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Acupuncture for Primary Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Electroacupuncture
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Acupuncture, Electroacupuncture, Randomized Clinical Trial, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Electroacupuncture

Placebo Acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Index
Subjects' credibility to the treatment measured by Credibility of treatment rating scale

Full Information

First Posted
February 6, 2009
Last Updated
January 12, 2010
Sponsor
The University of Hong Kong
Collaborators
Hong Kong Baptist University, Hong Kong Professional Teachers' Union
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1. Study Identification

Unique Protocol Identification Number
NCT00839592
Brief Title
Acupuncture for Primary Insomnia
Official Title
Acupuncture Treatment of Primary Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Hong Kong
Collaborators
Hong Kong Baptist University, Hong Kong Professional Teachers' Union

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Acupuncture, Electroacupuncture, Randomized Clinical Trial, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Acupuncture
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electroacupuncture
Other Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-rated sleep quality score measured by Insomnia Severity Index questionnaire
Time Frame
Baseline, weekly during the treatment course, 1-week posttreatment
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time Frame
Baseline, and 1-week posttreatment
Title
Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
Baseline, and 1-week posttreatment
Title
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Index
Time Frame
Baseline, and 1-week posttreatment
Title
Subjects' credibility to the treatment measured by Credibility of treatment rating scale
Time Frame
Second and the last time of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka-Fai Chung, MBBS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
27503746
Citation
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.
Results Reference
derived
PubMed Identifier
19725255
Citation
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.
Results Reference
derived

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Acupuncture for Primary Insomnia

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