Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial

Launched by JUAN JIAO · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transcutaneous auricular vagus nerve stimulation (taVNS) to see if it can help improve sleep quality for people with rheumatoid arthritis (RA). RA can cause pain and discomfort that often disrupts sleep, and this study aims to find out if taVNS is a safe and effective way to address those sleep problems. Participants will receive either the taVNS treatment or a placebo (a treatment that looks the same but has no active ingredients) every day for four weeks. They’ll keep a daily sleep diary and visit the hospital weekly for check-ups.

To be eligible for this trial, participants must be between 18 and 70 years old, have a diagnosis of rheumatoid arthritis, and experience poor sleep quality. They should have stable RA medication for at least four weeks and not have any other serious health issues that could interfere with the study. Throughout the trial, participants will be monitored closely to ensure their safety and to see how their sleep improves. This research could offer new hope for those struggling with sleep disturbances linked to rheumatoid arthritis without relying on medication.

Gender

ALL

Eligibility 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.