baseline
Primary	Potassium, serum	This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.	Baseline
Primary	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.	Baseline
Primary	Sodium, serum	This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.	Baseline
Primary	Cystatin C with estimated glomerular filtration rate (eGFR)	This laboratory test will be used to assess overall health outcomes.	Baseline
Primary	Cholesterol, total	This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	Triglycerides	This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.	Baseline
Primary	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.	Baseline
Primary	Albumin/creatinine ratio, random urine	This laboratory test will be used to assess overall health outcomes.	Baseline
Primary	N-terminal pro b-type natriuretic peptide (NT-proBNP)	This laboratory test will be used to assess overall health outcomes.	Baseline