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

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

Inclusion Criteria:

1. Age ≥65 years;
2. Patients with comorbid diabetes mellitus and hypertension:
3. Sleep disturbance: Pittsburgh Sleep Quality Index (PSQI) total score ≥8;
4. Willing to participate in this study and sign the informed consent form;
5. Has resided in this village for at least six months.

Exclusion Criteria:

1. Stroke;
2. Severe mental illness or cognitive impairment;
3. Severe organ failure (e.g., end-stage renal disease);
4. Ear infection, eczema, breakage, or deformity;
5. Currently receiving regular other acupuncture treatments;
6. Use of any hypnotic medications within the past month
7. Bleeding disorders or use of anticoagulants (increased bleeding risk);
8. History of fainting during acupuncture;
9. Life expectancy less than six months.

Conditions3

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