Vagus Nerve Stimulation to the Ear to Improve Symptoms in Post-COVID-19 and ME/CFS (NCT06968104) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Vagus Nerve Stimulation to the Ear to Improve Symptoms in Post-COVID-19 and ME/CFS
Luxembourg48 participantsStarted 2025-07-18
Plain-language summary
This study is testing whether a gentle electrical stimulation of a nerve in the ear, called the vagus nerve, can help reduce fatigue and improve symptoms in people with Post-COVID Syndrome or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The treatment, known as transcutaneous auricular vagus nerve stimulation (taVNS), is non-invasive and can be done at home using a small device.
Participants will try two different types of stimulation, called Intervention A and Intervention B, to see which may be more effective. Each intervention lasts 4 weeks and will be separated by a break of at least 4 weeks.
Participants will use the device at home twice a day for 30 minutes. Fatigue, quality of life, sleep, and daily activity will be tracked through surveys and wearable devices. All parts of the study-including check-ins and data collection-will be done remotely.
The goal is to learn whether this type of at-home nerve stimulation can safely improve symptoms in people with Post-COVID Syndrome or ME/CFS.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of Post-COVID Syndrome (persistent symptoms \> 3 months post-infection)
* Diagnosis of ME/CFS (following Canadian Consensus Criteria) Aged 18-65
* Moderate to severe fatigue (Fatigue Severity Scale ≥ 5)
* Stable medical regimen for at least 3 months
* Participants who are willing to follow the treatment protocol, and able to comply with remote monitoring.
* Sufficient proficiency in German or English language
Exclusion Criteria:
* Pacemaker or other implanted electronic or metallic devices
* Neurological or psychiatric disorders unrelated to ME/CFS or Post-COVID Syndrome
* Pregnancy or breastfeeding
* History of vagus nerve damage or significant ear injury
* Previous or ongoing use of taVNS
* Bradycardia (resting heart rate below 60 beats per minute)
* permanent jewelry at close proximity to the ear tragus;
* Known severe coronary disease or recent heart attack (within 5 years)
* Medications that may influence autonomic function, HRV, and fatigue
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fatigue
Timeframe: From baseline to end of treatment at 4 weeks.