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CPAP Efficacy in Post-COVID Patients With Sleep Apnea (BreathePA)

Primary Purpose

COVID-19, Sleep Apnea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous positive airway pressure
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients more than 18 years of age. Diagnosed with COVID-19 and continues to have persistent symptoms beyond 4 weeks. Diagnosed with sleep apnea based on a home sleep study Exclusion Criteria: Patients with Narcolepsy or other acute Primary sleep problems. Cognitive impairment secondary to neurodegenerative disorders and dementia. Acute exacerbation of psychiatric illness including severe depression, schizophrenia, or bipolar disorder. Any serious medical or neurological illness which prevents the participant from enrolling in the study. Serious illness or infection in the past 30 days. Patients on corticosteroids on a daily basis. Patients who are on any active treatment for sleep apnea including CPAP, dental device or implant for two weeks before enrolling in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Post COVID patient with AHI > 15

    Post COVID patients with AHI≤15

    Arm Description

    Patients with post COVID syndrome and moderate and more severe OSA will be compared with OSA patients with mild OSA

    Patients with post COVID syndrome and moderate and more severe OSA will be compared with OSA patients with mild OSA

    Outcomes

    Primary Outcome Measures

    Post COVID patients with moderate or severe OSA have more cognitive fog as compared to pts with mild OSA

    Secondary Outcome Measures

    Treatment of OSA in post COVID patients with moderate OSA decreases cognitive fog

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    September 21, 2023
    Sponsor
    University of Pittsburgh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06052514
    Brief Title
    CPAP Efficacy in Post-COVID Patients With Sleep Apnea
    Acronym
    BreathePA
    Official Title
    Efficacy of CPAP in Reducing Cognitive Fog in Post-COVID Patients With Sleep Apnea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pittsburgh

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    The overarching goal of this proposal is to evaluate the extent to which OSA may be a common, treatable comorbidity in post-COVID patients suffering from cognitive fog and whether addressing the sleep apnea may help these patients in resolving this distressing symptom. According to the World Health Organization (WHO), "post-COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset, with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis". It is estimated that up to 20 to 90% of post-COVID patients will have at least one persisting symptom that lasts for more than 4 months. According to the WHO, the most common symptoms include, but are not limited to shortness of breath (78%), fatigue (78%), and cognitive dysfunction (74%). It has serious economic consequences as 46% of patients were working on a reduced schedule and 23% left the workforce. Though the underlying pathology is thought to be a pan-inflammatory response, the etiology can be multifactorial. OSA is one of the possible etiologies as its symptoms and underlying inflammatory pathophysiology overlaps with that of post-COVID syndrome. Obstructive sleep apnea (OSA), a pulmonary disorder in which patients have stopping breathing episodically at night, is common, occurring in up to 60% of post-COVID-19 patients[5]. Patients with preexisting OSA have a 59% and 89% chance of developing post-COVID symptoms in men and women respectively. The intermittent 'stopping breathing' episodes, sleep fragmentation and intermittent hypoxia in patients with OSA triggers a persistent, chronic low-grade inflammation within the central nervous system leading to activation of microglia and astrocytes which in turn leads to synaptic loss, neuronal necrosis and apoptosis which manifests as cognitive deficits. Interestingly, post COVID syndrome presents with similar symptoms of difficulty breathing and cognitive fog, and is associated with a similar but independent, chronic inflammatory process in the central nervous system, leading to synaptic and neuronal loss and cognitive fog. When patients with pre-existing OSA have post COVID syndrome, there may be worsening of the cognitive fog because of synergistic increase in inflammatory responses. Further, treatment of sleep apnea with CPAP can improve cognitive fog as it could decrease the inflammatory response in post-COVID patients with sleep apnea. Hence, it is important to understand the relationship between the severity of OSA to the severity of cognitive fog, and if CPAP treatment can decrease the cognitive fog, thereby improve quality of life in post COVID patients. We propose to conduct a four-week longitudinal, observational pilot study in a sample of 30 patients with sleep apnea, recruited from the post COVID clinic over a period of one year. We will evaluate the severity of cognitive fog at baseline and change in cognitive fog with CPAP treatment from baseline to four weeks of follow up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, Sleep Apnea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Post COVID patient with AHI > 15
    Arm Type
    Experimental
    Arm Description
    Patients with post COVID syndrome and moderate and more severe OSA will be compared with OSA patients with mild OSA
    Arm Title
    Post COVID patients with AHI≤15
    Arm Type
    No Intervention
    Arm Description
    Patients with post COVID syndrome and moderate and more severe OSA will be compared with OSA patients with mild OSA
    Intervention Type
    Device
    Intervention Name(s)
    Continuous positive airway pressure
    Intervention Description
    Patients with moderate or severe OSA will be treated with CPAP
    Primary Outcome Measure Information:
    Title
    Post COVID patients with moderate or severe OSA have more cognitive fog as compared to pts with mild OSA
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Treatment of OSA in post COVID patients with moderate OSA decreases cognitive fog
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients more than 18 years of age. Diagnosed with COVID-19 and continues to have persistent symptoms beyond 4 weeks. Diagnosed with sleep apnea based on a home sleep study Exclusion Criteria: Patients with Narcolepsy or other acute Primary sleep problems. Cognitive impairment secondary to neurodegenerative disorders and dementia. Acute exacerbation of psychiatric illness including severe depression, schizophrenia, or bipolar disorder. Any serious medical or neurological illness which prevents the participant from enrolling in the study. Serious illness or infection in the past 30 days. Patients on corticosteroids on a daily basis. Patients who are on any active treatment for sleep apnea including CPAP, dental device or implant for two weeks before enrolling in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Venkatesh B Krishnamurthy
    Phone
    4126922880
    Email
    krishnamurthyvb@upmc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    CPAP Efficacy in Post-COVID Patients With Sleep Apnea

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