Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
NCT Number: NCT06527547
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transcutaneous Electric Nerve Stimulation|Rheumatoid Arthritis|Sleep Quality
Interventions: DEVICE: Transcutaneous Auricular Vagus Nerve Stimulation
Sponsor: Juan Jiao
Collaborators: The Affiliated Gaobeidian Hospital of China Academy of Chinese Medical Sciences|Shenzhen Hospital of Traditional Chinese Medicine|Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine|Hebei Provincial Hospital of Traditional Chinese Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-06
Completion Date: 2024-12-31
Locations: Guang'anmen Hospital, Beijing, Beijing, 100053, China

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.

Primary Outcome Measures: 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: 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