AI-RCT: Acupuncture for Insomnia: a Randomized Controlled Trial

Sponsor

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02594670

Collaborator

University of British Columbia (Other), Ministry of Science and Technology of the People´s Republic of China (Other)

333

Enrollment

Locations

Arms

Duration (Months)

111

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Initiation and Maintenance Disorders	Other: DU20 and HT7 combination Other: DU20 and SP6 combination Other: DU20 and SA combination	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

333 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DU20 and HT7 combination combination of two acupoints based on location and Heart meridian, including Baihui (DU20) and Shenmen(HT7).	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.
Other: DU20 and SP6 combination combination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6).	Other: DU20 and SP6 combination acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.
Sham Comparator: DU20 and SA combination combination of local acupoint Baihui (DU20) and a sham acupoint (SA) not belonging to any regular meridian or acupoint.	Other: 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.

Arm

Intervention/Treatment

Experimental: DU20 and HT7 combination

combination of two acupoints based on location and Heart meridian, including Baihui (DU20) and Shenmen(HT7).

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.

Other: DU20 and SP6 combination

combination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6).

Other: DU20 and SP6 combination

acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.

Sham Comparator: DU20 and SA combination

combination of local acupoint Baihui (DU20) and a sham acupoint (SA) not belonging to any regular meridian or acupoint.

Other: 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.

Outcome Measures

Primary Outcome Measures

Pittsburgh sleep quality index (PSQI) [4 weeks]

Secondary Outcome Measures

Athens Insomnia Scale (AIS) [4 weeks and 8 weeks]
Short Form 36-item Health Survey(SF-36) [4 weeks and 8 weeks]
Self-anxiety scale (SAS) [4 weeks and 8 weeks]
Self-depression scale (SDS) [4 weeks and 8 weeks]

Other Outcome Measures

safety evaluation will summarize the incidence of adverse events，including itching and redness of local acupoints. [4 weeks]
adherence of acupuncture [4 weeks]
adherence to the treatment (adherence rate)will be calculated using formula: Adherence Rate = Number of Treatment Conducted/ Number of Treatment Planned

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Hospital of Hunan University of Chinese Medicine	Changsha	Hunan	China	410005
2	First Hospital of Hunan University of Chinese Medicine	Changsha	Hunan	China	410007
3	Hengyang hospital of Hunan University of Chinese Medicine	Hengyang	Hunan	China

Sponsors and Collaborators

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