Insomnia
Conditions
Interventions
Real acupuncture treatment group:The verum acupuncture group will receive a standardized acupuncture protocol. Acupoints include Guanyuan (CV4), Anmian (EX-HN22, bilateral), Shenmen (HT7, bilateral),
Sham acupuncture group:The sham acupuncture group will receive procedures matched to the verum acupuncture group in acupoint region, body position, treatment duration, and operational procedure. Non-p
Sponsors
Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Female, right-handed; (2) Age 40 = age = 65, with =6 years of education; (3) Meets diagnostic criteria for chronic insomnia disorder, manifested as difficulty falling asleep, difficulty maintaining sleep, early awakening, or dissatisfaction with sleep quality, accompanied by impaired daytime functioning; (4) Insomnia symptoms occur on at least 3 nights per week and have persisted for at least 3 months; (5) Sleep schedule has been relatively stable over the past month, and the participant is able to cooperate with treatment and follow-up; (6) Able to understand the study protocol, voluntarily participate in the study, and sign a written informed consent form; (7) Agrees to avoid receiving acupuncture, moxibustion, tuina massage, systematic CBT-I, mindfulness training, or other new interventions for insomnia outside the study protocol during the study period; (8) If currently taking hypnotics, anxiolytics, or antidepressants, the dosage must have been stable for at least 2 weeks prior to enrollment, and the participant must agree not to actively adjust medication during the treatment period; all medication information must be fully documented. Note: Only patients who meet all of the above criteria may be included in this study.
Exclusion criteria
Exclusion criteria: (1) Insomnia caused by or significantly influenced by other sleep disorders, such as moderate-to-severe obstructive sleep apnea, narcolepsy, REM sleep behavior disorder, severe restless legs syndrome, or periodic limb movement disorder; (2) Current severe depressive episode, bipolar disorder, schizophrenia, psychotic symptoms, substance use disorder, or a clear risk of suicide; (3) Presence of severe cardiac, cerebrovascular, hepatic, renal, hematopoietic, endocrine, or immune system diseases, where the investigator determines the participant is unsuitable for the clinical trial; (4) Active malignant neoplasm, or recent receipt of treatments such as radiotherapy, chemotherapy, or immunotherapy that may significantly affect sleep and immunometabolic status; (5) Pregnancy, breastfeeding, or plans to become pregnant during the study; (6) Having received traditional Chinese medicine external therapies for insomnia (e.g., acupuncture, moxibustion, cupping, or tuina) within the past 4 weeks; (7) Having previously undergone systematic CBT-I and currently practicing it regularly; (8) Having traveled across time zones, worked rotating shifts, or experienced significant circadian rhythm disruption within the past month; (9) Contraindications to acupuncture, such as severe coagulation disorders, ongoing high-dose anticoagulant therapy, infection or skin lesions at the acupuncture site, or a history of severe needle phobia; (10) Individuals who have used antibiotics, probiotics, laxatives, bowel cleansers, or other medications that may significantly affect the gut microbiota within the past month will not be included in the gut microbiota subgroup; inclusion in the main trial will be determined by the investigator's comprehensive assessment; (11) Patients with implanted devices incompatible with MRI equipment, claustrophobia, or other contraindications for MRI are excluded from the brain imaging subgroup; (12) Patients deemed by the investigator to have poor compliance, inability to complete follow-up, or other circumstances rendering them unsuitable for enrollment. Note: Any patient meeting any of the above criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Insomnia response rate;Insomnia remission rate;Seven-day sleep diary;Cognitive function assessment:Attention Network Test, Go/No-Go task, Stroop task, image memory task, and computational working memory test;Sex hormone indicators: Peripheral blood samples will be collected to measure follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), and progesterone (P);Neuroimaging: T1w, fMRI, DTI;Blood metabolomic;Gut microbiota; | — |
Countries
China
Contacts
Public ContactSiyi Yu
Chengdu University of Traditional Chinese Medicine
Outcome results
None listed