Auricular Acupuncture for Sleep Problems in Seniors with Diabetes
Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension
Recruiting
N/AInterventional Study
Insomnia DisorderDiabetesHypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
320 (estimated)
Sponsor
Jiangsu Taizhou People's Hospital · Other
Who this trial is looking for
This trial is looking for elderly patients aged 65 and older who have both diabetes and hypertension and are having trouble sleeping. Participants will receive auricular acupuncture treatment from village doctors to see if it helps improve their sleep quality.
Are You a Good Fit for This Trial?
You may be able to join if
I am 65 years or older.
I have diabetes and hypertension.
I have sleep problems with a PSQI score of 8 or higher.
I agree to participate and sign the consent form.
I have lived in this village for at least six months.
You may not be able to join if
I have had a stroke.
I have severe mental illness or cognitive impairment.
I have severe organ failure.
I have an ear infection or deformity.
I am currently receiving other acupuncture treatments.
I have taken any sleeping medications in the past month.
I have bleeding disorders or use anticoagulants.
My life expectancy is less than six months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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-l…
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.
Trial Locations
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City
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Status
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…
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.
Contacts
Zhimei Teng
CONTACT
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