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

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.

Conditions

• Transcutaneous Electric Nerve Stimulation
• Rheumatoid Arthritis
• Sleep Quality

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

Treatment using the Huatuo electronic acupuncture device (model SDZ-IIB) with electrodes placed on the auricular points related to the heart and kidney. Pulsed wave type is sparse-dense wave, with a frequency of 20Hz and intensity set to the highest level tolerable without pain. Patients will perform self-treatment at home for 30 minutes, twice daily, for 5 days a week over 4 weeks.

DEVICE

Sham Stimulation

Treatment using the same Huatuo electronic acupuncture device with electrodes placed on different ear points (over the ear helix). The device settings (pulse type, frequency, intensity) are the same as the experimental group but do not correspond to traditional acupuncture points. Patients will also perform self-treatment at home as per the same schedule as the experimental group.

Sponsors & Collaborators

• Hebei Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER_GOV

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• Shenzhen Futian Hospital of TCM

  collaborator OTHER_GOV

• Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Juan Jiao

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

72 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-06

Primary Completion

2025-12-31

Completion

2025-12-31

FDA Device

Yes

Countries

• China

Study Locations