Non-invasive nerve stimulation to improve sleep in PTSD patients
Transcutaneous Vagal Nerve Stimulation Improvement of Sleep Quality in Veterans With PTSD With or Without History of Mild TBI
This study is testing whether a non-invasive nerve stimulation can help veterans with PTSD sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT04021537 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of non-invasive nerve stimulation on sleep quality in individuals with Post Traumatic Stress Disorder (PTSD). It aims to identify optimal stimulation parameters through a cross-over design, where participants will undergo polysomnography to measure sleep architecture variables. The study will involve twenty veterans with PTSD, assessing their sleep over multiple nights to determine the impact of nerve stimulation on their sleep patterns. The goal is to find a more effective treatment for sleep difficulties associated with PTSD.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans diagnosed with PTSD, with or without a history of mild traumatic brain injury (mTBI).
Not a fit: Patients with neurological conditions other than mTBI, untreated sleep apnea, or significant psychiatric disorders unrelated to trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, effective treatment option for improving sleep in patients with PTSD.
How similar studies have performed: While the specific approach of non-invasive nerve stimulation for sleep in PTSD is novel, similar studies exploring nerve stimulation techniques have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD * English fluency Exclusion Criteria: * Neurological injuries or conditions aside from mTBI that may affect outcome variables and/or other variables in the study * Psychiatric issues that are unlikely to be related to trauma that may affect outcomes and/or other variables in the * e.g., schizophrenia * Untreated sleep apnea * CPAP controlled sleep apnea is okay * Major uncorrected sensory deficit * Current drug or alcohol abuse * Drug abuse within the last two months will result in exclusion or delay * Marijuana use or alcohol intoxication within 2 weeks of study will be acceptable * No pregnancy
Where this trial is running
Gainesville, Florida
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: John B. Williamson, PhD — North Florida/South Georgia Veterans Health System, Gainesville, FL
- Study coordinator: John B Williamson, PhD
- Email: john.williamson2@va.gov
- Phone: (352) 376-1611
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.