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Recruiting NCT06527547

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

No phase Interventional Transcutaneous Electric Nerve Stimulation Rheumatoid Arthritis Sleep Quality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Auricular Vagus Nerve Stimulation, Sham Stimulation.
Who it may be relevant to
Registry conditions: Transcutaneous Electric Nerve Stimulation, Rheumatoid Arthritis, Sleep Quality. Basic parameters: 18 years — 72 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Primary outcome measures

  • Pittsburgh Sleep Quality Index(PSQI) [Time frame: Baseline, week1, week2, week3, week4]
Secondary outcome measures (10)
  • Consensus Sleep Diary-Core(CSD) [Time frame: Baseline, week1, week2, week3, week4]
  • Medical outcomes study sleep scale(MOS-SS) [Time frame: Baseline,week4]
  • Epworth sleepiness scale(ESS) [Time frame: Baseline,week4]
  • the Multidimensional Fatigue Inventory-20 (MFI-20) [Time frame: Baseline,week4]
  • Tender joint count(TJC) [Time frame: Baseline, week2, week4]
  • Swollen joint count(SJC) [Time frame: Baseline, week2, week4]
  • Visual analogue scale(VAS) for pain [Time frame: Baseline, week1, week2, week3, week4]
  • Disease Activity Score - 28 joints（DAS-28 ESR/CRP） [Time frame: Baseline,week4]
  • Health Assessment Questionnaire（HAQ） [Time frame: Baseline,week4]
  • Hospital Anxiety and Depression Scale（HADS） [Time frame: Baseline,week4]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Guang'anmen Hospital — Beijing

Identifiers

NCT: NCT06527547 · 2024-139-KY-01 · CI2021B007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