Predictors of Post-COVID-19 Clinical and Cognitive Consequences

NCT06291870 | Recruiting DMC

• 2 other identifiers: F4396-PIRB-22-01-4294
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COVID-19; Quality of Life; Neurocognitive Function; Sleepiness; Sleep Quality; Six minute walk; Fatigue

Outcome Measures

Primary Outcomes (19)

• 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.

  Change from baseline at 3 months

• 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.

  Change from baseline at 3 months

• 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.

  Change from baseline at 3 months

• 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.

  Change from baseline at 3 months

• Neurocognitive function WASI

  Abbreviated Wechsler Abbreviated Scale of Intelligence (WASI) will be administered to evaluate verbal comprehension 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.

  Change from baseline at 3 months

• Neurocognitive function WMS

  Wechsler Memory test (WMS) will be administered to measure Verbal comprehension, and working and visual memory. Scored on a Standard scale of 100 +/- 15, where a higher score is a better outcome.

  Change from baseline at 3 months

• Neurocognitive function PVT

  Psychomotor Vigilance Test (PVT) will be administered to measure Alertness and vigilance, in terms of number of lapses and reaction time. The performance score ranges from 0-100, where a higher value is a better outcome.

  Change from baseline at 3 months

• Neurocognitive function HVLT-R

  Hopkins Verbal Learning Test - Revised (HVLT-R) will be administered to evaluate Verbal learning and memory. Scored on a Standard scale of 100 +/- 15, where a higher score is a better outcome.

  Change from baseline at 3 months

• Sleepiness ESS

  Epworth sleepiness scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates greater degree of sleepiness.

  Change from baseline at 3 months

• Sleep quality PSQI

  Pittsburgh Sleep Quality Index (PSQI) is a detailed assessment of subject sleep quality over the most recent month by considering seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score to assess sleep quality on a scale of "poor" to "good".

  Change from baseline at 3 months

• Quality of life SF-36v2

  QoL will be assessed using the survey SF-36v2 Health survey. Thirty-five of the SF-36v2 items are used to measure eight domains of health-related quality of life. These are on a scale of 0-100, where higher values indicate a better outcome.

  Change from baseline at 3 months

• Quality of life FOSQ

  Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire FOSQ/(FOSQ). There are 5 subscale domains of the FOSQ (General Productivity, Social Outcome, Activity Level, Vigilance, and Intimate Relationships and Sexual Activity). There all range from 0-20, where a higher value is a better outcome. The total FOSQ is the sum of these subscale domains and ranges from 0-100, where a higher value is a better outcome.

  Change from baseline at 3 months

• Quality of life SGRQ

  Disease specific QoL will be assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ has three subscale domains (Symptoms, Activity, and Impacts), which range from 0-100, where a higher value indicates a worse outcome. The total SGRQ is the average of these subscale domains and is on a scale of 0-100, where a higher value is a worse outcome.

  Change from baseline at 3 months

• Fatigue Severity

  Fatigue Severity Scale (FSS): FSS measures how fatigue affects motivation, exercise, physical functioning, carrying out duties, interfering with work, family, or social life. Where a higher value is a worse outcome.

  Change from baseline at 3 months

• PROMISE Sleep Disturbance

  Sleep disturbance short form assesses sleep disturbance over the past seven days.

  Change from baseline at 3 months

• Horne and Osteberg Morningness/Eveningness Questionnaire

  Morningness/Eveningness Questionnaire measures the degree of which respondents are active and alert at certain times of the day. Scale is 1 to 5.

  Change from baseline at 3 months

• Mini Mental State Examination (MMSE)

  Mini Mental State Examination (MMSE) is a simple way to quantify cognitive function and screen for cognitive loss. This score is on a scale of 0-30, a larger value is a better outcome.

  Change from baseline at 3 months

• Borg Scale

  This measures the level of dyspnea during the 6 minute walk test. It is on a scale of 0-10, where a larger value is a worse outcome.

  Change from baseline at 3 months

• Dyspnea: Six-minute walk test (6MWT) distance

  Participants are instructed to achieve maximal distance. There is no scale, but a larger value is a better outcome.

  Change from baseline at 3 months

Study Arms (2)

COVID+

Patients with post-acute sequelae of SARS-COV-2 infection (PSAC) and obstructive sleep apnea (OSA)

Control

Patients with obstructive sleep apnea and no history of COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• John D. Dingell VA Medical Center: collaborator

Study Sites (1)

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201-1916, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood ApoE

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Sleep Apnea, Obstructive; COVID-19; Sleepiness; Sleep Initiation and Maintenance Disorders; Fatigue

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms; Mental Disorders

Study Officials

• Susmita Chowdhuri, MD MS

  John D. Dingell VA Medical Center, Detroit, MI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruchi Rastogi, MS

CONTACT

(313) 576-4464; ruchi.rastogi@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 4, 2024
• Study Start: January 19, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)