Auricular Acupuncture for Primary Insomnia (AAPI)

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

Study Overview

• Status: Completed
• Conditions: Primary Insomnia
• Intervention / Treatment: Other: auricular acupuncture(AA); Drug: Eszopiclone; Other: placebo AA

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.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • Chengdu university of Traditonal Chinese Medcine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: auricular acupuncture(AA) & Eszopiclone; 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.	Other: auricular acupuncture(AA); 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.; Drug: Eszopiclone; 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.; Other Names: Lunesta or Estorra
Placebo Comparator: placebo AA & Eszopiclone; 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.	Drug: Eszopiclone; 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.; Other Names: Lunesta or Estorra; Other: placebo AA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)		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

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Investigators: Study Chair: Fanrong Liang, Professor, Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine; Study Director: Xi Wu, A.P., Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 28, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 14, 2014

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: primary insomnia; auricular acupuncture
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Eszopiclone
• Other Study ID Numbers: 2011SZ0302-3