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Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension

StatusRecruiting
PhaseNot applicable
Started2026-04-22
View on ClinicalTrials.gov ↗

Amendment history

2026-06-25
Study Identification, Study Status, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v1
Recruitment opened
Primary endpoint(s) modified1 entry, revised
Wasthe change in Pittsburgh Sleep Quality Index (PSQI)score from baseline to Week 6 (T1).
NowChange in Pittsburgh Sleep Quality Index (PSQI)score from baseline to Week 6 (T1).
Primary completion pushed: 2026-08-01 → 2026-12-31
Completion pushed: 2026-12-01 → 2027-02-20
Start dateestimated 2026-04-01→confirmed 2026-04-22
Study sites0→1
Eligibility criteria+54 characters
[...] ; Currently receiving regular other acupuncture treatments; Use of any hypnotic medications within the past month Bleeding disorders or use of anticoagulants (increased bleed [...]
2026-04-23
Original filing
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 Details
NCT Number NCT07554235
Lead Sponsor Jiangsu Taizhou People's Hospital
Conditions Insomnia Disorder, Diabetes, Hypertension
Enrollment 320 participants
Start Date 2026-04-22
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-02-20 (estimated)
Updated on ClinicalTrials.gov 2026-06-29