Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
Status
Enrolling
Conditions
Long COVID
Treatments
Other: Training: Progressive Carbon Dioxide Ramping
Other: Training: Intermittent Hypoxic Exposure
Other: Acute Progressive Carbon Dioxide
Other: Acute Placebo Visit
Other: Acute Intermittent Hypoxia
Other: Training: Placebo Control
Details and patient eligibility
About
This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome.
Enrollment
45 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
45 participants in 8 patient groups, including a placebo group
Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia
Experimental group
Description:
Study group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia
Treatment:
Other: Acute Intermittent Hypoxia
Other: Acute Progressive Carbon Dioxide
Other: Acute Placebo Visit
Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
Experimental group
Description:
Study group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
Treatment:
Other: Acute Intermittent Hypoxia
Other: Acute Progressive Carbon Dioxide
Other: Acute Placebo Visit
Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
Experimental group
Description:
Study group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
Treatment:
Other: Acute Intermittent Hypoxia
Other: Acute Progressive Carbon Dioxide
Other: Acute Placebo Visit
Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
Experimental group
Description:
Study group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
Treatment:
Other: Acute Intermittent Hypoxia
Other: Acute Progressive Carbon Dioxide
Other: Acute Placebo Visit
Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
Experimental group
Description:
Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
Treatment:
Other: Acute Intermittent Hypoxia
Other: Acute Progressive Carbon Dioxide
Other: Acute Placebo Visit
Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
Experimental group
Description:
Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
Treatment:
Other: Acute Intermittent Hypoxia
Other: Acute Progressive Carbon Dioxide
Other: Acute Placebo Visit
Placebo Group
Placebo Comparator group
Description:
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
Treatment:
Other: Training: Placebo Control
Training Group
Experimental group
Description:
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
Treatment:
Other: Training: Intermittent Hypoxic Exposure
Other: Training: Progressive Carbon Dioxide Ramping
Trial contacts and locations
1
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Central trial contact
Jordan Parks
Data sourced from clinicaltrials.gov
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