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.
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).
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;
Juan Jiao
Lead sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor institution
Hebei Provincial Hospital of Traditional Chinese Medicine
Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborator
Shenzhen Futian Hospital of TCM
Collaborator
Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
Collaborator