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Long COVIDNCT06614309

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

A study testing Acute Progressive Carbon Dioxide, Acute Intermittent Hypoxia and Training: Progressive Carbon Dioxide Ramping in people with Long COVID, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Long COVID
What is being tested?
Acute Progressive Carbon Dioxide, Acute Intermittent Hypoxia and Training: Progressive Carbon Dioxide Ramping
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteUnited States
Study dates
24 Sep 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English speaking
  • Diagnosis of Long COVID

Who cannot join

  • 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:
Show all 25Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

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

    Courtney M Wheatley-Guy, PhD

    Recruiting

Other trials in United States

About this study

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

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

Conditions
Long COVID
Being tested
Acute Placebo Visit, Acute Progressive Carbon Dioxide, Acute Intermittent Hypoxia, Training: Progressive Carbon Dioxide Ramping, Training: Intermittent Hypoxic Exposure
Keywords
brain fog, brain blood flow, heart rate variability, fatigue
Medical subject headings
Post-Acute COVID-19 Syndrome, Mental Fatigue, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute Placebo VisitOther

    The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.

  • Acute Progressive Carbon DioxideOther

    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.

  • Acute Intermittent HypoxiaOther

    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.

  • Training: Progressive Carbon Dioxide RampingOther

    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.

  • Training: Intermittent Hypoxic ExposureOther

    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.

  • Training: Placebo ControlOther

    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.

Study groups in NCT06614309
Study groupRoleWhat they receive
Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent HypoxiaExperimentalStudy group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia
Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia
Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon DioxideExperimentalStudy group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia
Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon DioxideExperimentalStudy group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia
Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, PlaceboExperimentalStudy group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia
Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent HypoxiaExperimentalStudy group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia
Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, PlaceboExperimentalStudy group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
Receives: Other: Acute Placebo Visit; Other: Acute Progressive Carbon Dioxide; Other: Acute Intermittent Hypoxia
Placebo GroupPlacebo comparatorStudy 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
Receives: Other: Training: Placebo Control
Training GroupExperimentalTraining 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
Receives: Other: Training: Progressive Carbon Dioxide Ramping; Other: Training: Intermittent Hypoxic Exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cerebral blood flow

    The intracranial middle cerebral arteries will be obtained (MCAv) will be imaged with a linear probe and duplex ultrasound system to simultaneously measure CBFv by pulse wave doppler (peak and mean flow)

    Measured: Baseline, post-acute exposure and 14 days post training

  2. Change in heart rate variability

    Short- term HRV analysis of a 3-lead ECG recording (5 minute recording) will evaluate both time-domain parameters (mean heart rate, standard deviation of normal-to-normal (NN) intervals (SDNN) and root mean square of successive differences between NN intervals rMSSD) and frequency-domain parameters (total power, high frequency (HF) and low frequency (LF) and LF/HF ratio).

    Measured: Baseline, post-acute exposure and 14 days post training

  3. Change in brain fog scale

    Questionnaire assessing of how much brain fog is affecting daily abilities

    Measured: Baseline, post-acute exposure and 14 days post training

Secondary outcomes (6)
  1. Change in fatigue functional assessment of chronic illness therapy-fatigue scale

    Fatigue functional assessment of chronic illness therapy-fatigue scale (FACIT-Fatigue): assessment of how much fatigue is affecting daily abilities. Scores range from 0-52 for the FACIT with a higher score indicating higher levels of fatigue experienced.

    Measured: Baseline, post-acute exposure and 14 days post training

  2. Change in short form health survey (SF-36)

    The Short Form (SF-36) Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.

    Measured: Baseline, post-acute exposure and 14 days post training

  3. Change in Trail making test

    Trail making test: Consists of two parts. For part one, the subject will be presented with 25 numbered dots. The goal is to connect all 25 dots in numerical order quickly and accurately. The second part consists of 25 dots on the screen labelled with numbers and letters. The subject will then click the dots in sequential order by number followed by letter. For example, 1-A-2-B-3-C…, in the shortest amount of time possible while maintaining accuracy.

    Measured: Baseline, post-acute exposure and 14 days post training

  4. Change in rapid cognitive assessment tool (RCAT) score

    The premise is to click spawning targets quickly and accurately. The assessment lasts one minute during which the game will add or reduce intensity based on real time performance. It is used to interpret psychological and psychomotor functions including hand-eye coordination, speed, response time, spatial awareness, situational awareness, and decision-making. Test takes one minute and score is calculate based on number of correct clicks.

    Measured: Baseline, post-acute exposure and 14 days post training

  5. Change in Task switching test performance

    Task switching test will evaluate the individual's ability to switch between different tasks or operations. Participants are presented with a number between 1 and 9. The number will appear in one of two colors: purple or yellow. If the number is purple, the participant will answer with yes or no if the number is even. If yellow, the participants will answer with yes or no if the number is less than 5. Participants will see 40 numbers and their performance will be scored based on response time and accuracy.

    Measured: Baseline, post-acute exposure and 14 days post training

  6. Change in Rey Auditory Verbal Learning Test (AVLT) recall

    Rey Auditory Verbal Learning Test (AVLT) will assess short term auditory recall. Subjects are read a list of 15 words and asked to repeat as many words as possible that they can remember back to the test administrator. They repeat this 5 times, then read a new list of 15 words to repeat back one time before returning to recall the first list of words.

    Measured: Baseline, post-acute exposure and 14 days post training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start24 Sep 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06614309
Sponsor's protocol ID
24-006115
Status last verified
Jun 2026
First submitted
24 Sep 2024
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Acute Progressive Carbon Dioxide, Acute Intermittent Hypoxia and Training: Progressive Carbon Dioxide Ramping in people with Long COVID, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jordan Parks (480-301-6616, parks.jordan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cerebral blood flow (time frame: Baseline, post-acute exposure and 14 days post training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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