Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease. (NCT04569643) | Clinical Trial Compass
UnknownNot Applicable
Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease.
Russia76 participantsStarted 2020-12-01
Plain-language summary
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).
Who can participate
Age range
60 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of a cerebral small vessel disease - assessed by MRI.
* Ability to follow the procedures of the study, fluent Russian language - assessed by self-report.
Exclusion Criteria:
* History of symptomatic stroke, brain tumor or traumatic brain injury - assessed by self-report and clinical history.
* History of severe psychiatric comorbidities other than anxiety and depression, substance use disorder - assessed by self-report and clinical history.
* Significant visual loss (leading to difficulties with performing cognitive tasks) - assessed by self-report and clinical history.
* Presence of dementia - assessed by history and clinical examination.
* Movement disorders (e.g. tremor, dystonia etc.) leading to lower velocity of performing cognitive tasks against the clock - assessed by clinical examination.
* Obstructive sleep apnea syndrome - according to the criteria of International classification of sleep disorders III.
* Restless legs syndrome - according to the criteria of the International restless legs syndrome study group.
* Current intake of neuroleptics, benzodiazepines, selective serotonin reuptake inhibitors - assessed by self-report and clinical history.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
White matter hyperintensities volume change
Timeframe: 1 year
2
Degree of Cognitive Decline
Timeframe: 1 year
Trial details
NCT IDNCT04569643
SponsorI.M. Sechenov First Moscow State Medical University