Evaluating therapies for sympathetic overactivity in PTSD
Mechanisms of Sympathetic Overactivity in Post-traumatic Stress Disorder
This study is testing if breathing exercises and a nerve stimulation device can help people with PTSD reduce their stress response and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Decatur, Georgia) |
| Trial ID | NCT01627301 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of device-guided breathing (DGB) therapy and transcutaneous vagus nerve stimulation (tVNS) on sympathetic nervous system (SNS) activity in individuals with post-traumatic stress disorder (PTSD). Over an 8-week period, participants will engage in daily sessions to assess improvements in SNS activity both at rest and during stress. The research aims to understand the mechanistic role of sympathetic overactivation in PTSD and its link to cardiovascular disease and hypertension. By utilizing innovative therapies, the study seeks to provide insights into effective treatments for PTSD-related cardiovascular risks.
Who should consider this trial
Good fit: Ideal candidates include prehypertensive and normotensive veterans diagnosed with PTSD, as well as controls without PTSD.
Not a fit: Patients with existing heart or vascular disease, autonomic dysfunction, or those on medications affecting SNS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of PTSD symptoms and reduced cardiovascular risks for affected patients.
How similar studies have performed: Other studies have shown promise in using similar therapeutic approaches for managing PTSD and its associated symptoms, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * prehypertensive and normotensive veterans with PTSD, and prehypertensive and normotensive veterans without PTSD (controls) Exclusion Criteria: * heart or vascular disease * illicit drug use within the last 6 months * excessive alcohol use (\>2 drinks per day) * pregnancy * autonomic dysfunction * medications known to affect SNS (clonidine) * treatment with monoamine oxidase (MAO) inhibitors within the last 14 days * any serious systemic disease
Where this trial is running
Decatur, Georgia
- Atlanta VA Medical Center — Decatur, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Jeanie Park, MD — Emory University and the Atlanta VA Medical Center
- Study coordinator: Deirdre Dixon, MS
- Email: deirdre.dixon@emory.edu
- Phone: 404-321-6111
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.