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NCT Number: NCT06527547

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.

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Key information

Conditions

Transcutaneous Electric Nerve Stimulation Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dyssomnias Immune System Diseases Joint Diseases Mental Disorders Musculoskeletal Diseases Nervous System Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Juan Jiao, PhD

CONTACT

[email protected]

+8688001060

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 70.
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Consensus Sleep Diary-Core(CSD)

    Time frame: 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.

  2. Medical outcomes study sleep scale(MOS-SS)

    Time frame: 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.

  3. Epworth sleepiness scale(ESS)

    Time frame: 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.

  4. the Multidimensional Fatigue Inventory-20 (MFI-20)

    Time frame: 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.

  5. Tender joint count(TJC)

    Time frame: 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.

  6. Swollen joint count(SJC)

    Time frame: 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.

  7. Visual analogue scale(VAS) for pain

    Time frame: Baseline, week1, week2, week3, week4

    Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe.

  8. Disease Activity Score - 28 joints（DAS-28 ESR/CRP）

    Time frame: Baseline,week4

    DAS28 helps monitor RA progression, guide treatment, and is used in research. It provides a reliable measure for managing RA effectively.

  9. Health Assessment Questionnaire（HAQ）

    Time frame: 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.

  10. Hospital Anxiety and Depression Scale（HADS）

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Jiao

CONTACT

[email protected]

18611511082

Sponsors and collaborators

Lead sponsor

Juan Jiao

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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