COVID-19BreathePANCT06052514
CPAP Efficacy in Post-COVID-19 Patients With Sleep Apnea
An observational study of COVID-19 and Sleep Apnea, run by Venkatesh Krishnamurthy at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19, Sleep Apnea
- What is being tested?
- Continuous positive airway pressure
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the post COVID clinic run by the Comprehensive lung Clinic at the Falk building, University of Pittsburgh.
Who may be able to join
- Patients more than 18 years of age.
- Diagnosed with COVID and continues to have persistent symptoms beyond 4 weeks.
- Diagnosed with sleep apnea based on a home sleep study
Who cannot join
- Patients with Narcolepsy or other acute Primary sleep problems.
- Cognitive impairment secondary to a neurodegenerative disorders and dementia.
- Acute exacerbation of psychiatric illness including severe depression, schizophrenia or bipolar disorder in the past 30 days.
- Serious medical or neurological illness or infection requiring hospitalization or unable to function in the past 30 days.
- Any medications that were started or change in dosage of the following medication in the past 30 days including: corticosteroids, stimulants, benzodiazepines/non benzodiazepine receptor agonists, antidepressants, antipsychotics or other medications which alter cognition.
- Patients who are on any active treatment for sleep apnea including CPAP, dental device or implant for two weeks before enrolling into the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Efficacy of CPAP in Reducing Cognitive Fog in Post-COVID Patients With Sleep Apnea
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.
Read the 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. Patients with preexisting OSA have a 59% and 89% chances 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.
The investigator proposes 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. The investigator 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.
- Conditions
- COVID-19, Sleep Apnea
- Being tested
- Continuous positive airway pressure
- Medical subject headings
- COVID-19, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Patients with moderate or severe OSA will be treated with CPAP
| Study group | Role | What they receive |
|---|---|---|
| Post COVID patient diagnosed with sleep apnea with AHI > 5 | Patients with post COVID syndrome diagnosed with sleep apnea starting CPAP Receives: Device: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Montreal Cognitive Assessment at 4-6 Weeks
Cognitive Fog as measured on Montreal Cognitive Assessment
Measured: Baseline, 4-6 Weeks
Secondary outcomes (9)
Change from Baseline Digit span backwards and sequential in at 4-6 Weeks
Neuropsychological assessment measuring attention, concentration and working memory as measured on Digit span backwards and sequential
Measured: Baseline, 4-6 Weeks
Change from Baseline in Trail making A and B test at 4-6 Weeks
Neuropsychological assessment measuring selective and divided attention, working memory, visuospatial skills and psychomotor performance as measured on Trail making A and B test
Measured: Baseline, 4-6 Weeks
Change from Baseline in Digit symbol substitution at 4-6 Weeks
Neuropsychological assessment measuring intelligence, response speed, sustained attention, visual spatial skills and set shifting as measured on Digit symbol substitution
Measured: Baseline, 4-6 Weeks
Change from Baseline in Benson complex figure at 4-6 Weeks
Neuropsychological assessment measuring visuospatial abilities, visual memory and executive abilities as measured on Benson complex figure
Measured: Baseline, 4-6 Weeks
Change from Baseline in Stroop color word test at 4-6 Weeks
Neuropsychological assessment measuring executive functions of selective and focused attention, cognitive flexibility and inhibition as measured on Stroop color word test
Measured: Baseline, 4-6 Weeks
Change from Baseline the psychomotor vigilance task (PVT) at 4-6 Weeks
Neuropsychological assessment measuring alertness, problem solving and psychomotor skills as measured on the psychomotor vigilance task (PVT)
Measured: Baseline, 4-6 Weeks
Change from Baseline Multilingual naming test (MINT) test at 4-6 Weeks
Neuropsychological assessment measuring naming impairment as measured on the Multilingual naming test (MINT)
Measured: Baseline, 4-6 Weeks
Change from Baseline Verbal fluency at 4-6 Weeks
Neuropsychological assessment measuring speeded word retrieval to phonemic cues as measured on Verbal fluency
Measured: Baseline, 4-6 Weeks
Change from Baseline Categorical fluency at 4-6 Weeks
Neuropsychological assessment measuring semantic memory as measured on Categorical fluency
Measured: Baseline, 4-6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start4 Jan 2024
- Primary completion21 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venkatesh Krishnamurthy
- Sponsor type
- University, hospital or other
- Collaborators
- Breathe Pennsylvania
- Responsible party
- Sponsor-investigator, Venkatesh Krishnamurthy, University of Pittsburgh
- Investigators
- Venkatesh Krishnamurthy, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052514
- Sponsor's protocol ID
- STUDY23070113
- Acronym
- BreathePA
- Status last verified
- Feb 2025
- First submitted
- 21 Sep 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of CPAP in Reducing Cognitive Fog in Post-COVID Patients With Sleep Apnea
- ClinicalTrials.gov ID
- NCT06052514
- Acronym / sponsor ID
- BreathePA / STUDY23070113
- Conditions
- COVID-19, Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Venkatesh KrishnamurthyUniversity, hospital or other
- Collaborators
- Breathe Pennsylvania
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Patients with preexisting OSA have a 59% and 89% chances 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.
