Executive Functioning and Sleep Fragmentation in COVID-19 Patients

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?

Study Overview

• Status: Completed
• Conditions: COVID-19; Healthy Volunteers
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Italy
  • Ita
    • Pavia, Ita, Italy, 27100
      • Istituti Clinici Scientifici Maugeri SpA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 patients; 38 patients admitted to the intensive care unit due to COVID-19 contagion	Other: No intervention; No intervention
Healthy control participants; An age- and education-matched group of 38 healthy individuals who did not report a previous COVID-19 contagion	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive/Inhibitory skills	Performance in a GoNogo task	Assessment day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of sleep-disordered breathing	NOSAS (Neck, Obesity, Snoring, Age, Sex)	Assessment day
Severity of nighttime and daytime components of insomnia	Insomnia Severity Index	Assessment day
Sleepiness	Epworth Sleepiness Scale	Assessment day

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Collaborators: Istituto Universitario di Studi Superiori Pavia

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19;executive functioning;quality of sleep
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Dyssomnias; Sleep Wake Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; COVID-19; Sleep Deprivation
• Other Study ID Numbers: 2439 (Inselspital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Requests for sharing will assessed case by case, and data will be made available on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No