Efficacy and Safety Evaluation of Remote Ischemic Adaptation ( Intermittent Pressure Stimulation ) in the Treatment of Insomnia After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Sleep efficiency as measured by polysomnography
研究概览
简要总结
The incidence of post-stroke depression is high, which will affect the rehabilitation of neurological function, damage cognitive function, and increase the risk of subsequent stroke recurrence. The guidelines recommend that in addition to antiplatelet, blood pressure control, lipid-lowering and other treatments, secondary prevention of post-stroke depression should also be strengthened. Moreover, after the occurrence of post-stroke depression, methods such as medication and psychotherapy have their own limitations, such as potential adverse drug reactions and limited psychotherapy. Therefore, it is necessary to pay attention to the prevention of post-stroke depression.
The remote ischemic adaptation therapy applied in our study is a safe, non-invasive and convenient physical therapy. By transiently and repeatedly applying ischemia-reperfusion stimulation to both upper arms, it induces a systemic protective response, improves the brain 's tolerance to ischemia and hypoxia, and exerts a protective effect on multiple organs such as the brain and heart. The RIC therapeutic instrument has been national patented and has been maturely applied to the prevention and treatment of acute cerebral infarction, which can promote the rehabilitation of neurological function. In addition, it also has certain curative effect in the treatment of cerebrovascular stenosis, refractory hypertension, depression, insomnia, anxiety and so on.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old ;
- •In line with the diagnostic criteria of ischemic stroke, with reference to the ' Chinese guidelines for the diagnosis and treatment of acute ischemic stroke ' diagnosed ischemic stroke ;
- •Despite adequate sleep opportunities, patients still have difficulty in falling asleep or maintaining sleep, staying asleep at least 3 times a week for at least 3 months, which leads to pain or impaired daytime function.
- •PSQI score ≥ 6 and ISI score ≥ 8 ;
- •All research contents have been understood and informed consent has been signed.
排除标准
- •Insomnia before stroke ;
- •Patients with mental disorders, bipolar disorder or depression, generalized anxiety disorder and other mental disorders ;
- •Patients were pregnant or lactating women ;
- •Other reasons identified by the researchers are not suitable for patients ;
研究组 & 干预措施
treatment group
The full-automatic ischemic preconditioning therapeutic instrument was used to pressurize the patients ' upper arms ( experimental group pressure = 200 mmHg ) for 5 minutes, and then breathe out for 5 minutes, which was an ischemia-reperfusion cycle. Each training was performed for 5 consecutive cycles, once in the morning and once in the afternoon, twice a day, at least 5 days a week, for a total of 4 weeks.
干预措施: Automatic ischemic preconditioning therapeutic apparatus (Device)
control group
Participants in this group will use a sham training device that is identical in appearance, sound, and sense of wear to the experimental device. The treatment plan was consistent with the experimental group in time and process : wearing a cuff for 5 minutes, rest for 5 minutes, a total of 5 cycles. The key difference is that during the so-called ' pressure ', the cuff is inflated to a pressure of only 60 mmHg to simulate the sense of operation of the device and a slight sense of skin contact. The treatment frequency, cycle and execution personnel were the same as those of the experimental group.
干预措施: Sham Ischemic Preconditioning Device (Device)
结局指标
主要结局
Sleep efficiency as measured by polysomnography
时间窗: 4 weeks
Sleep efficiency is calculated as (total sleep time / total time in bed) × 100%, assessed by overnight polysomnography. Higher percentage indicates better sleep efficiency.
Insomnia Severity Index (ISI) total score
时间窗: 4 weeks
The Insomnia Severity Index is a 7-item self-report questionnaire assessing perceived insomnia severity. Each item is rated on a 0-4 scale, yielding a total score ranging from 0 to 28. Higher scores indicate more severe insomnia.
次要结局
- Pittsburgh Sleep Quality Index (PSQI) global score(4 weeks, 3 months, 6 months)
- Change from baseline in sleep onset latency (SOL) as measured by polysomnography(4 weeks)
- Change from baseline in total sleep time (TST) as measured by polysomnography(4 weeks)
- Change from baseline in percentage of stage N1 sleep (N1%) as measured by polysomnography(4 weeks)
- Change from baseline in percentage of stage N2 sleep (N2%) as measured by polysomnography(4 weeks)
- Change from baseline in percentage of stage N3 sleep (N3%) as measured by polysomnography(4 weeks)
- National Institutes of Health Stroke Scale (NIHSS) total score(4 weeks, 3 months, 6 months)
- modified Rankin Scale (mRS) score(4 weeks, 3 months, 6 months)
- Barthel Index (BI) score(4 weeks,3 months,6 months)
- Functional Independence Measure (FIM) total score(4 weeks,3months,6months)
- Mini-Mental State Examination (MMSE) total score(4 weeks,3months,6months)
- Montreal Cognitive Assessment (MoCA) total score(4 weeks,3 months,6 months)