Non-invasive nerve stimulation to improve sleep in PTSD and TBI patients
Non-invasive Vagal Nerve Stimulation and Sleep
This study is testing two types of nerve stimulation to see if they can help veterans with PTSD and mild brain injuries sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 221 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 3 sites (Gainesville, Florida and 2 other locations) |
| Trial ID | NCT03170440 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of two different types of transcutaneous nerve stimulation on sleep architecture in individuals suffering from Post Traumatic Stress Disorder (PTSD) and mild Traumatic Brain Injury (TBI). Participants will undergo nerve stimulation treatments to assess improvements in sleep quality and overall well-being. The study focuses on veterans who experience sleep deprivation as a result of their conditions. By exploring non-invasive treatment options, the research seeks to provide alternative solutions for better sleep management.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans with a history of PTSD, with or without mild TBI.
Not a fit: Patients with severe psychiatric illnesses unrelated to PTSD or TBI, or those with significant medical conditions affecting cognition, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality for patients suffering from PTSD and mild TBI.
How similar studies have performed: While nerve stimulation has been explored in various contexts, this specific approach for PTSD and TBI is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * veterans with history of PTSD with and without history of mild TBI Exclusion Criteria with: * history of severe psychiatric illness unrelated to PTSD or TBI * other medical conditions of severity that may impair cognition * current illicit or prescription drug abuse * breathing disorder requiring constant use of oxygen
Where this trial is running
Gainesville, Florida and 2 other locations
- UF Health Jacksonville — Gainesville, Florida, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- UF Health Jacksonville — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: John Williamson, Ph.D. — University of Florida
- Study coordinator: John Williamson, PhD
- Email: john.williamson2@va.gov
- Phone: 35523761611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.