Print

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

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.