Predictors of Post-COVID Clinical and Cognitive Consequences

Obstructive Sleep Apnea Clinical Trial

— SCLC  

Official title:

Predictors of Post-COVID Clinical and Cognitive Consequences

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291870
• Other study ID #: F4396-P
• Secondary ID: IRB-22-01-4294
• Status: Recruiting
• Start date: January 19, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: Ruchi Rastogi, MS
• Phone: (313) 576-4464
• Email: ruchi.rastogi[@]va.gov
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2025
• Est. primary completion date: July 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	John D. Dingell VA Medical Center, Detroit, MI	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	John D. Dingell VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	PROMISE Sleep Disturbance	Sleep disturbance short form assesses sleep disturbance over the past seven days.	Change from baseline at 3 months
Primary	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
Primary	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
Primary	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
Primary	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