Insomnia
Conditions
Keywords
Insomnia, Acupuncture, Electroacupuncture, Randomized Clinical Trial, Traditional Chinese Medicine
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.
Interventions
OTHERElectroacupuncture
Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, 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.
Sponsors
Hong Kong Baptist University
Hong Kong Professional Teachers' Union
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-rated sleep quality score measured by Insomnia Severity Index questionnaire | Baseline, weekly during the treatment course, 1-week posttreatment |
Secondary
| Measure | Time frame |
|---|---|
| Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Index | Baseline, and 1-week posttreatment |
| Subjects' credibility to the treatment measured by Credibility of treatment rating scale | Second and the last time of the treatment |
| Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS) | Baseline, and 1-week posttreatment |
| Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy | Baseline, and 1-week posttreatment |
| Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire | Baseline, and 1-week posttreatment |
| Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log. | Baseline, weekly during the treatment course, and 1-week posttreatment |
Countries
Hong Kong
Outcome results
None listed