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NCT Number: NCT05242393

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

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.

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Key information

Conditions

Stroke, Ischemic Apnea Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Dyssomnias Ischemic Stroke Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorder Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

Location status: Recruiting

Location contact

Lyudmila Korostovtseva

CONTACT

[email protected]

89217873548

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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
  • 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

Treatment and study plan

No intervention is planned

Other

No intervention is planned

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

Secondary outcomes

  1. Sleep quality assessed by Pittsburgh Sleep Quality Index

    Time frame: Baseline

    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

  2. Sleepiness assessed by Epworth Sleepiness Scale

    Time frame: Baseline

    a common tool to assess sleepiness; 0-24 points, higher score indicate greater sleepiness

  3. Fatigue assessed by Fatigue severity Scale

    Time frame: Baseline

    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

  4. Insomnia assessed by Insomnia severity index

    Time frame: Baseline

    a 7-item tool to assess the severity of insomnia, 0-5 points per each item, higher score indicates more severe insomnia

  5. Chronotype assessed by Morningness-Eveningness Questionnaire

    Time frame: Baseline

    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"

Other outcomes

  1. sleep-related respiratory characteristics: apnea-hypopnea index

    Time frame: Baseline

    assessed by routine polygraphy: apnea-hypopnea index (higher values indicate greater severity; <5 episodes/h - normal, >=5 episodes/h - pathological)

  2. sleep-related respiratory characteristics: oxygen desaturation index

    Time frame: Baseline

    assessed by routine polygraphy: oxygen desaturation index (higher values indicate greater severity; <5 episodes/h - normal, >=5 episodes/h - pathological)

  3. sleep-related respiratory characteristics: time under oxygen saturation <90%

    Time frame: Baseline

    assessed by routine polygraphy: time under oxygen saturation <90% (higher values indicate greater severity), in minutes

  4. sleep-related respiratory characteristics: average oxygen saturation

    Time frame: Baseline

    assessed by routine polygraphy: average oxygen saturation (lower values indicate greater severity), in %

  5. sleep-related respiratory characteristics: lowest oxygen saturation

    Time frame: Baseline

    assessed by routine polygraphy: lowes oxygen saturation (lower values indicate greater severity), in %

  6. Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: standard deviation of normal-to-normal intervals

    Time frame: Baseline

    standard deviation of normal-to-normal intervals (msec)

  7. Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: number of interval differences of successive heart beats greater than 50 ms

    Time frame: Baseline

    number of interval differences of successive heart beats greater than 50 ms

  8. Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: spectral power in high-frequency power bands

    Time frame: Baseline

    spectral power in high-frequency power bands (Hz)

  9. Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: spectral power in low-frequency power bands

    Time frame: Baseline

    spectral power in low-frequency power bands (Hz)

  10. Sleep duration assessed by polysomnography

    Time frame: Baseline

    Sleep duration (minutes)

  11. Sleep efficiency assessed by polysomnography

    Time frame: Baseline

    sleep efficiency (%)

  12. Sleep latency assessed by polysomnography

    Time frame: Baseline

    sleep latency (minutes)

  13. Sleep S1 stage duration assessed by polysomnography

    Time frame: Baseline

    S1 sleep stage percentage of total sleep time (%)

  14. Sleep S2 stage duration assessed by polysomnography

    Time frame: Baseline

    S2 sleep stage percentage of total sleep time (%)

  15. Sleep S3 stage duration assessed by polysomnography

    Time frame: Baseline

    S3 sleep stage percentage of total sleep time (%)

  16. Rapid eye movement (REM) stage duration assessed by polysomnography

    Time frame: Baseline

    Rapid eye movement (REM) sleep stage percentage of total sleep time (%)

  17. Wake after sleep onset time assessed by polysomnography

    Time frame: Baseline

    wake after sleep onset time (minutes), higher values indicate worse disturbance

  18. Arousal index assessed by polysomnography

    Time frame: Baseline

    Arousal index (episodes/hour of sleep), higher values indicate worse disturbance

  19. periodic limb movement index assessed by polysomnography

    Time frame: Baseline

    periodic limb movement index (episodes/hour of sleep), higher values indicate worse disturbance

  20. Stroke lesion volume

    Time frame: Baseline

    Stroke lesion volume assessed by neuroimaging (computer tomography scan or magnetic resonance imaging) (ml or mm3)

Study contacts

Contact information is provided by the study sponsor or research team.

Lyudmila Korostovtseva, MD, PHD

CONTACT

[email protected]

+79217873548

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Feb 16, 2022
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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