Clinical trial NCT05764096: Executive Functioning and Sleep Fragmentation in COVID-19 Patients
Official title: Executive Functioning and Sleep Fragmentation in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Healthy Volunteers
Keywords: COVID-19;executive functioning;quality of sleep
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Istituto Universitario di Studi Superiori Pavia
First posted: 2023-03-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

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

Primary outcomes:
measure: Executive/Inhibitory skills
timeFrame: Assessment day
Secondary outcomes:
measure: Risk of sleep-disordered breathing
timeFrame: Assessment day
measure: Severity of nighttime and daytime components of insomnia
timeFrame: Assessment day
measure: Sleepiness
timeFrame: Assessment day
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri SpA
state: Ita
Study officials:
References: