Chronic Insomnia
Conditions
Interventions
Treatment group:Acupuncture
Control Group:Sham acupuncture
Sponsors
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the Western medical diagnostic criteria, Chinese medical diagnostic criteria and the syndrome differentiation ; 2. Age between 18 and 70 years old, with no restriction on gender; 3. ISI score = 8 points; 4. No mental or intellectual abnormalities, able to understand the content of various scales and complete the assessment; 5. Agree to participate in this study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Long-term night shifts or irregular sleep-wake patterns; 2. History of substance abuse or addiction; 3. Use of sedative-hypnotic drugs or antipsychotic medications within 4 weeks prior to the baseline visit (excluding emergency use), or receipt of other insomnia treatments (e.g., cognitive-behavioral therapy) within 3 months prior to the baseline visit; 4. Severe primary diseases of the heart, lungs, kidneys, or hematopoietic system; 5. Pregnant or breastfeeding individuals; 6. Receipt of acupuncture treatment within 1 year prior to enrollment; 7. Ulcers, abscesses, or skin infections at the acupuncture site; 8. Left-handedness; 9. Presence of contraindications for functional magnetic resonance imaging (fMRI), including metallic objects in the body (e.g., cardiac stents, pacemakers, metal dental appliances, steel nails), or claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response rate of Insomnia Severity Index ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of Insomnia Severity Index (ISI) ;Treatment remission rate of Insomnia Severity Index ;Actigraphy sleep assessment ;Generalized Anxiety Disorder Scale (GAD-7) ;Patient Health Questionnaire-9 (PHQ-9) ;12-Item Short Form Health Survey(SF-12);Usage of remedial drugs ;Incidence of adverse events ;Resting-state functional MRI ; | — |
Countries
China
Contacts
Public ContactLumin Liu
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed