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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Sleep Quality; Transcutaneous Electric Nerve Stimulation
• Intervention / Treatment: Device: Transcutaneous Auricular Vagus Nerve Stimulation; Device: Sham Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Jiao; Phone Number: 18611511082; Email: jiao.juan@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Guang'anmen Hospital
      • Contact: Juan Jiao, PhD; Phone Number: +8688001060; Email: jiao.juan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Sham Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index(PSQI)	Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.	Baseline, week1, week2, week3, week4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consensus Sleep Diary-Core(CSD)	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.	Baseline, week1, week2, week3, week4
Medical outcomes study sleep scale(MOS-SS)	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.	Baseline,week4
Epworth sleepiness scale(ESS)	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.	Baseline,week4
the Multidimensional Fatigue Inventory-20 (MFI-20)	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.	Baseline,week4
Tender joint count(TJC)	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.	Baseline, week2, week4
Swollen joint count(SJC)	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.	Baseline, week2, week4
Visual analogue scale(VAS) for pain	Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe.	Baseline, week1, week2, week3, week4
Disease Activity Score - 28 joints（DAS-28 ESR/CRP）	DAS28 helps monitor RA progression, guide treatment, and is used in research. It provides a reliable measure for managing RA effectively.	Baseline,week4
Health Assessment Questionnaire（HAQ）	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.	Baseline,week4
Hospital Anxiety and Depression Scale（HADS）	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.	Baseline,week4

Collaborators and Investigators

• Sponsor: Juan Jiao
• Collaborators: Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine; Hebei Provincial Hospital of Traditional Chinese Medicine; Shenzhen Futian Hospital of TCM

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Mental Disorders; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Wake Disorders; Arthritis; Dyssomnias; Parasomnias; Arthritis, Rheumatoid
• Other Study ID Numbers: 2024-139-KY-01; CI2021B007 (Other Grant/Funding Number: Traditional Chinese Medicine Technology Innovation Team for Rheumatology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes