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

This study aims to apply traditional auricular press-needle acupuncture to treat sleep disturbances in elderly patients (aged ≥65 years) with comorbid diabetes mellitus and hypertension in rural areas of China. Given the complex bidirectional relationship between diabetes mellitus with hypertension and sleep disturbances, this cluster randomized trial is designed to test whether a village doctor-led intervention model supported by telemedicine can improve sleep disturbances in patients with comorbid diabetes mellitus and hypertension, compared to sham auricular press-needle acupuncture. Participants will be recruited by local village doctors according to the inclusion and exclusion criteria. The protocol is based on Traditional Chinese Medicine theory for core point selection: Heart, Liver, Kidney, Shenmen, and Forehead area, along with optimized medication regimens supported by remote cardiovascular specialists. The investigators will evaluate the overall improvement in sleep disturbances using the Pittsburgh Sleep Quality Index (PSQI) at the end of the 6-week treatment period, and assess sleep disturbances, anxiety, depression, daytime sleepiness, and fatigue at 12 weeks.

NCT Number	NCT07554235
Lead Sponsor	Jiangsu Taizhou People's Hospital
Conditions	Insomnia Disorder, Diabetes, Hypertension
Enrollment	320 participants
Start Date	2026-04-22
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-02-20 (estimated)
Updated on ClinicalTrials.gov	2026-06-29