Auricular Acupuncture for Primary Insomnia (AAPI)

Chengdu University of Traditional Chinese Medicine

Status: Completed

Conditions: Primary Insomnia

Treatments: Drug: Eszopiclone; Other: auricular acupuncture(AA); Other: placebo AA

Study type: Interventional

Funder types: Other

Identifiers

NCT02087488

2011SZ0302-3

Details and patient eligibility

About

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

Full description

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.

Enrollment: 288 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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288 participants in 2 patient groups, including a placebo group

auricular acupuncture(AA) & Eszopiclone

Experimental group

Description:

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.

Treatment:

Other: auricular acupuncture(AA)

Drug: Eszopiclone

placebo AA & Eszopiclone

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo AA

Drug: Eszopiclone