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

NCT07554235 | Recruiting DMC

• 1 other identifier: LSKY 2025-145-02
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Disorder; Diabetes; Hypertension

Keywords

Village Doctors; Acupuncture needles; Hypertension; Diabetes; insomnia

Outcome Measures

Primary Outcomes (1)

• Change in Pittsburgh Sleep Quality Index (PSQI)score from baseline to Week 6 (T1).

  The total score range of the Pittsburgh Sleep Quality Index (PSQI) is 0 to 21, with higher scores indicating poorer sleep quality.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (6)

• Change in the Pittsburgh Sleep Quality Index (PSQI) score from baseline to week 12

  From enrollment to the end of follow-up at 12 weeks

• Change in the Epworth Sleepiness Scale (ESS) score from baseline to weeks 6 and 12.

  From enrollment to the end of follow-up at 12 weeks

• Change in the Hamilton Anxiety Scale (HAMA) score from baseline to weeks 6 and 12.

  From enrollment to the end of follow-up at 12 weeks

• Change in the Hamilton Depression Scale (HAMD-17) score from baseline to weeks 6 and 12.

  From enrollment to the end of follow-up at 12 weeks

• Change in the Flinders Fatigue Scale (FFS) score from baseline to weeks 6 and 12.

  From enrollment to the end of follow-up at 12 weeks

Other Outcomes (3)

• Exploratory Outcomes

  From enrollment to the end of treatment at 12 weeks

• Exploratory Outcomes

  From enrollment to the end of follow-up at 12 weeks

• Exploratory Outcomes

  From enrollment to the end of follow-up at 12 weeks

Study Arms (2)

Real Auricular Press-needle Acupuncture Group

EXPERIMENTAL

Point Selection: Core points are selected based on Traditional Chinese Medicine theory: Heart, Liver, Kidney, Shenmen, Forehead A total of 160 randomly assigned participants received auricular acupuncture for 6 weeks using disposable, sterile Hua Tuo brand thumb-tack needles (press needles). For each session, needles were applied to one ear, retained for 2 days, and then replaced, alternating between the left and right ears. From this group, a subgroup of 50 participants underwent additional 24-hour ambulatory electrocardiogram monitoring and functional magnetic resonance imaging (fMRI) scans.

Device: Auricular Acupuncture Therapy

Sham Auricular Press-needle Acupuncture Group

SHAM COMPARATOR

The same locations on the ear as the experimental group. Use press needles identical in appearance to the treatment group but without needle tips, applied to the point locations.Similarly, a subgroup of 50 participants from this group underwent 24-hour ambulatory electrocardiogram monitoring and fMRI scans.

Device: Sham Auricular Acupuncture Group

Interventions

Auricular Acupuncture Therapy DEVICE

Point Selection: Heart, Liver, Kidney, Shenmen, Forehead.① The patient sits, and the ear is disinfected with alcohol. ② The practitioner's hands and the local point area are routinely disinfected. Use Huatuo brand imported sterile disposable press needles (with release paper, Medical Device Registration No.: Su Xie Zhu Zhun 20162200966), specification 0.22×1.5mm. ③ After inserting the needle body into the aforementioned points, remove the release paper and gently press the adhesive tape to ensure tight adhesion. After needling, the village doctor presses the embedded needle site to induce a "deqi" sensation.

Real Auricular Press-needle Acupuncture Group

Sham Auricular Acupuncture Group DEVICE

Point Selection: The same locations on the ear as the experimental group. Procedure: Use press needles identical in appearance to the treatment group but without needle tips, applied to the point locations. The operation procedure, disinfection, replacement frequency, and pressing instructions are completely consistent with the experimental group. Avoid inducing a "deqi" sensation during the procedure. Key point: The patient is also instructed to press the points.

Sham Auricular Press-needle Acupuncture Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify 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 may not qualify 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
• Bleeding disorders or use of anticoagulants (increased bleeding risk);
• History of fainting during acupuncture;
• Life expectancy less than six months.

Sponsors & Collaborators

• Jiangsu Taizhou People's Hospital: lead

Study Sites (1)

Taizhou People's Hospital affiliated to Nanjing Medical University

Taizhou, Jiangsu, 225300, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Zhimei Teng

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Village Doctor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The deputy dean of the hospital

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 28, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)