Ischemic Stroke and Sleep: The Linking Genetic Factors.
Lyudmila Korostovtseva
https://pubmed.ncbi.nlm.nih.gov/34191267Actively Recruiting
Phase 4
Age: 18Years - 80Years
All Genders
ID05247125
The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
Led by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Updated on 2025-08-08
80
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how circadian rhythm factors, including genetic influences, affect recovery and short-term outcomes after acute ischemic stroke. The study focuses on how sleep-driven regulation of brain plasticity may influence stroke recovery. This prospective, randomized, placebo-controlled trial aims to explore the combined effects of melatonin therapy and blue light exposure on molecular circadian markers, sleep, neuroplasticity, and clinical outcomes in stroke patients. The trial involves about 80 patients admitted with acute ischemic stroke, divided randomly into four groups receiving different treatments for 14 days: combined blue light exposure and melatonin, melatonin alone, blue light alone, or placebo light and pill. Melatonin is given as a 3 mg pill about an hour before sleep (around 8 pm), and blue light exposure sessions last 30 minutes each morning using specialized lamps. Stroke characteristics, sleep patterns, and circadian biomarkers are measured at baseline and after 14 days, with stroke outcomes re-evaluated at 3 months. Participants undergo detailed assessments including medical history, stroke evaluation, sleep studies with polysomnography, cognitive and mood tests, and blood sampling for circadian markers. Researchers track changes in neurological function and disability scales from baseline through 14 and 90 days. The study also monitors safety and tolerability of the treatments. The entire participation spans from admission through a 3-month follow-up to assess recovery and functional improvements.
CONDITIONS
Brief Title
The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Acute ischemic stroke with symptom onset to admission less than 1 day
- Stroke affecting branches of anterior, middle, or posterior cerebral arteries
- Age between 18 and 80 years
- Moderate or severe stroke with NIH Stroke Scale score of 5 or higher
- Received intravascular stroke treatment (thrombolysis or thrombectomy) with satisfactory reperfusion if applicable
- Provided informed consent
You will not qualify if you...
- Secondary parenchymal hemorrhage with hemorrhage index greater than 2
- Clinically unstable or life-threatening conditions
- Previous stroke within the last 6 months
- Known progressive neurological diseases
- Known psychiatric diseases
- Using benzodiazepine medications
- Drug or alcohol abuse
- Pregnancy
- Unable to participate in the study
- Severe sensory aphasia
- Melatonin intake before admission
- Light therapy use before admission
- Blindness
- Severe sleep-disordered breathing with apnea-hypopnea index 30 or higher per hour
- Contraindications to light therapy such as severe retinopathy, epilepsy, porphyria, or photosensitizing drugs
- Contraindications to melatonin such as severe bronchial asthma, autoimmune disorders, chronic kidney disease stage 3b or higher, leukemia
- Congestive heart failure with ejection fraction 45% or less or NYHA functional class III-IV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 14 days
Participants receive assigned interventions including blue light exposure and/or melatonin treatment or placebo for 14 days to study their effects on stroke outcomes, sleep, and circadian biomarkers.
Daily morning sessions for blue light exposure and daily evening pill intake for melatonin or placebo
Follow-up
Duration - Approximately 3 months
Participants are assessed for stroke outcomes and other measures at 3 months after treatment to evaluate long-term effects.
1 follow-up visit at about 90 days after treatment initiation
Trial Site Locations
Total: 1 location
1
Almazov National Medical Research Centre
Saint Petersburg, Russia, 197341
Actively Recruiting
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Research Team
L
Lyudmila Korostovtseva
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
[Sleep disorders and stroke: data of the esse-rf study].
M V Bochkarev, L S Korostovtseva, E A Medvedeva...
https://pubmed.ncbi.nlm.nih.gov/31317919