Ischemic Stroke, AcutePhase 4NCT05247125
The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
A Phase 4 study testing Blue light exposure + Melatonin treatment, Melatonin treatment and Blue light exposure in people with Ischemic Stroke, Acute and Sleep Disorders, Circadian Rhythm, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute, Sleep Disorders, Circadian Rhythm
- What is being tested?
- Blue light exposure + Melatonin treatment, Melatonin treatment and Blue light exposure
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2022to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- intravascular stroke treatment with thrombolysis or thrombectomy leading to satisfactory reperfusion (if applicable)
- informed consent
Who cannot join
- secondary parenchymal hemorrhage (>hemorrhage index (HI)-2)
- clinically unstable or life-threatening conditions
- previous stroke in the last 6 months
- known progressive neurological diseases
- known psychiatric diseases
- concomitant benzodiazepine medication
Show all 17Show fewer
- drug or alcohol abuse
- pregnancy
- inability to participate in the study
- severe sensory aphasia
- melatonin intake at/before admission
- light therapy use at/before admission
- blindness
- severe sleep-disordered breathing (apnea-hypopnea index >=30/h)
- contraindications to light therapy (severe retinopathy, epilepsy, porphyria, intake of drugs with photosensitizing effects)
- contraindications to melatonin intake (severe bronchial asthma, severe autoimmune disorders, chronic kidney disease 3b stage and higher, leukosis)
- congestive heart failure with reduced ejection fraction (<=45%) or New York Heart Association (NYHA) classification III-IV functional class.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Almazov National Medical Research Centre
Saint Petersburg, 197341
Lyudmila Korostovtseva, 89217873548, lyudmila_korosto@mail.ru
About this study
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.
Read more
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.
Read the detailed description
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).
- Being tested
- Blue light exposure + Melatonin treatment, Melatonin treatment, Blue light exposure, Placebo
- Keywords
- circadian misalignment, neuroplasticity, melatonin, light therapy, circadian disorder
- Medical subject headings
- Ischemic Stroke, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue light exposure + Melatonin treatmentCombination product
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.
Melatonin treatmentDrug
Also called Melaxen
3 mg Melatonin pill will be given 1 hour before going to bed.
Blue light exposureDevice
Also called Lamps Lumie/Vitamin L
Blue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie/Vitamin L) in the morning.
PlaceboCombination product
Placebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening
| Study group | Role | What they receive |
|---|---|---|
| Blue light exposure + Melatonin treatment | Experimental | The participants will receive the combination of blue light exposure according to the protocol described by Killgore et al. (2020) and 3 mg of melatonin 1 hour before going to sleep (approximately at 20:00) (Ramos et al 2020) for 14 days Receives: Combination Product: Blue light exposure + Melatonin treatment |
| Melatonin treatment | Experimental | The participants will receive 3 mg of melatonin 1 hour before going to sleep (approximately at 20:00) (Ramos et al 2020) and the morning placebo-light exposure according to the protocol described by Killgore et al. (2020) for 14 days Receives: Drug: Melatonin treatment |
| Blue light exposure | Experimental | The participants will receive the morning blue light exposure according to the protocol described by Killgore et al. (2020) for 14 days and placebo pill 1 hour before going to sleep (approximately at 20:00) Receives: Device: Blue light exposure |
| Placebo group | Placebo comparator | The participants will receive placebo light exposure in the morning (lamp turned off) and placebo pill treatment in the evening for 14 days Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From baseline to 14 days after treatment initiation
Secondary outcomes (33)
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 90±7 days after inclusion
Change from baseline in objective sleep duration assessed by polysomnography
Sleep duration (minutes)
Measured: From baseline to 14 days after treatment initiation
Change from baseline in objective sleep efficiency assessed by polysomnography
sleep efficiency (%)
Measured: From baseline to 14 days after treatment initiation
Change from baseline in objective sleep latency assessed by polysomnography
sleep latency (minutes)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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)
Measured: From baseline to 14 days after treatment initiation
Change from baseline in arousal index assessed by polysomnography
Arousal index (episodes/hour of sleep)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From baseline to 90±7 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Mar 2022
- Primary completion30 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomized into 4 parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyudmila Korostovtseva, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Investigators
- Lyudmila Korostovtseva, Principal investigator, Almazov National Medical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247125
- Sponsor's protocol ID
- 21-75-10173-1 (interventional)
- Status last verified
- Aug 2025
- First submitted
- 26 Jan 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korostovtseva L. Ischemic Stroke and Sleep: The Linking Genetic Factors. Cardiol Ther. 2021 Dec;10(2):349-375. doi: 10.1007/s40119-021-00231-9. Epub 2021 Jun 30.
