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Procedure

CPAP for Sleep Apnea in Post-COVID-19 Patients (BreathePA Trial)

N/A
Recruiting
Led By Venkatesh Krishnamurthy, MD
Research Sponsored by Venkatesh Krishnamurthy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients more than 18 years of age.
Diagnosed with COVID-19 and continues to have persistent symptoms beyond 4 weeks.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4-6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how treating sleep apnea can help reduce brain fog in people who had COVID-19.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
CPAP side effects may include discomfort, nasal congestion, dry mouth, skin irritation, headaches, and sometimes stomach bloating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.
Select...
I have had COVID-19 symptoms for more than 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4-6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Montreal Cognitive Assessment at 4-6 Weeks
Secondary study objectives
Change from Baseline Categorical fluency at 4-6 Weeks
Change from Baseline Digit span backwards and sequential in at 4-6 Weeks
Change from Baseline Multilingual naming test (MINT) test at 4-6 Weeks
+6 more

Side effects data

From 2020 Phase 4 trial • 74 Patients • NCT01807897
16%
Increased dyspnea
6%
Excessive sleepiness
3%
Stroke
3%
Bronchitis
3%
Heart failure
3%
Fall
3%
Pneumonia
3%
Toothache
3%
Skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
CPAP
Oxygen
HLSE

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Post COVID patient diagnosed with sleep apnea with AHI > 5Experimental Treatment1 Intervention
Patients with post COVID syndrome diagnosed with sleep apnea starting CPAP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous positive airway pressure
2013
Completed Phase 4
~1630

Find a Location

Who is running the clinical trial?

Breathe PennsylvaniaUNKNOWN
Venkatesh KrishnamurthyLead Sponsor
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,593 Total Patients Enrolled
~3 spots leftby Jan 2025