The study is aimed at the investigation of the association of biomarkers of circadian rhythms with sleep characteristics and stroke outcome in acute stroke patients. It is designed as an observational cohort study with the retrospective and prospective longitudinal arms.
In the retrospective arm of the study, the routinely collected data of patients admitted to the stroke unit with acute ischemic stroke (from 2018 till 2022) will be evaluated. In the prospective longitudinal arm, about 200-250 patients admitted to the Stroke Unit of one participating center will undergo examination including the assessment of medical records, stroke characteristics, sleep characteristics and blood sampling for the evaluation of genetic biomarkers of circadian rhythms within the first 2-3 days after admission.The assessment of stroke severity and functional deficit will be repeated at 10-14 days after stroke. The following associations will be assessed: * the association of genetic biomarkers of circadian rhythms with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke), with stroke characteristics (stroke subtype and neuroimaging stroke parameters) and with sleep characteristics. * the association of sleep characteristics with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke) and with stroke characteristics (stroke subtype and neuroimaging stroke parameters).
Study Type
OBSERVATIONAL
Enrollment
250
No intervention is planned
Almazov National Medical Research Centre
Saint Petersburg, Russia
RECRUITINGChange in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion
National Institutes of Health Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke, 0-42 scores, higher scores characterize worse impairment
Time frame: From baseline to 14th day after treatment initiation
Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14th day after treatment initiation
values of modified Rankin scale (scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke, from 0 (no symptoms) to 6 (dead) points)
Time frame: From baseline to 14th day after treatment initiation
Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14th day after treatment initiation
a standardized scale used to assess mobility in patients with neurological deficits, a maximum of 15 points is possible; higher scores indicate better mobility performance
Time frame: From baseline to 14th day after treatment initiation
Stroke-related disability assessed by the change in Barthel Index from baseline to 14th day after treatment initiation
a common scale used to measure performance in activities of daily living, 0-100 scores, higher scores define better performance
Time frame: From baseline to 14th day after treatment initiation
Sleep quality assessed by Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index is a self-rated questionnaire which assesses sleep quality and disturbances over the last (previous) 1-month (a retrospective assessment) time interval, Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score indicating worse sleep quality
Time frame: Baseline
Sleepiness assessed by Epworth Sleepiness Scale
a common tool to assess sleepiness; 0-24 points, higher score indicate greater sleepiness
Time frame: Baseline
Fatigue assessed by Fatigue severity Scale
a common 9-item tool used to determine and quantify fatigue as subjective feeling of exhaustion, persisting lack of energy and rapid inanition, 9-63 points, higher score indicates more severe fatigue
Time frame: Baseline
Insomnia assessed by Insomnia severity index
a 7-item tool to assess the severity of insomnia, 0-5 points per each item, higher score indicates more severe insomnia
Time frame: Baseline
Chronotype assessed by Morningness-Eveningness Questionnaire
a common 19-item tool to estimate individual chronotype, a score ranging from 16 to 86; scores of 41 and below indicate "evening types", scores of 59 and above indicate "morning types", scores between 42-58 indicate "intermediate types"
Time frame: Baseline
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