PubMed 34191267Bochkarev MV, Korostovtseva LS, Medvedeva EA, Rotar OP, Sviryaev YV, Zhernakova YV, Shalnova SA, Konradi AO, Chazova IE, Boitsov SA, Shlyakhto EV. [Sleep disorders and stroke: data of the esse-rf study]. Zh Nevrol Psikhiatr Im S S Korsakova. 2019;119(4. Vyp. 2):73-80. doi: 10.17116/jnevro201911904273. Russian.
PubMed 31317919
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
- ClinicalTrials.gov ID
- NCT05247125
- Acronym / sponsor ID
- 21-75-10173-1 (interventional)
- Keywords
- circadian misalignment, neuroplasticity, melatonin, light therapy, circadian disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- patients will be randomized into 4 parallel groups
| Arm | Type | Receives |
|---|---|---|
| Blue light exposure + Melatonin treatment | Experimental | Combination Product: Blue light exposure + Melatonin treatmentThe participants will receive the combination of blue light exposure according to the protocol described by Killgore et al. (2020) and 3 mg of melatonin 1 hour before going to sleep (approximately at 20:00) (Ramos et al 2020) for 14 days |
| Melatonin treatment | Experimental | Drug: Melatonin treatmentThe participants will receive 3 mg of melatonin 1 hour before going to sleep (approximately at 20:00) (Ramos et al 2020) and the morning placebo-light exposure according to the protocol described by Killgore et al. (2020) for 14 days |
| Blue light exposure | Experimental | Device: Blue light exposureThe participants will receive the morning blue light exposure according to the protocol described by Killgore et al. (2020) for 14 days and placebo pill 1 hour before going to sleep (approximately at 20:00) |
| Placebo group | Placebo comparator | Combination Product: PlaceboThe participants will receive placebo light exposure in the morning (lamp turned off) and placebo pill treatment in the evening for 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
- intravascular stroke treatment with thrombolysis or thrombectomy leading to satisfactory reperfusion (if applicable)
Key exclusion criteria (17 listed)
- secondary parenchymal hemorrhage (>hemorrhage index (HI)-2)
- clinically unstable or life-threatening conditions
- previous stroke in the last 6 months
- known progressive neurological diseases
- known psychiatric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue light exposure + Melatonin treatment3 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. | Combination product | Blue light exposure + Melatonin treatment |
| Melatonin treatmentAlso: Melaxen3 mg Melatonin pill will be given 1 hour before going to bed. | Drug | Melatonin treatment |
| Blue light exposureAlso: Lamps Lumie/Vitamin LBlue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie/Vitamin L) in the morning. | Device | Blue light exposure |
| PlaceboPlacebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening | Combination product | Placebo group |
Primary outcome
Change in the value of National Institutes of Health Stroke Scale from baseline to 14 days after inclusion
Time frame: From baseline to 14 days after treatment initiation
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 14 days after treatment initiation
Time frame: 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)
Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14 days after treatment initiation
Time frame: 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)
Stroke-related disability assessed by the change in Barthel Index from baseline to 14 days after treatment initiation
Time frame: 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)
33 secondary outcomes
Change in Psychomotor vigilance task (mean reaction time) from baseline to 14 days after treatment initiation
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
Time frame: From baseline to 90±7 days after inclusion
Change in Kraepelin test from baseline to 14 days after treatment initiation
Time frame: From baseline to 14 days after treatment initiation
Change in Kraepelin test from baseline to 90 days after inclusion
Time frame: From baseline to 90±7 days after inclusion
Change in Trail Making test from baseline to 14 days after treatment initiation
Time frame: From baseline to 14 days after treatment initiation
Change in Trail Making test from baseline to 90 days after inclusion
