Clinical trial NCT06614309: Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
Official title: Pilot Study to Investigate Possible Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long COVID
Keywords: brain fog
brain blood flow
heart rate variability
fatigue
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Change in cerebral blood flow
timeFrame: Baseline, post-acute exposure and 14 days post training
measure: Change in heart rate variability
timeFrame: Baseline, post-acute exposure and 14 days post training
measure: Change in brain fog scale
timeFrame: Baseline, post-acute exposure and 14 days post training
Secondary outcomes:
measure: Change in fatigue functional assessment of chronic illness therapy-fatigue scale
timeFrame: Baseline, post-acute exposure and 14 days post training
measure: Change in short form health survey (SF-36)
timeFrame: Baseline, post-acute exposure and 14 days post training
measure: Change in Trail making test
timeFrame: Baseline, post-acute exposure and 14 days post training
measure: Change in rapid cognitive assessment tool (RCAT) score
timeFrame: Baseline, post-acute exposure and 14 days post training
measure: Change in Task switching test performance
timeFrame: Baseline, post-acute exposure and 14 days post training
measure: Change in Rey Auditory Verbal Learning Test (AVLT) recall
timeFrame: Baseline, post-acute exposure and 14 days post training
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Courtney Wheatley-Guy
role: PRINCIPAL_INVESTIGATOR
References: