Predictors of Post-COVID-19 Clinical and Cognitive Consequences
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
The CDC describes Post-acute sequelae of SARS-COV-2 infection (PASC) for the wide range of physical and mental health consequences experienced by some patients. These sequelae may be present four or more weeks after SARS-COV-2 infection, including patients who had initial mild or asymptomatic acute infection. However, there is complete absence of data whether chronic sleep changes due to COVID-19 infection may influence these physical and mental health consequences. While fatigue is one of the common post-COVID conditions, there are no systematic examinations of sleep disturbances in COVID-19 survivors. This will be a pilot observational retrospective and prospective cohort study, to systematically assess if sleep disturbances and severity of sleep apnea comprise a modifiable facet of PASC as well as the short-term and longer-term effects of COVID-19 infection itself on sleep, cognitive function, exercise capacity and lung function.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All individuals 18 years or older, with prior history of COVID-19 infection diagnosis
Both genders including all racial and ethnic groups
Patients with OSA (apnea hypopnea index of 5/hour on polysomnography) with history of COVID-19 infection will be eligible with prior history of COVID-19 infection and without COVID-19 for Aim 2
Disqualifiers
Inability to give consent
Active suicidal symptoms
Children of all ages
Pregnant women
Trial population
The investigators will include all individuals 18 years or older, both genders, all racial and ethnic groups, with diagnosis of COVID-19 infection, diagnosed using any validated antigen detection test and/or polymerase chain reaction (PCR) test and of any severity level of COVID. Eligible patients with COVID-19 history of infection should be at least 1 month after the diagnosis of COVID-19 and should have been discharged to home if admitted to an acute care facility. COVID-19 antigen test positive patients who were completely asymptomatic at the time of COVID positive testing will be excluded. Controls will be patients without history of COVID-19 infection and age 18 years or older. In addition, patients with OSA (apnea hypopnea index = of 5/hour on polysomnography) with history of COVID-19 infection will be eligible for Aim 2.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: COVID+
Group B: Control
Trial outcomes
Primary outcomes
1
Neurocognitive function Trails A and Trails B
Trails A and Trails B test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Time frame
Change from baseline at 3 months2
Neurocognitive function PASAT
PASAT (Paced Auditory Serial Addition Test) will be administered to evaluate vigilance and executive function. The PASAT is recorded as the total number of correct responses (from 0-60), or the percent of correct responses out of 60 (from 0-100), where a higher value is a better outcome.
Time frame
Change from baseline at 3 months3
Neurocognitive function Stroop color-word interference
Stroop color-word interference test will be administered to evaluate executive function. This score is adjusted for age, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Time frame
Change from baseline at 3 months4
Neurocognitive function DIGIT
DIGIT test will be administered to evaluate short-term and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Time frame
Change from baseline at 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
John D. Dingell VA Medical Center
Collaborator
Source ClinicalTrials.gov