Chronic insomnia
Conditions
Interventions
Electroacupuncture Group:(1) Acupoint Selection: Baihui (GV20), Yintang (GV29), Shenmen (HT7), and Sanyinjiao (SP6). Localization strictly followed the National Standard of the People's Republic of Ch
Sham Electroacupuncture Group:(1) Acupoint Selection: The same acupoints were selected as in the electroacupuncture group. (2) Procedure: Participants took a supine position. After routine disinfecti
Sponsors
The Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)Meets the diagnostic criteria for Chronic Insomnia Disorder as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3). 2)Aged between 18 and 65 years, inclusive. 3)Pittsburgh Sleep Quality Index (PSQI) global score > 7. 4)Not currently receiving and have not received any psychotropic medications (e.g., antidepressants, anxiolytics, hypnotics) within the [specify time frame, e.g., 4 weeks] prior to screening. 5)Able to comprehend the content of study questionnaires, cooperate with the treatment protocol, and perform basic smartphone operations without significant communication or cognitive barriers. 6)Voluntarily agrees to participate in the study, accept randomized group assignment, and has provided written informed consent.
Exclusion criteria
Exclusion criteria: 1)Presence of severe cardiovascular diseases (e.g., unstable angina, heart failure NYHA Class III/IV, severe arrhythmia, recent myocardial infarction or stroke within the past 6 months). 2)History of severe primary diseases of the brain, liver, kidney, or hematopoietic system; acute illness, infectious diseases, or malignancy; or current pregnancy. 3)Insomnia primarily attributed to major depressive disorder, generalized anxiety disorder, or other severe psychiatric disorders; or insomnia clearly caused by poor sleep hygiene. 4)Other diagnosed sleep disorders, such as obstructive sleep apnea syndrome or restless legs syndrome. 5)History of alcohol abuse or dependence on psychoactive substances. 6)Received acupuncture therapy specifically for insomnia within the past 1 month. 7)Inability or unwillingness to undergo the polysomnography (PSG) sleep monitoring procedures. 8)Contraindications to acupuncture therapy, including breastfeeding or a history of severe needle phobia/vasovagal syncope triggered by needle insertion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-Rapid Eye Movement (NREM) stage beta wave power; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality evaluation metrics monitored by PSG.;Sleep structure evaluation metrics monitored by PSG;Pittsburgh Sleep Quality Index (PSQI);Hyperarousal Scale (HAS);Pre-Sleep Awakening Assessment Scale;Anxiety Self-Rating Scale;Depression Self-Rating Scale (SDS);Autonomic Function Scale (AFS);ECG indicators;EEG indicators;blood pressure;Norepinephrine;cortisol; | — |
Countries
China
Contacts
Public ContactLiuChengyong
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)
Outcome results
None listed