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.
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Parallel
TVNS + Slow-Paced Breathing (TVNS+SDB)
DeviceParticipants 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)
DeviceParticipants 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
DeviceParticipants 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
DeviceParticipants 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.
Change in Heart Rate From Supine to Standing (Delta HR) After 12 Weeks of Daily taVNS With or Without Slow-Paced Breathing in Individuals With POTS
Heart rate (HR) is continuously recorded via 12-lead ECG during a standardized Tilt test. Participants lie supine for 25 minutes and then stand upright for 10 minutes. The average HR from the last 10 minutes supine and the 10-minute standing phase is calculated. The primary outcome, Delta HR, is defined as the difference between upright and supine HR. This measure reflects autonomic cardiovascular response and is assessed before and after the 12-week intervention phase.
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Ali Kapan
Lead sponsor
Medical University of Vienna
Sponsor institution
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