Effects of Auricular Vagus Nerve Stimulation Combined With Slow-paced Breathing on Individuals With Postural Orthostatic Tachycardia Syndrome.

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.

NCT Number	NCT06996314
Lead Sponsor	Ali Kapan
Conditions	Postural Orthostatic Tachycardia Syndrome (POTS), Post-acute COVID-19 Syndromes
Enrollment	100 participants
Start Date	2025-09-01
Primary Completion	2028-03-01 (estimated)
Study Completion	2028-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-04