Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and caRdiovascular Health InvesTigation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypertension, Cardiovascular Diseases, Sleep Disorder, Arrythmia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes (SPIRIT)
Overview
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.
Primary outcome measures
- Frequency of arrhythmias [Time frame: 7 days of wear]
- Frequency of atrial fibrillation [Time frame: 7 days of wear]
- Frequency of atrial flutter [Time frame: 7 days of wear]
- Density of premature ventricular contractions (PVCs) [Time frame: 7 days of wear]
- Frequency of ventricular tachycardia [Time frame: 7 days of wear]
- Heart rate [Time frame: 7 days of wear]
- Standard deviation of beat-to-beat intervals (SDNN) [Time frame: 7 days of wear]
- Root mean square of successive differences (RMSSD) [Time frame: 7 days of wear]
- Low frequency power [Time frame: 7 days of wear]
- High frequency power [Time frame: 7 days of wear]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Uniformed Services University of the Health Sciences — Bethesda
Publications
- Walker LE, Jurick SM, Thomas V, Arnold T, Elisman K, Kalra S, Mains A, Rioux S, Galarneau M, McCabe C, Lavender JM, Collen J, Haigney MC, Solhjoo S, Stewart IJ. A study protocol for determining the role of Sympathetic activity in Post-injury outcomes: Impact on sleep and caRdiovascular health InvesTigation (SPIRIT). PLoS One. 2025 Jul 17;20(7):e0321035. doi: 10.1371/journal.pone.0321035. eCollecti PMID 40674309
Identifiers
NCT: NCT05971433 · USUHS.2022-110