Status:
RECRUITING
Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
Lead Sponsor:
Juan Jiao
Collaborating Sponsors:
Hebei Provincial Hospital of Traditional Chinese Medicine
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Transcutaneous Electric Nerve Stimulation
Rheumatoid Arthritis
Eligibility:
All Genders
18-72 years
Phase:
NA
Brief Summary
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)...
Eligibility Criteria
Inclusion
- Meets the 2010 ACR/EULAR criteria for rheumatoid arthritis.
- Poor sleep quality (PSQI score \> 7).
- Disease activity is moderate to low or in remission (DAS28 score ≤ 5.1).
- No risk of sleep apnea (STOP-Bang questionnaire \< 3).
- Aged between 18 and 70.
- The type and dosage of rheumatoid arthritis medication must be stable for at least 4 weeks.
- Signed informed consent.
Exclusion
- People with acute infectious diseases, whether generalized or localized;
- Those with severe internal organ diseases (such as coronary heart disease, arrhythmia, malignant tumors, renal failure, etc.);
- Those working night shifts during the intervention period;
- Those with other rheumatic diseases such as systemic lupus erythematosus, fibromyalgia, and Sjogren's syndrome;
- Those undergoing treatment with steroids, sleeping pills, antidepressants, or antipsychotics;
- Pregnant and breastfeeding women;
- Those who cannot tolerate transcutaneous auricular electrostimulation.
Key Trial Info
Start Date :
June 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06527547
Start Date
June 6 2024
End Date
December 31 2025
Last Update
April 13 2025
Active Locations (1)
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1
Guang'anmen Hospital
Beijing, Beijing Municipality, China, 100053