Acupuncture for Primary Insomnia

Insomnia Clinical Trial

Official title:

Acupuncture Treatment of Primary Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839592
• Other study ID #: ACUP-001
• Status: Completed
• Phase: N/A
• First received: February 6, 2009
• Last updated: January 12, 2010
• Start date: July 2006
• Est. completion date: April 2007

Study information

• Verified date: January 2010
• Source: The University of Hong Kong
• Contact: n/a
• 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 acupuncture treatment on insomnia in the adult population in Hong Kong.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Insomnia

Intervention

Other:
• Electroacupuncture
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.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	Hong Kong Baptist University, Hong Kong Professional Teachers' Union

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-rated sleep quality score measured by Insomnia Severity Index questionnaire		Baseline, weekly during the treatment course, 1-week posttreatment	No
Secondary	Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy		Baseline, and 1-week posttreatment	No
Secondary	Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.		Baseline, weekly during the treatment course, and 1-week posttreatment	No
Secondary	Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire		Baseline, and 1-week posttreatment	No
Secondary	Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)		Baseline, and 1-week posttreatment	No
Secondary	Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Index		Baseline, and 1-week posttreatment	No
Secondary	Subjects' credibility to the treatment measured by Credibility of treatment rating scale		Second and the last time of the treatment	No