Clinical trial NCT05971433: Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and caRdiovascular Health InvesTigation
Official title: Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes (SPIRIT)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hypertension
Cardiovascular Diseases
Sleep Disorder
Arrythmia
Sympathetic Nervous System
Injury Traumatic
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: Naval Health Research Center
First posted: 2023-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Wounded Warrior Recovery Project participants who 1) agreed to be contacted about future research studies and 2) have a record of injury within the established Injury Severity Score cutoffs for this study

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of arrhythmias
timeFrame: 7 days of wear
measure: Frequency of atrial fibrillation
timeFrame: 7 days of wear
measure: Frequency of atrial flutter
timeFrame: 7 days of wear
measure: Density of premature ventricular contractions (PVCs)
timeFrame: 7 days of wear
measure: Frequency of ventricular tachycardia
timeFrame: 7 days of wear
measure: Heart rate
timeFrame: 7 days of wear
measure: Standard deviation of beat-to-beat intervals (SDNN)
timeFrame: 7 days of wear
measure: Root mean square of successive differences (RMSSD)
timeFrame: 7 days of wear
measure: Low frequency power
timeFrame: 7 days of wear
measure: High frequency power
timeFrame: 7 days of wear
measure: Log-transformed QT variance (logQTv)
timeFrame: 7 days of wear
measure: Beat-to-beat QT variability index (QTVI)
timeFrame: 7 days of wear
measure: Presence of obstructive sleep apnea
timeFrame: One night
measure: Presence of nocturnal hypoxemia
timeFrame: One night
measure: 24-hour ambulatory blood pressure monitor (ABPM)
timeFrame: 24 hours
measure: High sensitivity C-reactive protein (hs-CRP)
timeFrame: Baseline
measure: Posttraumatic Stress Disorder Checklist for Diagnostic and Statistics Manual of Mental Disorder 5 (PCL-5)
timeFrame: Baseline
measure: 8-item Patient Health Questionnaire depression scale (PHQ-8)
timeFrame: Baseline
measure: Brief Dissociative Experience Scale (DES-B)
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline
measure: Berlin Sleep Questionnaire
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Blood Pressure
timeFrame: Baseline
measure: Hemoglobin A1C (HBA1C)
timeFrame: Baseline
measure: Alanine aminotransferase (ALT/SGPT)
timeFrame: Baseline
measure: Albumin:globulin (A:G) ratio
timeFrame: Baseline
measure: Albumin, serum
timeFrame: Baseline
measure: Alkaline phosphatase, serum
timeFrame: Baseline
measure: Aspartate aminotransferase (AST/SGOT)
timeFrame: Baseline
measure: Bilirubin, total
timeFrame: Baseline
measure: Blood urea nitrogen (BUN)
timeFrame: Baseline
measure: Blood urea nitrogen (BUN):creatinine ratio
timeFrame: Baseline
measure: Calcium, serum
timeFrame: Baseline
measure: Carbon dioxide, total
timeFrame: Baseline
measure: Chloride, serum
timeFrame: Baseline
measure: Creatinine, serum
timeFrame: Baseline
measure: Estimated glomerular filtration rate (eGFR) calculation
timeFrame: Baseline
measure: Globulin, total
timeFrame: Baseline
measure: Glucose, serum
timeFrame: Baseline
measure: Potassium, serum
timeFrame: Baseline
measure: Protein, total, serum
timeFrame: Baseline
measure: Sodium, serum
timeFrame: Baseline
measure: Cystatin C with estimated glomerular filtration rate (eGFR)
timeFrame: Baseline
measure: Cholesterol, total
timeFrame: Baseline
measure: High-density lipoprotein (HDL) cholesterol
timeFrame: Baseline
measure: Low-density lipoprotein (LDL) cholesterol (calculation)
timeFrame: Baseline
measure: Triglycerides
timeFrame: Baseline
measure: Very low-density lipoprotein (VLDL) cholesterol (calculation)
timeFrame: Baseline
measure: Albumin/creatinine ratio, random urine
timeFrame: Baseline
measure: N-terminal pro b-type natriuretic peptide (NT-proBNP)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Ian Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References: