Acupuncture for Insomnia: a Randomized Controlled Trial

Not Applicable

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Other: DU20 and SP6 combination; Other: DU20 and HT7 combination; Other: DU20 and SA combination

• Registration Number: NCT02594670
• Lead Sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-30
• Status Verified: 2015-03
• Study Start: 2015-10
• Study First Submitted QC: 2015-11-02
• Last Update Submitted: 2015-11-02
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03
• Primary Completion: 2016-12
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 333

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DU20 and SP6 combination	DU20 and SP6 combination	combination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6).
DU20 and HT7 combination	DU20 and HT7 combination	combination of two acupoints based on location and Heart meridian, including Baihui (DU20) and Shenmen(HT7).
DU20 and SA combination	DU20 and SA combination	combination of local acupoint Baihui (DU20) and a sham acupoint (SA) not belonging to any regular meridian or acupoint.

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index (PSQI)	4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Second Hospital of Hunan University of Chinese Medicine; 🇨🇳 Changsha, Hunan, China

First Hospital of Hunan University of Chinese Medicine; 🇨🇳 Changsha, Hunan, China

Hengyang hospital of Hunan University of Chinese Medicine; 🇨🇳 Hengyang, Hunan, China