Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Changes of Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
This trial intends to observe the clinical efficacy and safety of grain moxibustion at Baihui(GV20), Xinshu(BL15) and Pishu(BL20) in the treatment of insomnia.
详细描述
Insomnia is one of the most common sleep disorders. The main symptoms are difficulty in falling asleep, decreased sleep quality and sleep time, and affect the normal work, study and life during the day.
Acupuncture has a good clinical effect on insomnia, but most of the treatment methods are acupuncture or electroacupuncture. Moxibustion therapy, as one of the main components of the therapy, has the advantages of simple operation, wide acceptance, which is suitable for a wide range of promotion and application.At present, the trials of moxibustion in the treatment of insomnia mainly focus on mild moxibustion. The number of studies is small, and the research is designed insufficiently, so it is difficult to draw a positive conclusion, and needs to be further confirmed by rigorous designed experiments. In addition, grain moxibustion, which is widely used in clinic, has the advantages of more convenient operation, short treatment time and strong permeability. However, its efficacy and safety in the treatment of insomnia are still unclear, so it is necessary to carry out a randomized controlled trial to confirm it.
One hundred and two eligible patients will be randomly assigned to one of 3 groups: grain moxibustion group, sham grain moxibustion group and wait-list control group. Treatment will be given 3 times per week for 4 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are changes of PSQI scores from baseline to 8 week follow-up, sleep monitoring of bracelet, Athens Insomnia Scale（AIS）, Generalized Anxiety Disorder Scale-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9) and recurrence observation during the follow-up period. Daily dose of patients' estazolam will be recorded in the dairy. All adverse effects will be assessed by the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks post-treatment, as well as at 8 week and 12 week follow-up.
This trial intends to observe the clinical efficacy and safety of grain moxibustion at Baihui(GV20), Xinshu(BL15) and Pishu(BL20) in the treatment of insomnia, which will provide an experimental basis for the treatment of insomnia with grain moxibustion and lay the foundation for the promotion and application of moxibustion in the future.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of insomnia;
- •TCM syndrome differentiation belongs to deficiency of both heart and spleen;
- •Male or female participants aged 18-75;
- •Participants whose PSQI score is 5-15;
- •The course of disease is more than 3 months;
- •Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.
排除标准
- •Participants with mental retardation;
- •Participants with serious cardiovascular diseases, liver, kidney and hematopoietic system diseases;
- •Insomnia is caused by nervous system diseases (such as stroke, Parkinson's disease) or mental disorders (including depression or anxiety);
- •Female participants who is pregnant or lactating;
- •Participants with diabetes and sensory dysfunction.
- •Participants with skin diseases of acupoints;
- •Taking sedative hypnotics (including barbiturates, benzodiazepines, tranquilizers, diphenylmethane, etc) and other insomnia related drugs within 2 weeks before the trial;
- •Participants with dependence on sleeping drugs;
- •Participants suffering from malignant tumor, sequelae of severe cerebral apoplexy, organ failure and other major diseases that affect insomnia and therapeutic effect.
研究组 & 干预措施
Grain moxibustion
Grain moxibustion +standard care
干预措施: Grain moxibustion (Device)
Sham grain moxibustion
Sham grain moxibustion +standard care
干预措施: Sham grain moxibustion (Device)
Wait-list control
Standard care
干预措施: Standard care (Other)
结局指标
主要结局
Changes of Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline and week 4
The Pittsburgh Sleep Quality Index (PSQI) is a widely-used questionnaire to assess one's sleep disorders over one month. It is comprised of 19 self-rated items and 5 other-rated items. The scores include the following indicators: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of medication, and daytime dysfunction. Each indicator is rated from 0 to 3. The accumulated scores of the seven indicators constitute the total score of PSQI (0-21). The higher score indicates the worse sleep quality and severer sleep disorders. The investigators set the changes of PSQI scores between baseline to week 4 as the primary outcome, to evaluate the effectiveness of acupuncture for depression related insomnia.
次要结局
- Sleep monitoring of bracelet(Week 12)
- Changes of Patient Health Questionnaire-9 (PHQ-9)(Baseline and week 12)
- Changes of Generalized Anxiety Disorder Scale-7(GAD-7)(Baseline and week 12)
- Recurrence observation during the follow-up period(Week 12)
- Dose dairy(12 weeks)
- Changes of PSQI scores(Baseline and week 12)
- Changes of Athens Insomnia Scale(AIS)(Baseline and week 12)