NCT06291870

Predictors of Post-COVID-19 Clinical and Cognitive Consequences

Predictors of Post-COVID Clinical and Cognitive Consequences

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post Acute Sequelae of SARS CoV 2 Infection
• Obstructive Sleep Apnea

Timeline

• Start date: 2023-01-19
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-03-04
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States