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

Conditions

• Long COVID

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Acute Placebo Visit — OTHER
  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
  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
  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 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 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 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 Details

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

Key Dates

Start date

Sep 24, 2024

Status verified

Jun 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia
  Study group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia
• Experimental: Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
  Study group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide
• Experimental: Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
  Study group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide
• Experimental: Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
  Study group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo
• Experimental: Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
  Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia
• Experimental: Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
  Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo
• Placebo Comparator: Placebo Group
  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
• Experimental: Training Group
  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

Primary Outcome Measure

Change in cerebral blood flow [ Time Frame: Baseline, post-acute exposure and 14 days post training ]

Central Contacts

• Jordan Parks
  480-301-6616
  [email protected]

Locations (1)

Find similar trials in Scottsdale, AZ

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