Stroke, IschemicNCT05242393
The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)
An observational study of Stroke, Ischemic and Sleep Disorder, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
Trial summary
The study is aimed at the investigation of the association of biomarkers of circadian rhythms with sleep characteristics and stroke outcome in acute stroke patients. It is designed as an observational cohort study with the retrospective and prospective longitudinal arms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemic, Sleep Disorder
- How many people
- 250 participants
- Where
- 1 siteRussia
- Study dates
- 1 May 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the patients with confirmed acute ischemic stroke admitted to the Stroke Unit
Who may be able to join
- 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
Who cannot join
- secondary parenchymal hemorrhage (>hemorrhage index -2)
- clinically unstable or life-threatening conditions
- known progressive neurological diseases
- known psychiatric diseases
- concomitant benzodiazepine medication
- drug or alcohol abuse
Show all 9Show fewer
- pregnancy
- disability to participate in the study
- congestive heart failure with reduced ejection fraction (<=45%) or New York Heart Association (NYHA) classification III-IV functional class
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Almazov National Medical Research Centre
Saint Petersburg, 197341
Lyudmila Korostovtseva, 89217873548, lyudmila_korosto@mail.ru
About this study
The study is aimed at the investigation of the association of biomarkers of circadian rhythms with sleep characteristics and stroke outcome in acute stroke patients. It is designed as an observational cohort study with the retrospective and prospective longitudinal arms.
Read the detailed description
In the retrospective arm of the study, the routinely collected data of patients admitted to the stroke unit with acute ischemic stroke (from 2018 till 2022) will be evaluated. In the prospective longitudinal arm, about 200-250 patients admitted to the Stroke Unit of one participating center will undergo examination including the assessment of medical records, stroke characteristics, sleep characteristics and blood sampling for the evaluation of genetic biomarkers of circadian rhythms within the first 2-3 days after admission.The assessment of stroke severity and functional deficit will be repeated at 10-14 days after stroke.
The following associations will be assessed:
- the association of genetic biomarkers of circadian rhythms with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke), with stroke characteristics (stroke subtype and neuroimaging stroke parameters) and with sleep characteristics.
- the association of sleep characteristics with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke) and with stroke characteristics (stroke subtype and neuroimaging stroke parameters).
- Conditions
- Stroke, Ischemic, Sleep Disorder
- Being tested
- No intervention is planned
- Keywords
- neuroplasticity, cognitive dysfunction, disability, circadian rhythm, functional deficit, stroke outcome, sleep-disordered breathing, heart rate variability
- Medical subject headings
- Ischemic Stroke, Sleep Wake Disorders, Cognitive Dysfunction, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is plannedOther
No intervention is planned
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Patients with acute ischemic stroke admitted to the Stroke Unit of one participating center in 2018-2022. The data collected within clinical routine will be analyzed including stroke characteristics at baseline and at discharge (10-14 days after admission), neuroimaging data, sleep characteristics (routine polygraphy study), heart rate variability, routine blood tests. Receives: Other: No intervention is planned | |
| Prospective cohort | Approximately 200-250 patients with acute ischemic stroke admitted to the Stroke Unit of one participating center in 2022-2024 will undergo the assessment of medical records, stroke characteristics, the assessment of sleep characteristics and blood sampling for the evaluation of genetic biomarkers of circadian rhythms at baseline (within 2-3 days of admission) and at 10-14 days (at discharge). Receives: Other: No intervention is planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion
National Institutes of Health Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke, 0-42 scores, higher scores characterize worse impairment
Measured: From baseline to 14th day after treatment initiation
Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14th day after treatment initiation
