Sympathetic Overactivity in Post-traumatic Stress Disorder (SO-PTSD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Jeanie Park, Emory University
ClinicalTrials.gov Identifier:
NCT01627301
First received: June 21, 2012
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

Patients with post-traumatic stress disorder (PTSD)and prehypertension (borderline high blood pressure) are at higher risk for developing high blood pressure and heart disease. The purpose of this study is to test whether PTSD patients have exaggerated increases in blood pressure, heart rate, and adrenaline levels during different forms of stress, that might predispose them to developing high blood pressure and heart disease. This study will also evaluate whether regular sessions of slow breathing that is guided by a device (RESPeRATE) improves blood pressure, heart rate, and adrenaline levels during stress in patients with PTSD and prehypertension.


Condition Intervention Phase
Post-traumatic Stress Disorder
Prehypertension
Device: Device-Guided Breathing using the RESPeRATE device
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanisms of Sympathetic Overactivity in Post-traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Sympathetic activity [ Time Frame: 0 weeks and 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: 0 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • Ambulatory Blood Pressure [ Time Frame: 0 weeks and 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device-Guided Breathing at low breathing rate
Device-guided breathing at low breathing rate daily for 15 minutes up to 8 weeks
Device: Device-Guided Breathing using the RESPeRATE device
15 minutes of device-guided breathing daily for 8 weeks
Active Comparator: Device guided breathing at normal rate
Device-guided breathing at a normal breathing rate daily for 15 minutes for up to 8 weeks
Device: Device-Guided Breathing using the RESPeRATE device
15 minutes of device-guided breathing daily for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prehypertensive Operation Enduring Freedom (OEF)/ Operation Iraqi Freedom (OIF)/ Operation New Dawn (OND) veterans with PTSD
  • Prehypertensive OEF/OIF/OND veterans without PTSD (controls)

Exclusion Criteria:

  • hypertension
  • diabetes
  • current smoker
  • heart or vascular disease
  • illicit drug use
  • excessive alcohol use (>2 drinks per day)
  • hyperlipidemia
  • autonomic dysfunction
  • treatment with medications known to affect the sympathetic nervous system (clonidine, beta blockers, ACE inhibitors)
  • treatment with MAO inhibitors within the last 14 days
  • any serious systemic disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627301

Contacts
Contact: Melanie Jefferson, MS 404-321-6111 ext 7040 melanie.l.jefferson@emory.edu

Locations
United States, Georgia
Atlanta VA Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Jeanie Park, MD       jeanie.park@emory.edu   
Principal Investigator: Jeanie Park, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Jeanie Park, MD Emory University and the Atlanta VA Medical Center
  More Information

No publications provided

Responsible Party: Jeanie Park, Assistant Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01627301     History of Changes
Other Study ID Numbers: IRB00054697
Study First Received: June 21, 2012
Last Updated: May 14, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Prehypertension
Anxiety Disorders
Mental Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014