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

Juan Jiao

Status: Enrolling

Conditions: Sleep Quality; Transcutaneous Electric Nerve Stimulation; Rheumatoid Arthritis

Treatments: Device: Sham Stimulation; Device: Transcutaneous Auricular Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06527547

2024-139-KY-01

CI2021B007 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

taVNS Group

Experimental group

Description:

This arm consists of 26 participants diagnosed with rheumatoid arthritis who will receive transcutaneous auricular vagus nerve stimulation (taVNS) using the Huatuo electronic acupuncture device (model SDZ-IIB). Participants will be trained by a qualified physician to correctly position the earpieces on the auricular points corresponding to the heart and kidney. Treatment will be conducted at home, with each participant undergoing stimulation twice daily for 30 minutes each session, over a period of 5 consecutive days each week. The total intervention duration will last for 4 weeks. The stimulation frequency will be set at 20 Hz, using a sparse-dense wave pattern, with the intensity adjusted to the maximum level tolerated by the patient without causing pain.

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Sham Stimulation Group

Sham Comparator group

Description:

This arm includes 26 participants with rheumatoid arthritis who will receive sham stimulation using the same Huatuo electronic acupuncture device (model SDZ-IIB). Participants will be instructed on how to properly use the device, which will involve special sham electrodes placed over different ear areas not corresponding to therapeutic points (on the ear helix, specifically over the clavicle and shoulder points). The sham treatment will follow the same schedule as the experimental group: stimulation twice daily for 30 minutes per session, for 5 consecutive days each week, over 4 weeks. The device will be set to the same frequency and intensity as the experimental group, simulating the feeling of stimulation without delivering effective therapeutic intervention.

Treatment:

Device: Sham Stimulation