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InsomniaNCT01891097

Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia

A study testing Acupuncture plus auricular acupuncture and Acupuncture in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.

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 is a randomized controlled trial to evaluate the clinical efficacy of combined electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult population in Hong Kong. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Insomnia
What is being tested?
Acupuncture plus auricular acupuncture and Acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteHong Kong
Study dates
Jul 2012to May 2015
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or above
  • Hong Kong residents
  • Ethnic Chinese
  • Meet the diagnosis criteria of presistent insomnia for at least 3 months according to Current Diagnostic and Statistical Manual of Mental Disorders (the proposed Fifth Edition)
  • Insomnia more than 3 nights per week for at least 3 months
  • Willing to give informed consent
  • Able to comply with trial protocol

Who cannot join

  • Have a Hamilton Depression Rating Scale scores above 18
  • Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
  • Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item
  • Have current major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders except caffeine and nicotine, organic mental disorder, schizophrenia or any other psychotic disorder
  • Receiving psychotropic drugs with dosage changes in the last 4 weeks prior to screening, baseline or during the study
  • Have valvular heart defects or bleeding disorders or were taking anticoagulant drugs
Show all 11Show fewer
  • Are pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
  • Have any unstable psychiatric conditions or serious physical illnesses which are judged by the investigator to render unsuitable or unsafe
  • Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
  • Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
  • Any acupuncture or auricular acupuncture treatment during the previous 6 months prior to baseline

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia: A Randomized Controlled Trial of Dose-Response Effect

This is a randomized controlled trial to evaluate the clinical efficacy of combined electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult population in Hong Kong.

Read the detailed description

Combined electro-acupuncture and auricular acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of combined electroacupuncture and auricular acupuncture on persistent insomnia. This is a randomized double-blinded controlled trial. Patients will be randomly assigned to the electro-acupuncture group, the electro-acupuncture plus auricular acupuncture group or the waitlist controlled group. Patients will be put into groups and then compared.The chance of getting into each group is 3:3:1.

Conditions
Insomnia
Being tested
Acupuncture plus auricular acupuncture, Acupuncture
Keywords
Insomnia, Acupuncture, Electroacupuncture, Aricular acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine
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.

  • Acupuncture plus auricular acupunctureProcedure or surgery

    Also called Acupuncture, Electroacupuncture

    Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

    Aricular acupuncture at Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex.In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours.

  • AcupunctureProcedure or surgery

    Also called Electroacupuncture

    Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Study groups in NCT01891097
Study groupRoleWhat they receive
AcupunctureActive comparatorPatients will be treated at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, Neiguan PC6, Shenmen HT7, Sanyinjiao SP6, and unilateral Yintang EX-HN3 and Baihui GV20. Acupuncture treatment will be performed by a registered Chinese medicine practitioner. "De qi"(an irradiating feeling considered to be indicative of effective needling) is achieved if possible. An electric-stimulator (ITO ES160, Japan) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.4 ms square wave pulses and constant current. Surgical tape or hair pin will be adhered to the needles.The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Receives: Procedure: Acupuncture
Acupuncture plus auricular acupunctureExperimentalSubjects will be treated with electroacupuncture plus auricular acupuncture for 3 weeks. The acupuncture regimen, is the same as in electroacupuncture group. In additional to electroacupuncture, subjects will receive auricular acupuncture using borneol. The following 6 ear acupoints points will be selected: Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex. In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours. We will check for skin irritation at each treatment visit.
Receives: Procedure: Acupuncture plus auricular acupuncture
Waiting-list controlNo interventionThis group will receive no treatment. Subjects will be assessed at baseline and the 4th and 7th week; afterwards, they will be randomized to one of the other two groups in the ratio of 1:1.

What is being measured

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

  1. Changes of sleep parameters by subjective measures using sleep log

    We will measure sleep parameters (including sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log. The measure is a composite outcome measure consisting of multiple measures

    Measured: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

Secondary outcomes (12)

  1. Change of self-rated sleep quality score measured by Insomnia Severity Index (ISI) questionnaire

    Measured: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  2. Change of self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire

    Measured: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  3. Change of anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)

    Measured: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  4. Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)

    Measured: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  5. Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)

    Measured: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  6. Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)

    Measured: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  7. Change of subjects' sleep-related cognition measured by Dysfunctional Beliefs and Attitudes about Sleep (DBAS)

    Measured: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  8. Change of subjects' sleep inhibitory behaviors measured by Sleep Hygiene Practice Scale (SHPS)

    Measured: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  9. Change of subjects' credibility to the treatment measured by Credibility of treatment rating scale

    Measured: Second and the last time of the treatment; 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  10. Change of sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy

    Sleep parameters include sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep. The measure is a composite outcome measure consisting of multiple measures

    Measured: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  11. Change of serious adverse events measured by Serious Adverse Event (SAE)

    Measured: 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  12. Change of potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture

    Measured: 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

Timeline

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

  1. First posted2 Jul 2013 (estimated)
  2. Study startJul 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

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
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01891097
Sponsor's protocol ID
ACUP-005
Status last verified
May 2016
First submitted
20 Jun 2013
Last updated
12 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Chung KF, Yeung WF, Ho FYY, Ng TK. Dysfunctional cognition regarding sleep as a mediator of outcome following acupuncture for insomnia. Acupunct Med. 2018 Jun;36(3):193-194. doi: 10.1136/acupmed-2017-011520. Epub 2018 Mar 22. No abstract available.

    PubMed 29567667

  • Chung KF, Yeung WF, Yu BY, Leung FC, Zhang SP, Zhang ZJ, Ng RM, Yiu GC. Acupuncture with or without combined auricular acupuncture for insomnia: a randomised, waitlist-controlled trial. Acupunct Med. 2018 Feb;36(1):2-13. doi: 10.1136/acupmed-2017-011371. Epub 2017 Dec 11.

    PubMed 29229613

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture plus auricular acupuncture and Acupuncture in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.

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 7 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 12 May 2016. 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 Hong Kong. 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. 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?

Changes of sleep parameters by subjective measures using sleep log (time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment). 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 NCT01891097, which also lists 2 linked publications.

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 12 May 2016.

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