There is a lack of complex studies which could establish the association between genetic circadian factors with the features and short-term outcomes of ischemic stroke, as well as the effects of various auxiliary therapies for circadian rhythm modulation for neuroplasticity enhancement and improvement of short-term outcomes in ischemic stroke. The main research hypothesis is that circadian factors influence the recovery from ischemic stroke via sleep-mediated regulation of synaptic plasticity. The project aims at the investigation of the influence of combined melatonin therapy and blue light exposure on molecular circadian biomarkers, sleep characteristics, neuroplasticity markers and stroke outcome in acute stroke patients. This study is a prospective, interventional, randomized placebo-controlled trial.
The study will investigate the influence of combined blue light exposure and melatonin therapy on molecular biomarkers of circadian rhythms, sleep characteristics and stroke outcome in acute stroke patients This study is designed as a prospective study in acute stroke patients (approx 80 patients) admitted to the Stroke Unit. After initial assessment, the participants will be randomly assigned in 4 groups (the treatment or control) with approx.20 participants in each group. In all participants, the following parameters will be assessed: medical records, stroke characteristics, sleep characteristics, cardiovascular circadian rhythms and blood samples for the evaluation of circadian molecular biomarkers at baseline and 14 days after inclusion. Stroke outcomes will be reassessed at 3-month follow-up. The following associations will be assessed: * the role of blue light exposure and melatonin treatment for stroke outcome * the role of blue light exposure and melatonin treatment in the modulation of sleep parameters in acute stroke * the association of molecular biomarkers of circadian rhythms with stroke outcome (the difference in neurological and functional deficit from admission to 14 and 90 days after study inclusion), with stroke characteristics (stroke subtype and neuroimaging stroke parameters, routine protocol) and with sleep characteristics. * the association of sleep characteristics with stroke outcome (the difference in neurological and functional deficit from admission to 14 and 90 days after stroke) and with stroke characteristics (stroke subtype and neuroimaging stroke parameters, routine protocol).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
3 mg Melatonin pill will be given 1 hour before going to bed. Blue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie/Vitamin L) in the morning.
3 mg Melatonin pill will be given 1 hour before going to bed.
Blue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie/Vitamin L) in the morning.
Placebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening
Almazov National Medical Research Centre
Saint Petersburg, Russia
RECRUITINGChange in the value of National Institutes of Health Stroke Scale from baseline to 14 days 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 14 days after treatment initiation
Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14 days 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 14 days after treatment initiation
Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14 days after treatment initiation
Rivermead Mobility Index (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 14 days after treatment initiation
Stroke-related disability assessed by the change in Barthel Index from baseline to 14 days after treatment initiation
Barthel Index (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 14 days after treatment initiation
Change in Psychomotor vigilance task (mean reaction time) from baseline to 14 days after treatment initiation
The psychomotor vigilance task is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus, the outcome (mean reaction time) is measured in msec
Time frame: From baseline to 14 days after treatment initiation
Change in Psychomotor vigilance task (mean reaction time) from baseline to 90 days after inclusion
The psychomotor vigilance task is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus, the outcome (mean reaction time) is measured in msec
Time frame: From baseline to 90±7 days after inclusion
Change in Kraepelin test from baseline to 14 days after treatment initiation
Kraepelin test is the test in which the examinee performs a simple single-digit addition. The outcome is the number of correct and incorrect addition operations per each 30 sec and during the whole task, performance index (number of correct addition operations during second part of task / number of correct addition operations during first part of task)
Time frame: From baseline to 14 days after treatment initiation
Change in Kraepelin test from baseline to 90 days after inclusion
Kraepelin test is the test in which the examinee performs a simple single-digit addition. The outcome is the number of correct and incorrect addition operations per each 30 sec and during the whole task, performance index (number of correct addition operations during second part of task / number of correct addition operations during first part of task)
Time frame: From baseline to 90±7 days after inclusion
Change in Trail Making test from baseline to 14 days after treatment initiation
Trails Making Test (Trails) is a neuropsychological test of visual attention and task switching. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning
Time frame: From baseline to 14 days after treatment initiation
Change in Trail Making test from baseline to 90 days after inclusion
Trails Making Test (Trails) is a neuropsychological test of visual attention and task switching. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. Execution time will be assessed (in msec)
Time frame: From baseline to 90±7 days after inclusion
Change in Victoria Stroop test from baseline to 14 days after treatment initiation
Victoria Stroop is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference. Execution time will be measured. (in msec)
Time frame: From baseline to 14 days after treatment initiation
Change in Victoria Stroop test from baseline to 90 days after inclusion
Victoria Stroop is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference. Execution time will be measured. (in msec)
Time frame: From baseline to 90±7 day after inclusion
Change in Hopkins Verbal Learning Test (Revised) from baseline to 14 days after treatment initiation
Hopkins Verbal Learning Test - Revised brief assessment of immediate recall, delayed recall and delayed recognition. The number of words recalled will be assessed.
