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

June 25, 2026 updated by: Ming Chu, Jiangsu Taizhou People's Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Elderly patients with comorbid diabetes mellitus and hypertension have a high incidence of sleep disturbances. The occurrence of sleep disturbances often leads to poorer control of blood glucose and blood pressure, and the mutual influence between these conditions creates a vicious cycle. A total of 320 patients aged ≥65 years with comorbid diabetes mellitus and hypertension and a Pittsburgh Sleep Quality Index (PSQI) total score ≥8 will be enrolled from 20 village clinics in Taizhou City, Jiangsu Province. Villages will be randomly assigned in a 1:1 ratio to the real auricular acupuncture group or the sham auricular acupuncture group. The real auricular press-needle acupuncture group will receive treatment using disposable intradermal needles (0.22 × 1.5 mm) at five core auricular points: Heart, Liver, Kidney, Shenmen, and Frontal region. Needles will be retained for two days, alternating between ears, with daily pressing four times per day. The sham auricular press-needle acupuncture group will receive adhesive patches identical in appearance but without needles applied to the same points, without inducing deqi sensation. Village doctors will be trained by specialists from higher-level hospitals and will receive quality control support via a telemedicine platform. The intervention will last 6 weeks, with follow-up at 12 weeks. The findings will provide high-quality evidence-based support for the management of sleep disturbances in elderly rural patients with comorbid diabetes mellitus and hypertension and promote the standardized application of auricular press-needle acupuncture in primary care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Zhimei Teng

Study Locations

  • China
    • Jiangsu
      • Taizhou, Jiangsu, China, 225300
        • Recruiting
        • Taizhou People's Hospital affiliated to Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Real Auricular Press-needle Acupuncture Group
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
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.
Sham Comparator: Sham Auricular Press-needle Acupuncture Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI)score from baseline to Week 6 (T1).
Time Frame: From enrollment to the end of treatment at 6 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the Pittsburgh Sleep Quality Index (PSQI) score from baseline to week 12
Time Frame: From enrollment to the end of follow-up at 12 weeks
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 follow-up at 12 weeks
Change in the Epworth Sleepiness Scale (ESS) score from baseline to weeks 6 and 12.
Time Frame: From enrollment to the end of follow-up at 12 weeks
Daytime sleepiness was assessed using the Epworth Sleepiness Scale (ESS). The total score of this scale ranges from 0 to 24, with higher scores indicating more severe daytime sleepiness.
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.
Time Frame: From enrollment to the end of follow-up at 12 weeks
Anxiety and depression mood was assessed using the Hamilton Anxiety Scale (HAMA). The total score of this scale ranges from 0 to 56, with higher scores indicating more severe anxiety.
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.
Time Frame: From enrollment to the end of follow-up at 12 weeks
Depression severity was assessed using the Hamilton Depression Scale (HAMD-17). The total score of this scale ranges from 0 to 52, with higher scores indicating more severe depression.
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.
Time Frame: From enrollment to the end of follow-up at 12 weeks
Quality of life, specifically daytime fatigue, was assessed using the Flinders Fatigue Scale (FFS). The total score of this scale ranges from 0 to 31, with higher scores indicating more severe fatigue .
From enrollment to the end of follow-up at 12 weeks
Change in the Insomnia Severity Index (ISI) score from baseline to weeks 6 and 12.
Time Frame: From enrollment to the end of follow-up at 12 weeks
The Insomnia Severity Index (ISI) was used to assess the severity of insomnia. The total score of this scale ranges from 0 to 28, with higher scores indicating more severe insomnia.
From enrollment to the end of follow-up at 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory Outcomes
Time Frame: From enrollment to the end of treatment at 12 weeks
Mean overall changes in HbA1c：The formation rate of glycated haemoglobin A1c (HbA1c) is proportional to the blood glucose concentration. Once formed, it remains stable throughout the entire lifespan of red blood cells (approximately 120 days), reflecting the average blood glucose level over the previous 2-3 months. Normal range: < 6.0%; Prediabetes: 6.0% - 6.4%; Diabetes diagnostic criterion: ≥ 6.5%.
From enrollment to the end of treatment at 12 weeks
Exploratory Outcomes
Time Frame: From enrollment to the end of follow-up at 12 weeks

Mean overall changes in SBP：Systolic Blood Pressure (SBP) refers to the highest value of arterial blood pressure reached when the heart contracts. The normal range is 90-140 mmHg. SBP greater than 140 mmHg is the diagnostic criterion for hypertension, while SBP below 90 mmHg indicates hypotension.

Low-density lipoprotein
From enrollment to the end of follow-up at 12 weeks
Exploratory Outcomes
Time Frame: From enrollment to the end of follow-up at 12 weeks
Mean overall changes in LDL-C：Low-density lipoprotein cholesterol (LDL-C) refers to the cholesterol content carried within LDL particles and is the most important and core lipid test target for assessing and managing the risk of atherosclerotic cardiovascular disease. Ideal level: < 2.6 mmol/L; Desirable level: 2.6-3.39 mmol/L; Borderline high: 3.4-4.
From enrollment to the end of follow-up at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Taizhou People's Hospital

Publications and helpful links

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Helpful Links

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LSKY 2025-145-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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