Executive Functioning and Sleep Fragmentation in COVID-19 Patients
- Conditions
- COVID-19Healthy Volunteers
- Interventions
- Other: No intervention
- Registration Number
- NCT05764096
- Lead Sponsor
- Istituti Clinici Scientifici Maugeri SpA
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- 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.
- current or past neuro-psychiatric disorder
- current or past sleep disorder
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 patients No intervention 38 patients admitted to the intensive care unit due to COVID-19 contagion Healthy control participants No intervention An age- and education-matched group of 38 healthy individuals who did not report a previous COVID-19 contagion
- Primary Outcome Measures
Name Time Method Executive/Inhibitory skills Assessment day Performance in a GoNogo task
- Secondary Outcome Measures
Name Time Method Risk of sleep-disordered breathing Assessment day NOSAS (Neck, Obesity, Snoring, Age, Sex)
Sleepiness Assessment day Epworth Sleepiness Scale
Severity of nighttime and daytime components of insomnia Assessment day Insomnia Severity Index
Trial Locations
- Locations (1)
Istituti Clinici Scientifici Maugeri SpA
🇮🇹Pavia, Ita, Italy