NCT06614309 · Mayo Clinic
Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
What this study is about
This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome.
View original scientific description
This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome.
Interventions
OTHER
Acute Placebo Visit
The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.
OTHER
Acute Progressive Carbon Dioxide
The progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles.
OTHER
Acute Intermittent Hypoxia
The intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air.
OTHER
Training: Progressive Carbon Dioxide Ramping
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the progressive CO2 ramp protocol of 60-minute sessions, which will include 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles, for every visit during the 14 days.
OTHER
Training: Intermittent Hypoxic Exposure
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the intermittent hypoxia exposure protocol of 60-minute sessions, which will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air for every visit during the 14 days.
OTHER
Training: Placebo Control
Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days.
Primary outcome measures
Change in cerebral blood flow
Time frame: Baseline, post-acute exposure and 14 days post training
The intracranial middle cerebral arteries will be obtained (MCAv) will be imaged with a linear probe and duplex ultrasound system to simultaneously measure CBFv by pulse wave doppler (peak and mean flow)
Change in heart rate variability
Time frame: Baseline, post-acute exposure and 14 days post training
Short- term HRV analysis of a 3-lead ECG recording (5 minute recording) will evaluate both time-domain parameters (mean heart rate, standard deviation of normal-to-normal (NN) intervals (SDNN) and root mean square of successive differences between NN intervals rMSSD) and frequency-domain parameters (total power, high frequency (HF) and low frequency (LF) and LF/HF ratio).
Change in brain fog scale
Time frame: Baseline, post-acute exposure and 14 days post training
Questionnaire assessing of how much brain fog is affecting daily abilities
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Study staff unable to obtain adequate signal for cerebral blood flow
Where
- Scottsdale, Arizona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations