Clinical trial NCT00839592: Acupuncture for Primary Insomnia
Official title: Acupuncture Treatment of Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Acupuncture
Electroacupuncture
Randomized Clinical Trial
Traditional Chinese Medicine
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Baptist University
name: Hong Kong Professional Teachers' Union
First posted: 2009-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to evaluate acupuncture treatment on insomnia in the adult population in Hong Kong.

Detailed description: Acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on primary insomnia. This is a randomized single-blinded controlled trial. Patients will be randomly assigned to the electro-acupuncture group or the placebo acupuncture group. Patients will be put into groups and then compared.

Eligibility criteria: Inclusion Criteria:

* Hong Kong residents
* aged 18-65
* Ethnic Chinese
* Meet the diagnosis criteria of primary insomnia for at least 3 months according to DSM-IV using the Structured Clinical Interview for DSM-IV (SCID)
* Willing to give informed consent
* total score of Insomnia Severity Index (ISI) at least 15
* Able to comply with trial protocol

Exclusion Criteria:

* Participation in any clinical trial during the previous 3 months prior to baseline
* Any current major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders besides caffeine and nicotine, organic mental disorder, schizophrenia or any other psychotic disorder as defined by DSM-IV criteria
* Serious physical illness or mental disorders due to a general medical condition which is judged by the investigator to render unsafe
* Valvular heart defects, bleeding disorders or taking anticoagulant drugs.
* Any acupuncture treatment during the previous 12 months prior to baseline.
* In the investigator's opinion, the patient has a significant risk of suicide
* Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
* Infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
* Herbal remedies, over-the-counter medications or psychotropic drugs, which are intended for insomnia, were taken within the last 2 weeks prior to baseline or during the study

Primary outcomes:
measure: Self-rated sleep quality score measured by Insomnia Severity Index questionnaire
timeFrame: Baseline, weekly during the treatment course, 1-week posttreatment
Secondary outcomes:
measure: Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy
timeFrame: Baseline, and 1-week posttreatment
measure: Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.
timeFrame: Baseline, weekly during the treatment course, and 1-week posttreatment
measure: Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: Baseline, and 1-week posttreatment
measure: Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, and 1-week posttreatment
measure: Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Index
timeFrame: Baseline, and 1-week posttreatment
measure: Subjects' credibility to the treatment measured by Credibility of treatment rating scale
timeFrame: Second and the last time of the treatment
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: Yeung WF, Chung KF, Yu YB, Lao L. What predicts a positive response to acupuncture? A secondary analysis of three randomised controlled trials of insomnia. Acupunct Med. 2017 Mar;35(1):24-29. doi: 10.1136/acupmed-2016-011058. Epub 2016 Aug 8.
citation: Yeung WF, Chung KF, Zhang SP, Yap TG, Law AC. Electroacupuncture for primary insomnia: a randomized controlled trial. Sleep. 2009 Aug;32(8):1039-47. doi: 10.1093/sleep/32.8.1039.