Status:
RECRUITING
The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)
Lead Sponsor:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Conditions:
Ischemic Stroke, Acute
Sleep Disorders, Circadian Rhythm
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 vario...
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 pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05247125
Start Date
March 1 2022
End Date
December 31 2026
Last Update
August 8 2025
Active Locations (1)
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1
Almazov National Medical Research Centre
Saint Petersburg, Russia, 197341