values of modified Rankin scale (scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke, from 0 (no symptoms) to 6 (dead) points)
Measured: From baseline to 14th day after treatment initiation
Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14th day after treatment initiation
a standardized scale used to assess mobility in patients with neurological deficits, a maximum of 15 points is possible; higher scores indicate better mobility performance
Measured: From baseline to 14th day after treatment initiation
Stroke-related disability assessed by the change in Barthel Index from baseline to 14th day after treatment initiation
a common scale used to measure performance in activities of daily living, 0-100 scores, higher scores define better performance
Measured: From baseline to 14th day after treatment initiation
Secondary outcomes (5)
Sleep quality assessed by Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index is a self-rated questionnaire which assesses sleep quality and disturbances over the last (previous) 1-month (a retrospective assessment) time interval, Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score indicating worse sleep quality
Measured: Baseline
Sleepiness assessed by Epworth Sleepiness Scale
a common tool to assess sleepiness; 0-24 points, higher score indicate greater sleepiness
Measured: Baseline
Fatigue assessed by Fatigue severity Scale
a common 9-item tool used to determine and quantify fatigue as subjective feeling of exhaustion, persisting lack of energy and rapid inanition, 9-63 points, higher score indicates more severe fatigue
Measured: Baseline
Insomnia assessed by Insomnia severity index
a 7-item tool to assess the severity of insomnia, 0-5 points per each item, higher score indicates more severe insomnia
Measured: Baseline
Chronotype assessed by Morningness-Eveningness Questionnaire
a common 19-item tool to estimate individual chronotype, a score ranging from 16 to 86; scores of 41 and below indicate "evening types", scores of 59 and above indicate "morning types", scores between 42-58 indicate "intermediate types"
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 May 2018
- Primary completion30 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyudmila Korostovtseva, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Investigators
- Lyudmila Korostovtseva, MD, PhD, Principal investigator, Almazov National Medical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242393
- Sponsor's protocol ID
- 21-75-1017-2 (observational)
- Status last verified
- Aug 2025
- First submitted
- 26 Jan 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korostovtseva L. Ischemic Stroke and Sleep: The Linking Genetic Factors. Cardiol Ther. 2021 Dec;10(2):349-375. doi: 10.1007/s40119-021-00231-9. Epub 2021 Jun 30.
PubMed 34191267Bochkarev MV, Korostovtseva LS, Medvedeva EA, Rotar OP, Sviryaev YV, Zhernakova YV, Shalnova SA, Konradi AO, Chazova IE, Boitsov SA, Shlyakhto EV. [Sleep disorders and stroke: data of the esse-rf study]. Zh Nevrol Psikhiatr Im S S Korsakova. 2019;119(4. Vyp. 2):73-80. doi: 10.17116/jnevro201911904273. Russian.
PubMed 31317919Seiler A, Camilo M, Korostovtseva L, Haynes AG, Brill AK, Horvath T, Egger M, Bassetti CL. Prevalence of sleep-disordered breathing after stroke and TIA: A meta-analysis. Neurology. 2019 Feb 12;92(7):e648-e654. doi: 10.1212/WNL.0000000000006904. Epub 2019 Jan 11.
PubMed 30635478
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)
- ClinicalTrials.gov ID
- NCT05242393
- Acronym / sponsor ID
- 21-75-1017-2 (observational)
- Conditions
- Stroke, Ischemic, Sleep Disorder
- Keywords
- neuroplasticity, cognitive dysfunction, disability, circadian rhythm, functional deficit, stroke outcome, sleep-disordered breathing, heart rate variability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed at the investigation of the association of biomarkers of circadian rhythms with sleep characteristics and stroke outcome in acute stroke patients. It is designed as an observational cohort study with the retrospective and prospective longitudinal arms.
Detailed description
In the retrospective arm of the study, the routinely collected data of patients admitted to the stroke unit with acute ischemic stroke (from 2018 till 2022) will be evaluated. In the prospective longitudinal arm, about 200-250 patients admitted to the Stroke Unit of one participating center will undergo examination including the assessment of medical records, stroke characteristics, sleep characteristics and blood sampling for the evaluation of genetic biomarkers of circadian rhythms within the first 2-3 days after admission.The assessment of stroke severity and functional deficit will be repeated at 10-14 days after stroke.
