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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Pittsburgh Sleep Quality Index(PSQI) [Срок оценки: Baseline, week1, week2, week3, week4]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guang'anmen Hospital — Пекин

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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