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Completed

NCT Number: NCT01891097

Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

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

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Acupuncture plus auricular acupuncture

Procedure

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

Acupuncture

Procedure

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 names: Electroacupuncture

Primary outcomes

  1. Changes of sleep parameters by subjective measures using sleep log

    Time frame: Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

    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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

    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

  11. Change of serious adverse events measured by Serious Adverse Event (SAE)

    Time frame: 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

  12. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Hong Kong Baptist University

Registry information

Official study title

Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia: A Randomized Controlled Trial of Dose-Response Effect

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2013
Registry last updated
May 12, 2016

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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