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Executive Functioning and Sleep Fragmentation in COVID-19 Patients

Executive Functioning and Sleep Fragmentation in COVID-19 Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05764096
Enrollment
76
Registered
2023-03-10
Start date
2020-06-12
Completion date
2023-12-31
Last updated
2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Healthy Volunteers

Keywords

COVID-19;executive functioning;quality of sleep

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Istituto Universitario di Studi Superiori Pavia
CollaboratorOTHER
Istituti Clinici Scientifici Maugeri SpA
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Executive/Inhibitory skillsAssessment dayPerformance in a GoNogo task

Secondary

MeasureTime frameDescription
Risk of sleep-disordered breathingAssessment dayNOSAS (Neck, Obesity, Snoring, Age, Sex)
Severity of nighttime and daytime components of insomniaAssessment dayInsomnia Severity Index
SleepinessAssessment dayEpworth Sleepiness Scale

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026