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Official title Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension
ClinicalTrials.gov ID: NCT07554235
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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.
You likely can't join if
- Stroke;
- 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
See the full eligibility criteria
- 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.
- Stroke;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taizhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taizhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.