Overview

Auricular Acupuncture for Primary Insomnia

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
Summary
This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular acupuncture(AA) for primary insomnia(PI) .
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chengdu University of Traditional Chinese Medicine
Treatments:
Eszopiclone
Criteria
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.