Efficacy of Head-point Acupuncture on Insomnia
Efficacy of Head-point Acupuncture on Insomnia: A Prospective Case Series Study
研究概览
地位
条件
详细说明
The investigators will conduct a single-center case series study. A total of 40 participants with insomnia will be enrolled, and will undergo GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 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).
研究类型
注册 (预期的)
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
- aged 20~80 years,
- persistent difficulty in either falling asleep, remaining asleep through the night, or waking up too early at least three nights a week for more than a month, and not suffered from any secondary diseases.
描述
Inclusion Criteria:
- aged 20~80 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
HADS(医院焦虑抑郁量表)的变化
大体时间:基线第 0 周、第 2 周、第 4 周和交易后 2 周(第 6 周)
|
医院焦虑抑郁量表为14项自填问卷,焦虑评分范围为0~21分,抑郁评分范围为0~21分,得分越高预后越差。
|
基线第 0 周、第 2 周、第 4 周和交易后 2 周(第 6 周)
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PSQI(匹兹堡睡眠质量指数)的变化
大体时间:基线第 0 周、第 2 周、第 4 周和交易后 2 周(第 6 周)
|
这 19 个问题被组合成七个临床衍生的成分分数,每个分数从 0-3 平均加权。
七项得分相加得到0-21分的总体得分,得分越高表示睡眠质量越差。
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基线第 0 周、第 2 周、第 4 周和交易后 2 周(第 6 周)
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Changes of The Epworth sleepiness scale (ESS)
大体时间:Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
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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.
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Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
HRV(心率活力)
大体时间:基线第 0 周、第 1 周、第 2 周、第 3 周、第 4 周和第 6 周;针灸前 30 分钟和针灸后 60 分钟直至研究完成,平均 1 年。
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心率变异性 (HRV) 的频域分析是一种无创方法,已被用于反映人类的心脏自主神经活动。
高频功率(HF;0.15-0.4
HRV 的 Hz) 表示心率的迷走神经(副交感神经)控制。
HRV 的低频功率 (LF; 0.04-0.15 Hz) 由交感神经和迷走神经共同贡献,而归一化 LF (nLF) 被视为交感神经调制。
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基线第 0 周、第 1 周、第 2 周、第 3 周、第 4 周和第 6 周;针灸前 30 分钟和针灸后 60 分钟直至研究完成,平均 1 年。
|
体动记录仪(3 天)
大体时间:基线第 0 周、第 2 周、第 4 周和交易后 2 周(第 6 周)
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Actigraphy 提供睡眠参数的客观估计,包括:SE(睡眠效率)、SA(睡眠觉醒)、TST(总睡眠时间)
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基线第 0 周、第 2 周、第 4 周和交易后 2 周(第 6 周)
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睡眠日记
大体时间:基线第 0 周、第 2 周、第 4 周和交易后 2 周(第 6 周)
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睡眠日记提供每日对睡眠参数的主观估计,包括:白天小睡、助眠剂摄入、就寝时间、入睡潜伏期、夜间觉醒频率、觉醒持续时间、醒来时间、起床时间、起床时的感觉(五分制)和睡眠质量(五分制)。
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基线第 0 周、第 2 周、第 4 周和交易后 2 周(第 6 周)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
There will be a research number representing the identity. This number will not display the name, identification number, and address.
For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential.
Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.
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