The following associations will be assessed:
- the association of genetic biomarkers of circadian rhythms with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke), with stroke characteristics (stroke subtype and neuroimaging stroke parameters) and with sleep characteristics.
- the association of sleep characteristics with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke) and with stroke characteristics (stroke subtype and neuroimaging stroke parameters).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Other: No intervention is plannedPatients with acute ischemic stroke admitted to the Stroke Unit of one participating center in 2018-2022. The data collected within clinical routine will be analyzed including stroke characteristics at baseline and at discharge (10-14 days after admission), neuroimaging data, sleep characteristics (routine polygraphy study), heart rate variability, routine blood tests. |
| Prospective cohort | – | Other: No intervention is plannedApproximately 200-250 patients with acute ischemic stroke admitted to the Stroke Unit of one participating center in 2022-2024 will undergo the assessment of medical records, stroke characteristics, the assessment of sleep characteristics and blood sampling for the evaluation of genetic biomarkers of circadian rhythms at baseline (within 2-3 days of admission) and at 10-14 days (at discharge). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the patients with confirmed acute ischemic stroke admitted to the Stroke Unit
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- secondary parenchymal hemorrhage (>hemorrhage index -2)
- clinically unstable or life-threatening conditions
- known progressive neurological diseases
- known psychiatric diseases
- concomitant benzodiazepine medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is plannedNo intervention is planned | Other | Prospective cohort, Retrospective cohort |
Primary outcome
Change in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion
Time frame: From baseline to 14th day after treatment initiation
National Institutes of Health Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke, 0-42 scores, higher scores characterize worse impairment
Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14th day after treatment initiation
Time frame: From baseline to 14th day after treatment initiation
values of modified Rankin scale (scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke, from 0 (no symptoms) to 6 (dead) points)
Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14th day after treatment initiation
Time frame: From baseline to 14th day after treatment initiation
a standardized scale used to assess mobility in patients with neurological deficits, a maximum of 15 points is possible; higher scores indicate better mobility performance
Stroke-related disability assessed by the change in Barthel Index from baseline to 14th day after treatment initiation
Time frame: From baseline to 14th day after treatment initiation
a common scale used to measure performance in activities of daily living, 0-100 scores, higher scores define better performance
5 secondary outcomes
Sleep quality assessed by Pittsburgh Sleep Quality Index
Time frame: Baseline
Sleepiness assessed by Epworth Sleepiness Scale
Time frame: Baseline
Fatigue assessed by Fatigue severity Scale
Time frame: Baseline
Insomnia assessed by Insomnia severity index
Time frame: Baseline
Chronotype assessed by Morningness-Eveningness Questionnaire
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 34191267Korostovtseva L. Ischemic Stroke and Sleep: The Linking Genetic Factors. Cardiol Ther. 2021 Dec;10(2):349-375. doi: 10.1007/s40119-021-00231-9. Epub 2021 Jun 30.
- Background: PubMed 31317919Bochkarev MV, Korostovtseva LS, Medvedeva EA, Rotar OP, Sviryaev YV, Zhernakova YV, Shalnova SA, Konradi AO, Chazova IE, Boitsov SA, Shlyakhto EV. [Sleep disorders and stroke: data of the esse-rf study]. Zh Nevrol Psikhiatr Im S S Korsakova. 2019;119(4. Vyp. 2):73-80. doi: 10.17116/jnevro201911904273. Russian.
- Background: PubMed 30635478Seiler A, Camilo M, Korostovtseva L, Haynes AG, Brill AK, Horvath T, Egger M, Bassetti CL. Prevalence of sleep-disordered breathing after stroke and TIA: A meta-analysis. Neurology. 2019 Feb 12;92(7):e648-e654. doi: 10.1212/WNL.0000000000006904. Epub 2019 Jan 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lyudmila Korostovtseva, MD, PhD principal investigator
Almazov National Medical Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Sleep Disorder, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lyudmila Korostovtseva, MD, PHD (+79217873548, lyudmila_korosto@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion (time frame: From baseline to 14th day after treatment initiation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242393, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.