Actively Recruiting
Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome
Led by Vanderbilt University Medical Center · Updated on 2026-01-20
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Post-acute COVID-19 syndrome, also known as Long COVID, is a disabling condition that continues beyond three months after COVID-19 infection. It mostly affects women and presents with chronic rapid heart rate (tachycardia) and symptoms of orthostatic intolerance without a clear cause. Common symptoms include fatigue, headache, and brain fog, similar to those seen in Postural Tachycardia Syndrome (POTS). Researchers think that reduced vagal nerve activity and ongoing inflammation may cause this post-COVID tachycardia syndrome. The study investigates the relationship between reduced parasympathetic nervous system (PNS) activity and persistent inflammation in patients with post-COVID POTS. It also evaluates whether restoring PNS function using chronic transcutaneous vagus nerve stimulation (tVNS) can improve inflammation, orthostatic tachycardia, and related symptoms. Participants with post-COVID POTS will use an FDA-approved TENS 7000 device with ear clip electrodes for 30 minutes twice daily over 28 days, randomized to different stimulation sites. Participants will have five study visits including in-person and telemedicine appointments. Assessments include EKG, urine and blood tests, orthostatic standing and tilt table tests, blood volume measurement, and questionnaires on autonomic symptoms, quality of life, and cognitive function. Researchers will measure inflammatory markers like IL-6 and symptom changes before and after tVNS treatment. Safety and data quality will be monitored regularly throughout the study, which plans to enroll 60 participants and run until mid-2027.
CONDITIONS
Brief Title
Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prior RT-PCR-confirmed COVID-19 infection
- Post-COVID-19 Postural Tachycardia Syndrome defined by orthostatic tachycardia (>30 bpm) and chronic pre-syncopal symptoms lasting more than 3 months
- Adults aged 18 years or older
You will not qualify if you...
- History of heart disease such as myocardial infarction, angina, or heart failure
- History of stroke or transient ischemic attack
- Previous invasive cardiovascular procedure like bypass graft, angioplasty, valve replacement, or pacemaker placement
- Uncontrolled hypertension with blood pressure >140/90
- Post-menopausal women
- Diabetes Mellitus Type 1 or Type 2
- Impaired liver function
- Impaired kidney function with eGFR <60 mL/min/1.73m2
- Ongoing substance abuse
- Mental conditions preventing understanding of the study
- History of seizures
- Chronic use of steroids or NSAIDs
- Use of biologic drugs such as anti-IL6 or anti-TNF-alpha
- Pregnancy or breastfeeding
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
5 visits, 3 in person and 1 telemedicine
Duration - Baseline assessments before treatment
Participants undergo diagnostic tests to measure inflammatory markers (especially IL-6) and assess parasympathetic nervous system function and immune activation.
Includes EKG, urine and blood sample collection, Orthostatic Standing Test, measurement of blood volume, and tilt table test
Duration - 28 days
Participants with post-COVID-19 POTS receive chronic transcutaneous vagus nerve stimulation (tVNS) twice daily to restore parasympathetic function and reduce inflammation and symptoms.
Device used for 30 minutes twice a day for 28 days
Duration - After 28 days of tVNS stimulation
Participants are assessed after treatment to evaluate changes in inflammatory markers and orthostatic intolerance symptoms.
Includes autonomic symptoms questionnaire, quality of life assessments, neuropsychological tests, and blood sample collection
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
M
Meena Vinayagam, M.D.
C
Cyndya Shibao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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