The RCT Study on the Evaluation of Clinical Effect of Primary Insomnia Treated With the Tiaoshen Acupuncture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Pittsburgh sleep quality index
研究概览
简要总结
Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the acupuncture group adopts Tiaoshen acupuncture, and the placebo acupuncture group adopts non-insertive acupuncture supported by the Park device, and the Pittsburgh Sleep Quality Index (PSQI) is used as the main index to evaluate the patients through the scale; subjective indicators like Chalder 14-item fatigue scale, Epworth sleepiness rating, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and objective indicators like polysomnography (PSG), heart rate variability (HRV) is regarded as a secondary index, and then evaluate the clinical efficacy of Tiaoshen acupuncture on PI and explore its mechanism.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia;
- •Age range: 18-70 years old;
- •PSQI score>7 points; SAS score > 50 or SDS score > 53;
- •No communication and cognitive impairment;
- •No use or withdrawal of psychoactive drugs such as anti-anxiety within one month; ·No major physical diseases;
- •Those who voluntarily accept the research content and can complete various scale evaluations, polysomnography monitoring and HRV;
- •Sign an informed consent form prior to the start of the study.
排除标准
- •Those who do not meet the inclusion criteria;
- •Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness;
- •Those with severe liver and renal insufficiency and bleeding tendencies;
- •Alcoholism (liquor ≥ 100ml/day), smoking (≥ 15 cigarettes/day), drug abuse or taking psychotropic drugs;
- •People with other sleep disorders, such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, and REM sleep behavioral disorders;
- •Pregnant or nursing;
- •Those with other major diseases and poor control;
- •Other persons who are unwilling to sign informed consent.
研究组 & 干预措施
the acupuncture group
the patients included in this arm will recept the Tiaoshen acupuncture.
干预措施: the acupuncture group (Other)
the placebo acupuncture group
Subjects in the placebo acupuncture group will receive non-insertive acupuncture using the sham needle supported by the Park device, and the selected acupoints is the same as the acupuncture group.
干预措施: the placebo acupuncture group (Other)
结局指标
主要结局
Pittsburgh sleep quality index
时间窗: 4 weeks after treatment
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data.The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Pittsburgh sleep quality index
时间窗: Before treatment
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Pittsburgh sleep quality index
时间窗: the 4th week of treatment
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
次要结局
- Self-rating depression scale(4 weeks after treatment)
- Heart rate variability(the 4th week of treatment)
- Epworth Sleepiness Scale(4 weeks after treatment)
- Fatigue Scale-14(4 weeks after treatment)
- Self-Rating Anxiety Scale(4 weeks after treatment)
- Polysomnography(the 4th week of treatment)
- Fatigue Scale-14(Before treatment)
- Fatigue Scale-14(the 4th week of treatment)
- Epworth Sleepiness Scale(Before treatment)
- Epworth Sleepiness Scale(he 4th week of treatment)
- Self-Rating Anxiety Scale(Before treatment)
- Self-Rating Anxiety Scale(4th week of treatment)
- Self-rating depression scale(Before treatment)
- Self-rating depression scale(the 4th week of treatment)
研究者
Liu Yingjun
Attending doctor
The Third Affiliated hospital of Zhejiang Chinese Medical University