Acupuncture for Primary Insomnia

The University of Hong Kong60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Insomnia

Interventions

ElectroacupunctureOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Self-rated sleep quality score measured by Insomnia Severity Index questionnaire

Time frame: Baseline, weekly during the treatment course, 1-week posttreatment

Secondary Outcomes

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

Time frame: 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.

Time frame: Baseline, weekly during the treatment course, and 1-week posttreatment

Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire

Time frame: Baseline, and 1-week posttreatment

Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)

Time frame: Baseline, and 1-week posttreatment

Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Index

Time frame: Baseline, and 1-week posttreatment

Subjects' credibility to the treatment measured by Credibility of treatment rating scale

Time frame: Second and the last time of the treatment

Data from ClinicalTrials.gov

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