Clinical Trial

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

Recruiting
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Record status
This record was last updated April 13, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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). 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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-07-25; most recent amendment 2025-04-10.
Trial Details
NCT Number NCT06527547
Lead Sponsor Juan Jiao
Collaborators: Hebei Provincial Hospital of Traditional Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Shenzhen Futian Hospital of TCM, Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
Conditions Transcutaneous Electric Nerve Stimulation, Rheumatoid Arthritis, Sleep Quality
Enrollment 52 participants
Start Date 2024-06-06
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-13