[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100180746":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":55,"locations":64,"responsibleParty":79,"collaborators":82,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":41,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":41,"overallStatus":67,"whyStopped":41,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Emory University","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Device-guided Breathing (DGB)","EXPERIMENTAL","Participants randomized to the DGB group use a device to guide their breathing to a slow breathing rate.",[13],"Device: Device-Guided Breathing (DGB)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham DGB","SHAM_COMPARATOR","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.",[19],"Device: Sham DGB",{"label":21,"type":10,"description":22,"interventionNames":23},"Transcutaneous Vagal Nerve Stimulation (tVNS)","Participants randomized to use a tVNS device to deliver mild electrical stimulation to the vagal nerve.",[24],"Device: Transcutaneous Vagal Nerve Stimulation (tVNS)",{"label":26,"type":16,"description":27,"interventionNames":28},"Sham tVNS","Participants randomized to use the sham tVNS device which vibrates but does not stimulate the vagal nerve.",[29],"Device: Sham tVNS",[31,38,42,47],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Device-Guided Breathing (DGB)","The RESPeRATE device will be used for 15 minutes of device-guided breathing daily for 8 weeks. The participant places the elastic belt with a respiration sensor around the upper abdomen, and wears earbuds for audio feedback. The device monitors the breathing rate, calculates inspiration and expiration times, and generates a personalized melody of two distinct ascending and descending tones for inhalation versus exhalation. Users effortlessly entrain their breathing pattern with the tones, and the device gradually guides the user to a prolonged expiration time and slower respiratory rate (to \\\u003C 10 breaths\u002Fminute). The device automatically stores usage data, allowing for quantification of adherence and performance.",[9],[37],"RESPeRATE",{"type":32,"name":15,"description":39,"armGroupLabels":40,"otherNames":41},"The sham device is identical to the DGB device, except it does not guide respiratory rates to slow down and instead maintains a rate of 14 breaths per minute. The sham device is used for 15 minutes per day for 8 weeks.",[15],null,{"type":32,"name":21,"description":43,"armGroupLabels":44,"otherNames":45},"tVNS is a noninvasive method that involves placing a device over the skin overlying the vagus nerve on the neck. The device delivers mild electrical stimulation, using transcutaneous electrical nerve stimulation (TENS) unit. The stimulation is increased until there is a vibration and slight muscle contraction in the lower face or neck. Then the stimulation is delivered for 2 minutes on the left side of the neck, and on the right side of the neck, for a total of 4 minutes. The tVNS device is used twice daily for 8 weeks.",[21],[46],"gammaCore",{"type":32,"name":26,"description":48,"armGroupLabels":49,"otherNames":41},"Sham stimulation is delivered using a device that is identical to the gammaCore device but is programed to deliver a lower frequency that can be felt by the participant but does not actually stimulate the vagus nerve. The sham device is used twice daily for 8 weeks.",[26],[51],{"name":52,"affiliation":53,"role":54},"Jeanie Park, MD","Emory University and the Atlanta VA Medical Center","PRINCIPAL_INVESTIGATOR",[56,62],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Deirdre Dixon, MS","CONTACT","404-321-6111","207040","deirdre.dixon@emory.edu",{"name":52,"role":58,"phone":59,"phoneExt":63,"email":41},"207070",[65],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":41},"Atlanta VA Medical Center","RECRUITING","Decatur","Georgia","30033","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-84.29631,33.77483,{"lat":77,"lon":76},{"type":54,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Jeanie Park","Professor",[83],{"name":84,"class":85},"US Department of Veterans Affairs","FED","100180746","sympathetic-overactivity-in-post-traumatic-stress-disorder-100180746",false,"NCT01627301","Sympathetic Overactivity in Post-traumatic Stress Disorder","Mechanisms of Sympathetic Overactivity in Post-traumatic Stress Disorder","SO-PTSD","Inclusion Criteria:\n\n* prehypertensive and normotensive veterans with PTSD, and prehypertensive and normotensive veterans without PTSD (controls)\n\nExclusion Criteria:\n\n* heart or vascular disease\n* illicit drug use within the last 6 months\n* excessive alcohol use (\\>2 drinks per day)\n* pregnancy\n* autonomic dysfunction\n* medications known to affect SNS (clonidine)\n* treatment with monoamine oxidase (MAO) inhibitors within the last 14 days\n* any serious systemic disease",true,"ALL","18 Years","65 Years",{"count":99,"type":100},120,"ESTIMATED","INTERVENTIONAL",[103],"NA","Post-traumatic stress disorder (PTSD) is a highly prevalent anxiety disorder that is associated with an increased risk of cardiovascular (CV) disease and hypertension. One potential mechanism is overactivation of the sympathetic nervous system (SNS), both at rest and particularly during stress. This study will evaluate whether 8 weeks of daily DGB therapy or transcutaneous vagus nerve stimulation (tVNS) therapy improves SNS activity at rest and during stress.",[106,107],"Post-traumatic Stress Disorder","Prehypertension","2026-01-13",{"date":110,"type":111},"2026-01-15","ACTUAL",{"date":113,"type":111},"2012-07",{"date":115,"type":100},"2027-12",{"name":5,"class":6},1]