NCT07554235Recruiting
Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension
Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes and Hypertension
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- 22 Apr 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Diseases
- High blood pressure
- NCT number
- NCT07554235
What you commit to
- Study type: Interventional
- Planned participants: 320
- From 22 Apr 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving regular other acupuncture treatments;
- Use of any hypnotic medications within the past month
Other illness
- Stroke;
- Severe mental illness or cognitive impairment;
- Severe organ failure (e.g., end-stage renal disease);
- Ear infection, eczema, breakage, or deformity;
- Bleeding disorders or use of anticoagulants (increased bleeding risk);
- History of fainting during acupuncture;
Other
- Life expectancy less than six months.
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taizhou People's Hospital affiliated to Nanjing Medical University Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.