Sleep Initiation and Maintenance Disorders
Conditions
Keywords
acupoints, insomnia, acupuncture, randomized controlled trial
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.
Interventions
OTHERDU20 and HT7 combination
acupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints.
OTHERDU20 and SP6 combination
acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.
OTHERDU20 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.
Sponsors
University of British Columbia
Ministry of Science and Technology of the People´s Republic of China
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index (PSQI) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYan Wang
Outcome results
None listed