Auricular Acupuncture for Primary Insomnia (AAPI)

February 13, 2020 updated by: Li ying, Chengdu University of Traditional Chinese Medicine
This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular acupuncture(AA) for primary insomnia(PI) .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep Onset Latency (SOL)
Time Frame: Change from baseline in SOL at 4 weeks
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)
Time Frame: Change from baseline in WASO at 4 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index(PSQI)
Time Frame: Change from baseline in PSQI at 4 weeks
Change from baseline in PSQI at 4 weeks
Insomnia Severity Index (ISI)
Time Frame: Change from baseline in ISI at 4 weeks
Change from baseline in ISI at 4 weeks
Beck Depression Inventory (BDI)
Time Frame: Change from baseline in BDI at 4 weeks
Change from baseline in BDI at 4 weeks
State-Trait Anxiety Inventory (STAI)
Time Frame: Change from baseline in STAI at 4 weeks
Change from baseline in STAI at 4 weeks
Self-rating Anxiety Scale (SAS)
Time Frame: Change from baseline in SAS at 4 weeks
Change from baseline in SAS at 4 weeks
The Epworth Sleeping Scale (ESS)
Time Frame: Change from baseline in ESS at 4 weeks
Change from baseline in ESS at 4 weeks
Flinders Fatigue Scale (FFS)
Time Frame: Change from baseline in FFS at 4 weeks
Change from baseline in FFS at 4 weeks
The MOS 36-Item Short-Form Health Survey questionnaire (SF-36)
Time Frame: Change from baseline in SF-36 at 4 weeks
Change from baseline in SF-36 at 4 weeks
Total Sleep Time (TST)
Time Frame: Change from baseline in TST at 4 weeks
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)
Time Frame: Change from baseline in SE at 4 weeks
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)
Time Frame: Change from baseline in nWAK at 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chengdu University of Traditional Chinese Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011SZ0302-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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