Clinical trial NCT05242393: The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)
Official title: The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Ischemic
Sleep Disorder
Keywords: neuroplasticity
cognitive dysfunction
disability
circadian rhythm
functional deficit
stroke outcome
sleep-disordered breathing
heart rate variability
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the patients with confirmed acute ischemic stroke admitted to the Stroke Unit

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion
timeFrame: From baseline to 14th day after treatment initiation
measure: Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14th day after treatment initiation
timeFrame: From baseline to 14th day after treatment initiation
measure: Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14th day after treatment initiation
timeFrame: From baseline to 14th day after treatment initiation
measure: Stroke-related disability assessed by the change in Barthel Index from baseline to 14th day after treatment initiation
timeFrame: From baseline to 14th day after treatment initiation
Secondary outcomes:
measure: Sleep quality assessed by Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Sleepiness assessed by Epworth Sleepiness Scale
timeFrame: Baseline
measure: Fatigue assessed by Fatigue severity Scale
timeFrame: Baseline
measure: Insomnia assessed by Insomnia severity index
timeFrame: Baseline
measure: Chronotype assessed by Morningness-Eveningness Questionnaire
timeFrame: Baseline
Other outcomes:
measure: sleep-related respiratory characteristics: apnea-hypopnea index
timeFrame: Baseline
measure: sleep-related respiratory characteristics: oxygen desaturation index
timeFrame: Baseline
measure: sleep-related respiratory characteristics: time under oxygen saturation <90%
timeFrame: Baseline
measure: sleep-related respiratory characteristics: average oxygen saturation
timeFrame: Baseline
measure: sleep-related respiratory characteristics: lowest oxygen saturation
timeFrame: Baseline
measure: Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: standard deviation of normal-to-normal intervals
timeFrame: Baseline
measure: Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: number of interval differences of successive heart beats greater than 50 ms
timeFrame: Baseline
measure: Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: spectral power in high-frequency power bands
timeFrame: Baseline
measure: Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: spectral power in low-frequency power bands
timeFrame: Baseline
measure: Sleep duration assessed by polysomnography
timeFrame: Baseline
measure: Sleep efficiency assessed by polysomnography
timeFrame: Baseline
measure: Sleep latency assessed by polysomnography
timeFrame: Baseline
measure: Sleep S1 stage duration assessed by polysomnography
timeFrame: Baseline
measure: Sleep S2 stage duration assessed by polysomnography
timeFrame: Baseline
measure: Sleep S3 stage duration assessed by polysomnography
timeFrame: Baseline
measure: Rapid eye movement (REM) stage duration assessed by polysomnography
timeFrame: Baseline
measure: Wake after sleep onset time assessed by polysomnography
timeFrame: Baseline
measure: Arousal index assessed by polysomnography
timeFrame: Baseline
measure: periodic limb movement index assessed by polysomnography
timeFrame: Baseline
measure: Stroke lesion volume
timeFrame: Baseline
Locations:
city: St Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
Study officials:
affiliation: Almazov National Medical Research Centre
name: Lyudmila Korostovtseva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bochkarev 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.
citation: Seiler 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.