Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real Auricular Press-needle Acupuncture Group | Experimental | 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. |
|
| Sham Auricular Press-needle Acupuncture Group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular Acupuncture Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimei Teng | Contact |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taizhou People's Hospital affiliated to Nanjing Medical University | Recruiting | Taizhou | Jiangsu | 225300 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Village Doctor
Not provided
|
| Sham Auricular Acupuncture Group | Device | 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. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | Quality of life, specifically daytime fatigue, was assessed using the Flinders Fatigue Scale (FFS). The total score of this scale ranges from 0 to 31, with higher scores indicating more severe fatigue . | 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. | The Insomnia Severity Index (ISI) was used to assess the severity of insomnia. The total score of this scale ranges from 0 to 28, with higher scores indicating more severe insomnia. | From enrollment to the end of follow-up at 12 weeks |
| From enrollment to the end of treatment at 12 weeks |
| 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 | From enrollment to the end of follow-up at 12 weeks |
| 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. | From enrollment to the end of follow-up at 12 weeks |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided