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OpenTrials
Completed

NCT Number: NCT05764096

Executive Functioning and Sleep Fragmentation in COVID-19 Patients

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituti Clinici Scientifici Maugeri SpA

Pavia, Ita, 27100, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Executive/Inhibitory skills

    Time frame: Assessment day

    Performance in a GoNogo task

Secondary outcomes

  1. Risk of sleep-disordered breathing

    Time frame: Assessment day

    NOSAS (Neck, Obesity, Snoring, Age, Sex)

  2. Severity of nighttime and daytime components of insomnia

    Time frame: Assessment day

    Insomnia Severity Index

  3. Sleepiness

    Time frame: Assessment day

    Epworth Sleepiness Scale

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

  • Istituto Universitario di Studi Superiori Pavia

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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