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

Study acronym: SPIRIT
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoints: details revised at 3 of 52 entries
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Eligibility criteria expanded, about 6 words
    • Publications: details revised at 1 of 1 entry
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Notable Primary and study completion dates: Oct 2025 to Oct 2026v5
  4. Minor Primary and study completion dates: Apr 2025 to Oct 2025
    • Study title shortened, about 5 words
    v4
  5. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    • Primary and study completion dates: Feb 2025 to Apr 2025
    • Start date changed from estimate of Jan 15, 2024 to Apr 1, 2024
    v3
  6. Notable Start date: Aug 1, 2023 to Jan 15, 2024
    • Primary completion date: Aug 2024 to Feb 2025
    • Study completion date: Dec 2024 to Feb 2025
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05971433
Lead Sponsor Uniformed Services University of the Health Sciences
Collaborators: Naval Health Research Center
Conditions
(from sponsor)
Hypertension, Cardiovascular Diseases, Sleep Disorder, Arrythmia, Sympathetic Nervous System, Injury Traumatic
Related terms Arrhythmias, Cardiac, Cardiovascular Diseases, Hypertension, Sleep Wake Disorders, Wounds and Injuries
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov