Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog

Purpose

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

Condition

  • Long COVID

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia 		Study group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia
  • 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.
Experimental
Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide 		Study group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
  • 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.
Experimental
Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide 		Study group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
  • 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.
Experimental
Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo 		Study group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
  • 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.
Experimental
Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia 		Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
  • 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.
Experimental
Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo 		Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
  • 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.
Placebo Comparator
Placebo Group 		Study group 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 intervention period. Subjects will then return within 7 days of their final training visit to repeat baseline testing
  • 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.
Experimental
Training Group 		Training Study group will be complete 6 cycles of either progressive CO2 ramp protocol or the intermittent hypoxia protocol for 60 minutes for every visit during the 14 days. Subjects will then return within 7 days of their final training visit to repeat baseline testing
  • 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.

Recruiting Locations

Mayo Clinic in Arizona
Scottsdale, Arizona 85259
Contact:
Jordan Parks
480-301-6616
parks.jordan@mayo.edu

More Details

NCT ID
NCT06614309
Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Parks
480-31-6616
parks.jrdan@mayo.edu