Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01891097
• Other study ID #: ACUP-005
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2013
• Last updated: June 27, 2013
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2013
• Source: The University of Hong Kong
• Contact: Ka-Fai Chung, MBBS
• Phone: (852)22553656
• Email: kfchung[@]hkucc.hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hong Kong Baptist University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of self-rated sleep quality score measured by Insomnia Severity Index (ISI) questionnaire		Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire		Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)		Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)		Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)		Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)		Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of subjects' sleep-related cognition measured by Dysfunctional Beliefs and Attitudes about Sleep (DBAS)		Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of subjects' sleep inhibitory behaviors measured by Sleep Hygiene Practice Scale (SHPS)		Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of subjects' credibility to the treatment measured by Credibility of treatment rating scale		Second and the last time of the treatment; 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	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	Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of serious adverse events measured by Serious Adverse Event (SAE)		1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No
Secondary	Change of potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture		1-week posttreatment, 4-week posttreatment, and 13-week posttreatment	No