Acupuncture for Primary Insomnia

NCT00839592 | Completed

• 1 other identifier: ACUP-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia

Keywords

Insomnia; Acupuncture; Electroacupuncture; Randomized Clinical Trial; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

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

  Baseline, weekly during the treatment course, 1-week posttreatment

Secondary Outcomes (6)

• 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

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

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

Placebo Acupuncture

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Acupuncture

Electroacupuncture; Placebo Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hong Kong Baptist University: collaborator
• Hong Kong Professional Teachers' Union: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (2)

• Yeung WF, Chung KF, Yu YB, Lao L. What predicts a positive response to acupuncture? A secondary analysis of three randomised controlled trials of insomnia. Acupunct Med. 2017 Mar;35(1):24-29. doi: 10.1136/acupmed-2016-011058. Epub 2016 Aug 8.

  PMID: 27503746 DERIVED

• Yeung WF, Chung KF, Zhang SP, Yap TG, Law AC. Electroacupuncture for primary insomnia: a randomized controlled trial. Sleep. 2009 Aug;32(8):1039-47. doi: 10.1093/sleep/32.8.1039.

  PMID: 19725255 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Electroacupuncture; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Ka-Fai Chung, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: July 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 14, 2010

Record last verified: 2010-01

Locations

HK (1)