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Completed

NCT Number: NCT00839592

Acupuncture for Primary Insomnia

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroacupuncture

Other

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

Primary outcomes

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

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

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: Baseline, and 1-week posttreatment

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

    Time frame: Baseline, and 1-week posttreatment

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

    Time frame: Baseline, and 1-week posttreatment

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

    Time frame: Second and the last time of the treatment

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Hong Kong Baptist University
  • Hong Kong Professional Teachers' Union

Registry information

Official study title

Acupuncture Treatment of Primary Insomnia

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 9, 2009
Registry last updated
Jan 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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