Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and caRdiovascular Health InvesTigation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension Cardiovascular Diseases Sleep Disorder Arrythmia Sympathetic Nervous System Injury Traumatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Injury severity scored as "severe"

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.

No interventions assigned to this group

Injury severity scored as "minimal"

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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No