NCT06996314Not yet recruiting
Effects of Auricular Vagus Nerve Stimulation Combined With Slow-paced Breathing on Individuals With Postural Orthostatic Tachycardia Syndrome.
Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Slow-Paced Diaphragmatic Breathing on Postural Tachycardia Syndrome: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 21 May 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- Ali Kapan
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06996314
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Sept 2025 to the primary completion date, 1 Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant hypertension (BP \>150/100 mmHg supine or standing).
- Recent stroke or myocardial infarction (within 6 months).
- Significant immunological or hematological disorders.
- History of vagotomy.
Other
- Orthostatic hypotension: drop in BP \>20 mmHg systolic or \>10 mmHg diastolic upon standing.
- Severe anemia (hematocrit \<28%).
- Pregnancy or lactation.
- Inability or unwillingness to provide informed consent.
Who the study is looking for
- Formal diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS), confirmed by clinical criteria: a sustained increase in heart rate (HR) of ≥30 bpm within 10 minutes of standing, without orthostatic hypotension.
- History of POTS diagnosis for at least 6 months.
- Participants with Post-acute COVID-19 syndrome may be included if they meet the formal POTS criteria. These participants will be stratified based on the presence or absence of Post-Exertional Malaise (PEM).
- Stable medication for POTS (same dosage/class) for at least 4 weeks before enrollment.
- Willingness and ability to provide informed consent.
- Screening of Undiagnosed Participants:
- Suspected POTS based on clinical symptoms (e.g., dizziness, fatigue, syncope, brain fog, palpitations, exercise intolerance) persisting ≥6 months.
- Preliminary Schellong test by study team.
- If criteria are met, referral to a specialist (neurology or cardiology) for diagnostic confirmation.
- Inclusion only after specialist-confirmed POTS diagnosis.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.