NCT03163615Unknown不适用
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Tibet Rhodiola Capsule on Hypoxia and Cardiovascular Risk Factors in Patients With Obstructive Sleep Apnea: A Pilot Trial
Shao-Ping Nie1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年6月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Average oxygen saturation
研究概览
简要总结
The purpose of this study is to evaluate the effect of Tibet Rhodiola Capsule on hypoxia and the cardiovascular risk factors in patients with mild to moderate OSA.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years, males or females;
- •HSAT or PSG testing within recent 3 months;
- •AHI 5-30 and lowest oxygen saturation<85%;
- •Refuse to accept CPAP, Mandibular orthosis device, surgery, or other medications to improve OSA;
- •Written informed consent.
排除标准
- •History of CPAP, Mandibular orthosis device, surgery, or other medications to improve OSA;
- •Significant central sleep apnea;
- •Histories of other sleep disorders: insomnia, chronic sleep deprivation, long-term use of sleeping pills or sedatives, restless legs syndrome;
- •Histories of underlying heart disease (cardiomyopathy, myocarditis, pericarditis or severe valvular disease), cardiogenic shock and heart failure (NYHA or Killip class 3-4), persistent atrial or ventricular arrhythmias;
- •History of myocardial infarction, coronary revascularization, and a known degree of stenosis > 75% of the coronary lesions;
- •Histories of known serious liver dysfunction (ALT or AST levels above 3 times the normal limit), renal insufficiency (GFR<30ml/min), moderate and severe chronic obstructive pulmonary disease, and pulmonary arterial hypertension;
- •Patients with malignant tumors, lymphoma and neuropsychiatric disorders;
- •Patients with major surgery or trauma within 3 months, and active bleeding or cerebrovascular accident within 6 months;
- •History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte <90×10^9/L);
- •Breastfeeding, pregnant, or potentially fertile women;
- •Patients who have known to be allergic to Tibet Rhodiola Capsule or its components or patients with serious adverse effect;
- •Participation in other clinical trials in recent 3 months;
- •Patients who cannot complete this trial or comply with the protocol.
研究组 & 干预措施
Tibet Rhodiola Capsule
Experimental
干预措施: Tibet Rhodiola Capsule (Drug)
Placebo oral capsule
Placebo Comparator
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Average oxygen saturation
时间窗: Change from Baseline to 84±4days
Average oxygen saturation was assessed by home sleep apnea testing(HSAT)
次要结局
- Lowest saturation(baseline and 84±4days)
- Percentage of total sleep time associated with saturation lower than 90% (T90SaO2 )(baseline and 84±4days)
- AHI(baseline and 84±4days)
- Heart rate variability(baseline and 84±4days)
- Low density lipoprotein-cholesterol(LDL-C)(baseline, 28±2days and 84±4days)
- Epworth sleepiness scale (ESS)(baseline and 84±4days)
- Quality of life scale (WHOQOL-BREF)(baseline and 84±4days)
- Coronary flow reserve(baseline and 84±4days)
- Platelet(PLT) count(baseline, 28±2days and 84±4days)
- Glycosylated hemoglobin (HbAlc)(baseline and 84±4days)
研究者
Shao-Ping Nie
MD, PhD
Beijing Anzhen Hospital
研究点 (1)
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