Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and CaRdiovascular Health InvesTigation (SPIRIT)

Uniformed Services University (USU)

Status: Invitation-only

Conditions: Hypertension; Sympathetic Nervous System; Arrythmia; Injury Traumatic; Sleep Disorder; Cardiovascular Diseases

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT05971433

USUHS.2022-110

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Injury severity scored as "severe"

Description:

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"

Description:

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.