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New treatment option for Transcutaneous Electric Nerve Stimulation
Official title Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
ClinicalTrials.gov ID: NCT06527547
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 72
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 72 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.