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This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular acupuncture(AA) for primary insomnia(PI) .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| auricular acupuncture(AA) & Eszopiclone | Experimental | 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. |
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| placebo AA & Eszopiclone | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| auricular acupuncture(AA) | Other | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fanrong Liang, Professor | Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine | Study Chair |
| Xi Wu, A.P. | Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu university of Traditonal Chinese Medcine | Chengdu | Sichuan | 610075 | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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| placebo AA | Other | 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. |
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| Eszopiclone | Drug | 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. |
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| 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 |
| D001523 |
| Mental Disorders |
| D010879 |
| Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D011725 | Pyridines |