The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia

The RCT Study on the Evaluation of Clinical Effect of Primary Insomnia Treated With the Tiaoshen Acupuncture

Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the acupuncture group adopts Tiaoshen acupuncture, and the placebo acupuncture group adopts non-insertive acupuncture supported by the Park device, and the Pittsburgh Sleep Quality Index (PSQI) is used as the main index to evaluate the patients through the scale; subjective indicators like Chalder 14-item fatigue scale, Epworth sleepiness rating, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and objective indicators like polysomnography (PSG), heart rate variability (HRV) is regarded as a secondary index, and then evaluate the clinical efficacy of Tiaoshen acupuncture on PI and explore its mechanism.

Inclusion Criteria:

• Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia;
• Age range: 18-70 years old;
• PSQI score>7 points; SAS score > 50 or SDS score > 53;
• No communication and cognitive impairment;
• No use or withdrawal of psychoactive drugs such as anti-anxiety within one month; ·No major physical diseases;
• Those who voluntarily accept the research content and can complete various scale evaluations, polysomnography monitoring and HRV;
• Sign an informed consent form prior to the start of the study.

Exclusion Criteria:

• Those who do not meet the inclusion criteria;
• Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness;
• Those with severe liver and renal insufficiency and bleeding tendencies;
• Alcoholism (liquor ≥ 100ml/day), smoking (≥ 15 cigarettes/day), drug abuse or taking psychotropic drugs;
• People with other sleep disorders, such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, and REM sleep behavioral disorders;
• Pregnant or nursing;
• Those with other major diseases and poor control;
• Other persons who are unwilling to sign informed consent.