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Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Acupuncture plus auricular acupuncture
Acupuncture
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, Aricular acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Acupuncture

Acupuncture plus auricular acupuncture

Waiting-list control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes of sleep parameters by subjective measures using sleep log
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
Change of self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Change of anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)
Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)
Change of subjects' sleep-related cognition measured by Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
Change of subjects' sleep inhibitory behaviors measured by Sleep Hygiene Practice Scale (SHPS)
Change of subjects' credibility to the treatment measured by Credibility of treatment rating scale
Change of sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy
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)
Change of potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture

Full Information

First Posted
June 20, 2013
Last Updated
May 10, 2016
Sponsor
The University of Hong Kong
Collaborators
Hong Kong Baptist University
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1. Study Identification

Unique Protocol Identification Number
NCT01891097
Brief Title
Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia
Official Title
Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia: A Randomized Controlled Trial of Dose-Response Effect
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Hong Kong Baptist University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Acupuncture plus auricular acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting-list control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture plus auricular acupuncture
Other Intervention Name(s)
Acupuncture, Electroacupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
Electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of sleep parameters by subjective measures using sleep log
Description
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
Time Frame
Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Change of sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy
Description
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
Time Frame
Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Title
Change of serious adverse events measured by Serious Adverse Event (SAE)
Time Frame
1-week posttreatment, 4-week posttreatment, and 13-week posttreatment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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

Plan to Share IPD
Yes
Citations:
PubMed Identifier
29567667
Citation
Chung KF, Yeung WF, Ho FYY, Ng TK. Dysfunctional cognition regarding sleep as a mediator of outcome following acupuncture for insomnia. Acupunct Med. 2018 Jun;36(3):193-194. doi: 10.1136/acupmed-2017-011520. Epub 2018 Mar 22. No abstract available.
Results Reference
derived
PubMed Identifier
29229613
Citation
Chung KF, Yeung WF, Yu BY, Leung FC, Zhang SP, Zhang ZJ, Ng RM, Yiu GC. Acupuncture with or without combined auricular acupuncture for insomnia: a randomised, waitlist-controlled trial. Acupunct Med. 2018 Feb;36(1):2-13. doi: 10.1136/acupmed-2017-011371. Epub 2017 Dec 11.
Results Reference
derived

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Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia

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