RecruitingNot ApplicableNCT06614309

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

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


Sponsor

Mayo Clinic

Enrollment

45 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • English speaking
  • Diagnosis of Long COVID

Exclusion Criteria25

  • 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

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Interventions

OTHERAcute 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.

OTHERAcute 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.

OTHERAcute 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.

OTHERTraining: 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.

OTHERTraining: 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.

OTHERTraining: 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.


Locations(1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

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NCT06614309


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