Time frame: From baseline to 14 days after treatment initiation
Change in Hopkins Verbal Learning Test (Revised) from baseline to 90 days after inclusion
Hopkins Verbal Learning Test - Revised brief assessment of immediate recall, delayed recall and delayed recognition. The number of words recalled will be assessed.
Time frame: From baseline to 90±7 days after inclusion
Change in Brief Visuospatial Memory Test (Revised) from baseline to 14 days after treatment initiation
Brief Visuospatial Memory Test (Revised)is a commonly used, commercialized, assessment tool to measure visuospatial learning and memory abilities across research and clinical settings. The number of figures will be assessed.
Time frame: From baseline to 14 days after treatment initiation
Change in Brief Visuospatial Memory Test (Revised) from baseline to 90 days after inclusion
Brief Visuospatial Memory Test (Revised)is a commonly used, commercialized, assessment tool to measure visuospatial learning and memory abilities across research and clinical settings. The number of figures will be assessed.
Time frame: From baseline to 90±7 days after inclusion
Change in Wechsler Memory Scale (Revised) from baseline to 14 days after treatment initiation
Wechsler Memory Scale - Revised is a neuropsychological test designed to measure different memory functions in a person. A composite score will be assessed.
Time frame: From baseline to 14 days after treatment initiation
Change in Wechsler Memory Scale (Revised) from baseline to 90 days after inclusion
Wechsler Memory Scale - Revised is a neuropsychological test designed to measure different memory functions in a person. A composite score will be assessed.
Time frame: From baseline to 90±7 days after inclusion
Change in Corsi block-tapping test from baseline to 14 days after treatment initiation
The Corsi block-tapping test is a psychological test that assesses visuo-spatial short term working memory. The visual span raw score will be assessed.
Time frame: From baseline to 14 days after treatment initiation
Change in Corsi block-tapping test from baseline to 90 days after inclusion
The Corsi block-tapping test is a psychological test that assesses visuo-spatial short term working memory. The visual span raw score will be assessed.
Time frame: From baseline to 90±7 days after inclusion
Change from baseline in objective sleep duration assessed by polysomnography
Sleep duration (minutes)
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in objective sleep efficiency assessed by polysomnography
sleep efficiency (%)
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in objective sleep latency assessed by polysomnography
sleep latency (minutes)
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in sleep S1 stage duration assessed by polysomnography
S1 sleep stage percentage of total sleep time (%)
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in sleep S2 stage duration assessed by polysomnography
S2 sleep stage percentage of total sleep time (%)
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in sleep S3 stage duration assessed by polysomnography
S3 sleep stage percentage of total sleep time (%)
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in rapid eye movement (REM) sleep stage duration assessed by polysomnography
Rapid eye movement (REM) sleep stage percentage of total sleep time (%)
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in wake-after-sleep-onset time assessed by polysomnography
wake after sleep onset time (minutes)
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in arousal index assessed by polysomnography
Arousal index (episodes/hour of sleep)
Time frame: From baseline to 14 days after treatment initiation
Change in emotional outcome assessed by Hospital anxiety and depression scale from baseline to 90 days after inclusion
Hospital anxiety and depression scale is used to determine the levels of anxiety and depression. It is a 14-item scale; Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression, higher scores indicate worse situation
Time frame: from baseline to 14 days after treatment initiation
Change in emotional outcome assessed by Hospital anxiety and depression scale from baseline to 14 days after treatment initiation
Hospital anxiety and depression scale is used to determine the levels of anxiety and depression. It is a 14-item scale; Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression, higher scores indicate worse situation
Time frame: From baseline to 90±7 days after inclusion
Assessment of mood by change in Visual Analogue Mood Scale from baseline to 14 days after treatment initiation
Visual Analogue Mood Scale is a reliable and valid measure of eight specific mood states: Afraid, Confused, Sad, Angry, Energetic, Tired, Happy, and Tense. The score for each mood ranges from 0 to 100 (100 mm vertical line), with 100 representing a maximal level of that mood and zero representing a minimal level (or absence) of that mood
Time frame: from baseline to 14 days after treatment initiation
Assessment of mood by change in Visual Analogue Mood Scale from baseline to 90 days after inclusion
Visual Analogue Mood Scale is a reliable and valid measure of eight specific mood states: Afraid, Confused, Sad, Angry, Energetic, Tired, Happy, and Tense. The score for each mood ranges from 0 to 100 (100 mm vertical line), with 100 representing a maximal level of that mood and zero representing a minimal level (or absence) of that mood
Time frame: From baseline to 90±7 days after inclusion
Change in the value of National Institutes of Health Stroke Scale from baseline to 90 days 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 90±7 days after inclusion
Change in modified Rankin scale from baseline to 90 days after inclusion
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 90±7 days after inclusion
Change in Rivermead Mobility Index from baseline to 90 days after inclusion
Rivermead Mobility Index (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 90±7 days after inclusion
Change in Barthel Index from baseline to 90 days after inclusion
Barthel Index (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 90±7 days after inclusion
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