About this trial
The classical literature combined with modern medicine to select acupoints, in order to intervene in the autonomic nerve function of the superior cervical sympathetic ganglion as an opportunity, put forward the meridian acupoints mainly to reconcile the head orifices Ying Wei, acupuncture treatment of primary insomnia clinical research. Heart rate variability ( HRV ), Pittsburgh sleep quality index ( PSQI ), polysomnography ( PSG ) and the MOS item short from health survey ( SF-36 ) were observed. Insomnia Severity Index ( ISI ), Dysfunctional Beliefs and Attitudes about Sleep Scale 16 ( DBAS-16 ), GABA, Glx and other secondary indicators were used to clarify the clinical short-term and long-term efficacy of different acupoints in the treatment of patients with primary insomnia and the intervention effect on HRV.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
In line with the Western diagnostic criteria for insomnia ;
18 ≤ age ≤ 40 years old, male or female ;
patients with a course of more than two weeks ; Note: The above criteria must be met for inclusion in this study.
Disqualifiers
Insomnia caused by a variety of organic diseases, neurological or psychiatric disorders
Pregnancy, lactation or drug allergy
There are more serious primary diseases such as cardiovascular and cerebrovascular diseases, gastrointestinal diseases, endocrine system diseases, or psychiatric patients.
Patients with coagulation dysfunction and bleeding tendency.
Trial design
Parallel
Treatments tested in this trial
Acupuncture
Deviceacupuncture Baihui, Sishencong ; acupuncture bilateral Qimen, Zhangmen, Hegu, Taichong, reinforcing and reducing, until the acid swelling is obvious,stopped ferforming acupuncture, the needle was retained for 30 min.
Acupuncture
Device(1)Acupuncture bilateral Tianrong points, obliquely 45 ± 5 ° backward, 1-1.5 inch deep, reinforcing and reducing horizontally, and stop the needle when the auricle has a heat sensation ; (2)Acupuncture at bilateral Tianyou points, pointing to the tip of the nose, with a depth of 0.5-1 inches, flat reinforcing and reducing, until the sense of soreness and distension obviously stops, and the needle is retained for 30 minutes.
Treatment groups
Trial outcomes
Primary outcomes
Sleep quality measured by Pittsburgh sleep quality index ( PSQI)
The patients will be assessed by PSQI Chinese fixed questionnaire at each observation point and the clinical efficacy will be observed.It consists of 19 self-evaluation and 5 other-evaluation items. Only 19 self-evaluation questions are scored, and 19 self-evaluation questions are composed of 7 factors, each factor consists of 7 factors of 0-3 points. '0 ' refers to no difficulty, ' 3 ' refers to very difficult. The total score of ' 21 ' refers to very difficult in all respects. The sum of all factor scores constitutes the total score of the 0-21 scale. The reference boundary value of adult sleep quality problems in China : poor sleep quality : PSQI ≥ 8 ; good sleep quality : PSQI ≤ 7 ; the higher the score, the worse the sleep quality.
Quality of life measure by 36-item short form health survey(SF-36)
The patients will be evaluated by SF-36 scale at each observation point. The SF-36 scale is a general scale developed by the American Medical Research Group to evaluate the quality of life. It is widely recognized and widely used in the world. This scale has eight dimensions to evaluate health-related quality of life ( HRQOL ), which belong to two categories of physical health and mental health, namely physiological function ( PF ), role physical ( RP ), bodily pain ( BP ), general health ( CH ), vitality ( VT ), social function ( SF ), role emotional ( RE ), mental health ( MH ). In addition, the SF-36 scale also includes another indicator - health change ( HT ), which is used to evaluate health changes over the past year.Add the scores of each item to the actual score, and then calculate the final score RP according to the following formula. The higher the RP score, the better the health status.
Secondary outcomes
Insomnia Severity Index(ISI)
The patients were evaluated by ISI scale at each observation point. According to the total score, the degree of insomnia is divided into the following degrees:The total score between 0 and 7 indicates no clinically significant insomnia, the total score between 8 and 14 indicates subthreshold insomnia, the total score between 15 and 21 indicates clinical insomnia ( moderate to severe ), and the total score between 22 and 28 indicates clinical insomnia ( severe ).
Dysfunctional Beliefs and Attitudes about Sleep Scale 16,DBAS-16 (DBAS-16)
There were 16 items in DBAS-16, including 4 factors : an estimated factor for the consequences of insomnia ; worry about sleep factor ; expectation factors of sleep ; cognition factors of insomnia drugs.The lower the total score, the more likely it is that the subjects ' cognition of sleep is biased.
GABA
GABA is the most important inhibitory neurotransmitter in the central nervous system. In clinical studies, proton magnetic resonance spectroscopy showed that GABA in the brain of patients with primary insomnia was 30 % lower than that of normal people, and sleep time was prolonged with the increase of GABA content.
Glx
Glutamate glutamine complex ( Glx ) is glutamic acid ( Glu ) + glutamine ( Gln ). Glu is the main excitatory neurotransmitter, maintaining the excitability of organisms. In the clinical study, the content of Glu in the brain of insomnia patients was analyzed by EEG ultra-slow fluctuation technique. The results showed that the content of Glu in insomnia patients increased.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chuanlong Zhou
Lead sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor institution