Non-invasive neuromodulation for patients with Long-COVID
Effectiveness of Non-invasive Neuromodulation Compared to Placebo on Sleep Quality in Patients With Post-COVID Symptoms: a Randomized Clinical Trial.
This study is testing if a new non-invasive treatment can help people with Long-COVID improve their sleep and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Rey Juan Carlos Academic / other |
| Locations | 1 site (Alcorcón, Madrid) |
| Trial ID | NCT06456502 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of non-invasive neuromodulation techniques in improving sleep quality and overall well-being in patients suffering from Long-COVID or post-acute COVID-19 syndrome. Participants will receive either the neuromodulation treatment or a placebo, with the aim of assessing changes in sleep quality, mood, and cognitive function. The study focuses on individuals who have experienced symptoms for at least six months following their initial COVID-19 infection. By examining the physiological effects of improved sleep, the study seeks to address the broader impacts of Long-COVID on health.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Long-COVID or post-acute COVID syndrome who have experienced symptoms for at least six months.
Not a fit: Patients who are pregnant, have pacemakers, or suffer from certain neurological or cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance sleep quality and overall health outcomes for patients suffering from Long-COVID.
How similar studies have performed: While the specific application of non-invasive neuromodulation for Long-COVID is novel, similar approaches have shown promise in improving sleep and cognitive function in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with long COVID or post- acute COVID syndrome * With a evolution of at least 6 months after acute SARS-cov-2 infection * Whit symptoms present at baseline. Exclusion Criteria: * Pregnancy. * Pacemakers * Ulcerations or wounds in the area of electrode application. * Decompensated heart disease. * Epilepsy and/or choreic syndromes. * Frequent medication with corticosteroids, hypnotics or supplements such as melatonin, Ashwagandha or phosphatidylserine. * Hypersensitivity on hands and feet that influence the use of the gloves and socks from the neuromodulation system.
Where this trial is running
Alcorcón, Madrid
- Rey Juan Carlos University — Alcorcón, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Stella Fuensalida Novo, PhD — Universidad Rey Juan Carlos
- Study coordinator: Stella Fuensalida Novo, PhD
- Email: stella.fuensalida@urjc.es
- Phone: +34914884865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.