Using auricular electroacupuncture to improve sleep in rheumatoid arthritis patients
Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
This study is testing whether a new treatment using auricular electroacupuncture can help people with rheumatoid arthritis sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 72 Years |
| Sex | All |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06527547 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in enhancing sleep quality among patients with rheumatoid arthritis (RA). Participants will receive either taVNS or a placebo daily for four weeks while maintaining a sleep diary and attending weekly check-ups. The study aims to assess both the efficacy of taVNS in improving sleep disturbances and its safety profile. By comparing the treatment group with a control group, researchers hope to establish a new non-drug therapy for sleep issues related to RA.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with rheumatoid arthritis who experience poor sleep quality and have stable medication regimens.
Not a fit: Patients with severe internal organ diseases, those on certain medications, or individuals with other rheumatic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safe and effective non-pharmacological option for improving sleep quality in patients with rheumatoid arthritis.
How similar studies have performed: While the approach of using taVNS is relatively novel, similar studies have shown promise in using non-invasive stimulation techniques for various conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meets the 2010 ACR/EULAR criteria for rheumatoid arthritis. 2. Poor sleep quality (PSQI score \> 7). 3. Disease activity is moderate to low or in remission (DAS28 score ≤ 5.1). 4. No risk of sleep apnea (STOP-Bang questionnaire \< 3). 5. Aged between 18 and 70. 6. The type and dosage of rheumatoid arthritis medication must be stable for at least 4 weeks. 7. Signed informed consent. Exclusion Criteria: 1. People with acute infectious diseases, whether generalized or localized; 2. Those with severe internal organ diseases (such as coronary heart disease, arrhythmia, malignant tumors, renal failure, etc.); 3. Those working night shifts during the intervention period; 4. Those with other rheumatic diseases such as systemic lupus erythematosus, fibromyalgia, and Sjogren's syndrome; 5. Those undergoing treatment with steroids, sleeping pills, antidepressants, or antipsychotics; 6. Pregnant and breastfeeding women; 7. Those who cannot tolerate transcutaneous auricular electrostimulation.
Where this trial is running
Beijing, Beijing Municipality
- Guang'anmen Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Juan Jiao
- Email: jiao.juan@hotmail.com
- Phone: 18611511082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.