Acupuncture for Primary Insomnia

Not Applicable

Completed

• Conditions: Insomnia

• Registration Number: NCT00839592
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-rated sleep quality score measured by Insomnia Severity Index questionnaire	Baseline, weekly during the treatment course, 1-week posttreatment

Secondary Outcome Measures

Name	Time	Method
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
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
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire	Baseline, and 1-week posttreatment
Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)	Baseline, and 1-week posttreatment
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

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong