TrialX
Image

tVNS in Long COVID-19

Testing Vagus Nerve Stimulation for Long COVID and ME/CFS

Recruiting
21-70 years
All
Phase N/A

This study investigates the use of transcutaneous vagus nerve stimulation (tVNS) for patients who have post-acute sequelae of SARS-CoV-2 infection (PASC) and meet the criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). PASC refers to long-term symptoms following a COVID-19 infection, and ME/CFS is a condition characterized by severe fatigue and other symptoms. The purpose of this study is to compare two different sets of tVNS parameters to determine which one best improves the quality of life for these patients over a 6-week period.

Participants will be assigned to one of two treatment arms and will use a device for 35 minutes each morning for 6 weeks. During the fifth week, participants will use a stick-on device to measure heart rate variability, an objective measure of treatment success. They will complete questionnaires about their symptoms and must use the device for at least 30 out of 42 days to qualify for an additional 6-week treatment with the best-performing device.

  • Who can participate: Adults who have had COVID-19 and meet the 2015 case definition for ME/CFS are eligible. Participants must have a Chalder Fatigue Scale score of 4 or greater and certain symptom severity scores. Individuals with a BMI of 30 or higher, those who were hospitalized for COVID-19, or who are pregnant are excluded.
  • Study details: Participants use the device for 35 minutes each morning for a 6-week period and complete questionnaires about their symptoms and functional status. A placebo is not used, as all participants receive active treatment.
  • Study Timelines: The study will last 6 weeks, with a potential additional 6-week period for further treatment.
Study details
    Long Covid Also Fulfilling Criteria for Chronic Fatigue Syndrome

NCT06585254

Icahn School of Medicine at Mount Sinai

5 May 2025

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.