NCT05630040

VNS for Long-COVID-19

Vagus Nerve Simulation for Long-COVID-19

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be randomized into one of two arms. Those in the "active VNS" arm will be sent home with a portable VNS device and asked to perform a daily VNS protocol designed to down regulate sympathetic nervous system activity for six weeks. Those in the "sham VNS" arm will be asked to use the VNS device daily on a sham setting for six weeks. Those randomized to the sham group will be given the opportunity to "crossover" into the active VNS arm once they have completed the sham arm (Week 12). The participant and assessor will be blinded.

Conditions

• Post-COVID-19 Syndrome
• Postural Tachycardia Syndrome
• Dysautonomia

Interventions

Type	Name	Description
DEVICE	Non-invasive vagus nerve stimulation	Participants will take the VNS device home and asked to perform a daily VNS protocol designed to down regulate sympathetic nervous system activity for 6 weeks.
DEVICE	Sham Intervention	Participants will take a placebo device home for 6 weeks and use daily.

Timeline

• Start date: 2022-11-11
• Primary completion: 2024-10-03
• Completion: 2024-10-03
• First posted: 2022-11-29
• Last updated: 2024-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study