Actively Recruiting
Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
Led by Juan Jiao · Updated on 2025-04-13
52
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
Sponsors
J
Juan Jiao
Lead Sponsor
H
Hebei Provincial Hospital of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to determine whether transcutaneous auricular vagus nerve stimulation (taVNS) is suitable for improving sleep disorders in patients with rheumatoid arthritis (RA). It will also evaluate the safety of taVNS. The main questions it aims to answer are: Can taVNS improve the sleep quality of RA patients? What medical issues might RA patients experience while receiving taVNS treatment? Researchers will compare taVNS with a placebo (a similar substance that does not contain the actual treatment) to see if taVNS is effective in improving sleep disorders in RA patients. Participants will: Receive taVNS or sham stimulation daily for 4 weeks Keep a daily sleep diary and visit the hospital once a week for check-ups and tests Record their sleep quality and related symptoms This study aims to provide a new, safe, and effective non-drug therapy for sleep disorders related to RA.
CONDITIONS
Official Title
Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets the 2010 ACR/EULAR criteria for rheumatoid arthritis
- Poor sleep quality with a Pittsburgh Sleep Quality Index (PSQI) score greater than 7
- Moderate to low disease activity or remission with DAS28 score of 5.1 or less
- No risk of sleep apnea with STOP-Bang questionnaire score less than 3
- Aged between 18 and 70 years
- Stable type and dosage of rheumatoid arthritis medication for at least 4 weeks
- Signed informed consent
You will not qualify if you...
- Acute infectious diseases, generalized or localized
- Severe internal organ diseases such as coronary heart disease, arrhythmia, malignant tumors, or renal failure
- Working night shifts during the intervention period
- Other rheumatic diseases like systemic lupus erythematosus, fibromyalgia, or Sjogren's syndrome
- Treatment with steroids, sleeping pills, antidepressants, or antipsychotics
- Pregnant or breastfeeding women
- Unable to tolerate transcutaneous auricular electrostimulation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guang'anmen Hospital
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
J
Juan Jiao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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