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Primary InsomniaAAPINCT02087488

Auricular Acupuncture for Primary Insomnia

A study testing auricular acupuncture(AA) and Eszopiclone in people with Primary Insomnia, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Primary Insomnia
What is being tested?
auricular acupuncture(AA) and Eszopiclone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
288 participants
Where
1 siteChina
Study dates
Mar 2014to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chengdu university of Traditonal Chinese Medcine

    Chengdu, Sichuan, 610075

Other trials in China

About this study

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

Read the 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.

Being tested
auricular acupuncture(AA), placebo AA, Eszopiclone
Keywords
primary insomnia, auricular acupuncture
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • placebo AAOther

    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.

  • EszopicloneDrug

    Also called Lunesta or Estorra

    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.

Study groups in NCT02087488
Study groupRoleWhat they receive
auricular acupuncture(AA) & EszopicloneExperimentalThe 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.
Receives: Other: auricular acupuncture(AA); Drug: Eszopiclone
placebo AA & EszopiclonePlacebo comparatorThe 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.
Receives: Other: placebo AA; Drug: Eszopiclone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline in SOL at 4 weeks

  2. 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.

    Measured: Change from baseline in WASO at 4 weeks

Secondary outcomes (11)

  1. Pittsburgh Sleep Quality Index(PSQI)

    Measured: Change from baseline in PSQI at 4 weeks

  2. Insomnia Severity Index (ISI)

    Measured: Change from baseline in ISI at 4 weeks

  3. Beck Depression Inventory (BDI)

    Measured: Change from baseline in BDI at 4 weeks

  4. State-Trait Anxiety Inventory (STAI)

    Measured: Change from baseline in STAI at 4 weeks

  5. Self-rating Anxiety Scale (SAS)

    Measured: Change from baseline in SAS at 4 weeks

  6. The Epworth Sleeping Scale (ESS)

    Measured: Change from baseline in ESS at 4 weeks

  7. Flinders Fatigue Scale (FFS)

    Measured: Change from baseline in FFS at 4 weeks

  8. The MOS 36-Item Short-Form Health Survey questionnaire (SF-36)

    Measured: Change from baseline in SF-36 at 4 weeks

  9. 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.

    Measured: Change from baseline in TST at 4 weeks

  10. 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%.

    Measured: Change from baseline in SE at 4 weeks

  11. 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.

    Measured: Change from baseline in nWAK at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2015
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02087488
Sponsor's protocol ID
2011SZ0302-3
Acronym
AAPI
Status last verified
Feb 2020
First submitted
28 Feb 2014
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing auricular acupuncture(AA) and Eszopiclone in people with Primary Insomnia, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Onset Latency (SOL) (time frame: Change from baseline in SOL at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02087488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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