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

NCT06527547 | Recruiting FDA Device

• 2 other identifiers: 2024-139-KY-01CI2021B007
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcutaneous Electric Nerve Stimulation; Rheumatoid Arthritis; Sleep Quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• the Multidimensional Fatigue Inventory-20 (MFI-20)

  Baseline,week4

• Tender joint count(TJC)

  Baseline, week2, week4

Study Arms (2)

taVNS Group

EXPERIMENTAL

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

Sham Stimulation Group

SHAM COMPARATOR

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

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

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.

taVNS Group

Sham Stimulation DEVICE

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.

Sham Stimulation Group

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 70.
• The type and dosage of rheumatoid arthritis medication must be stable for at least 4 weeks.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Juan Jiao

CONTACT

18611511082; jiao.juan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: June 6, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 13, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)