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Clinical Trial Summary

The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management.


Clinical Trial Description

Project purpose: The investigators will study the use of non invasive vagal nerve stimulation in newly diagnosed adolescent patients with POTS to see if symptom management improves over 2 months. Surveys will include COMPASS-31. Child Functional Disability Inventory, and PHQ-9. Patient logs will evaluate headache frequency, exercise duration and VNS use. Research objectives: The investigators hypothesize that: Primary Aim 1. Use of noninvasive vagal nerve stimulation will decrease autonomic symptom intensity compared to control group. Primary Aim 2. Use of noninvasive vagal nerve stimulator will improve child function. Primary Aim 3. Heart rate elevation measured by head up tilt table test will decrease in the treatment group compared to the control group. Secondary goals include: Secondary Aim 1: To determine if utilization of noninvasive vagal nerve stimulation influences headache frequency Secondary Aim 2: Determine if utilization of noninvasive vagal nerve stimulation will influence weekly duration of aerobic exercise. Secondary Aim 3: Determine if utilization of noninvasive vagal nerve stimulator results in significant side effects, particularly depression, in adolescent patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06268288
Study type Interventional
Source Mayo Clinic
Contact Brandi Johnson
Phone 507-284-3373
Email johnson.brandi1@mayo.edu
Status Recruiting
Phase N/A
Start date February 14, 2024
Completion date July 2024

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