The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia

Launched by THE THIRD AFFILIATED HOSPITAL OF ZHEJIANG CHINESE MEDICAL UNIVERSITY · Apr 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of acupuncture therapy on people with primary insomnia, a condition where individuals have trouble sleeping. Participants will be divided into two groups: one will receive a specific type of acupuncture called Tiaoshen acupuncture, while the other group will get a placebo treatment, which means they will experience a similar procedure but without the actual acupuncture needles being inserted. Researchers will use several questionnaires and tests to measure sleep quality and related factors to see how effective the acupuncture treatment is and understand how it works.

To be eligible for this study, participants should be between 18 and 70 years old, have a score indicating significant sleep issues, and not have any major health problems or cognitive impairments. They should also not be taking certain medications that affect mood or sleep. If you join the trial, you can expect to undergo some evaluations and sleep monitoring to track your progress. It's important to know that participants will need to sign an informed consent form before starting the study, which means you agree to take part after understanding what it involves.

Gender

ALL

Eligibility criteria

• 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.