NCT00839592已完成不适用
Acupuncture Treatment of Primary Insomnia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Self-rated sleep quality score measured by Insomnia Severity Index questionnaire
研究概览
简要总结
This is a randomized controlled trial to evaluate acupuncture treatment on insomnia in the adult population in Hong Kong.
详细描述
Acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on primary insomnia. This is a randomized single-blinded controlled trial. Patients will be randomly assigned to the electro-acupuncture group or the placebo acupuncture group. Patients will be put into groups and then compared.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents
- •aged 18-65
- •Ethnic Chinese
- •Meet the diagnosis criteria of primary insomnia for at least 3 months according to DSM-IV using the Structured Clinical Interview for DSM-IV (SCID)
- •Willing to give informed consent
- •total score of Insomnia Severity Index (ISI) at least 15
- •Able to comply with trial protocol
排除标准
- •Participation in any clinical trial during the previous 3 months prior to baseline
- •Any current major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders besides caffeine and nicotine, organic mental disorder, schizophrenia or any other psychotic disorder as defined by DSM-IV criteria
- •Serious physical illness or mental disorders due to a general medical condition which is judged by the investigator to render unsafe
- •Valvular heart defects, bleeding disorders or taking anticoagulant drugs.
- •Any acupuncture treatment during the previous 12 months prior to baseline.
- •In the investigator's opinion, the patient has a significant risk of suicide
- •Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
- •Infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
- •Herbal remedies, over-the-counter medications or psychotropic drugs, which are intended for insomnia, were taken within the last 2 weeks prior to baseline or during the study
结局指标
主要结局
Self-rated sleep quality score measured by Insomnia Severity Index questionnaire
时间窗: Baseline, weekly during the treatment course, 1-week posttreatment
次要结局
- Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy(Baseline, and 1-week posttreatment)
- Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.(Baseline, weekly during the treatment course, and 1-week posttreatment)
- Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire(Baseline, and 1-week posttreatment)
- Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)(Baseline, and 1-week posttreatment)
- Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Index(Baseline, and 1-week posttreatment)
- Subjects' credibility to the treatment measured by Credibility of treatment rating scale(Second and the last time of the treatment)
研究者
研究点 (1)
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