Official Title
Predictors of Post-COVID Clinical and Cognitive Consequences
Brief Summary

The CDC describes Post-acute sequelae of SARS-COV-2 infection (PASC) for the wide rangeof physical and mental health consequences experienced by some patients. These sequelaemay be present four or more weeks after SARS-COV-2 infection, including patients who hadinitial mild or asymptomatic acute infection. However, there is complete absence of datawhether chronic sleep changes due to COVID-19 infection may influence these physical andmental health consequences. While fatigue is one of the common post-COVID conditions,there are no systematic examinations of sleep disturbances in COVID-19 survivors. Thiswill be a pilot observational retrospective and prospective cohort study, tosystematically assess if sleep disturbances and severity of sleep apnea comprise amodifiable facet of PASC as well as the short-term and longer-term effects of COVID-19infection 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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States

Investigator: Ruchi Rastogi, MS
Contact: 313-576-4464
ruchi.rastogi@va.gov

Investigator: Susmita Chowdhuri, MD MS

Contacts

Ruchi Rastogi, MS
(313) 576-4464
ruchi.rastogi@va.gov

Susmita Chowdhuri, MD MS, Principal Investigator
John D. Dingell VA Medical Center, Detroit, MI

John D. Dingell VA Medical Center
NCT Number
Keywords
Covid-19
Quality of Life
Neurocognitive Function
Sleepiness
sleep quality
Six minute walk
Fatigue
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome
Sleep Apnea, Obstructive