Taizhou People's Hospital affiliated to Nanjing Medical University
Taizhou, Jiangsu, 225300, China
Location status: Recruiting
NCT Number: NCT07554235
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Taizhou, Jiangsu, 225300, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: From enrollment to the end of follow-up at 12 weeks
The total score range of the Pittsburgh Sleep Quality Index (PSQI) is 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: From enrollment to the end of follow-up at 12 weeks
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.
Time frame: From enrollment to the end of follow-up at 12 weeks
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.
Time frame: From enrollment to the end of follow-up at 12 weeks
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.
Time frame: From enrollment to the end of follow-up at 12 weeks
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 .
Time frame: From enrollment to the end of follow-up at 12 weeks
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.
Time frame: From enrollment to the end of treatment at 12 weeks
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%.
Time frame: From enrollment to the end of follow-up at 12 weeks
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
Time frame: From enrollment to the end of follow-up at 12 weeks
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.
Contact information is provided by the study sponsor or research team.
Zhimei Teng
CONTACT
Jiangsu Taizhou People's Hospital
Other
Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes and Hypertension
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