Official Title
Pilot Study to Investigate Possible Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
Brief Summary

This study aims to assess the effects of both acute and chronic exposures to hypoxia andhypercapnia in patients with Long COVID syndrome.

Detailed Description

Not Provided

Recruiting
Long Covid

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.

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Mayo Clinic in Arizona
Scottsdale, Arizona, United States

Investigator: Jordan Parks
Contact: 480-301-6616
parks.jordan@mayo.edu

Investigator: Courtney M Wheatley-Guy, PhD

Contacts

Jordan Parks
480-301-6616
parks.jordan@mayo.edu

Courtney Wheatley-Guy, Principal Investigator
Mayo Clinic

NCT Number
Keywords
brain fog
brain blood flow
Heart Rate Variability
Fatigue
MeSH Terms
Post-Acute COVID-19 Syndrome
Mental Fatigue