Autoimmune Basis for Postural Tachycardia Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to test the hypothesis that an antibody-mediated autoimmune reaction will cause symptoms of autonomic dysfunction in some patients with postural tachycardia syndrome (POTS). The investigators further hypothesize that electrical stimulation of the vagus nerve will improve POTS symptoms, autoimmunity and inflammation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 18-80 years old, female or male

• Either healthy control or individual with postural tachycardia syndrome (POTS) defined as heart rate increase \>30 bpm from supine within 10 min of standing, in the absence of orthostatic hypotension (\>20/10 mmHg fall in blood pressure), with chronic symptoms (\>6 months), and in the absence of other acute cause of orthostatic tachycardia

• Able and willing to provide informed consent

• Understand and be able to comply with the study procedures and restrictions

Locations
United States
Oklahoma
Oklahoma Clinical and Translational Science Institute
RECRUITING
Oklahoma City
Contact Information
Primary
Xichun Yu
xichun-yu@ouhsc.edu
405-271-5896
Backup
Brittany Karfonta
Brittany-Karfonta@ouhsc.edu
405-271-3480
Time Frame
Start Date: 2022-01-14
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Vagal stimulation
Vagal stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the tragus for 2 months.
Sham_comparator: Sham stimulation
Sham stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the earlobe for 2 months.
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov

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