NCT05247125

The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Ischemic Stroke, Acute
• Sleep Disorders, Circadian Rhythm

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.
DRUG	Melatonin treatment	3 mg Melatonin pill will be given 1 hour before going to bed.
DEVICE	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.
COMBINATION_PRODUCT	Placebo	Placebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening

Timeline

• Start date: 2022-03-01
• Primary completion: 2026-01-30
• Completion: 2026-12-31
• First posted: 2022-02-18
• Last updated: 2025-08-08

Locations

1 site across 1 country: Russia