Acupuncture for Insomnia: a Randomized Controlled Trial

Study Overview
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Brief Summary
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Selecting different acupoints as an combination of acupoints is a key factor to clinical efficacy of acupuncture. Different combinations of acupoints will generate different clinical efficacy. So,the purpose of this study is to determine the different clinical efficacy among three types of combinations of acupoints in the treatment of primary insomnia.

Official Title
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Acupuncture Based on Different Acupoints Combination for Insomnia: a Randomized Controlled Trial

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Other: DU20 and HT7 combination
* Other: DU20 and SP6 combination
* Other: DU20 and SA combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,2013, American psychiatric association PSQI score >7 AIS score ≥6 SDS ≤60 SAS ≤60 Age between 18 and 65 years old Not involved in other clinical trial in the lasted 6 months before screening Have the ability to write the informed consent. Exclusion Criteria: Breathing-related sleep disorders Circadian rhythm sleep-wake disorders Medication-induced sleep disorder Substance induced sleep disorders,such as alcohol, coffee, strong tea Secondary insomnia caused by systemic diseases or caused by external environment disturbance Pregnant or lactating women Combined with serious cardiovascular, lung, liver, kidney, hematopoietic system, and mental diseases Advanced malignant tumor or other serious debilitating diseases Location of acupoints combined with infection and bleeding Declined to acupuncture Couldn't provide the written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DU20 and HT7 combination<br>combination of two acupoints based on location and Heart meridian, including Baihui (DU20) and Shenmen(HT7). | Other: DU20 and HT7 combination<br>* acupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints.<br>|
| Other: DU20 and SP6 combination<br>combination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6). | Other: DU20 and SP6 combination<br>* acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.<br>|
| Sham Comparator: DU20 and SA combination<br>combination of local acupoint Baihui (DU20) and a sham acupoint (SA) not belonging to any regular meridian or acupoint. | Other: DU20 and SA combination<br>* Combination of Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh sleep quality index (PSQI) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Athens Insomnia Scale (AIS) |  | 4 weeks and 8 weeks | 
| Short Form 36-item Health Survey(SF-36) |  | 4 weeks and 8 weeks | 
| Self-anxiety scale (SAS) |  | 4 weeks and 8 weeks | 
| Self-depression scale (SDS) |  | 4 weeks and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupoints, insomnia, acupuncture, randomized controlled trial