Clinical trial NCT06291870: Predictors of Post-COVID-19 Clinical and Cognitive Consequences
Official title: Predictors of Post-COVID Clinical and Cognitive Consequences
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Acute Sequelae of SARS CoV 2 Infection
Obstructive Sleep Apnea
Keywords: COVID-19
Quality of Life
Neurocognitive Function
Sleepiness
Sleep Quality
Six minute walk
Fatigue
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: John D. Dingell VA Medical Center
First posted: 2024-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: This pilot study will systematically collect data to assess if sleep disturbances and severity of sleep apnea comprises a modifiable facet of PASC. This study will be the first step towards collecting preliminary data for a larger, longer-duration and more comprehensive study regarding the relationships between long-COVID and sleep disturbances which can inform future healthcare strategies and clinical decision-making. The study will also explore whether inflammatory biomarkers levels during acute COVID infection predict severity and duration of long-COVID or PASC and sleep fragmentation post-COVID.

Objectives: The overall goal of this project is to determine the associations between chronic post-COVID fatigue and sleep duration and sleep quality in patients after recovery from SARS-CoV-2 infection. The investigators have adopted the CDC definition for Post-COVID Conditions which persist for four or more weeks after SARS-CoV-2 infection and also is known as Post-Acute Sequelae of SARS-COV-2 infection (PASC).

Specific Aim 1: Determine associations between sleep duration and sleep quality on PASC-related fatigue symptoms, cognitive function, biomarker levels and vigilance.

Specific Aim 2. Determine if presence of obstructive sleep apnea (OSA) and level of PAP adherence during and prior to COVID-9 infection in patients with OSA predicts PASC- related fatigue, cognitive function and quality of life (QoL).

Exploratory Aim: Determine whether partial or full/booster vaccinations with COVID-19 mRNA vaccine vs. no vaccination has an impact on chronic post-COVID fatigue and sleep disturbances.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Inability to give consent
* Active suicidal symptoms
* Children of all ages
* Pregnant women

Primary outcomes:
measure: Neurocognitive function Trails A and Trails B
timeFrame: Change from baseline at 3 months
measure: Neurocognitive function PASAT
timeFrame: Change from baseline at 3 months
measure: Neurocognitive function Stroop color-word interference
timeFrame: Change from baseline at 3 months
measure: Neurocognitive function DIGIT
timeFrame: Change from baseline at 3 months
measure: Neurocognitive function WASI
timeFrame: Change from baseline at 3 months
measure: Neurocognitive function WMS
timeFrame: Change from baseline at 3 months
measure: Neurocognitive function PVT
timeFrame: Change from baseline at 3 months
measure: Neurocognitive function HVLT-R
timeFrame: Change from baseline at 3 months
measure: Sleepiness ESS
timeFrame: Change from baseline at 3 months
measure: Sleep quality PSQI
timeFrame: Change from baseline at 3 months
measure: Quality of life SF-36v2
timeFrame: Change from baseline at 3 months
measure: Quality of life FOSQ
timeFrame: Change from baseline at 3 months
measure: Quality of life SGRQ
timeFrame: Change from baseline at 3 months
measure: Fatigue Severity
timeFrame: Change from baseline at 3 months
measure: PROMISE Sleep Disturbance
timeFrame: Change from baseline at 3 months
measure: Horne and Osteberg Morningness/Eveningness Questionnaire
timeFrame: Change from baseline at 3 months
measure: Mini Mental State Examination (MMSE)
timeFrame: Change from baseline at 3 months
measure: Borg Scale
timeFrame: Change from baseline at 3 months
measure: Dyspnea: Six-minute walk test (6MWT) distance
timeFrame: Change from baseline at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center, Detroit, MI
state: Michigan
Study officials:
affiliation: John D. Dingell VA Medical Center, Detroit, MI
name: Susmita Chowdhuri, MD MS
role: PRINCIPAL_INVESTIGATOR
References: