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

ClinicalTrials.gov IDNCT07554235

PhaseNA

Enrollment320

SponsorJiangsu Taizhou People's Hospital

Age65 Years

SexALL

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Conditions studied

Insomnia Disorder, Diabetes, Hypertension

About this study

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.

Interventions

Device: Auricular Acupuncture Therapy — Point Selection: Heart, Liver, Kidney, Shenmen, Forehead.① The patient sits, and the ear is disinfected with alcohol. ② The practitioner's hands and the local point area are routinely disinfected. Use Huatuo brand imported sterile disposable press needles (with release paper, Medical Device Registration No.: Su Xie Zhu Zhun 20162200966), specification 0.22×1.5mm. ③ After inserting the needle body into the aforementioned points, remove the release paper and gently press the adhesive tape to ensure tight adhesion. After needling, the village doctor presses the embedded needle site to induce a "deqi" sensation.
Device: Sham Auricular Acupuncture Group — Point Selection: The same locations on the ear as the experimental group. Procedure: Use press needles identical in appearance to the treatment group but without needle tips, applied to the point locations. The operation procedure, disinfection, replacement frequency, and pressing instructions are completely consistent with the experimental group. Avoid inducing a "deqi" sensation during the procedure. Key point: The patient is also instructed to press the points.

Primary outcomes

Change in Pittsburgh Sleep Quality Index (PSQI)score from baseline to Week 6 (T1). (From enrollment to the end of treatment at 6 weeks)

Eligibility information

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.

Study locations

Taizhou People's Hospital affiliated to Nanjing Medical University, Taizhou, Jiangsu 225300 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.