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This study intends to further reveal the effect of RIC in stroke-related insomnia and explore its potential mechanisms.
Sleep disturbance after stroke is an important factor affecting the prognosis of stroke function. At present, most studies have focused on the diagnosis and treatment of sleep disordered breathing after stroke, while stroke-related insomnia has been neglected. Therefore, it is of great significance to explore a treatment that combines stroke protection with sleep improvement.
Remote ischemic conditioning (RIC) triggers endogenous protective effect through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of autonomic nervous system, release of humoral factors, improvement of vascular endothelial function and modulation of immune/inflammatory responses, which participate in the regulation of sleep after stroke.Therefore, this study intends to conduct a randomized controlled trial to further reveal the effect of RIC in stroke-related insomnia and explore its potential mechanisms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Subjects in the intervention group will recieve remote ischemic conditioning (RIC) treatment twice a day for 3 months. |
|
| Sham control group | Sham Comparator | Subject in the sham control group will recieve sham remote ischemic conditioning (Sham-RIC) treatment twice a day for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning (RIC) | Device | RIC is a non-invasive therapy which is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol include five cycles of 5-min inflation to 220mmHg and 5-min deflation. |
| Measure | Description | Time Frame |
|---|---|---|
| PSQI score(Pittsburgh sleep quality index) | PSQI score of baseline and treatment after 1, 2, 3months . The the minimum value is 0, and the maximum value is 21.Higher scores mean a worse outcome. | From baseline to 3months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD, PhD | Contact | 101-83199430 | jixm@ccmu.edu.cn | |
| Jin Ma, MD | Contact | 13699188306 | 2753297695@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuan Wu Hospital,Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sham remote ischemic conditioning (Sham-RIC) | Device | The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms. |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |