Non-invasive treatment for brain fog in Long COVID patients
Pilot Study to Investigate Possible Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
This study is testing a new non-invasive treatment for brain fog in people with Long COVID to see if changes in oxygen and carbon dioxide levels can help improve their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT06614309 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of both acute and chronic exposure to hypoxia and hypercapnia on patients suffering from Long COVID syndrome, specifically targeting symptoms like brain fog. Participants will undergo various interventions, including acute placebo visits and progressive carbon dioxide exposure, to assess their impact on brain blood flow and heart rate variability. The study aims to provide insights into non-invasive treatment options for managing fatigue and cognitive difficulties associated with Long COVID.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking individuals diagnosed with Long COVID.
Not a fit: Patients with a history of significant cardiovascular or neurological diseases, or those requiring supplemental oxygen, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer new non-invasive treatment options for patients experiencing brain fog due to Long COVID.
How similar studies have performed: While the approach of using hypoxia and hypercapnia is novel in the context of Long COVID, similar interventions have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * English speaking * Diagnosis of Long COVID Exclusion criteria: * Any history of: * Coronary artery dissection or aortic dissection * Neurological disease (e.g. dementia, Alzheimer's disease, or other brain-related disease) * Cerebrovascular disease or stroke * Aneurysm * If currently has: * Moderate-severe chronic obstructive pulmonary disease * Uncontrolled moderate-severe asthma * Moderate-severe bronchiectasis * Moderate-severe interstitial lung disease, requiring the use of supplemental oxygen * A necessity to use supplemental oxygen, for any reason * New or worsening symptoms (decompensation) of heart failure * Right heart disease due to chronic pulmonary disease/sleep apnea * Uncontrolled myocardial ischemia or angina * Uncontrolled heart arrhythmias * Heart or lung infection (e.g. myocarditis or pericarditis) * Left main coronary artery stenosis * Moderate-severe aortic stenosis * Pulmonary embolism, pulmonary infarction, or other blood clots * Severe respiratory disease * Chronic kidney disease * Chronic liver disease * Females of childbearing potential will complete a urine pregnancy test at their baseline visit to rule out pregnancy * BMI \>40 * Study staff unable to obtain adequate signal for cerebral blood flow
Where this trial is running
Scottsdale, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Courtney Wheatley-Guy — Mayo Clinic
- Study coordinator: Jordan Parks
- Email: parks.jordan@mayo.edu
- Phone: 480-301-6616
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.