RecruitingPhase 4NCT05247125

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


Sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Enrollment

80 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Blue light exposure, Blue light exposure + Melatonin treatment, and others for people with ischemic stroke, acute and sleep disorders, circadian rhythm. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTBlue 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.

DRUGMelatonin treatment

3 mg Melatonin pill will be given 1 hour before going to bed.

DEVICEBlue 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_PRODUCTPlacebo

Placebo light exposure will be performed by using lamp turned off; and placebo pill will be given in the evening


Locations(1)

Almazov National Medical Research Centre

Saint Petersburg, Russia

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NCT05247125


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