Efficacy and Safety Evaluation of Remote Ischemic Adaptation ( Intermittent Pressure Stimulation ) in the Treatment of Insomnia After Stroke

Stroke is the second leading cause of death and one of the main causes of disability. The incidence of stroke is increasing worldwide. In 2010, the number of patients with first stroke increased by 68 % compared with 1990. The long-term effects of stroke sequelae include mobility, cognitive ability, language and communication disorders, as well as emotional problems, difficulties in daily life activities and social barriers. Sleep often changes after stroke. Insomnia disorder is a risk factor for stroke and an independent predictor of life satisfaction 6 months after stroke. Insomnia disorder is a sleep disorder characterized by frequent and persistent difficulty in falling asleep and / or difficulty in maintaining sleep and leading to poor sleep quality. Insomnia disorder can exist in isolation or co-exist with mental disorders, physical diseases or substance abuse, which can be accompanied by a variety of functional impairments during awakening. It is reported that in the general population, the prevalence of insomnia is 6 % to 48 % according to different definitions of insomnia. The prevalence of insomnia is higher in stroke patients. Insomnia after stroke has a high correlation with depression, disability and fatigue, and has a greater impact on returning to work one year after stroke. Therefore, actively dealing with the insomnia symptoms of stroke patients is conducive to improving the prognosis of stroke patients and improving the quality of life of stroke patients. The current treatment methods are divided into drug therapy and non-drug therapy. Drug therapy mainly includes benzodiazepines and barbiturates, but its clinical application and long-term use are limited due to many adverse reactions, contraindications, and strong dependence. In addition to drug therapy, other treatments for post-stroke depression and insomnia include psychotherapy, strong light therapy, transcranial magnetic stimulation and acupuncture. Some evidence shows that these methods are beneficial to the improvement of insomnia, fatigue, mood and quality of life, but the conclusions are different and the quality of evidence is low.

Remote ischemic condition ( RIC ), also known as intermittent pressure stimulation, is a non-invasive and easy-to-use physical therapy that has been used in clinical trials to protect the brain ( including ischemic and hemorrhagic stroke ), heart and many other organs. Studies have shown that RIC also has the effect of treating depression, insomnia and anxiety, but the research reports on the treatment of insomnia after stroke are still limited. At present, the mechanism of insomnia after stroke is unknown, and there may be many factors involved, such as inflammatory stress, stroke location, environmental factors, etc. The potential mechanisms of RIC include anti-inflammatory, anti-oxidative stress, immune system regulation and other potential pathways. Therefore, RIC can be used as a promising non-invasive physical therapy for post-stroke insomnia.

Therefore, this study takes patients with post-stroke insomnia as the research object, uses RIC technology to treat patients with post-stroke insomnia, and observes its therapeutic effect and adverse reactions.

• Pittsburgh Sleep Quality Index (PSQI) global score [Срок оценки: 4 weeks, 3 months, 6 months]
• Change from baseline in sleep onset latency (SOL) as measured by polysomnography [Срок оценки: 4 weeks]
• Change from baseline in total sleep time (TST) as measured by polysomnography [Срок оценки: 4 weeks]
• Change from baseline in percentage of stage N1 sleep (N1%) as measured by polysomnography [Срок оценки: 4 weeks]
• Change from baseline in percentage of stage N2 sleep (N2%) as measured by polysomnography [Срок оценки: 4 weeks]
• Change from baseline in percentage of stage N3 sleep (N3%) as measured by polysomnography [Срок оценки: 4 weeks]
• National Institutes of Health Stroke Scale (NIHSS) total score [Срок оценки: 4 weeks, 3 months, 6 months]
• modified Rankin Scale (mRS) score [Срок оценки: 4 weeks, 3 months, 6 months]
• Barthel Index (BI) score [Срок оценки: 4 weeks,3 months,6 months]
• Functional Independence Measure (FIM) total score [Срок оценки: 4 weeks,3months,6months]
• Mini-Mental State Examination (MMSE) total score [Срок оценки: 4 weeks,3months,6months]
• Montreal Cognitive Assessment (MoCA) total score [Срок оценки: 4 weeks,3 months,6 months]