Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transcutaneous Electric Nerve Stimulation
- Sponsor
- Juan Jiao
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Pittsburgh Sleep Quality Index(PSQI)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Juan Jiao
professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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
- •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.
Outcomes
Primary Outcomes
Pittsburgh Sleep Quality Index(PSQI)
Time Frame: 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.
Secondary Outcomes
- Consensus Sleep Diary-Core(CSD)(Baseline, week1, week2, week3, week4)
- Medical outcomes study sleep scale(MOS-SS)(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)
- the Multidimensional Fatigue Inventory-20 (MFI-20)(Baseline,week4)
- Health Assessment Questionnaire（HAQ）(Baseline,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)