Primary Insomnia
Conditions
Keywords
Different acupoints compatibility
Brief summary
With primary insomnia as the research object, by the method of multi-center RCT and needle single cavity and different acupoints compatibility treatment for primary insomnia, to Pittsburgh sleep quality index(PSQI) and evaluation, sleep log evaluation and Polysomnogram(PSG) as the means, such as the single cavity with different acupoints compatibility evaluate clinical curative effect of treating primary insomnia.
Detailed description
In order to establish a spectrum of acupoints compatibility of the law, is clear about the factors affecting the compatibility effect of acupoints, the formation of strong operability of acupoints compatibility optimization evaluation method, the project choice of the clinical acupuncture and moxibustion have curative effect of primary insomnia as the breakthrough point of the study, carried out clinical multi-center RCT research, through objective and scientific evaluation method, comparing the effect of different acupoints compatibility. Primary insomnia in clinical common disease, frequently-occurring disease, acupuncture curative effect is distinct, disease diagnosis, curative effect evaluation standard. Previous clinical data also show that the primary insomnia is acupuncture clinical diseases. This project by primary insomnia as the research object, research to better guide clinical practice, improve the clinical curative effect, promote acupuncture of the inheritance and innovation, promote scientification of acupuncture and moxibustion, modernization and internationalization, and will have broad prospect of application and significant scientific research value.
Interventions
OTHERacupuncture
Patients will be treated with Shenmen(HT7), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
Sponsors
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Hengyang Traditional Chinese Medicine Hospital
Second People's Hospital of Hunan
Jilin University
Qilu Hospital of Shandong University
Changchun University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Insomnia 's Disease; * Aged 18-60 (including 18 and 60); * Does not attend other clinical researchers; * Participation in the researchers signed informed consent and voluntary; * Pittsburgh sleep index (PSQI) index \> 7 points; * Athens scale or 6 points; * Depression scale and anxiety scale 50 points or less.
Exclusion criteria
* Breathing-Related Sleep disorder; * Circadian rhythm disorders; * Sleep disorders; * Drug-induced insomnia (such as drug abuse, drug treatment); * Sleep disorders caused by poor diet, lifestyle factors(Long-term excessive drinking, coffee, tea, etc.); * All systemic diseases (such as pain, fever, cough, surgery, etc.) and the external environment disturbance factors; * With cardiovascular, lung, liver, kidney and hematopoietic system such as serious primary diseases; * Patients with mental illness; * Pregnancy or breast-feeding women; * Acupoints with severe skin infections; * Patients who are afraid of acupuncture; * Advanced malignant tumor or other serious wasting disease, infection and bleeding; * Who do not meet the inclusion criteria, poor compliance, treatment, not according to stipulations can not judge the curative effect or data not congruent affect curative effect and safety of judgment; * Caused by excessive anxiety and depression of patients with insomnia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index(PSQI) | 9 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Sleep Time Measured by PSG | 5 weeks | Measuring indexes including total record time(TRT), sleep time(SPT), total sleep time(TST, sleep efficiency, sleep latency(SL), sleep cycle changes, awakening times, fall asleep after waking hours, REM times incubation period, incubation period of REM, REM (except the awakening times). |
| Sleep diary | 5 weeks | — |
| Test GABA,Glu,5-HT,Ach,NE,DA in the human brain to reflect the state of brain function by the Encephalofluctuograph(ET) | 5 weeks | — |
| Self-rating anxiety scale(SAS) | 1 week | — |
| Self-Rating Depression Scale(SDS) | 1 week | — |
| Athens insomnia scale | 9 weeks | — |
Countries
China
Contacts
Primary ContactTie Li, Ph.D
Outcome results
None listed