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

Not Applicable

Recruiting

• Conditions: Transcutaneous Electric Nerve Stimulation; Rheumatoid Arthritis; Sleep Quality
• Interventions: Device: Transcutaneous Auricular Vagus Nerve Stimulation

• Registration Number: NCT06527547
• Lead Sponsor: Juan Jiao

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-06
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
taVNS Group	Transcutaneous Auricular Vagus Nerve Stimulation	Using the Huatuo Electronic Acupuncture Treatment Instrument (Model SDZ-IIB, Suzhou Medical Appliance Factory Co., Ltd.) for auricular vagus nerve stimulation, place the electrostimulating ear clip on the concha area where the auricular branch of the vagus nerve is located. Set the pulse type to intermittent waves, with a frequency of 20Hz; pulse width to 0.2ms ± 30%; and current ≤ 50mA (500Ω load impedance). The intensity should be at a tolerable level and not cause pain. Under the guidance of a professional physician, the patient learns how to operate the acupuncture device, and then take it home for treatment. The treatment is performed twice daily, once in the morning and once in the evening, treating both ears simultaneously for 30 minutes each session. This treatment is conducted 5 days a week with a 2-day rest period, for a total of 4 weeks.
Sham Stimulation Group	Transcutaneous Auricular Vagus Nerve Stimulation	Using the Huatuo Electronic Acupuncture Treatment Instrument (Model SDZ-IIB, Suzhou Medical Appliance Factory Co., Ltd.). Place the sham stimulation ear clip on the scaphoid fossa, an area without the distribution of the auricular branch of the vagus nerve. Set the pulse frequency to dense-dispersed waves, with a frequency of 20Hz; pulse width to 0.2ms ± 30%; and current ≤ 50mA (500Ω load impedance). The intensity should be at a tolerable level and not cause pain. Under the guidance of a professional physician, the patient learns how to operate the acupuncture device and then takes it home for treatment. The treatment is performed twice daily, once in the morning and once in the evening, treating both ears simultaneously for 30 minutes each session. This treatment is conducted 5 days a week with a 2-day rest period, for a total of 4 weeks.

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index(PSQI)	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 Outcome Measures

Name	Time	Method
Consensus Sleep Diary-Core(CSD)	Baseline, week1, week2, week3, week4	The Consensus Sleep Diary is primarily used to record and analyze sleep patterns and quality to help identify insomnia issues. While the Consensus Sleep Diary itself does not directly provide a scoring system, the recorded data can be used to calculate key sleep parameters. These parameters can be used to assess the severity of insomnia and the effectiveness of treatments.
Medical outcomes study sleep scale(MOS-SS)	Baseline,week4	The MOS-SS Sleep Scale consists of 12 items and requires respondents to recall their sleep conditions over the past 4 weeks. Based on the scores for each item, the key indicators' scores are calculated.
Epworth sleepiness scale(ESS)	Baseline,week4	The ESS consists of 8 questions, each describing a common daily activity. For each activity, respondents rate their tendency to doze off or fall asleep. The total score ranges from 0 to 24.
Swollen joint count(SJC)	Baseline, week2, week4	Swollen Joint Count (SJC) is another key clinical indicator for evaluating rheumatoid arthritis (RA). It measures the number of joints that are swollen due to inflammation, involving a total of 28 joints throughout the body.
Visual analogue scale(VAS) for pain	Baseline, week1, week2, week3, week4	Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe.
the Multidimensional Fatigue Inventory-20 (MFI-20)	Baseline,week4	The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Health Assessment Questionnaire（HAQ）	Baseline,week4	The Health Assessment Questionnaire (HAQ) has a total of 20 items, each scored to reflect the patient's functional ability in daily life. The scores for each item are averaged, resulting in a total score ranging from 0 to 3.
Tender joint count(TJC)	Baseline, week2, week4	Tender Joint Count is a key clinical indicator in evaluating rheumatoid arthritis (RA). It measures the number of joints where patients feel pain upon touch or movement, helping to assess the disease's activity and severity. It involves 28 joints throughout the body.
Disease Activity Score - 28 joints（DAS-28 ESR/CRP）	Baseline,week4	DAS28 helps monitor RA progression, guide treatment, and is used in research. It provides a reliable measure for managing RA effectively.
Hospital Anxiety and Depression Scale（HADS）	Baseline,week4	The Hospital Anxiety and Depression Scale (HADS) is a commonly used tool for screening and assessing anxiety and depression in general medical patients. The scale consists of 14 items. Each item is scored from 0 to 3 based on the severity of the symptoms, with a total score of 28.

Trial Locations

Locations (1)

Guang'anmen Hospital; 🇨🇳 Beijing, Beijing, China