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Recruiting NCT05630040

VNS for Long-COVID-19

Conditions: Post-COVID-19 Syndrome, Postural Tachycardia Syndrome, Dysautonomia

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 40
Sponsor: Icahn School of Medicine at Mount Sinai

Location: United States

Summary

The goal of this proposed clinical case series is to evaluate the effect of a non-invasive vagus nerve stimulation paradigm on: 1) Symptom reporting via validated patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous system function.This will be a placebo controlled, randomized controlled trial with a crossover design built in. This study will aim to recruit 40 people with Long COVID to be a part of this research.

Eligibility Criteria

Inclusion Criteria:Provision of signed and dated informed consent formStated willingness to comply with all study procedures and availability for the duration of the studyAt least 18 years of ageClinical diagnosis of dysautonomia following an acute COVID-19 infection at least 3 months prior. See below for criteria:clinical diagnosis of autonomic dysfunction as evaluated by a qualified healthcare provider2 or more if the following clinical assessment findingssymptomatic exacerbation during active stand testtachycardia on active stand testtachycardia on orthostatic vitals assessmenthypotension on orthostatic vitals assessmenthypertension in orthostatic vitals assessmentsymptom exacerbation on orthostatic vitals assessmentEnglish speakingExclusion Criteria:• Pregnancy or lactation:Pregnant persons will not be included in this study for the following reasons:There is not sufficient data surrounding the hormone cycle changes during pregnancy and its effects on the condition being studied (PCD). The results could be skewed due to pregnancy.Of note, there are no risks for pregnant persons to participate.According to the device manufacturer, the following contraindications will be followed during the screening process:Patients with an active implantable medical device, such as a cardiac pacemaker, heading aid implant, or any implanted metallic or electronic devicePatients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heath failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years)Patients with diagnosed bradycardiaPatients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)Patients whose pain syndromes are undiagnosedPediatric patientsPregnant women

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05630040). StuddyBuddy aggregates publicly available trial information.