Exploratory Study of the Impact of Intermittent Hypoxia-hyperoxia Training on Patients with Cerebral Venous Outflow Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 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-hyperoxia treatment in patients with cerebral venous outflow disorders.
详细描述
Cerebral venous outflow disorder (CVOD), resulting from internal blockage, external oppression, or jugular valve incompetence, can cause hemodynamic disturbance and abnormal perfusion status. Restricted applicable populations and limited benefits constrain the application of existing CVOD management approaches. Previous studies indicate intermittent hypoxia hyperoxia training (IHHT) might improve circulatory status via hypoxic stimulation and allow hypoxic-related symptom amelioration through oxygen supply. Thus, IHHT might be a promising therapy for the CVOD population. Studies have so far proved inconclusive as to whether IHHT is safe and effective for CVOD. Therefore, the present study aimed to investigate the safety and feasibility of IHHT in patients with cerebral venous outflow disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 range from 18 to 80 years.
- •Diagnosis of CVOD confirmed by CE-MRV, DSA, CTV, or ultrasound, including cerebral venous sinus stenosis (CVSS), internal jugular venous stenosis (IJVS), or internal jugular venous valve incompetence.
- •Unexplained chronic neurological deficits or other symptoms > 3 months.
- •Signed informed consent from the patient or legally authorized representative.
排除标准
- •Life-threatening comorbidities.
- •Clinical symptoms and signs explained by other diseases.
- •Intracranial hypertension; moderate to severe intracranial/extracranial arterial stenosis.
- •History of ischemic/hemorrhagic stroke or cerebral endovascular surgery.
- •Intracranial abnormalities, such as tumors, abscesses, vascular malformations, or cerebral venous sinus thrombosis.
- •Confirmed sleep apnea, plateau residency, traveling history of altitude > 1000m, or relative hypoxic exposure within last six months.
- •Poor compliance.
结局指标
主要结局
Incidence of adverse reactions
时间窗: After the first-time IHHT intervention.
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness, and insomnia.
次要结局
- Heart rate(At the first-time IHHT intervention.)
- Blood pressure(At the first-time IHHT intervention.)
- Tissue oxygen saturation(At the first-time IHHT intervention.)
- Twenty-four-hour ambulatory blood pressure(The day before the 14-time treatment; The day after the 14-time treatment.)
- Blood routine indexes(The day before the 14-time treatment; The day after the 14-time treatment.)
- Blood biochemical changes(The day before the 14-time treatment; The day after the 14-time treatment.)
- The global impression of the treatment(The day after the 7-day treatment.)
- Symptoms(The day before the 14-time treatment ;The day after the 14-time treatment.)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University