A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia: A Randomized Controlled Case Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes of The PSQI(Pittsburgh Sleep Quality Index)
研究概览
简要总结
The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled. The aim of the study is to compare the therapeutic effect between head-acupoints acupuncture and body-acupoints acupuncture on Insomnia.
详细描述
The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled, and randomly assigned into two groups, 60 of them are the head-acupoints acupuncture group, who will receive GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 head-acupoints acupuncture treatment, and 60 of them are the body-acupoints acupuncture group, who will receive bilateral HT7, PC6, SP6, ST36, KI3, LR3 body-acupoints acupuncture treatment for 4 weeks.
The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week 4 and week 6.
The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate viability(HRV) recorded by the ECG monitor (time frame: baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion).
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 20~70 years,
- •met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V)
- •experienced insomnia at least three times a week for more than a month
- •voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started.
排除标准
- •a pregnant or lactating woman
- •the patient's insomnia is caused by mental disorders other than mild anxiety,
- •the patient has serious cardiovascular, liver, kidney or hematopoietic system disease
- •the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease)
- •the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial
- •the patient with cardiac pacemaker
- •the patient does not want to wear portable physiological signal recording device (SOMNOwatchTM) and handheld ECG monitor
- •the patient has a history of sleep apnea
研究组 & 干预措施
head acupoints acupuncture
Acupuncture treatment for 12 acupoints on both sides of the head
干预措施: head acupoints acupuncture (Procedure)
body acupoints acupuncture
Acupuncture treatment for 12 acupoints on both sides of the body
干预措施: body acupoints acupuncture (Procedure)
结局指标
主要结局
Changes of The PSQI(Pittsburgh Sleep Quality Index)
时间窗: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
The 19 questions are combined into seven clinically-derived component scores, each weighted equally from 0-3. The seven component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.
Changes of The Epworth sleepiness scale (ESS)
时间窗: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
The Epworth sleepiness scale (ESS) containing eight items that ask for self-reported disclosure of the expectation of "dozing" in a variety of situations. A sum of responses is calculated for a total score ranging from 0 to 24, higher scores mean a worse. outcome.
Changes of The HADS(The Hospital Anxiety and Depression Scale)
时间窗: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, the scores ranged from 0 to 21 for anxiety and 0 to 21 for depression, higher scores mean a worse outcome.
次要结局
- HRV(Heart rate viability)(Baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion, an average of 1 year.)
- actigraphy (3-day)(Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6))
- sleep diary(Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6))