Acupuncture for Primary Insomnia

January 12, 2010 updated by: The University of Hong Kong

Acupuncture Treatment of Primary Insomnia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Electroacupuncture

Acupoints will be treated at bilateral Ear Shenmen, Sishencong (EX-HN1), Anmian, and unilateral Yintang (EX-HN3) and Baihui (GV20).

Acupuncture will be performed by a registered Chinese medicine practitioner. "De qi"(an irradiating feeling considered to be indicative of effective needling) is achieved if possible. An electric-stimulator (CEFAR Acus II, Lund, Sweden) will be connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.45 ms square wave pulses and constant current. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Other: Electroacupuncture
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.
Other Names:
  • Acupuncture
PLACEBO_COMPARATOR: Placebo Acupuncture
Placebo needles designed by Streitberger (1998) will be used. The placebo needles are blunt needle that will not penetrate the skin during needle insertion. The handles of these placebo needles will slide over the needle when it is compressed, giving it the appearance of penetrating the skin. The placebo needles are inserted to the same acupoints as stated in the electroacupuncture group. The needles are held by a surgical tape or hair pin in hairy region to imitate the retention of needles. The needles are connected to an electric-stimulator with zero frequency and amplitude. The number, duration and frequency of the treatment sessions, and the intervention procedure will be the same for electro-acupuncture and placebo acupuncture.
Other: Electroacupuncture
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.
Other Names:
  • Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-rated sleep quality score measured by Insomnia Severity Index questionnaire
Time Frame: Baseline, weekly during the treatment course, 1-week posttreatment
Baseline, weekly during the treatment course, 1-week posttreatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Baseline, and 1-week posttreatment
Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, and 1-week posttreatment
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
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
Second and the last time of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Hong Kong Baptist University
Hong Kong Professional Teachers' Union

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (ESTIMATE)

February 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACUP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insomnia

Clinical Trials on Electroacupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe