Efficacy and acupoint specificity of sedative-tranquilizing acupuncture for Alzheimer's disease with sleep disorders: A three-arm randomized controlled trial protocol.

Researchers are conducting a study to determine whether a specialized form of acupuncture called "sedative-tranquilizing acupuncture" can help people with Alzheimer's disease who also struggle with sleep problems. Sleep disturbances are extremely common in Alzheimer's patients, but current medications often have unwanted side effects or don't work well enough. This trial will include 72 participants with both conditions, divided into three groups. One group will receive standard treatment (medication plus behavioral therapy), another will receive standard treatment plus real acupuncture, and the third will receive standard treatment plus sham (fake) acupuncture. The study will run at multiple centers and track several important measures. The main focus is on sleep quality, measured using a standardized questionnaire. Researchers will also examine whether the treatment affects memory and thinking abilities, quality of life, and symptoms of anxiety and depression. Additionally, they'll analyze blood markers, brain activity during sleep, and brain imaging to understand how acupuncture might work. The study design is rigorous, with participants randomly assigned to groups and all data analyzed according to intention-to-treat principles. Results from this trial could provide important evidence about whether acupuncture can safely improve both sleep and cognitive function in people living with Alzheimer's disease, potentially offering a new treatment option that works alongside conventional care. If you're considering acupuncture for any condition, seek a licensed acupuncturist with appropriate credentials in your area.

This multicenter RCT protocol evaluates sedative-tranquilizing acupuncture as adjunctive therapy for Alzheimer's disease patients with comorbid sleep disorders. The three-arm trial (n=72, 1:1:1 randomization) compares standard care (donepezil + CBT-I) alone versus with verum acupuncture versus with sham acupuncture. Primary outcome is PSQI change from baseline. Secondary measures include MMSE for cognitive function, AD-QOL, HAMA, and HAMD-17. Mechanistic exploration incorporates peripheral biochemical markers, polysomnography parameters, and neuroimaging. ITT analysis will be employed. The study design appropriately addresses both acupoint specificity (sham control) and clinical efficacy (standard care control), enabling assessment of the proposed "sleep-cognition co-modulation" effect. Approved by Nanchang Hongdu Hospital Ethics Committee and registered with International Traditional Medicine Clinical Trial Registry. Results may establish evidence-based protocols for integrating sedative-tranquilizing acupuncture into AD-SD management and elucidate neurobiological mechanisms underlying acupuncture's therapeutic effects in neurodegenerative disease.