Auricular Acupuncture by Village Doctors to Improve Sleep in Older Adults with Diabetes and High Blood Pressure

What this Trial Is About

Researchers are investigating whether traditional auricular press-needle acupuncture can improve sleep disturbances in elderly patients aged 65 years and older who have both diabetes mellitus and hypertension, living in rural areas of China. This cluster randomized trial compares a village doctor-led acupuncture intervention supported by telemedicine with a sham acupuncture approach. The study aims to provide evidence for managing sleep problems in this population and to promote standardized acupuncture use in primary care. Participants are randomly assigned to either the real auricular acupuncture group or the sham group. The real acupuncture involves disposable intradermal needles applied to five specific ear points based on Traditional Chinese Medicine theory Heart, Liver, Kidney, Shenmen, and Forehead. Needles are retained for two days, alternating ears, with four daily presses. The sham group receives adhesive patches without needles at the same points. Village doctors are trained and supported remotely by cardiovascular specialists. The treatment phase lasts 6 weeks, followed by a 12-week follow-up period. During the study, participants undergo assessments including the Pittsburgh Sleep Quality Index PSQI to measure sleep quality changes at 6 weeks and 12 weeks. Additional measures include evaluations of anxiety, depression, daytime sleepiness, and fatigue. Some participants also receive 24-hour ambulatory electrocardiogram monitoring and functional MRI scans. The study monitors overall improvements in sleep disturbances and related symptoms, with the total participation lasting at least 12 weeks.

Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension