The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
NCT ID: NCT05247125
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2022-03-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Blue light exposure + Melatonin treatment
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
Blue light exposure + Melatonin treatment
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 treatment
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
Melatonin treatment
3 mg Melatonin pill will be given 1 hour before going to bed.
Blue light exposure
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)
Blue light exposure
Blue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie/Vitamin L) in the morning.
Placebo group
The participants will receive placebo light exposure in the morning (lamp turned off) and placebo pill treatment in the evening for 14 days
Placebo
Placebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening
Interventions
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Blue light exposure + Melatonin treatment
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 treatment
3 mg Melatonin pill will be given 1 hour before going to bed.
Blue light exposure
Blue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie/Vitamin L) in the morning.
Placebo
Placebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* clinically unstable or life-threatening conditions
* previous stroke in the last 6 months
* known progressive neurological diseases
* known psychiatric diseases
* concomitant benzodiazepine medication
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
OTHER
Responsible Party
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Lyudmila Korostovtseva
Senior Researcher, Department for Hypertension
Principal Investigators
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Lyudmila Korostovtseva
Role: PRINCIPAL_INVESTIGATOR
Almazov National Medical Research Centre
Locations
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Almazov National Medical Research Centre
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Bochkarev 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.
Other Identifiers
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21-75-10173-1 (interventional)
Identifier Type: -
Identifier Source: org_study_id
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