Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes and Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- the change in Pittsburgh Sleep Quality Index (PSQI)score from baseline to Week 6 (T1).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider)
盲法说明
Village Doctor
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Real Auricular Press-needle Acupuncture Group
Point Selection: Core points are selected based on Traditional Chinese Medicine theory: Heart, Liver, Kidney, Shenmen, Forehead A total of 160 randomly assigned participants received auricular acupuncture for 6 weeks using disposable, sterile Hua Tuo brand thumb-tack needles (press needles). For each session, needles were applied to one ear, retained for 2 days, and then replaced, alternating between the left and right ears. From this group, a subgroup of 50 participants underwent additional 24-hour ambulatory electrocardiogram monitoring and functional magnetic resonance imaging (fMRI) scans.
干预措施: Auricular Acupuncture Therapy (Device)
Sham Auricular Press-needle Acupuncture Group
The same locations on the ear as the experimental group. Use press needles identical in appearance to the treatment group but without needle tips, applied to the point locations.Similarly, a subgroup of 50 participants from this group underwent 24-hour ambulatory electrocardiogram monitoring and fMRI scans.
干预措施: Sham Auricular Acupuncture Group (Device)
结局指标
主要结局
the change in Pittsburgh Sleep Quality Index (PSQI)score from baseline to Week 6 (T1).
时间窗: From enrollment to the end of treatment at 6 weeks
The total score range of the Pittsburgh Sleep Quality Index (PSQI) is 0 to 21, with higher scores indicating poorer sleep quality.
Change in Pittsburgh Sleep Quality Index (PSQI)score from baseline to Week 6 (T1).
时间窗: From enrollment to the end of treatment at 6 weeks
The total score range of the Pittsburgh Sleep Quality Index (PSQI) is 0 to 21, with higher scores indicating poorer sleep quality.
次要结局
- Change in the Pittsburgh Sleep Quality Index (PSQI) score from baseline to week 12(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.(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.(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.(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.(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.(From enrollment to the end of follow-up at 12 weeks)
研究者
Ming Chu
The deputy dean of the hospital
Jiangsu Taizhou People's Hospital