Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by The University of Hong Kong
Sponsor:
Collaborator:
Hong Kong Baptist University
Information provided by (Responsible Party):
Dr. Chung Ka-Fai, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01891097
First received: June 20, 2013
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

This is a randomized controlled trial to evaluate the clinical efficacy of combined electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult population in Hong Kong.


Condition Intervention
Insomnia
Procedure: Acupuncture plus auricular acupuncture
Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia: A Randomized Controlled Trial of Dose-Response Effect

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Changes of sleep parameters by subjective measures using sleep log [ Time Frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
    We will measure sleep parameters (including sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log. The measure is a composite outcome measure consisting of multiple measures


Secondary Outcome Measures:
  • Change of self-rated sleep quality score measured by Insomnia Severity Index (ISI) questionnaire [ Time Frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
  • Change of self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire [ Time Frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
  • Change of anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
  • Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS) [ Time Frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
  • Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
  • Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
  • Change of subjects' sleep-related cognition measured by Dysfunctional Beliefs and Attitudes about Sleep (DBAS) [ Time Frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
  • Change of subjects' sleep inhibitory behaviors measured by Sleep Hygiene Practice Scale (SHPS) [ Time Frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
  • Change of subjects' credibility to the treatment measured by Credibility of treatment rating scale [ Time Frame: Second and the last time of the treatment; 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
  • Change of sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy [ Time Frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
    Sleep parameters include sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep. The measure is a composite outcome measure consisting of multiple measures

  • Change of serious adverse events measured by Serious Adverse Event (SAE) [ Time Frame: 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]
  • Change of potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture [ Time Frame: 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acupuncture
Patients will be treated at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, Neiguan PC6, Shenmen HT7, Sanyinjiao SP6, and unilateral Yintang EX-HN3 and Baihui GV20. Acupuncture treatment 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 (ITO ES160, Japan) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.4 ms square wave pulses and constant current. Surgical tape or hair pin will be adhered to the needles.The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Procedure: Acupuncture
Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , 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: Electroacupuncture
Experimental: Acupuncture plus auricular acupuncture
Subjects will be treated with electroacupuncture plus auricular acupuncture for 3 weeks. The acupuncture regimen, is the same as in electroacupuncture group. In additional to electroacupuncture, subjects will receive auricular acupuncture using borneol. The following 6 ear acupoints points will be selected: Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex. In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours. We will check for skin irritation at each treatment visit.
Procedure: Acupuncture plus auricular acupuncture

Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , 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.

Aricular acupuncture at Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex.In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours.

Other Names:
  • Acupuncture
  • Electroacupuncture
No Intervention: Waiting-list control
This group will receive no treatment. Subjects will be assessed at baseline and the 4th and 7th week; afterwards, they will be randomized to one of the other two groups in the ratio of 1:1.

Detailed Description:

Combined electro-acupuncture and auricular acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of combined electroacupuncture and auricular acupuncture on persistent insomnia. This is a randomized double-blinded controlled trial. Patients will be randomly assigned to the electro-acupuncture group, the electro-acupuncture plus auricular acupuncture group or the waitlist controlled group. Patients will be put into groups and then compared.The chance of getting into each group is 3:3:1.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 years or above
  • Hong Kong residents
  • Ethnic Chinese
  • Meet the diagnosis criteria of presistent insomnia for at least 3 months according to Current Diagnostic and Statistical Manual of Mental Disorders (the proposed Fifth Edition)
  • Insomnia more than 3 nights per week for at least 3 months
  • Willing to give informed consent
  • Able to comply with trial protocol

Exclusion Criteria:

  • Have a Hamilton Depression Rating Scale scores above 18
  • Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
  • Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item
  • Have current major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders except caffeine and nicotine, organic mental disorder, schizophrenia or any other psychotic disorder
  • Receiving psychotropic drugs with dosage changes in the last 4 weeks prior to screening, baseline or during the study
  • Have valvular heart defects or bleeding disorders or were taking anticoagulant drugs
  • Are pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
  • Have any unstable psychiatric conditions or serious physical illnesses which are judged by the investigator to render unsuitable or unsafe
  • Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
  • Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
  • Any acupuncture or auricular acupuncture treatment during the previous 6 months prior to baseline
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891097

Contacts
Contact: Ka-Fai Chung, MBBS (852)22553656 kfchung@hkucc.hku.hk

Locations
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Ka-Fai Chung, MBBS    (852)22553656    kfchung@hkucc.hku.hk   
Principal Investigator: Ka-Fai Chung, MBBS         
Sub-Investigator: Wing-Fai Yeung, PhD         
Sponsors and Collaborators
The University of Hong Kong
Hong Kong Baptist University
Investigators
Principal Investigator: Ka-Fai Chung, MBBS The University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr. Chung Ka-Fai, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01891097     History of Changes
Other Study ID Numbers: ACUP-005
Study First Received: June 20, 2013
Last Updated: June 27, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Insomnia
Acupuncture
Electroacupuncture
Aricular acupuncture
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 July 31, 2014