[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458246":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":52,"centralContacts":57,"locations":62,"responsibleParty":78,"collaborators":35,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":35,"eligibilityCriteria":85,"healthyVolunteers":82,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":35,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":64,"whyStopped":35,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Combination Product: Blue light exposure + Melatonin treatment",{"label":15,"type":10,"description":16,"interventionNames":17},"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",[18],"Drug: Melatonin treatment",{"label":20,"type":10,"description":21,"interventionNames":22},"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)",[23],"Device: Blue light exposure",{"label":25,"type":26,"description":27,"interventionNames":28},"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",[29],"Combination Product: Placebo",[31,36,42,48],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"COMBINATION_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\u002FVitamin L) in the morning.",[9],null,{"type":37,"name":15,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","3 mg Melatonin pill will be given 1 hour before going to bed.",[15],[41],"Melaxen",{"type":43,"name":20,"description":44,"armGroupLabels":45,"otherNames":46},"DEVICE","Blue light exposure will be performed during 30-minute sessions with the use of the lamps (Lumie\u002FVitamin L) in the morning.",[20],[47],"Lamps Lumie\u002FVitamin L",{"type":32,"name":49,"description":50,"armGroupLabels":51,"otherNames":35},"Placebo","Placebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening",[25],[53],{"name":54,"affiliation":55,"role":56},"Lyudmila Korostovtseva","Almazov National Medical Research Centre","PRINCIPAL_INVESTIGATOR",[58],{"name":54,"role":59,"phone":60,"phoneExt":35,"email":61},"CONTACT","+79217873548","lyudmila_korosto@mail.ru",[63],{"facility":55,"status":64,"city":65,"state":35,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Saint Petersburg","197341","Russia","RU",{"type":70,"coordinates":71},"Point",[72,73],30.31413,59.93863,{"lat":73,"lon":72},[76],{"name":54,"role":59,"phone":77,"phoneExt":35,"email":61},"89217873548",{"type":56,"investigatorFullName":54,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Senior Researcher, Department for Hypertension","100458246","phase-4-the-role-of-circadian-factors-in-regulation-of-neuroplasticity-in-ischemic-stroke-interventional-100458246",false,"NCT05247125","The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)","Inclusion Criteria:\n\n* acute (symptom onset to admission \\\u003C1 days) ischemic stroke\n* ischemic stroke affecting the branches of anterior cerebral artery, middle cerebral artery and posterior cerebral artery\n* age 18-80 years\n* moderate or severe stroke (National Institutes of Health Stroke Scale, NIHSS\\>=5)\n* intravascular stroke treatment with thrombolysis or thrombectomy leading to satisfactory reperfusion (if applicable)\n* informed consent\n\nExclusion Criteria:\n\n* secondary parenchymal hemorrhage (\\>hemorrhage index (HI)-2)\n* clinically unstable or life-threatening conditions\n* previous stroke in the last 6 months\n* known progressive neurological diseases\n* known psychiatric diseases\n* concomitant benzodiazepine medication\n* drug or alcohol abuse\n* pregnancy\n* inability to participate in the study\n* severe sensory aphasia\n* melatonin intake at\u002Fbefore admission\n* light therapy use at\u002Fbefore admission\n* blindness\n* severe sleep-disordered breathing (apnea-hypopnea index \\>=30\u002Fh)\n* contraindications to light therapy (severe retinopathy, epilepsy, porphyria, intake of drugs with photosensitizing effects)\n* contraindications to melatonin intake (severe bronchial asthma, severe autoimmune disorders, chronic kidney disease 3b stage and higher, leukosis)\n* congestive heart failure with reduced ejection fraction (\\\u003C=45%) or New York Heart Association (NYHA) classification III-IV functional class.","ALL","18 Years","80 Years",{"count":90,"type":91},80,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","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.\n\nThe main research hypothesis is that circadian factors influence the recovery from ischemic stroke via sleep-mediated regulation of synaptic plasticity.\n\nThe 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.\n\nThis study is a prospective, interventional, randomized placebo-controlled trial.",[97,98],"Ischemic Stroke, Acute","Sleep Disorders, Circadian Rhythm",[100,101,102,103,104],"circadian misalignment","neuroplasticity","melatonin","light therapy","circadian disorder","2025-08-05",{"date":107,"type":108},"2025-08-08","ACTUAL",{"date":110,"type":108},"2022-03-01",{"date":112,"type":91},"2026-12-31",{"name":5,"class":6},1]