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The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia

Recruiting
18 - 70 years of age
Both
Phase N/A

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Overview

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

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.

Study details

Primary Insomnia

NCT05830877

The Third Affiliated hospital of Zhejiang Chinese Medical University

26 June 2024

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