Auricular Acupuncture for Primary Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Sleep Onset Latency (SOL)
研究概览
简要总结
This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular acupuncture(AA) for primary insomnia(PI) .
详细描述
Investigators will conduct a 2-year clinical trial on auricular acupuncture (AA) for primary insomnia (PI), which is a double-blind (patient-blind and assessor-blind) RCT. 288 patients will be randomly assigned into 2 groups: the treatment group (Group A) and the control group (Group B). Group A will be treated with AA plus oral Eszopiclone, while Group B will be treated with sham AA plus oral Eszopiclone. All patients will receive a continuous 4-week treatment and 28-week follow-up. The data will be analyzed by the third party who is not clear about allocation and treatment.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnosis of PI according to DSM-5;
- •Aged 18-64 (including 18 and 64);
- •Provided a signed written consent form.
排除标准
- •The patient has somatic disease like severe respiratory, circulatory, endocrine system disease and hepatic/renal insufficiency;
- •The patient suffers from moderate / major depression (BDI score ≧ 8 points), moderate / severe anxiety disorder (SAS score ≧ 61 points) or any other serious mental disease;
- •The patient who abuse drug alcohol or substance;
- •The patient suffers from dementia or any other severe cognitive impairment;
- •The patient is in pregnancy or lactation period;
- •Patient who is a night worker or stick to irregular sleep pattern, and can't or don't want to terminate this kind of work mode;
- •The patient has history of suicide or suicidal tendency;
- •The patient is allergic to Eszopiclone or any other sedative-hypnotic drugs;
- •The patient who has taken psychiatric, hypnotic or antihistamine drugs during the last 4 weeks before baseline, however, the patient who use the prescription or nonprescription hypnotic drugs no more than twice a week can be recruited as soon as drug withdrawal;
- •The patient who is receiving ongoing psychological treatment;
- •The patient who has obstructive sleep apnea, restless leg syndrome, sleep rhythm disorders, parasomnias, etc.
研究组 & 干预措施
auricular acupuncture(AA) & Eszopiclone
The disposable Seirin Pyonex Needle will be chosen as AA material to attach every 3 days for 4 weeks, meanwhile, oral Eszopiclone 1 piece (3mg) will be applied 15 minutes before going to sleep everyday for 4 weeks. The manufacturer of disposable Seirin Pyonex Needles is Seirin Corporation, a Japanese company.
干预措施: auricular acupuncture(AA) (Other)
auricular acupuncture(AA) & Eszopiclone
The disposable Seirin Pyonex Needle will be chosen as AA material to attach every 3 days for 4 weeks, meanwhile, oral Eszopiclone 1 piece (3mg) will be applied 15 minutes before going to sleep everyday for 4 weeks. The manufacturer of disposable Seirin Pyonex Needles is Seirin Corporation, a Japanese company.
干预措施: Eszopiclone (Drug)
placebo AA & Eszopiclone
The disposable Pyonex Zero Needle, a non-invasive material will be chosen as placebo AA, with auricular acupoints have no certain effect on PI. Additionally, 1 piece (3mg) Eszopiclone will be administrated to participants 15 minutes before going to sleep everyday for 4 weeks.
干预措施: placebo AA (Other)
placebo AA & Eszopiclone
The disposable Pyonex Zero Needle, a non-invasive material will be chosen as placebo AA, with auricular acupoints have no certain effect on PI. Additionally, 1 piece (3mg) Eszopiclone will be administrated to participants 15 minutes before going to sleep everyday for 4 weeks.
干预措施: Eszopiclone (Drug)
结局指标
主要结局
Sleep Onset Latency (SOL)
时间窗: Change from baseline in SOL at 4 weeks
SOL is one of the sleep parameters mainly measured by actigraphy and sleep diaries, referring to the time it takes to fall asleep, starting from the moment of having intention to fall asleep, stopping at the moment of getting a 5-minute continuous sleep.
Wake After Sleep Onset (WASO)
时间窗: Change from baseline in WASO at 4 weeks
WASO is one of the sleep parameters mainly measured by actigraphy and sleep diaries, referring to the total time of awakening which from the initial sleep onset to the last awakening.
次要结局
- Pittsburgh Sleep Quality Index(PSQI)(Change from baseline in PSQI at 4 weeks)
- Insomnia Severity Index (ISI)(Change from baseline in ISI at 4 weeks)
- Beck Depression Inventory (BDI)(Change from baseline in BDI at 4 weeks)
- State-Trait Anxiety Inventory (STAI)(Change from baseline in STAI at 4 weeks)
- Self-rating Anxiety Scale (SAS)(Change from baseline in SAS at 4 weeks)
- The Epworth Sleeping Scale (ESS)(Change from baseline in ESS at 4 weeks)
- Flinders Fatigue Scale (FFS)(Change from baseline in FFS at 4 weeks)
- The MOS 36-Item Short-Form Health Survey questionnaire (SF-36)(Change from baseline in SF-36 at 4 weeks)
- Total Sleep Time (TST)(Change from baseline in TST at 4 weeks)
- Sleep Efficiency (SE)(Change from baseline in SE at 4 weeks)
- Number of awakenings (nWAK)(Change from baseline in nWAK at 4 weeks)
研究者
Li ying
Principal Investigator
Chengdu University of Traditional Chinese Medicine