BreathePA: CPAP Efficacy in Post-COVID Patients With Sleep Apnea

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06052514
Collaborator
(none)
30
2
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Continuous positive airway pressure
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of CPAP in Reducing Cognitive Fog in Post-COVID Patients With Sleep Apnea
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Post COVID patient with AHI > 15

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

Device: Continuous positive airway pressure
Patients with moderate or severe OSA will be treated with CPAP

No Intervention: Post COVID patients with AHIā‰¤15

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

Outcome Measures

Primary Outcome Measures

  1. Post COVID patients with moderate or severe OSA have more cognitive fog as compared to pts with mild OSA [1 year]

Secondary Outcome Measures

  1. Treatment of OSA in post COVID patients with moderate OSA decreases cognitive fog [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Venkatesh Krishnamurthy, MD, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT06052514
Other Study ID Numbers:
  • STUDY23070113
First Posted:
Sep 25, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2023