Clinical trial NCT06527547: Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
Official title: Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcutaneous Electric Nerve Stimulation
Rheumatoid Arthritis
Sleep Quality
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Hebei Provincial Hospital of Traditional Chinese Medicine
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Shenzhen Futian Hospital of TCM
name: Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
First posted: 2024-07-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Meets the 2010 ACR/EULAR criteria for rheumatoid arthritis.
2. Poor sleep quality (PSQI score \> 7).
3. Disease activity is moderate to low or in remission (DAS28 score ≤ 5.1).
4. No risk of sleep apnea (STOP-Bang questionnaire \< 3).
5. Aged between 18 and 70.
6. The type and dosage of rheumatoid arthritis medication must be stable for at least 4 weeks.
7. Signed informed consent.

Exclusion Criteria:

1. People with acute infectious diseases, whether generalized or localized;
2. Those with severe internal organ diseases (such as coronary heart disease, arrhythmia, malignant tumors, renal failure, etc.);
3. Those working night shifts during the intervention period;
4. Those with other rheumatic diseases such as systemic lupus erythematosus, fibromyalgia, and Sjogren's syndrome;
5. Those undergoing treatment with steroids, sleeping pills, antidepressants, or antipsychotics;
6. Pregnant and breastfeeding women;
7. Those who cannot tolerate transcutaneous auricular electrostimulation.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index(PSQI)
timeFrame: Baseline, week1, week2, week3, week4
Secondary outcomes:
measure: Consensus Sleep Diary-Core(CSD)
timeFrame: Baseline, week1, week2, week3, week4
measure: Medical outcomes study sleep scale(MOS-SS)
timeFrame: Baseline,week4
measure: Epworth sleepiness scale(ESS)
timeFrame: Baseline,week4
measure: the Multidimensional Fatigue Inventory-20 (MFI-20)
timeFrame: Baseline,week4
measure: Tender joint count(TJC)
timeFrame: Baseline, week2, week4
measure: Swollen joint count(SJC)
timeFrame: Baseline, week2, week4
measure: Visual analogue scale(VAS) for pain
timeFrame: Baseline, week1, week2, week3, week4
measure: Disease Activity Score - 28 joints（DAS-28 ESR/CRP）
timeFrame: Baseline,week4
measure: Health Assessment Questionnaire（HAQ）
timeFrame: Baseline,week4
measure: Hospital Anxiety and Depression Scale（HADS）
timeFrame: Baseline,week4
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
References: