Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The sleep perception
研究概览
简要总结
The investigators will conduct acupuncture for participants with chronic fatigue syndrome(CFS). Firstly the investigators aim to figure out the characteristic of sleep structure of CFS and the changes caused by acupuncture. Secondly the investigators seek to investigate the characteristic of sleep-wake rhythm, slow wave sleep(SWS)-rapid eye movement(REM)sleep rhythm, and REM sleep rhythm of CFS and the readjusting of acupuncture for it. Thirdly the investigators want to know the efficacy of acupuncture for relieving the fatigue, reducing accompanying symptoms and for improving the life quality of CFS.
详细描述
This trial is a randomized, placebo controlled clinical trial. 72 participants with CFS are randomly allocated to two different groups. Treatment group is acupuncture, while the control group is sham acupuncture. The ratio of treatment group and control group is 2:1. Both acupuncture and sham acupuncture group will receive 12 sessions of verum/sham acupuncture in 4 weeks.
The result of this trial (available in 2011) will supply evidence on the efficacy of acupuncture for sleep disorder of CFS.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who meet the diagnosis criteria of CFS;
- •Clinically evaluated, exclude any disease that can explain the chronic fatigue;
- •The onset age of CFS is between 18 and 50 years old;
- •Have not taken any hypnotic, melatonin, or antidepressants within 45 days;
- •Willing to finish the whole observation period;
- •With written consent form signed by themselves.
排除标准
- •Chronic fatigue caused by diseases such as internal diseases(for example, pulmonary emphysema, rheumatoid arthritis, etc.), mental illness(for example, any type of dementia paranoids, depression, etc.), some diseases that just onset or evaluated (for example, sleep deprivation, untreated diabetes, etc.), some diseases that need recovery gradually(for example, restless legs syndrome, lactation, etc.), morbid obesity;
- •Participants in other clinical research;
- •Pregnant women, lactating women.
结局指标
主要结局
The sleep perception
时间窗: Change from baseline in sleep perception at 4 weeks
The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG.
次要结局
- The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36)(Change from baseline in SF-36 at 4 weeks)
- The Somatic and Psychological Health Report(SPHR)(Change from baseline in SPHR at 4 weeks)
- DSWS-REM sleep rhythm(Change from baseline in DSWS-REM sleep rhythm at 4 weeks)
- Sleep efficiency(Change from baseline in sleep efficiency at 4 weeks)
- The Fatigue Severity Scale(FSS)(Change from baseline in FSS at 4 weeks)
- Sleep-wake rhythm(Change from baseline in sleep-wake rhythm at 4 weeks)
- REM sleep rhythm(Change from baseline in REM sleep rhythm at 4 weeks)
- Total sleep time(Change from baseline in total sleep time at 4 weeks)
- The Pittsburgh Sleep Quality Index(PSQI)(Change from baseline in PSQI at 4 weeks)
- Sleep latency(Change from baseline in sleep latency at 4 weeks)
- Percentage of every sleep stage(Change from baseline in percentage of every sleep stage at 4 weeks)
研究者
Li ying
Principal Investigator
Chengdu University of Traditional Chinese Medicine