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.
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.
Stroke;
Severe mental illness or cognitive impairment;
Severe organ failure (e.g., end-stage renal disease);
Ear infection, eczema, breakage, or deformity;
Parallel
Auricular Acupuncture Therapy
DevicePoint 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.
Sham Auricular Acupuncture Group
DevicePoint 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.
Change in Pittsburgh Sleep Quality Index (PSQI)score from baseline to Week 6 (T1).
The total score range of the Pittsburgh Sleep Quality Index (PSQI) is 0 to 21, with higher scores indicating poorer sleep quality.
Change in the Pittsburgh Sleep Quality Index (PSQI) score from baseline to week 12
The total score range of the Pittsburgh Sleep Quality Index (PSQI) is 0 to 21, with higher scores indicating poorer sleep quality.
Change in the Epworth Sleepiness Scale (ESS) score from baseline to weeks 6 and 12.
Daytime sleepiness was assessed using the Epworth Sleepiness Scale (ESS). The total score of this scale ranges from 0 to 24, with higher scores indicating more severe daytime sleepiness.
Change in the Hamilton Anxiety Scale (HAMA) score from baseline to weeks 6 and 12.
Anxiety and depression mood was assessed using the Hamilton Anxiety Scale (HAMA). The total score of this scale ranges from 0 to 56, with higher scores indicating more severe anxiety.
Change in the Hamilton Depression Scale (HAMD-17) score from baseline to weeks 6 and 12.
Depression severity was assessed using the Hamilton Depression Scale (HAMD-17). The total score of this scale ranges from 0 to 52, with higher scores indicating more severe depression.
Exploratory Outcomes
Mean overall changes in HbA1c：The formation rate of glycated haemoglobin A1c (HbA1c) is proportional to the blood glucose concentration. Once formed, it remains stable throughout the entire lifespan of red blood cells (approximately 120 days), reflecting the average blood glucose level over the previous 2-3 months. Normal range: \< 6.0%; Prediabetes: 6.0% - 6.4%; Diabetes diagnostic criterion: ≥ 6.5%.
Exploratory Outcomes
Mean overall changes in SBP：Systolic Blood Pressure (SBP) refers to the highest value of arterial blood pressure reached when the heart contracts. The normal range is 90-140 mmHg. SBP greater than 140 mmHg is the diagnostic criterion for hypertension, while SBP below 90 mmHg indicates hypotension. Low-density lipoprotein
Exploratory Outcomes
Mean overall changes in LDL-C：Low-density lipoprotein cholesterol (LDL-C) refers to the cholesterol content carried within LDL particles and is the most important and core lipid test target for assessing and managing the risk of atherosclerotic cardiovascular disease. Ideal level: \< 2.6 mmol/L; Desirable level: 2.6-3.39 mmol/L; Borderline high: 3.4-4.
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