Clinical trial NCT02594670: Acupuncture for Insomnia: a Randomized Controlled Trial
Official title: Acupuncture Based on Different Acupoints Combination for Insomnia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: acupoints
insomnia
acupuncture
randomized controlled trial
Lead sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2015-11-03
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Athens Insomnia Scale (AIS)
timeFrame: 4 weeks and 8 weeks
measure: Short Form 36-item Health Survey(SF-36)
timeFrame: 4 weeks and 8 weeks
measure: Self-anxiety scale (SAS)
timeFrame: 4 weeks and 8 weeks
measure: Self-depression scale (SDS)
timeFrame: 4 weeks and 8 weeks
Other outcomes:
measure: safety evaluation will summarize the incidence of adverse events，including itching and redness of local acupoints.
timeFrame: 4 weeks
measure: adherence of acupuncture
timeFrame: 4 weeks
Locations:
city: Changsha
country: China
facility: Second Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Changsha
country: China
facility: First Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Hengyang
country: China
facility: Hengyang hospital of Hunan University of Chinese Medicine
state: Hunan
Study officials:
affiliation: Hunan University of Chinese Medicine
name: Zenghui Yue
role: STUDY_CHAIR
References: