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Behavioural Intervention

DGB + tVNS for Post-Traumatic Stress Disorder (SO-PTSD Trial)

N/A

Recruiting

Led By Jeanie Park, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8

Awards & highlights

SO-PTSD Trial Summary

This trial will test whether two treatments, DGB therapy and transcutaneous vagus nerve stimulation (tVNS) therapy, can help improve symptoms of post-traumatic stress disorder (PTSD).

Who is the study for?

This trial is for prehypertensive and normotensive veterans with or without PTSD, aiming to study the effects of certain therapies on their nervous system. Pregnant individuals, those with serious systemic diseases, heart or vascular disease, autonomic dysfunction, excessive alcohol use, illicit drug users, and people on specific SNS-affecting medications or recent MAO inhibitors cannot participate.Check my eligibility

What is being tested?

The study tests if 8 weeks of daily Device-Guided Breathing (DGB) therapy or Transcutaneous Vagal Nerve Stimulation (tVNS) can improve sympathetic nervous system activity in veterans with PTSD. It includes control interventions like Sham tVNS and Sham DGB to compare results against.See study design

What are the potential side effects?

Potential side effects from DGB are minimal but may include discomfort due to breathing patterns. tVNS might cause local irritation at the stimulation site or slight headaches. However, these therapies are generally considered low-risk.

SO-PTSD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in BRS While Under Mental Stress

Change in Baroreflex Sensitivity (BRS) at Rest

Change in MSNA Burst Frequency While Under Mental Stress

+1 more

Secondary outcome measures

Endothelial Function

Vascular Stiffness

SO-PTSD Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Transcutaneous Vagal Nerve Stimulation (tVNS)Experimental Treatment1 Intervention

Participants randomized to use a tVNS device to deliver mild electrical stimulation to the vagal nerve.

Group II: Device-guided Breathing (DGB)Experimental Treatment1 Intervention

Participants randomized to the DGB group use a device to guide their breathing to a slow breathing rate.

Group III: Sham DGBPlacebo Group1 Intervention

Participants randomized to the sham DGB group use a device identical to the DGB device but respiratory rates are not guided lower than the physiological rate.

Group IV: Sham tVNSPlacebo Group1 Intervention

Participants randomized to use the sham tVNS device which vibrates but does not stimulate the vagal nerve.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous Vagal Nerve Stimulation (tVNS)

2019

N/A

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

US Department of Veterans AffairsFED

869 Previous Clinical Trials

495,843 Total Patients Enrolled

24 Trials studying Hypertension

50,436 Patients Enrolled for Hypertension

Emory UniversityLead Sponsor

1,642 Previous Clinical Trials

2,563,802 Total Patients Enrolled

31 Trials studying Hypertension

13,724 Patients Enrolled for Hypertension

Jeanie Park, MDPrincipal Investigator - Emory University and the Atlanta VA Medical Center

Emory University Hospital, Emory University Hospital Midtown, Select Specialty Hospital-Atlanta

University Of Alabama School Of Medicine (Medical School)

4 Previous Clinical Trials

474 Total Patients Enrolled

Media Library

Device-Guided Breathing (DGB) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT01627301 — N/A

Hypertension Research Study Groups: Sham DGB, Device-guided Breathing (DGB), Transcutaneous Vagal Nerve Stimulation (tVNS), Sham tVNS

Hypertension Clinical Trial 2023: Device-Guided Breathing (DGB) Highlights & Side Effects. Trial Name: NCT01627301 — N/A

Device-Guided Breathing (DGB) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01627301 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being enlisted for this research initiative?

"Affirmative. Clinicaltrials.gov attests that this medical research was posted on July 1st 2012 and is still ongoing, with the last update being dated July 26th 2022. The study necessitates 100 individuals to be recruited from one place of clinical care."

Answered by AI

Is the age restriction for this clinical trial higher than 45 years old?

"The inclusionary requirements of this trial indicate that participants should be aged 18-65. Additionally, there are 36 distinct trials for minors and 283 studies open to patients over 65 years old."

Answered by AI

What criteria must a person fulfil in order to be considered for this medical experimentation?

"This clinical trial is actively looking for 100 individuals who have prehypertension and are between 18-65 years of age."

Answered by AI

Does this research project currently have open enrollment?

"Indeed, the information on clinicaltrials.gov confirm that this study is actively enrolling participants. It was first posted July 1st 2012 and has since been updated on July 26th 2022. At present, 100 subjects are required at a single site of recruitment."

Answered by AI

Recent research and studies

American Journal of Physiology-Regulatory, Integrative and Comparative PhysiologyJournal

Eight Weeks of Device-guided Slow Breathing Decreases Sympathetic Nervous Reactivity to Stress in Posttraumatic Stress Disorder

Fonkoue, Ida T., Yingtian Hu, Toure Jones, Monica Vemulapalli, Justin D. Sprick, Barbara Rothbaum, and Jeanie Park. 2020. “Eight Weeks of Device-guided Slow Breathing Decreases Sympathetic Nervous Reactivity to Stress in Posttraumatic Stress Disorder”. American Journal of Physiology-regulatory, Integrative and Comparative Physiology. American Physiological Society. doi:10.1152/ajpregu.00079.2020.

American Journal of Physiology-Regulatory, Integrative and Comparative PhysiologyJournal

Eight Weeks of Device-guided Slow Breathing Decreases Sympathetic Nervous Reactivity to Stress in Posttraumatic Stress Disorder

clinicaltrials.govStudy

Sympathetic Overactivity in Post-traumatic Stress Disorder

Jeanie Park 2012. "Sympathetic Overactivity in Post-traumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01627301.

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