NCT07554235 Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension
| NCT ID | NCT07554235 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jiangsu Taizhou People's Hospital |
| Condition | Insomnia Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2026-04-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥65 years; 2. Patients with comorbid diabetes mellitus and hypertension: 3. Sleep disturbance: Pittsburgh Sleep Quality Index (PSQI) total score ≥8; 4. Willing to participate in this study and sign the informed consent form; 5. Has resided in this village for at least six months. Exclusion Criteria: 1. Stroke; 2. Severe mental illness or cognitive impairment; 3. Severe organ failure (e.g., end-stage renal disease); 4. Ear infection, eczema, breakage, or deformity; 5. Currently receiving regular other acupuncture treatments; 6. Use of any hypnotic medications within the past month 7. Bleeding disorders or use of anticoagulants (increased bleeding risk); 8. History of fainting during acupuncture; 9. Life expectancy less than six months.
Contact & Investigator
Zhimei Teng
Frequently Asked Questions
Who can join the NCT07554235 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Insomnia Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07554235 currently recruiting?
Yes, NCT07554235 is actively recruiting participants. Visit ClinicalTrials.gov or contact Jiangsu Taizhou People's Hospital to inquire about joining.
Where is the NCT07554235 trial being conducted?
This trial is being conducted at Taizhou, China.
Who is sponsoring the NCT07554235 clinical trial?
NCT07554235 is sponsored by Jiangsu Taizhou People's Hospital. The trial plans to enroll 320 participants.
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