Insomnia DisorderNCT07554235
Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension
A study testing Auricular Acupuncture Therapy in people with Insomnia Disorder and Diabetes, run by Jiangsu Taizhou People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia Disorder, Diabetes, Hypertension
- What is being tested?
- Auricular Acupuncture Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2026to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Bleeding disorders or use of anticoagulants (increased bleeding risk);
- History of fainting during acupuncture;
- Life expectancy less than six months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhimei Teng contact
China1 site, 1 recruiting
- Recruiting
Taizhou People's Hospital affiliated to Nanjing Medical University
Taizhou, Jiangsu, 225300
zhimei teng, master, 0523-89890056, 985292358@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Insomnia Disorder, Diabetes, Hypertension
- Being tested
- Auricular Acupuncture Therapy, Sham Auricular Acupuncture Group
- Keywords
- Village Doctors, Acupuncture needles, Hypertension, Diabetes, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Acupuncture TherapyDevice
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 Auricular Acupuncture GroupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Auricular Acupuncture Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The total score range of the Pittsburgh Sleep Quality Index (PSQI) is 0 to 21, with higher scores indicating poorer sleep quality.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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 .
Measured: 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.
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.
Measured: From enrollment to the end of follow-up at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start22 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Chu, Jiangsu Taizhou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554235
- Sponsor's protocol ID
- LSKY 2025-145-02
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes and Hypertension
- ClinicalTrials.gov ID
- NCT07554235
- Acronym / sponsor ID
- LSKY 2025-145-02
- Conditions
- Insomnia Disorder, Diabetes, Hypertension
- Keywords
- Village Doctors, Acupuncture needles, Hypertension, Diabetes, insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Auricular Press-needle Acupuncture Group | Experimental | Device: Auricular Acupuncture TherapyPoint 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. |
| Sham Auricular Press-needle Acupuncture Group | Sham comparator | Device: Sham Auricular Acupuncture GroupThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Acupuncture TherapyPoint 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. | Device | Real Auricular Press-needle Acupuncture Group |
| Sham Auricular Acupuncture GroupPoint 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. | Device | Sham Auricular Press-needle Acupuncture Group |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhimei Teng contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupuncture Therapy in people with Insomnia Disorder and Diabetes, run by Jiangsu Taizhou People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimei Teng, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.