Clinical trial Recruiting at 3 sites Interventional Ages 18 to 55

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.

More Traumatic Brain Injury trials

Quick facts

Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment221 (estimated)
SponsorUniversity of Florida
Academic / other
Locations3 sites (Gainesville, Florida and 2 other locations)
StatusRecruiting
StartedNovember 1, 2017
Main results expectedOctober 30, 2025
Study endsOctober 30, 2025
Registry record updatedJuly 1, 2025
Trial IDNCT03170440 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.