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RecruitingNCT06614309

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
45 (estimated)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
OTHERAcute Placebo VisitThe 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 DioxideThe 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 HypoxiaThe 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 RampingIntervention 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 ExposureIntervention 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 ControlIntervention 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.

Timeline

Start date
2024-09-24
Primary completion
2026-04-01
Completion
2026-05-01
First posted
2024-09-26
Last updated
2025-11-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06614309. Inclusion in this directory is not an endorsement.