Clinical trial NCT01891097: Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia
Official title: Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia: A Randomized Controlled Trial of Dose-Response Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Acupuncture
Electroacupuncture
Aricular acupuncture
Randomized Clinical Trial
Traditional Chinese Medicine
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Baptist University
First posted: 2013-07-02
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Changes of sleep parameters by subjective measures using sleep log
timeFrame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Secondary outcomes:
measure: Change of self-rated sleep quality score measured by Insomnia Severity Index (ISI) questionnaire
timeFrame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
timeFrame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of subjects' sleep-related cognition measured by Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
timeFrame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of subjects' sleep inhibitory behaviors measured by Sleep Hygiene Practice Scale (SHPS)
timeFrame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of subjects' credibility to the treatment measured by Credibility of treatment rating scale
timeFrame: Second and the last time of the treatment; 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy
timeFrame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of serious adverse events measured by Serious Adverse Event (SAE)
timeFrame: 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
measure: Change of potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture
timeFrame: 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Ka-Fai Chung, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.