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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01627301
Recruitment Status : Suspended (The study activities are suspended due to COVID-19)
First Posted : June 25, 2012
Last Update Posted : May 21, 2020
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

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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 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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


Locations
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United States, Georgia
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Jeanie Park, MD Emory University and the Atlanta VA Medical Center
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Responsible Party: Jeanie Park, Assistant Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01627301    
Other Study ID Numbers: IRB00054697
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Prehypertension
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Vascular Diseases
Cardiovascular Diseases