Clinical trial NCT02087488: Auricular Acupuncture for Primary Insomnia
Official title: Auricular Acupuncture for Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Insomnia
Keywords: primary insomnia
auricular acupuncture
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Sleep Onset Latency (SOL)
timeFrame: Change from baseline in SOL at 4 weeks
measure: Wake After Sleep Onset (WASO)
timeFrame: Change from baseline in WASO at 4 weeks
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index(PSQI)
timeFrame: Change from baseline in PSQI at 4 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline in ISI at 4 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: Change from baseline in BDI at 4 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Change from baseline in STAI at 4 weeks
measure: Self-rating Anxiety Scale (SAS)
timeFrame: Change from baseline in SAS at 4 weeks
measure: The Epworth Sleeping Scale (ESS)
timeFrame: Change from baseline in ESS at 4 weeks
measure: Flinders Fatigue Scale (FFS)
timeFrame: Change from baseline in FFS at 4 weeks
measure: The MOS 36-Item Short-Form Health Survey questionnaire (SF-36)
timeFrame: Change from baseline in SF-36 at 4 weeks
measure: Total Sleep Time (TST)
timeFrame: Change from baseline in TST at 4 weeks
measure: Sleep Efficiency (SE)
timeFrame: Change from baseline in SE at 4 weeks
measure: Number of awakenings (nWAK)
timeFrame: Change from baseline in nWAK at 4 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu university of Traditonal Chinese Medcine
state: Sichuan
Study officials:
affiliation: Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine
name: Fanrong Liang, Professor
role: STUDY_CHAIR
affiliation: Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine
name: Xi Wu, A.P.
role: STUDY_DIRECTOR
References: