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Search / Trial NCT07026643

aVNT in POTS - Pilot

Launched by UNIVERSITY OF CALGARY · Jun 10, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Postural Orthostatic Tachycardia Syndrome Auricular Vagal Neuromodulation Therapy

ClinConnect Summary

This clinical trial is studying a new treatment called Auricular Vagal Neuromodulation Therapy (aVNT) for people with Postural Orthostatic Tachycardia Syndrome (POTS). POTS is a condition that causes a fast heartbeat and other symptoms when standing up, along with problems like brain fog and poor blood flow to the brain, which can make daily life very challenging. The treatment uses gentle stimulation of a nerve in the ear to help balance the nervous system, which may improve heart rate, blood flow, brain function, and reduce inflammation. The goal is to see if this therapy can help ease symptoms and improve quality of life for people with POTS.

People eligible to join the trial are adults aged 18 to 80 who have been diagnosed with POTS based on heart rate changes when standing up, without a drop in blood pressure, and who have ongoing symptoms without other known causes. Both men and women can participate. Those with serious heart problems, recent stimulant use, or other major health issues, as well as pregnant or nursing women, would not be eligible. Participants in the study can expect to receive the aVNT treatment and have their symptoms and heart function monitored to see if the therapy helps. This study is not yet recruiting, but it offers hope for a new approach to managing POTS symptoms in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • POTS Patients: POTS patients will meet Canadian Cardiovascular Society criteria. 6 POTS patients will have orthostatic tachycardia \>30 bpm increase in HR within 10 minutes of upright posture \[\>40 bpm in patients \<20 years\]), in the absence of orthostatic hypotension (drop in BP \>20/10 mmHg), chronic symptoms of orthostatic intolerance, and no obvious cause for the tachycardia.
  • Age between 18-80 years
  • Male and female subjects are eligible
  • Able and willing to provide informed consent
  • Exclusion Criteria:
  • Unable to give informed consent
  • Stimulant use within one week of the study
  • Systolic blood pressure \>150 mm Hg and/or diastolic blood pressure \> 100 mm Hg
  • Neurogenic orthostatic hypotension, prior stroke, myocardial infarction or heart failure, hematocrit \< 28%
  • Significant comorbidities (cardiovascular, metabolic, renal, respiratory, cancer, immunological or hematological)
  • History of vagotomy, permanent pacemakers
  • Pregnant or nursing females.

About University Of Calgary

The University of Calgary is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong emphasis on multidisciplinary collaboration, the university's clinical research initiatives aim to address pressing health challenges and improve patient outcomes. The institution fosters a robust environment for academic inquiry, leveraging state-of-the-art facilities and a diverse network of experts in various fields. Committed to ethical research practices and community engagement, the University of Calgary strives to translate scientific discoveries into tangible benefits for society.

Locations

Patients applied

0 patients applied

Trial Officials

Satish Raj, MD

Principal Investigator

University of Calgary

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported