Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Incidence of adverse reactions
研究概览
简要总结
This study aims to investigate the safety and efficacy of intermittent hypoxia treatment in patients with chronic cerebral hypoperfusion.
详细描述
Chronic cerebral hypoperfusion is a common and frequently occurring disease in middle-aged and senior people, and an important cause of multiple diseases such as acute ischemic stroke and vascular dementia. However, current treatments for chronic cerebral hypoperfusion are limited and nonspecific. Intermittent hypoxia refers to periodic intervention with alternating normoxia and hypoxia. Studies have shown that short-term (5-10min), low frequency (3-15 times), and mild to moderate hypoxia (9-16%) usually have protective effects and can improve cerebral blood perfusion. Therefore, this study is an exploratory study combining intermittent hypoxia treatment with chronic cerebral hypoperfusion, aiming to preliminarily explore the safety and potential effectiveness of intermittent hypoxia treatment in the using of chronic cerebral hypoperfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 45-70 years, BMI 18.5-24kg/m2, both sexes.
- •Subjects with risk factors of cerebrovascular disease, such as hypertension, diabetes, dyslipidemia, and so on, and the risk factors are well controlled.
- •Cerebral/carotid ultrasound showed mild stenosis of unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) (<50%) without stenosis of other major feeding arteries.
- •Subjects with the manifestations of chronic cerebral hypoperfusion, such as dizziness, head pain, memory loss, slow reaction, inattention, emotional instability, decreased ability to work, sleep disorders and mood disorders, the course of more than 3 months.
- •Subjects or their legally authorized representative can provide informed consent.
排除标准
- •Stroke onset in the past 3 months, other severe neurological diseases, such as epilepsy, intracranial infectious diseases or demyelination.
- •Uncontrolled hypertension (systolic blood pressure ≥200mmHg) with antihypertensive drugs before enrollment, other cardiovascular diseases.
- •History of pulmonary, hepatic, dermatologic, or hematologic diseases.
- •History of substance abuse.
- •Pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.
结局指标
主要结局
Incidence of adverse reactions
时间窗: Thirty days after the treatment.
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.
次要结局
- Neurobehavioral scale 1(Baseline, after the 7-day treatment.)
- Neurobehavioral scale 2(Baseline, after the 7-day treatment.)
- Cerebral blood flow(Baseline, after the 7-day treatment.)
- Tissue oxygen saturation(Baseline, after the 7-day treatment, 30 days after the treatment.)
- Blood pressure(Baseline, after the 7-day treatment, 30 days after the treatment.)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University