Study on Sympathetic Overactivity in PTSD

This study is investigating whether two different device-based therapies can help veterans with Post-traumatic Stress Disorder (PTSD) and prehypertension (blood pressure that is higher than normal but not yet high blood pressure). The therapies being tested are Device-Guided Breathing (DGB) using the RESPeRATE device, and Transcutaneous Vagal Nerve Stimulation (tVNS), which uses mild electrical stimulation on the neck. Researchers want to see if 8 weeks of daily use of these devices can improve the overactivity of the sympathetic nervous system (the part of your body that controls your 'fight or flight' response) both at rest and during stress. You may be able to join if you are a veteran between 18 and 65 years old with or without PTSD, and have prehypertension or normal blood pressure. The study will measure changes in your nerve activity and how your body responds to blood pressure changes to see if these treatments are successful. The current status of this study is unclear.

Study design
This interventional study plans to enroll 120 participants. It compares Device-Guided Breathing and Transcutaneous Vagal Nerve Stimulation to sham (inactive) versions of these devices.
What's involved
Participants will use a device for 15 minutes daily (DGB) or twice daily (tVNS) for 8 weeks. Measurements of nerve activity and blood pressure response will be taken at the beginning and end of the 8-week period.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for changes in nerve activity and baroreflex sensitivity at Week 8.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01627301

Sympathetic Overactivity in Post-traumatic Stress Disorder

Recruiting
NAAges 18–65InterventionalTreatment
Emory University
~120 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:Device-Guided Breathing (DGB)Sham DGBTranscutaneous Vagal Nerve Stimulation (tVNS)Sham tVNS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency at Rest
Measured over Baseline, Week 8
+3 more outcomes measured
Post-traumatic Stress Disorder
Prehypertension
1 sites across 1 states
Georgia1
  • Jeanie Park, MD · PRINCIPAL_INVESTIGATOR · Emory University and the Atlanta VA Medical Center

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

prehypertensive and normotensive veterans with PTSD, and prehypertensive and normotensive veterans without PTSD (controls)

Exclusion

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
  • Change in Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency at RestBaseline, Week 8

    MSNA is assessed with microneurography where a tungsten microelectrode inserted in the nerve records sympathetic nerve activity.

  • Change in Baroreflex Sensitivity (BRS) at RestBaseline, Week 8

    Arterial baroreflex sensitivity (BRS) will be tested using pharmacologic manipulation of blood pressure at rest. BRS is assessed by measuring changes in MSNA and heart rate during arterial blood pressure changes induced by nitroprusside and phenylephrine.

  • Change in MSNA Burst Frequency While Under Mental StressBaseline, Week 8

    Mental stress will be induced by having participants complete mental arithmetic and with a combat virtual reality clip.

  • Change in BRS While Under Mental StressBaseline, Week 8

    Mental stress will be induced by having participants complete mental arithmetic and with a combat virtual reality clip. Arterial baroreflex sensitivity (BRS) will be tested using pharmacologic manipulation of blood pressure at rest and during mental stress.