Non-invasive nerve stimulation to improve sleep in PTSD and TBI patients
Official title: Non-invasive Vagal Nerve Stimulation and Sleep
Run by University of Florida · NCT03170440 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 221 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 3 sites (Gainesville, Florida and 2 other locations) |
| Status | Recruiting |
| Started | November 1, 2017 |
| Main results expected | October 30, 2025 |
| Study ends | October 30, 2025 |
| Registry record updated | July 1, 2025 |
| Trial ID | NCT03170440 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are veterans with a history of PTSD, with or without mild TBI.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests whether benefits from HBOT persist over time for veterans with brain injury or related conditions.
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Non‑trauma PTSD treatment for veterans and service members with mild or moderate TBI
This pilot will test a non‑trauma psychotherapy program to help veterans and service members with mild or moderate traumatic brain injury who have PTSD.
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Rapid treatment for PTSD using brain stimulation
This study is testing a quick brain stimulation treatment for people with PTSD to see if it can help reduce their symptoms in just one week.
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Improving sleep for Veterans with traumatic brain injury, PTSD, and chronic pain
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Enhancing memory through amygdala stimulation
This study is testing if stimulating a part of the brain called the amygdala can help improve memory in people with epilepsy who are being monitored for seizures.
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Using cannabidiol to treat PTSD and traumatic brain injury symptoms
This study is testing if taking cannabidiol (CBD) can help people with PTSD, some of whom also have mild brain injuries, feel better compared to a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.