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Search / Trial NCT05971433

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

Launched by UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES · Jul 24, 2023

Trial Information

Current as of November 14, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This observational study, called SPIRIT (Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and caRdiovascular Health InvesTigation), is looking at how the severity of combat injuries might relate to long-term heart health, the sympathetic nervous system, blood pressure, sleep disorders, and mental health. It plans to enroll about 200 adults who are part of the Wounded Warrior Recovery Project and who have agreed to be contacted about future research, with injuries meeting the study’s criteria. Participants are adults 18 and older in the United States who can consent, receive study devices by mail, and provide blood and urine samples. People whose injuries don’t meet the Injury Severity Score cutoffs aren’t eligible.

Participants will have a baseline lab visit and complete questionnaires about PTSD, depression, dissociation, sleep quality, daytime sleepiness, and insomnia. They will wear several monitoring devices: a 24-hour ECG heart monitor for seven days, a home sleep study for one night, and a 24-hour blood pressure monitor the day after the sleep test. Blood and urine tests will be done, and basic health measurements will be taken. The study will look at heart rhythm findings (like arrhythmias and heart-rate variability), blood pressure, inflammatory markers, and sleep-related factors to understand how injury might affect these areas. The study is currently enrolling by invitation and is expected to finish around October 2025; results are not yet available for sharing.

Gender

ALL

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

About Uniformed Services University Of The Health Sciences

The Uniformed Services University of the Health Sciences (USU) is a premier academic institution dedicated to advancing the health and well-being of military personnel and their families through innovative research, education, and clinical training. As a key sponsor of clinical trials, USU focuses on addressing unique health challenges faced by service members and veterans, fostering collaboration among military and civilian researchers. By integrating cutting-edge scientific inquiry with practical applications, USU aims to improve healthcare outcomes and enhance the readiness of the armed forces, while contributing to the broader medical community through the dissemination of impactful findings.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Ian Stewart, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported