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Effects of Auricular Vagus Nerve Stimulation Combined With Slow-paced Breathing on Individuals With Postural Orthostatic Tachycardia Syndrome.
Sponsor: Ali Kapan
Summary
This study investigates a non-pharmacological treatment approach for Postural Orthostatic Tachycardia Syndrome (POTS), a disorder of the autonomic nervous system characterized by an excessive increase in heart rate upon standing. POTS is commonly associated with symptoms such as dizziness, fatigue, cognitive difficulties, sleep disturbances, as well as anxiety and depression, which significantly impair quality of life. This randomized, controlled clinical trial aims to evaluate whether combining transcutaneous auricular vagus nerve stimulation (taVNS) with slow-paced diaphragmatic breathing (at 0.1 Hz) provides greater therapeutic benefit compared to taVNS alone or sham stimulation. A total of 100 participants will be recruited and randomly assigned to one of four groups (25 per group): taVNS with slow-paced breathing, taVNS with spontaneous (normal) breathing, sham taVNS with slow-paced breathing, or sham taVNS with spontaneous breathing. Participants will perform the intervention daily at home for a duration of 12 weeks. Medical and psychological assessments will be conducted before and after the intervention, including measurements of heart rate, inflammatory cytokines, and patient-reported outcomes on sleep, mood, and quality of life. The study is conducted at the Center for Public Health, Medical University of Vienna, and is open to individuals diagnosed with POTS, including those with coexisting Post-COVID-19 syndrome.
Official title: Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Slow-Paced Diaphragmatic Breathing on Postural Tachycardia Syndrome: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-09-01
Completion Date
2028-08-31
Last Updated
2025-06-04
Healthy Volunteers
No
Interventions
TVNS + Slow-Paced Breathing (TVNS+SDB)
Participants receive active transcutaneous auricular vagus nerve stimulation (taVNS) using electrodes placed at the cymba conchae, combined with guided slow-paced diaphragmatic breathing (0.1 Hz). The intervention is performed daily at home for 12 weeks, with each session lasting 60 minutes.
TVNS without Breathing Training (TVNS+NB)
Participants receive active transcutaneous auricular vagus nerve stimulation (taVNS) using electrodes placed at the cymba conchae, combined with spontaneous breathing (no guided breathing exercises). The intervention is performed daily at home for 12 weeks, with each session lasting 60 minutes.
Sham TVNS + SDB
Participants receive transcutaneous auricular vagus nerve stimulation using a sham protocol via electrodes placed at the cymba conchae, combined with guided slow-paced diaphragmatic breathing (0.1 Hz). The intervention is performed daily at home for 12 weeks, with each session lasting 60 minutes.
Sham TVNS + NB
Participants receive transcutaneous auricular vagus nerve stimulation using a sham protocol via electrodes placed at the cymba conchae, combined with spontaneous breathing (no guided breathing exercises). The intervention is performed daily at home for 12 weeks, with each session lasting 60 minutes.