CPAP for Sleep Apnea in Post-COVID-19 Patients

(BreathePA Trial)

Overseen By Venkatesh B Krishnamurthy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Venkatesh Krishnamurthy

Must not be taking: Corticosteroids, Stimulants, Antidepressants, others

Disqualifiers: Narcolepsy, Dementia, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, observational study evaluating the relationship between severity of sleep apnea with severity of cognitive fog and if treatment of sleep apnea with CPAP improves cognitive fog in a cohort of post COVID patients with sleep apnea.

Research Team

Venkatesh Krishnamurthy, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults over 18 who have had COVID-19 with lingering symptoms past 4 weeks and are diagnosed with sleep apnea. They must have confirmed sleep apnea through a home study.

Inclusion Criteria

I am over 18 years old.

I have had COVID-19 symptoms for more than 4 weeks.

You have been diagnosed with sleep apnea through a home-based study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Evaluation of the severity of cognitive fog and other neuropsychological assessments

1 week

1 visit (in-person)

Treatment

Participants receive CPAP treatment for sleep apnea

4 weeks

Weekly check-ins (virtual)

Follow-up

Participants are monitored for changes in cognitive fog and other neuropsychological outcomes

4-6 weeks

1 visit (in-person)

Treatment Details

Interventions

• Continuous positive airway pressure (CPAP)

Trial Overview The study observes if using CPAP (a machine that helps people breathe easier while they sleep) can improve 'brain fog' in patients who had COVID-19 and suffer from sleep apnea.

Participant Groups

Group I: Post COVID patient diagnosed with sleep apnea with AHI > 5 Experimental Treatment 1 Intervention

Patients with post COVID syndrome diagnosed with sleep apnea starting CPAP

Continuous positive airway pressure (CPAP) is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as CPAP for:

• Obstructive Sleep Apnea (OSA)

Approved in United States as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)

Approved in Canada as CPAP for:

• Obstructive Sleep Apnea (OSA)

Approved in Japan as CPAP for:

• Obstructive Sleep Apnea (OSA)

Who Is Running the Clinical Trial?

Venkatesh Krishnamurthy

Lead Sponsor

Trials

1

Recruited

20+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Breathe Pennsylvania

Collaborator

Trials

1

Recruited

20+