NCT06968104Active, not recruiting
Vagus Nerve Stimulation to the Ear to Improve Symptoms in Post-COVID-19 and ME/CFS
Stimulation of the Transcutaneous Auricular Vagus Nerve for Improvement of Symptoms in Patients With Post-COVID Syndrome and ME/CFS
Source: ClinicalTrials.gov · Last updated 8 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 5 May 2025
- Start date
- 18 Jul 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- University of Luxembourg
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06968104
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 18 Jul 2025 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or ongoing use of taVNS
- Medications that may influence autonomic function, HRV, and fatigue
Other illness
- Neurological or psychiatric disorders unrelated to ME/CFS or Post-COVID Syndrome
- History of vagus nerve damage or significant ear injury
- Bradycardia (resting heart rate below 60 beats per minute)
- Known severe coronary disease or recent heart attack (within 5 years)
Other
- Pacemaker or other implanted electronic or metallic devices
- Pregnancy or breastfeeding
- permanent jewelry at close proximity to the ear tragus;
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Luxembourg Coordinator of this site? Confirm its status | Esch-sur-Alzette | Luxembourg | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.