About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- the acupuncture group
- the placebo acupuncture group