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

ConditionLong COVID

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMayo Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

English speaking

Diagnosis of Long COVID

Disqualifiers

Coronary artery dissection or aortic dissection

Neurological disease (e.g. dementia, Alzheimer's disease, or other brain-related disease)

Cerebrovascular disease or stroke

Aneurysm

Trial design

Design model

Crossover

Treatments tested in this trial

Acute Placebo Visit
Other intervention
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 Dioxide
Other intervention
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 Hypoxia
Other intervention
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 Ramping
Other intervention
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 Exposure
Other intervention
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 Control
Other intervention
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.

Treatment groups

45 Participants

are divided into 8 treatment groups

Treatment groups

See each treatment group below.

Group A: Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent HypoxiaExperimental treatment 3 interventions

Group B: Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon DioxideExperimental treatment 3 interventions

Group C: Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon DioxideExperimental treatment 3 interventions

Group D: Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, PlaceboExperimental treatment 3 interventions

Group E: Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent HypoxiaExperimental treatment 3 interventions

Group F: Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, PlaceboExperimental treatment 3 interventions

Group G: Placebo GroupPlacebo comparator 1 intervention

Group H: Training GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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)

Time frame