Executive Functioning and Sleep Fragmentation in COVID-19 Patients
1 other identifier
observational
76
1 country
1
Brief Summary
This project aims to investigate executive functioning abilities (primary outcome) and quality of sleep (secondary outcome) in patients with COVID-19 (while distinguishing between those with and without sleep fragmentation), compared with an age- and education matched control group of healthy individuals who did not experience contagion. Prefrontal electrical activity will be recorded with EEG in patients, and related to sleep and cognitive-executive metrics. The main questions it aims to answer are:
- is executive functioning impaired in COVID-19 patients compared with individuals who were not infected?
- is there a relationship between altered sleep and impaired executive functioning in COVID-19 patients?
- is such relationship related to altered prefrontal brain activitity in COVID-19 patients?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2020
CompletedFirst Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 22, 2024
March 1, 2023
3.6 years
March 7, 2023
March 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Executive/Inhibitory skills
Performance in a GoNogo task
Assessment day
Secondary Outcomes (3)
Risk of sleep-disordered breathing
Assessment day
Severity of nighttime and daytime components of insomnia
Assessment day
Sleepiness
Assessment day
Study Arms (2)
COVID-19 patients
38 patients admitted to the intensive care unit due to COVID-19 contagion
Healthy control participants
An age- and education-matched group of 38 healthy individuals who did not report a previous COVID-19 contagion
Interventions
Eligibility Criteria
38 patients admitted to the intensive care unit due to COVID-19 contagion, plus an age- and education-matched group of 38 healthy individuals who did not report a previous COVID-19 contagion
You may qualify if:
- For patients: current contagion from COVID-19
- For patients and controls:
- age\>18 years
- absence of clinical conditions, cognitive and sensory deficits, and severe psychiatric disorders that would impair participation in research identified through clinical history.
You may not qualify if:
- current or past neuro-psychiatric disorder
- current or past sleep disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituti Clinici Scientifici Maugeri SpA
Pavia, Ita, 27100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
March 10, 2023
Study Start
June 12, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
March 22, 2024
Record last verified: 2023-03