Executive Functioning and Sleep Fragmentation in COVID-19 Patients

March 20, 2024 updated by: Istituti Clinici Scientifici Maugeri SpA

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Assessment day
Performance in a GoNogo task
Assessment day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborators

Istituto Universitario di Studi Superiori Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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