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

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ClinicalTrials.gov Identifier: NCT01627301
Recruitment Status : Recruiting
First Posted : June 25, 2012
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Jeanie Park, Emory University

Brief Summary:
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 or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Prehypertension Device: Device-Guided Breathing using the RESPeRATE device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanisms of Sympathetic Overactivity in Post-traumatic Stress Disorder
Study Start Date : July 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Sympathetic activity [ Time Frame: 0 weeks and 8 weeks ]

Secondary Outcome Measures :
  1. Inflammatory markers [ Time Frame: 0 weeks and 8 weeks ]
  2. Ambulatory Blood Pressure [ Time Frame: 0 weeks and 8 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jeanie Park, Assistant Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01627301     History of Changes
Other Study ID Numbers: IRB00054697
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Prehypertension
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Vascular Diseases
Cardiovascular Diseases