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Acupuncture for Primary Insomnia

This study has been completed.
Sponsor:
Collaborators:
Hong Kong Baptist University
Hong Kong Professional Teachers' Union
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00839592
First received: February 6, 2009
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  Purpose

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


Condition Intervention
Insomnia
 Other: Electroacupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment of Primary Insomnia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Self-rated sleep quality score measured by Insomnia Severity Index questionnaire [ Time Frame: Baseline, weekly during the treatment course, 1-week posttreatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire [ Time Frame: Baseline, and 1-week posttreatment ] [ Designated as safety issue: No ]
  • Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, and 1-week posttreatment ] [ Designated as safety issue: No ]
  • Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Index [ Time Frame: Baseline, and 1-week posttreatment ] [ Designated as safety issue: No ]
  • Subjects' credibility to the treatment measured by Credibility of treatment rating scale [ Time Frame: Second and the last time of the treatment ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Acupuncture

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839592

Locations
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Hong Kong Baptist University
Hong Kong Professional Teachers' Union
Investigators
Principal Investigator: Ka-Fai Chung, MBBS The University of Hong Kong
  More Information

No publications provided by The University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Chung Ka-Fai/ Associate Professor, the University of Hong Kong
ClinicalTrials.gov Identifier: NCT00839592     History of Changes
Other Study ID Numbers: ACUP-001
Study First Received: February 6, 2009
Last Updated: January 12, 2010
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Insomnia
Acupuncture
Electroacupuncture
Randomized Clinical Trial
Traditional Chinese Medicine

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013