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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorJiangsu Taizhou People's Hospital

About this trial

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 criteria

Qualifiers

Age ≥65 years;

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.

Disqualifiers

Stroke;

Severe mental illness or cognitive impairment;

Severe organ failure (e.g., end-stage renal disease);

Ear infection, eczema, breakage, or deformity;

Trial design

Treatments tested in this trial

  • Auricular Acupuncture Therapy
  • Sham Auricular Acupuncture Group

Treatment groups

320 Participants
are divided into 2 treatment groups