Acupuncture for Insomnia: a Randomized Controlled Trial

Sleep Initiation and Maintenance Disorders Clinical Trial

— AI-RCT  

Official title:

Acupuncture Based on Different Acupoints Combination for Insomnia: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02594670
• Other study ID #: 2014CB543102-1
• Status: Not yet recruiting
• Phase: N/A
• First received: September 30, 2014
• Last updated: November 2, 2015
• Start date: October 2015
• Est. completion date: August 2017

Study information

• Verified date: March 2015
• Source: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
• Contact: Yan Wang
• Email: 48770045[@]qq.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

Selecting different acupoints as an combination of acupoints is a key factor to clinical efficacy of acupuncture. Different combinations of acupoints will generate different clinical efficacy. So,the purpose of this study is to determine the different clinical efficacy among three types of combinations of acupoints in the treatment of primary insomnia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 333
• Est. completion date: August 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed as insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,2013, American psychiatric association

• PSQI score >7

• AIS score =6

• SDS =60

• SAS =60

• Age between 18 and 65 years old

• Not involved in other clinical trial in the lasted 6 months before screening

• Have the ability to write the informed consent.

Exclusion Criteria:

• Breathing-related sleep disorders

• Circadian rhythm sleep-wake disorders

• Medication-induced sleep disorder

• Substance induced sleep disorders,such as alcohol, coffee, strong tea

• Secondary insomnia caused by systemic diseases or caused by external environment disturbance

• Pregnant or lactating women

• Combined with serious cardiovascular, lung, liver, kidney, hematopoietic system, and mental diseases

• Advanced malignant tumor or other serious debilitating diseases

• Location of acupoints combined with infection and bleeding

• Declined to acupuncture

• Couldn't provide the written informed consent.

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

• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• DU20 and HT7 combination
acupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints.
• DU20 and SP6 combination
acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.
• DU20 and SA combination
Combination of Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations.

Locations

Country	Name	City	State
China	First Hospital of Hunan University of Chinese Medicine	Changsha	Hunan
China	Second Hospital of Hunan University of Chinese Medicine	Changsha	Hunan
China	Hengyang hospital of Hunan University of Chinese Medicine	Hengyang	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine	Ministry of Science and Technology of the People´s Republic of China, University of British Columbia

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety evaluation will summarize the incidence of adverse events,including itching and redness of local acupoints.		4 weeks	Yes
Other	adherence of acupuncture	adherence to the treatment (adherence rate)will be calculated using formula: Adherence Rate = Number of Treatment Conducted/ Number of Treatment Planned	4 weeks	Yes
Primary	Pittsburgh sleep quality index (PSQI)		4 weeks	No
Secondary	Athens Insomnia Scale (AIS)		4 weeks and 8 weeks	No
Secondary	Short Form 36-item Health Survey(SF-36)		4 weeks and 8 weeks	No
Secondary	Self-anxiety scale (SAS)		4 weeks and 8 weeks	No
Secondary	Self-depression scale (SDS)		4 weeks and 8 weeks	No