Different Acupoints Compatibility Difference of the Effect of Treatment of the Primary Insomnia

Study Overview
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Brief Summary
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With primary insomnia as the research object, by the method of multi-center RCT and needle single cavity and different acupoints compatibility treatment for primary insomnia, to Pittsburgh sleep quality index(PSQI) and evaluation, sleep log evaluation and Polysomnogram(PSG) as the means, such as the single cavity with different acupoints compatibility evaluate clinical curative effect of treating primary insomnia.

Detailed Description
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In order to establish a spectrum of acupoints compatibility of the law, is clear about the factors affecting the compatibility effect of acupoints, the formation of strong operability of acupoints compatibility optimization evaluation method, the project choice of the clinical acupuncture and moxibustion have curative effect of primary insomnia as the breakthrough point of the study, carried out clinical multi-center RCT research, through objective and scientific evaluation method, comparing the effect of different acupoints compatibility. Primary insomnia in clinical common disease, frequently-occurring disease, acupuncture curative effect is distinct, disease diagnosis, curative effect evaluation standard. Previous clinical data also show that the primary insomnia is acupuncture clinical diseases. This project by primary insomnia as the research object, research to better guide clinical practice, improve the clinical curative effect, promote acupuncture of the inheritance and innovation, promote scientification of acupuncture and moxibustion, modernization and internationalization, and will have broad prospect of application and significant scientific research value.

Official Title
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Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect

Conditions
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Primary Insomnia

Intervention / Treatment
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* Other: acupuncture
* Other: acupuncture
* Other: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Insomnia 's Disease; Aged 18-60 (including 18 and 60); Does not attend other clinical researchers; Participation in the researchers signed informed consent and voluntary; Pittsburgh sleep index (PSQI) index > 7 points; Athens scale or 6 points; Depression scale and anxiety scale 50 points or less. Exclusion Criteria: Breathing-Related Sleep disorder; Circadian rhythm disorders; Sleep disorders; Drug-induced insomnia (such as drug abuse, drug treatment); Sleep disorders caused by poor diet, lifestyle factors(Long-term excessive drinking, coffee, tea, etc.); All systemic diseases (such as pain, fever, cough, surgery, etc.) and the external environment disturbance factors; With cardiovascular, lung, liver, kidney and hematopoietic system such as serious primary diseases; Patients with mental illness; Pregnancy or breast-feeding women; Acupoints with severe skin infections; Patients who are afraid of acupuncture; Advanced malignant tumor or other serious wasting disease, infection and bleeding; Who do not meet the inclusion criteria, poor compliance, treatment, not according to stipulations can not judge the curative effect or data not congruent affect curative effect and safety of judgment; Caused by excessive anxiety and depression of patients with insomnia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single point group (Shenmen)<br>Patients will be acupuncture with Shenmen(HT7). | Other: acupuncture<br>* Patients will be treated with Shenmen(HT7), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.<br>|
| Other: Sancai coordinated points group<br>Patients in Sancai coordinated points group, will be acupuncture with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6). | Other: acupuncture<br>* Patients in Sancai coordinated points group, will be treated with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.<br>|
| Other: Control group<br>Patients in Control group, will be acupuncture with at the junction of deltoid and biceps. | Other: acupuncture<br>* Patients in Control group, will be treated with at the junction of deltoid and biceps, needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh sleep quality index(PSQI) |  | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test GABA,Glu,5-HT,Ach,NE,DA in the human brain to reflect the state of brain function by the Encephalofluctuograph(ET) |  | 5 weeks | 
| Change in Total Sleep Time Measured by PSG | Measuring indexes including total record time(TRT), sleep time(SPT), total sleep time(TST, sleep efficiency, sleep latency(SL), sleep cycle changes, awakening times, fall asleep after waking hours, REM times incubation period, incubation period of REM, REM (except the awakening times). | 5 weeks | 
| Sleep diary |  | 5 weeks | 
| Athens insomnia scale |  | 9 weeks | 
| Self-rating anxiety scale(SAS) |  | 1 week | 
| Self-Rating Depression Scale(SDS) |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Different acupoints compatibility