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.
acute (symptom onset to admission <1 days) ischemic stroke
ischemic stroke affecting the branches of anterior cerebral artery, middle cerebral artery and posterior cerebral artery
age 18-80 years
moderate or severe stroke (National Institutes of Health Stroke Scale, NIHSS>=5)
secondary parenchymal hemorrhage (>hemorrhage index -2)
clinically unstable or life-threatening conditions
known progressive neurological diseases
known psychiatric diseases
Participants will be recruited from the patients with confirmed acute ischemic stroke admitted to the Stroke Unit
Cohort
Other
No intervention is planned
Other interventionNo intervention is planned
Change 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
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)
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
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
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
Sleepiness assessed by Epworth Sleepiness Scale
a common tool to assess sleepiness; 0-24 points, higher score indicate greater sleepiness
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
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
sleep-related respiratory characteristics: apnea-hypopnea index
assessed by routine polygraphy: apnea-hypopnea index (higher values indicate greater severity; \<5 episodes/h - normal, \>=5 episodes/h - pathological)
sleep-related respiratory characteristics: oxygen desaturation index
assessed by routine polygraphy: oxygen desaturation index (higher values indicate greater severity; \<5 episodes/h - normal, \>=5 episodes/h - pathological)
sleep-related respiratory characteristics: time under oxygen saturation <90%
assessed by routine polygraphy: time under oxygen saturation \<90% (higher values indicate greater severity), in minutes
sleep-related respiratory characteristics: average oxygen saturation
assessed by routine polygraphy: average oxygen saturation (lower values indicate greater severity), in %
Click on the lead sponsor to view all of their trials.
