Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index(PSQI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •The type and dosage of rheumatoid arthritis medication must be stable for at least 4 weeks.
- •Signed informed consent.
排除标准
- •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.
研究组 & 干预措施
taVNS Group
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.
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (Device)
Sham Stimulation Group
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.
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Pittsburgh Sleep Quality Index(PSQI)
时间窗: Baseline, week1, week2, week3, week4
Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
次要结局
- Consensus Sleep Diary-Core(CSD)(Baseline, week1, week2, week3, week4)
- Medical outcomes study sleep scale(MOS-SS)(Baseline,week4)
- the Multidimensional Fatigue Inventory-20 (MFI-20)(Baseline,week4)
- Health Assessment Questionnaire（HAQ）(Baseline,week4)
- Epworth sleepiness scale(ESS)(Baseline,week4)
- Swollen joint count(SJC)(Baseline, week2, week4)
- Visual analogue scale(VAS) for pain(Baseline, week1, week2, week3, week4)
- Tender joint count(TJC)(Baseline, week2, week4)
- Disease Activity Score - 28 joints（DAS-28 ESR/CRP）(Baseline,week4)
- Hospital Anxiety and Depression Scale（HADS）(Baseline,week4)
研究者
Juan Jiao
professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences