Transcutaneous Electric Nerve StimulationNCT06527547
Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Transcutaneous Electric Nerve Stimulation and Rheumatoid Arthritis, run by Juan Jiao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Transcutaneous Electric Nerve Stimulation, Rheumatoid Arthritis, Sleep Quality
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital
Beijing, Beijing Municipality, 100053
Juan Jiao, PhD, +8688001060, jiao.juan@hotmail.com
About this study
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.
Read more
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.
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation, Sham Stimulation
- Medical subject headings
- Arthritis, Rheumatoid, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week1, week2, week3, week4
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline,week4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start6 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electric Nerve StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Jiao
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Provincial Hospital of Traditional Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Shenzhen Futian Hospital of TCM, Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527547
- Sponsor's protocol ID
- 2024-139-KY-01
- Other IDs
- CI2021B007
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2024
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06527547
- Acronym / sponsor ID
- 2024-139-KY-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Juan JiaoUniversity, hospital or other
- Collaborators
- Hebei Provincial Hospital of Traditional Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Shenzhen Futian Hospital of TCM, Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS Group | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationThis 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. |
| Sham Stimulation Group | Sham comparator | Device: Sham StimulationThis 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. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationTreatment 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. | Device | taVNS Group |
| Sham StimulationTreatment 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. | Device | Sham Stimulation Group |
Primary outcome
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.
10 secondary outcomes
Consensus Sleep Diary-Core(CSD)
Time frame: Baseline, week1, week2, week3, week4
Medical outcomes study sleep scale(MOS-SS)
Time frame: Baseline,week4
Epworth sleepiness scale(ESS)
Time frame: Baseline,week4
the Multidimensional Fatigue Inventory-20 (MFI-20)
Time frame: Baseline,week4
Tender joint count(TJC)
Time frame: Baseline, week2, week4
Swollen joint count(SJC)
Time frame: Baseline, week2, week4
Visual analogue scale(VAS) for pain
Time frame: Baseline, week1, week2, week3, week4
Disease Activity Score - 28 joints（DAS-28 ESR/CRP）
Time frame: Baseline,week4
Health Assessment Questionnaire（HAQ）
Time frame: Baseline,week4
Hospital Anxiety and Depression Scale（HADS）
Time frame: Baseline,week4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Transcutaneous Electric Nerve Stimulation and Rheumatoid Arthritis, run by Juan Jiao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Jiao (18611511082, jiao.juan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index(PSQI) (time frame: Baseline, week1, week2, week3, week4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.