Auricular Acupuncture for Primary Insomnia

Study Overview
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Brief Summary
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This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular acupuncture(AA) for primary insomnia(PI) .

Detailed Description
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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.

Official Title
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Auricular Acupuncture for Primary Insomnia

Conditions
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Primary Insomnia

Intervention / Treatment
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* Other: auricular acupuncture(AA)
* Other: placebo AA
* Drug: Eszopiclone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnosis of PI according to DSM-5; Aged 18-64 (including 18 and 64); Provided a signed written consent form. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: auricular acupuncture(AA) & Eszopiclone<br>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. | Other: auricular acupuncture(AA)<br>* Auricular acupoints: Shenmen (TF4), Heart (CO15), Subcortex (AT4), modifying points according to different patterns. Auricular attachment material: disposable Seirin Pyonex Needle Seirin Pyonex Needle manufacturer: Seirin Corporation, a Japanese company. Medical Device Certification number: No. 15500BZZ00806000. Treatment frequency: every 3 days. Duration: 4 weeks.<br>Drug: Eszopiclone<br>* Dosage form: tablet. Dosage: 1 piece (3mg). Drug manufacturer: Kanghong pharmaceutical limited liability company, Chengdu. Production license: NO. H20100074 approved by the state. Treatment frequency: 15 mins before going to bed everyday. Duration: 4 weeks.<br>* Other names: Lunesta or Estorra;|
| Placebo Comparator: placebo AA & Eszopiclone<br>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. | Other: placebo AA<br>* Auricular acupoints: Wrist (SF1), Clavicle (SF6), Shoulder (SF4、5), Tooth (LO1), Tonsil (LO7, 8, 9). Auricular attachment material: the disposable Pyonex Zero Needle Pyonex Zero Needle manufacturer: Seirin Corporation, a Japanese company. Treatment frequency: every 3 days. Duration: 4 weeks.<br>Drug: Eszopiclone<br>* Dosage form: tablet. Dosage: 1 piece (3mg). Drug manufacturer: Kanghong pharmaceutical limited liability company, Chengdu. Production license: NO. H20100074 approved by the state. Treatment frequency: 15 mins before going to bed everyday. Duration: 4 weeks.<br>* Other names: Lunesta or Estorra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Onset Latency (SOL) | 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. | Change from baseline in SOL at 4 weeks | 
| Wake After Sleep Onset (WASO) | 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. | Change from baseline in WASO at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | TST is one of the sleep parameters mainly measured by actigraphy and sleep diaries, referring to actually time slept, it's the amount of time from the initial sleep to final awakening, excluding the awake time. | Change from baseline in TST at 4 weeks | 
| Sleep Efficiency (SE) | SE is one of the sleep parameters mainly measured by actigraphy and sleep diaries, sleep efficiency percentage = [total sleep time/total time in bed] ×100%. | Change from baseline in SE at 4 weeks | 
| Number of awakenings (nWAK) | Obtained by actigraphy and sleep diaries, it's the number of awakening times from the initial sleep onset to the end of sleep. | Change from baseline in nWAK at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary insomnia, auricular acupuncture