RecruitingNot ApplicableNCT01627301

Sympathetic Overactivity in Post-traumatic Stress Disorder

Mechanisms of Sympathetic Overactivity in Post-traumatic Stress Disorder

Sponsor

Emory University

Enrollment

120 participants

Start Date

Jul 1, 2012

Study Type

INTERVENTIONAL

Summary

Post-traumatic stress disorder (PTSD) is a highly prevalent anxiety disorder that is associated with an increased risk of cardiovascular (CV) disease and hypertension. One potential mechanism is overactivation of the sympathetic nervous system (SNS), both at rest and particularly during stress. This study will evaluate whether 8 weeks of daily DGB therapy or transcutaneous vagus nerve stimulation (tVNS) therapy improves SNS activity at rest and during stress.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether veterans with post-traumatic stress disorder (PTSD) have an overactive nervous system — specifically, whether their bodies release more adrenaline-like signals than normal — and whether this could explain the higher rates of high blood pressure seen in people with PTSD. **You may be eligible if...** - You are a veteran with PTSD and have normal or borderline-high blood pressure - You are a veteran without PTSD and have normal or borderline-high blood pressure (as a comparison participant) **You may NOT be eligible if...** - You have heart or blood vessel disease - You have used illicit drugs in the past 6 months - You drink more than 2 alcoholic drinks per day - You are pregnant - You have an autonomic nervous system disorder (a condition affecting automatic body functions) - You take medications that affect the nervous system such as clonidine - You have been on MAO inhibitor medications in the past 14 days - You have any serious systemic illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDevice-Guided Breathing (DGB)

The RESPeRATE device will be used for 15 minutes of device-guided breathing daily for 8 weeks. The participant places the elastic belt with a respiration sensor around the upper abdomen, and wears earbuds for audio feedback. The device monitors the breathing rate, calculates inspiration and expiration times, and generates a personalized melody of two distinct ascending and descending tones for inhalation versus exhalation. Users effortlessly entrain their breathing pattern with the tones, and the device gradually guides the user to a prolonged expiration time and slower respiratory rate (to \< 10 breaths/minute). The device automatically stores usage data, allowing for quantification of adherence and performance.

DEVICESham DGB

The sham device is identical to the DGB device, except it does not guide respiratory rates to slow down and instead maintains a rate of 14 breaths per minute. The sham device is used for 15 minutes per day for 8 weeks.

DEVICETranscutaneous Vagal Nerve Stimulation (tVNS)

tVNS is a noninvasive method that involves placing a device over the skin overlying the vagus nerve on the neck. The device delivers mild electrical stimulation, using transcutaneous electrical nerve stimulation (TENS) unit. The stimulation is increased until there is a vibration and slight muscle contraction in the lower face or neck. Then the stimulation is delivered for 2 minutes on the left side of the neck, and on the right side of the neck, for a total of 4 minutes. The tVNS device is used twice daily for 8 weeks.

DEVICESham tVNS

Sham stimulation is delivered using a device that is identical to the gammaCore device but is programed to deliver a lower frequency that can be felt by the participant but does not actually stimulate the vagus nerve. The sham device is used twice daily for 8 weeks.

Locations(1)

Atlanta VA Medical Center

Decatur, Georgia, United States

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NCT01627301