The investigator proposes 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. The investigator 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post COVID patient diagnosed with sleep apnea with AHI > 5 | – | Device: Continuous positive airway pressurePatients with post COVID syndrome diagnosed with sleep apnea starting CPAP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the post COVID clinic run by the Comprehensive lung Clinic at the Falk building, University of Pittsburgh.
Key inclusion criteria (3 listed)
- Patients more than 18 years of age.
- Diagnosed with COVID and continues to have persistent symptoms beyond 4 weeks.
- Diagnosed with sleep apnea based on a home sleep study
Key exclusion criteria (6 listed)
- Patients with Narcolepsy or other acute Primary sleep problems.
- Cognitive impairment secondary to a neurodegenerative disorders and dementia.
- Acute exacerbation of psychiatric illness including severe depression, schizophrenia or bipolar disorder in the past 30 days.
- Serious medical or neurological illness or infection requiring hospitalization or unable to function in the past 30 days.
- Any medications that were started or change in dosage of the following medication in the past 30 days including: corticosteroids, stimulants, benzodiazepines/non benzodiazepine receptor agonists, antidepressants, antipsychotics or other medications which alter cognition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressurePatients with moderate or severe OSA will be treated with CPAP | Device | Post COVID patient diagnosed with sleep apnea with AHI > 5 |
Primary outcome
Change from Baseline in Montreal Cognitive Assessment at 4-6 Weeks
Time frame: Baseline, 4-6 Weeks
Cognitive Fog as measured on Montreal Cognitive Assessment
9 secondary outcomes
Change from Baseline Digit span backwards and sequential in at 4-6 Weeks
Time frame: Baseline, 4-6 Weeks
Change from Baseline in Trail making A and B test at 4-6 Weeks
Time frame: Baseline, 4-6 Weeks
Change from Baseline in Digit symbol substitution at 4-6 Weeks
Time frame: Baseline, 4-6 Weeks
Change from Baseline in Benson complex figure at 4-6 Weeks
Time frame: Baseline, 4-6 Weeks
Change from Baseline in Stroop color word test at 4-6 Weeks
Time frame: Baseline, 4-6 Weeks
Change from Baseline the psychomotor vigilance task (PVT) at 4-6 Weeks
Time frame: Baseline, 4-6 Weeks
Change from Baseline Multilingual naming test (MINT) test at 4-6 Weeks
Time frame: Baseline, 4-6 Weeks
Change from Baseline Verbal fluency at 4-6 Weeks
Time frame: Baseline, 4-6 Weeks
Change from Baseline Categorical fluency at 4-6 Weeks
Time frame: Baseline, 4-6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkatesh Krishnamurthy, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Sleep Apnea, run by Venkatesh Krishnamurthy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Montreal Cognitive Assessment at 4-6 Weeks (time frame: Baseline, 4-6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.