Time frame: From baseline to 90±7 days after inclusion
Change in Victoria Stroop test from baseline to 14 days after treatment initiation
Time frame: From baseline to 14 days after treatment initiation
Change in Victoria Stroop test from baseline to 90 days after inclusion
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
Time frame: From baseline to 14 days after treatment initiation
Change in Hopkins Verbal Learning Test (Revised) from baseline to 90 days after inclusion
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
Time frame: From baseline to 14 days after treatment initiation
Change in Brief Visuospatial Memory Test (Revised) from baseline to 90 days after inclusion
Time frame: From baseline to 90±7 days after inclusion
Change in Wechsler Memory Scale (Revised) from baseline to 14 days after treatment initiation
Time frame: From baseline to 14 days after treatment initiation
Change in Wechsler Memory Scale (Revised) from baseline to 90 days after inclusion
Time frame: From baseline to 90±7 days after inclusion
Change in Corsi block-tapping test from baseline to 14 days after treatment initiation
Time frame: From baseline to 14 days after treatment initiation
Change in Corsi block-tapping test from baseline to 90 days after inclusion
Time frame: From baseline to 90±7 days after inclusion
Change from baseline in objective sleep duration assessed by polysomnography
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in objective sleep efficiency assessed by polysomnography
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in objective sleep latency assessed by polysomnography
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in sleep S1 stage duration assessed by polysomnography
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in sleep S2 stage duration assessed by polysomnography
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in sleep S3 stage duration assessed by polysomnography
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in rapid eye movement (REM) sleep stage duration assessed by polysomnography
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in wake-after-sleep-onset time assessed by polysomnography
Time frame: From baseline to 14 days after treatment initiation
Change from baseline in arousal index assessed by polysomnography
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
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
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
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
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
Time frame: From baseline to 90±7 days after inclusion
Change in modified Rankin scale from baseline to 90 days after inclusion
Time frame: From baseline to 90±7 days after inclusion
Change in Rivermead Mobility Index from baseline to 90 days after inclusion
Time frame: From baseline to 90±7 days after inclusion
Change in Barthel Index from baseline to 90 days after inclusion
Time frame: From baseline to 90±7 days after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 34191267Korostovtseva L. Ischemic Stroke and Sleep: The Linking Genetic Factors. Cardiol Ther. 2021 Dec;10(2):349-375. doi: 10.1007/s40119-021-00231-9. Epub 2021 Jun 30.
- Background: PubMed 31317919Bochkarev MV, Korostovtseva LS, Medvedeva EA, Rotar OP, Sviryaev YV, Zhernakova YV, Shalnova SA, Konradi AO, Chazova IE, Boitsov SA, Shlyakhto EV. [Sleep disorders and stroke: data of the esse-rf study]. Zh Nevrol Psikhiatr Im S S Korsakova. 2019;119(4. Vyp. 2):73-80. doi: 10.17116/jnevro201911904273. Russian.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lyudmila Korostovtseva principal investigator
Almazov National Medical Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blue light exposure + Melatonin treatment, Melatonin treatment and Blue light exposure in people with Ischemic Stroke, Acute and Sleep Disorders, Circadian Rhythm, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lyudmila Korostovtseva (+79217873548, lyudmila_korosto@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the value of National Institutes of Health Stroke Scale from baseline to 14 days after inclusion (time frame: From baseline to 14 days after treatment initiation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247125, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.