insomnia
Conditions
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicin, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 65 years (no gender limitation). 2.Comply with the diagnostic criteria for chronic insomnia in ICSD-3. 3.Comply with the diagnostic criteria for chronic insomnia in traditional Chinese Medicine and syndrome differentiation belongs to liver fire disturbing heart. 4.Patients has been taking sedative and hypnotic drugs regularly for more than 3 months or has not taken sedation before entering the study. 5.Pittsburgh Sleep Therapy Index (PSQI)>5 points. 6.Voluntarily participate in this study and sign the informed consent. 7.Patients has not received acupuncture treatment yet.
Exclusion criteria
Exclusion criteria: 1. Patients with severe impairment of heart, liver and kidney function, hematological and respiratory diseases, and mental disorders diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders. 2. Patients are identified as other sleep disorders rather than primary insomnia according to Semi-structured clinical interview. 3. Patients with liver disease, tuberculosis, AIDS and other infectious diseases. 4. Patients with severe digestive diseases and malnutrition. 5. Pregnant or lactating women. 6. Patients with severe trauma or other patients who are not suitable for acupuncture, such as allergic constitution and severe skin diseases. 7. Polysomnography (PSG) showed apnea hypopnea index (AHI) = 11 or periodic limb movements with arousal = 15. 8. Beck Depression Inventory 17-item version score =17. 9. Patients who have participated or are currently participating in other clinical trials within the last 3 months. 10. Contraindications to magnetic resonance imaging: patients with metal implants or metal foreign bodies in the body, such as pacemakers, artificial metal heart valves, metal joints, metal implants, dentures, insulin pumps, or contraceptive devices for women. 11. Those who are afraid of needles or sick of needles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Scale-14;Beck Anxiety Inventory;BOLD signal of multifunctional magnetic resonance imaging;Epworth Sleepiness Scale;Insomnia Severity Index;Blinding assessment;Pittsburgh sleep quality index;Beck Depression Inventory; | — |
Countries
China
Contacts
Public ContactYunFei Chen
Yue Yang Hospital, Shanghai University of TCM
Outcome results
None listed