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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Age ≥65 years;

• Patients with comorbid diabetes mellitus and hypertension:

• Sleep disturbance: Pittsburgh Sleep Quality Index (PSQI) total score ≥8;

• Willing to participate in this study and sign the informed consent form;

• Has resided in this village for at least six months.

Locations
Other Locations
China
Taizhou People's Hospital affiliated to Nanjing Medical University
RECRUITING
Taizhou
Contact Information
Primary
Zhimei Teng
Time Frame
Start Date: 2026-04-22
Estimated Completion Date: 2027-02-20
Participants
Target number of participants: 320
Treatments
Experimental: Real Auricular Press-needle Acupuncture Group
Point Selection: Core points are selected based on Traditional Chinese Medicine theory: Heart, Liver, Kidney, Shenmen, Forehead A total of 160 randomly assigned participants received auricular acupuncture for 6 weeks using disposable, sterile Hua Tuo brand thumb-tack needles (press needles). For each session, needles were applied to one ear, retained for 2 days, and then replaced, alternating between the left and right ears. From this group, a subgroup of 50 participants underwent additional 24-hour ambulatory electrocardiogram monitoring and functional magnetic resonance imaging (fMRI) scans.
Sham_comparator: Sham Auricular Press-needle Acupuncture Group
The same locations on the ear as the experimental group. Use press needles identical in appearance to the treatment group but without needle tips, applied to the point locations.Similarly, a subgroup of 50 participants from this group underwent 24-hour ambulatory electrocardiogram monitoring and fMRI scans.
Related Therapeutic Areas
Sponsors
Leads: Jiangsu Taizhou People's Hospital

This content was sourced from clinicaltrials.gov