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

Official title

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

Overview

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.

Detailed description

Elderly patients with comorbid diabetes mellitus and hypertension have a high incidence of sleep disturbances. The occurrence of sleep disturbances often leads to poorer control of blood glucose and blood pressure, and the mutual influence between these conditions creates a vicious cycle. A total of 320 patients aged ≥65 years with comorbid diabetes mellitus and hypertension and a Pittsburgh Sleep Quality Index (PSQI) total score ≥8 will be enrolled from 20 village clinics in Taizhou City, Jiangsu Province. Villages will be randomly assigned in a 1:1 ratio to the real auricular acupuncture group or the sham auricular acupuncture group. The real auricular press-needle acupuncture group will receive treatment using disposable intradermal needles (0.22 × 1.5 mm) at five core auricular points: Heart, Liver, Kidney, Shenmen, and Frontal region. Needles will be retained for two days, alternating between ears, with daily pressing four times per day. The sham auricular press-needle acupuncture group will receive adhesive patches identical in appearance but without needles applied to the same points, without inducing deqi sensation. Village doctors will be trained by specialists from higher-level hospitals and will receive quality control support via a telemedicine platform. The intervention will last 6 weeks, with follow-up at 12 weeks. The findings will provide high-quality evidence-based support for the management of sleep disturbances in elderly rural patients with comorbid diabetes mellitus and hypertension and promote the standardized application of auricular press-needle acupuncture in primary care.

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 ensur
• 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 outcome measures

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

Secondary outcome measures (6)

• Change in the Pittsburgh Sleep Quality Index (PSQI) score from baseline to week 12 [Time frame: From enrollment to the end of follow-up at 12 weeks]
• Change in the Epworth Sleepiness Scale (ESS) score from baseline to weeks 6 and 12. [Time frame: From enrollment to the end of follow-up at 12 weeks]
• Change in the Hamilton Anxiety Scale (HAMA) score from baseline to weeks 6 and 12. [Time frame: From enrollment to the end of follow-up at 12 weeks]
• Change in the Hamilton Depression Scale (HAMD-17) score from baseline to weeks 6 and 12. [Time frame: From enrollment to the end of follow-up at 12 weeks]
• Change in the Flinders Fatigue Scale (FFS) score from baseline to weeks 6 and 12. [Time frame: From enrollment to the end of follow-up at 12 weeks]
• Change in the Insomnia Severity Index (ISI) score from baseline to weeks 6 and 12. [Time frame: From enrollment to the end of follow-up at 12 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Taizhou People's Hospital affiliated to Nanjing Medical University — Taizhou

Identifiers

NCT: NCT07554235 · LSKY 2025-145-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