Auricular acupuncture given by village doctors to help sleep in elderly with diabetes and high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cluster randomized trial will recruit about 320 participants aged 65 and older with diabetes and hypertension and sleep disturbance from 20 village clinics in Taizhou, Jiangsu. Villages will be assigned to receive real auricular press-needle acupuncture or a sham procedure, with treatment lasting six weeks and follow-up at twelve weeks. Trained village doctors will apply disposable intradermal needles at core ear points under telemedicine-supported supervision, aiming to improve Pittsburgh Sleep Quality Index scores. The intervention integrates traditional point selection (Heart, Liver, Kidney, Shenmen, Frontal region) with optimized cardiovascular care guidance from specialists. The study assesses whether this village-based model can improve sleep quality in this high-risk elderly population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Taizhou People's Hospital affiliated to Nanjing Medical University
  Taizhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Zhimei Teng

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.