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Patients from 60 to 75 years old diagnosed with cerebral small vessel disease with no history of symptomatic stroke, brain tumor, traumatic brain injury, seizures and neurodegenerative or mental disorder will undergo overnight leg actigraphy and cardiorespiratory monitoring. Those of them with apnea/hypopnea index under 5 will be enrolled. Brain MRI and cognitive assessment will be performed at baseline and in 1-year follow-up, sleep quality will be assessed at baseline with self-reported questionnaires. Progression of cerebral small vessel disease markers and cognitive dysfunction will be compared between patients with high periodic limb movement index (the number of periodic limb movement ≥ 15 per hour of sleep) and controls (periodic limb movement index < 15/h).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main | Patients with cerebral small vessel disease and periodic limb movement index equal or more than 15 movements per hour of sleep. |
| |
| Control | Patients with cerebral small vessel disease and periodic limb movement index less than 15 movements per hour of sleep. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actigraphy | Diagnostic Test | Participants will undergo overnight leg actigraphy at baseline. Leg movements will be recorded bilaterally by actigraphic method with two ankle-worn recorders. |
| Measure | Description | Time Frame |
|---|---|---|
| White matter hyperintensities volume change | All the images will be processed with online software pipeline to make an automated volumetric measurement of white matter hyperintensities. The volume of the white matter lesion will be calculated separately for the periventricular, juxtacortical, infratentorial and deep white matter areas as well as total volume of the lesion. Baseline volumes will be subtracted from follow-up volumes to obtain absolute white matter hyperintensities volume change. | 1 year |
| Degree of Cognitive Decline | The scores of cognitive tests (Montreal Cognitive Assessment (MoCA), 12-word Verbal Memory Test, Benton Visual Retention Test, Frontal Assessment Battery, Trail Making Test (parts A and B), phonetic and semantic verbal fluency assessment, Symbol Digit Modalities Test) at baseline will be subtracted from the corresponding baseline scores. The obtained difference reflects the degree of cognitive decline in 1 year. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with сerebral small vessel disease will be recruited among in-hospital patients (1st and 2nd Department of Neurology, University clinic 3, Sechenov First Moscow State Medical University, Moscow).
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina D. Spektor, M.D. | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University (Sechenov University) | Moscow | Russia |
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| Cardiorespiratory monitoring | Diagnostic Test | All participants will be scanned for presence of sleep-related breathing disorders with a portable monitoring device at baseline. The compact screening device will be attached to the patient's wrist during the night sleep. |
|
| Neuroimaging | Diagnostic Test | All subjects will undergo brain MRI scanning at baseline and in 1-year follow-up. The imaging protocol will include axial T1, T2, T2*, FLAIR and diffusion-weighted imaging scans that will be made on a 3-Tesla scanner. |
|
| Assessment of cognitive function | Other | Assessment will take place at weeks 0 (baseline) and 52 (1 year follow-up). The neuropsychological protocol will be consist of Montreal Cognitive Assessment (MoCA), 12-word Verbal Memory Test, Benton Visual Retention Test, Frontal Assessment Battery, Trail Making Test (parts A and B), phonetic (as a part of the MoCA) and semantic verbal fluency assessment, Symbol Digit Modalities Test. |
|
| Sleep quality and mood questionnaires | Other | Self-reporting scales and questionnaires will be used at baseline to assess sleep quality, daytime functioning and mood. The protocol includes the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Geriatric Depression Scale. |
|
| ID | Term |
|---|---|
| D020189 | Nocturnal Myoclonus Syndrome |
| D059345 | Cerebral Small Vessel Diseases |
| D060825 | Cognitive Dysfunction |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D020447 | Parasomnias |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D056044 | Actigraphy |
| D059906 | Neuroimaging |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061725 | Accelerometry |
| D008919 | Investigative Techniques |
| D003952 | Diagnostic Imaging |
| D003943 | Diagnostic Techniques, Neurological |
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