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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial targets individuals who have had COVID-19 and are experiencing sleep apnea, a condition where breathing repeatedly stops and starts during sleep. Researchers aim to determine if using a CPAP machine, which keeps airways open, can alleviate brain fog (trouble with thinking and concentration) in these patients. It suits those diagnosed with sleep apnea who continue to experience symptoms weeks after COVID-19. Participants should not have other major sleep disorders or recent changes in certain medications. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Do I need to stop taking my current medications to join the trial?

If you've started or changed the dosage of certain medications like corticosteroids, stimulants, or antidepressants in the past 30 days, you may not be eligible. The trial doesn't specify if you need to stop other medications, but it does require you to not be on active sleep apnea treatments like CPAP for two weeks before joining.

What prior data suggests that CPAP therapy is safe for post-COVID-19 patients with sleep apnea?

Research shows that Continuous Positive Airway Pressure (CPAP) is generally easy for people with sleep apnea to use. Studies have found that CPAP reduces symptoms like daytime sleepiness and fatigue, helping many people sleep better.

No major reports have specifically linked CPAP to problems. In fact, regular CPAP use in those with obstructive sleep apnea is associated with better health outcomes. For example, individuals who used CPAP for more than two years had a lower risk of serious COVID-19 complications compared to those who did not use it.

Overall, CPAP is considered a safe and effective way to manage sleep apnea. Knowing that CPAP has a strong safety record might boost confidence in participating in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using CPAP for sleep apnea in post-COVID-19 patients because it addresses a unique combination of conditions: the lingering effects of COVID-19 and sleep apnea. While CPAP is a standard treatment for sleep apnea, its application here is novel as it aims to alleviate sleep apnea symptoms specifically in individuals with post-COVID syndrome. This approach could potentially improve sleep quality and overall recovery for patients still experiencing COVID-related health issues. By targeting the disrupted breathing patterns common in both conditions, CPAP may offer a dual benefit, making it a promising option to explore further.

What evidence suggests that CPAP therapy is effective for improving cognitive fog in post-COVID-19 patients with sleep apnea?

Studies have shown that continuous positive airway pressure (CPAP) effectively treats obstructive sleep apnea by keeping airways open during sleep, reducing breathing interruptions. Research indicates that regular CPAP users sleep better and feel more alert during the day. Additionally, a study found that patients with sleep apnea who consistently used CPAP therapy experienced milder COVID-19 symptoms. Although specific data on post-COVID brain fog is limited, the overall benefits of CPAP for sleep apnea suggest it might help. In this trial, post-COVID patients diagnosed with sleep apnea will start CPAP therapy to evaluate its effects in this specific context. ^{1 2 4 6 7}

Who Is on the Research Team?

Venkatesh Krishnamurthy, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9138500/

Telemetric Assessment of Continuous Positive Airways ... Therefore, we examined the effectiveness of CPAP and adherence to the therapy of 149 adults with obstructive sleep apnea in the period of two years from 4 March ...

2. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1472176/full

Impact of obstructive sleep apnea on inpatient outcomes ... However, a study showed that patients with OSA who were adherent to CPAP therapy were less likely to experience a severer course of COVID-19 (16) ...

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11266

Patient experience of the use of continuous positive airway ... This study aims to understand the patient's experience of CPAP treatment, the use of telemedicine and patient engagement with these technologies.

4. journals.lww.com journals.lww.com/aotm/fulltext/2025/01000/tracking_continuous_positive_airway_pressure.4.aspx

Tracking continuous positive airway pressure adherence in... In our study, CPAP treatment adherence among OSA patients decreased significantly during the COVID-19 lockdown, and this decrease persisted during the ...

5. thelancet.com thelancet.com/journals/lanres/article/PIIS2213-2600(25)00002-5/abstract

Positive airway pressure therapy and all‐cause and ... We aimed to conduct a systematic review and meta-analysis to test the hypothesis that PAP therapy is associated with reduced all-cause and cardiovascular ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.70082

Moderate to Severe Obstructive Sleep Apnea Is a Risk ... Interestingly, the risk for severe COVID-19 was lower in those OSA patients using PAP treatment for more than 2 years compared to those with ...

7. mdpi.com mdpi.com/2075-1729/14/8/1052

Obstructive Sleep Apnea after COVID-19: An Observational ... The aim of this study is to evaluate the prevalence and associated factors of post-COVID-19 OSA in hospitalized adult patients from southeastern Romania.