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

This study is currently recruiting participants.
Verified December 2016 by Jeanie Park, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627301
First Posted: June 25, 2012
Last Update Posted: December 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeanie Park, Emory University
June 21, 2012
June 25, 2012
December 22, 2016
July 2012
December 2017   (Final data collection date for primary outcome measure)
Sympathetic activity [ Time Frame: 0 weeks and 8 weeks ]
Same as current
Complete list of historical versions of study NCT01627301 on ClinicalTrials.gov Archive Site
  • Inflammatory markers [ Time Frame: 0 weeks and 8 weeks ]
  • Ambulatory Blood Pressure [ Time Frame: 0 weeks and 8 weeks ]
Same as current
Not Provided
Not Provided
 
Sympathetic Overactivity in Post-traumatic Stress Disorder
Mechanisms of Sympathetic Overactivity in Post-traumatic Stress Disorder
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Post-traumatic Stress Disorder
  • Prehypertension
Device: Device-Guided Breathing using the RESPeRATE device
15 minutes of device-guided breathing daily for 8 weeks
  • Experimental: Device-Guided Breathing at low breathing rate
    Device-guided breathing at low breathing rate daily for 15 minutes up to 8 weeks
    Intervention: Device: Device-Guided Breathing using the RESPeRATE device
  • 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
    Intervention: Device: Device-Guided Breathing using the RESPeRATE device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prehypertensive and Normotensive Operation Enduring Freedom (OEF)/ Operation Iraqi Freedom (OIF)/ Operation New Dawn (OND) veterans with PTSD
  • Prehypertensive and Normotensive 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact: Melanie Jefferson, MS 404-321-6111 ext 7040 melanie.l.jefferson@emory.edu
United States
 
 
NCT01627301
IRB00054697
No
Not Provided
Not Provided
Jeanie Park, Emory University
Emory University
Not Provided
Principal Investigator: Jeanie Park, MD Emory University and the Atlanta VA Medical Center
Emory University
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP