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Recruiting NCT06291870

Predictors of Post-COVID-19 Clinical and Cognitive Consequences

— Observational Post Acute Sequelae of SARS CoV 2 Infection Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Post Acute Sequelae of SARS CoV 2 Infection, Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Predictors of Post-COVID Clinical and Cognitive Consequences

Overview

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.

Primary outcome measures

  • Neurocognitive function Trails A and Trails B [Time frame: Change from baseline at 3 months]
  • Neurocognitive function PASAT [Time frame: Change from baseline at 3 months]
  • Neurocognitive function Stroop color-word interference [Time frame: Change from baseline at 3 months]
  • Neurocognitive function DIGIT [Time frame: Change from baseline at 3 months]
  • Neurocognitive function WASI [Time frame: Change from baseline at 3 months]
  • Neurocognitive function WMS [Time frame: Change from baseline at 3 months]
  • Neurocognitive function PVT [Time frame: Change from baseline at 3 months]
  • Neurocognitive function HVLT-R [Time frame: Change from baseline at 3 months]
  • Sleepiness ESS [Time frame: Change from baseline at 3 months]
  • Sleep quality PSQI [Time frame: Change from baseline at 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • John D. Dingell VA Medical Center, Detroit, MI — Detroit

Identifiers

NCT: NCT06291870 · F4396-P · IRB-22-01-4294

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