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Clinical Trials/NCT05764096
NCT05764096
Completed
Not Applicable

Executive Functioning and Sleep Fragmentation in COVID-19 Patients

Istituti Clinici Scientifici Maugeri SpA1 site in 1 country76 target enrollmentJune 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Enrollment
76
Locations
1
Primary Endpoint
Executive/Inhibitory skills
Status
Completed
Last Updated
2 years ago

Overview

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?

Detailed Description

While impaired executive functioning has been often reported in association with COVID-19 contagion, it is still unclear whether, and to what extent, executive deficits might be explained by an altered quality of sleep, that been also frequently reported in COVID-19 patients. On this basis, this project aims to investigate executive functioning abilities (primary outcome) in patients hospitalized for a COVID-19 contagion, while distinguishing between those with and without sleep fragmentation (quality of sleep; secondary outcome), compared with an age- and education matched control group of healthy individuals who did not experience contagion. To this purpose, 38 COVID-19 patients and 38 healthy controls will be administered questionnaires and cognitive tasks aimed to assess: a) executive functioning/inhibitory control (GoNogo task); b) quality of sleep (NOSAS; Insomnia Severity Index; Epworth sleepiness scale). Prefrontal electrical activity will be recorded with EEG in COVID-19 patients, and related to sleep and cognitive-executive metrics. Statistical analyses will be aimed to investigate: a) a possible decrease of executive skills in COVID-19 patients compared with healthy controls, and in COVID-19 patients with fragmented sleep compared with those with normal sleep; b) possible differences in the relationship between executive performance and quality of sleep across the three experimental groups; c) whether possible differences in such relationship relate to prefrontal brain activity in patients. The results of this study will provide novel insights into the consequences of COVID-19 at the cognitive level, thus informing about treatment strategies.

Registry
clinicaltrials.gov
Start Date
June 12, 2020
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • current or past neuro-psychiatric disorder
  • current or past sleep disorder

Outcomes

Primary Outcomes

Executive/Inhibitory skills

Time Frame: Assessment day

Performance in a GoNogo task

Secondary Outcomes

  • Risk of sleep-disordered breathing(Assessment day)
  • Sleepiness(Assessment day)
  • Severity of nighttime and daytime components of insomnia(Assessment day)

Study Sites (1)

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