Auricular Acupuncture for Primary Insomnia

NCT02087488 | Completed DMC

• 1 other identifier: 2011SZ0302-3
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Insomnia

Keywords

primary insomnia; auricular acupuncture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (2)

auricular acupuncture(AA) & Eszopiclone

EXPERIMENTAL

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); Drug: Eszopiclone

placebo AA & Eszopiclone

PLACEBO COMPARATOR

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.

Other: placebo AA; Drug: Eszopiclone

Interventions

auricular acupuncture(AA) OTHER

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 acupuncture(AA) & Eszopiclone

placebo AA OTHER

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.

placebo AA & Eszopiclone

Eszopiclone DRUG

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.

Also known as: Lunesta or Estorra

auricular acupuncture(AA) & Eszopiclone; placebo AA & Eszopiclone

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet the diagnosis of PI according to DSM-5;
• Aged 18-64 (including 18 and 64);
• Provided a signed written consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Chengdu university of Traditonal Chinese Medcine

Chengdu, Sichuan, 610075, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture, Ear; Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Study Officials

• Fanrong Liang, Professor

  Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine

  STUDY CHAIR

• Xi Wu, A.P.

  Faculty of Acupuncture & Tuina，Chengdu University of Traditional Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 14, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CN (1)