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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
288
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.
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.
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.
Chengdu university of Traditonal Chinese Medcine
Chengdu, Sichuan, China
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.
Time frame: 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.
Time frame: Change from baseline in WASO at 4 weeks
Pittsburgh Sleep Quality Index(PSQI)
Time frame: Change from baseline in PSQI at 4 weeks
Insomnia Severity Index (ISI)
Time frame: Change from baseline in ISI at 4 weeks
Beck Depression Inventory (BDI)
Time frame: Change from baseline in BDI at 4 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: Change from baseline in STAI at 4 weeks
Self-rating Anxiety Scale (SAS)
Time frame: Change from baseline in SAS at 4 weeks
The Epworth Sleeping Scale (ESS)
Time frame: Change from baseline in ESS at 4 weeks
Flinders Fatigue Scale (FFS)
Time frame: Change from baseline in FFS at 4 weeks
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The MOS 36-Item Short-Form Health Survey questionnaire (SF-36)
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: Change from baseline in nWAK at 4 weeks