Status:
NOT_YET_RECRUITING
Effects of Auricular Vagus Nerve Stimulation Combined With Slow-paced Breathing on Individuals With Postural Orthostatic Tachycardia Syndrome.
Lead Sponsor:
Ali Kapan
Conditions:
Postural Orthostatic Tachycardia Syndrome (POTS)
Post-acute COVID-19 Syndromes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Detailed Description
Postural Orthostatic Tachycardia Syndrome (POTS) is a disorder of the autonomic nervous system characterized by an excessive increase in heart rate (≥30 bpm) within 10 minutes of standing, without a s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Significant hypertension (BP \>150/100 mmHg supine or standing).
- Orthostatic hypotension: drop in BP \>20 mmHg systolic or \>10 mmHg diastolic upon standing.
- Recent stroke or myocardial infarction (within 6 months).
- Significant immunological or hematological disorders.
- Severe anemia (hematocrit \<28%).
- History of vagotomy.
- Pregnancy or lactation.
- Inability or unwillingness to provide informed consent.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06996314
Start Date
September 1 2025
End Date
August 31 2028
Last Update
June 4 2025
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