Executive Functioning and Sleep Fragmentation in COVID-19 Patients

COVID-19 Clinical Trial

Official title:

Executive Functioning and Sleep Fragmentation in COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05764096
• Other study ID #: 2439
• Status: Completed
• Start date: June 12, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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 information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Healthy Volunteers
• Sleep Deprivation

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri SpA	Pavia	Ita

Sponsors (2)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA	Istituto Universitario di Studi Superiori Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive/Inhibitory skills	Performance in a GoNogo task	Assessment day
Secondary	Risk of sleep-disordered breathing	NOSAS (Neck, Obesity, Snoring, Age, Sex)	Assessment day
Secondary	Severity of nighttime and daytime components of insomnia	Insomnia Severity Index	Assessment day
Secondary	Sleepiness	Epworth Sleepiness Scale	Assessment day