[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471617":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":70,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":26,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":26,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Compare inflammatory markers (IL-6) in post- COVID 19 POTS patients with Controls","EXPERIMENTAL","Biochemical endpoints: Measurement of Inflammatory markers (especially IL-6) in both Post- COVID-19 POTS patients and compare it with controls.\n\nControls are the participants who recovered from COVID 19 infection with no sequelae",[13,14],"Diagnostic Test: Levels of inflammatory cytokine ( IL-6) in post-COVID-19 POTS and controls","Diagnostic Test: Levels of inflammatory cytokine ( IL-6) in controls",{"label":16,"type":10,"description":17,"interventionNames":18},"Effect of OI symptoms & inflmmation after Restoring PNS functions in post-COVID POTS patients.","Effects of restoring PNS function in post-COVID-19 POTS patients with chronic transcutaneous vagus nerve stimulation (tVNS) on inflammation, orthostatic tachycardia and OI symptoms.The subjects with POTS will be randomized, where TENS 7000 device will be placed to active and sham location.Autonomic symptoms assessment questionnaire (COMPASS-31),32 quality of life EQ-5D and neuropsychological tests",[19],"Diagnostic Test: Effect on inflammation after chronic PNS stimulation",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Levels of inflammatory cytokine ( IL-6) in post-COVID-19 POTS and controls","Inflammatory and immune profile of post-COVID-19 POTS patients. Reduced PNS activity (vagal tone) in relation to persistent inflammation.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Levels of inflammatory cytokine ( IL-6) in controls","Inflammatory and immune profile of healthy controls. Controls are the subjects who recovered from COVID-19 infection with no sequelae.",[9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Effect on inflammation after chronic PNS stimulation","Inflammatory biomarkers after restoring PNS function in post-COVID-19 POTS patients, by chronic transcutaneous vagus nerve stimulation (tVNS) in post COVID-19 POTS patients",[16],[36],{"name":37,"affiliation":5,"role":38},"Cyndya Shibao, M.D","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Meena Vinayagam, M.D.","CONTACT","615-322-3447","meenakshi.golchha@vumc.org",{"name":46,"role":42,"phone":47,"phoneExt":26,"email":48},"Cyndya Shibao, MD","615-421-2998","cyndya.shibao@vumc.org",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-86.78444,36.16589,{"lat":61,"lon":60},[64,66,69],{"name":65,"role":42,"phone":26,"phoneExt":26,"email":48},"Cyndya Shibao, MD, MSCI",{"name":67,"role":42,"phone":68,"phoneExt":26,"email":48},"Cyndya A Shibao, MD, MSCI","6155120956",{"name":65,"role":38,"phone":26,"phoneExt":26,"email":26},{"type":38,"investigatorFullName":46,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Professor",[73],{"name":74,"class":6},"American Heart Association","100471617","cardiovascular-autonomic-and-immune-mechanism-of-post-covid-19-tachycardia-syndrome-100471617",false,"NCT05421208","Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome","Inclusion Criteria:\n\n* Prior RT-PCR-confirmed COVID-19 infection.\n* Post-COVID-19 POTS will be defined as the presence of orthostatic tachycardia (\\>30 bpm) and chronic (\\>3 months) pre-syncopal symptoms.\n\nExclusion criteria:\n\n* Heart Disease: Myocardial Infarction, angina, heart failure\n* History of stroke, or transient ischemic attack\n* Undergone an invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries)\n* Uncontrolled hypertension defined as persistent blood pressure \\>140\u002F90.\n* Post-menopausal women.\n* Diabetes Mellitus Type 1 or Type 2. ,\n* Impaired Hepatic function\n* Impaired renal function test (eGFR\\\u003C60 mL\u002Fmin\u002F1.73m2).\n* Ongoing substance abuse.\n* Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study.\n* History of seizures.\n* Chronic use of steroids, NSAIDs.\n* On biologics such as anti-IL6 (omalizumab) and anti-TNF-alpha drugs\n* Pregnancy or breastfeeding",true,"ALL","18 Years",{"count":85,"type":86},60,"ESTIMATED","INTERVENTIONAL",[89],"NA","The term post-acute COVID-19 syndrome or Long COVID is a disabling syndrome that persists beyond the 3-month convalescence period after COVID-19 infections.\n\nThis syndrome affects mostly women (\\~80%), present with chronic tachycardia and Orthostatic intolerance symptoms without any identifiable cause. In addition, non-specific symptoms such as fatigue, headache, and \"brain fog\", commonly described in POTS patients are also present in this novel condition, recently named post-COVID-19 tachycardia syndrome, POTS variant.\n\nReduced Vagal activity and unresolved inflammation is post-COVID-19 POTS is hypothesized as the cause of Long COVID",[92,93,94,95],"Post-acute COVID-19 Syndrome","Postural Tachycardia Syndrome (POTS)","Long COVID","SARS CoV 2 Infection",[97],"SARS-CoV-2 infection","2026-01-15",{"date":100,"type":101},"2026-01-20","ACTUAL",{"date":103,"type":101},"2022-06-01",{"date":105,"type":86},"2027-06-30",{"name":5,"class":6},1]