Sympathetic Overactivity in Post-traumatic Stress Disorder

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.

Conditions

• Post-traumatic Stress Disorder
• Prehypertension

Interventions

DEVICE

Device-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.

DEVICE

Sham 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.

DEVICE

Transcutaneous 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.

DEVICE

Sham 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.

Sponsors & Collaborators

• US Department of Veterans Affairs

  collaborator FED

• Emory University

  lead OTHER

Principal Investigators

• Jeanie Park, MD · Emory University and the Atlanta VA Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations