Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT ETIENNE · Mar 10, 2025

Keywords

ClinConnect Summary

The clinical trial titled "Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies" is studying how different treatment programs can help reduce fatigue in people with Sjögren's syndrome (SjS), a condition that often causes chronic tiredness. The trial will compare three approaches: a program of adapted physical activity (APA) alone, APA combined with acupuncture (ACU), and APA combined with a treatment called transcutaneous vagal nerve stimulation (tVNS). Researchers will also include control groups to compare the effects of sham acupuncture and simulated tVNS. The goal is to see which combination is most effective in improving fatigue over time.

To participate, individuals must be over 18 years old, have a confirmed diagnosis of Sjögren's syndrome, and have experienced unexplained fatigue for at least six months. Participants will be monitored for their fatigue levels and other related symptoms at the beginning of the study and again at 12, 24, and 48 weeks after starting the treatment. This trial is not yet recruiting, but if you or someone you know is interested, it could provide valuable insights into managing fatigue in Sjögren's syndrome.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient affiliated or entitled to a social security scheme.
• • Age \> 18 years.
• • Patient informed and having signed the information form and consent to participate in the study.
• • Patient with Sjögren's syndrome according to ACR/EULAR 2016 or AECG 2002 criteria, usually followed up every year or more frequently
• • Fatigue present for ≥ 6 months, without obvious explanation and/or specific treatment to conduct (e.g., disease's flare, chronic infection), with a current FACIT-F score \< 34
• Exclusion Criteria:
• • Pre-existing atrial fibrillation or severe cardiac conduction disorders,
• • Recent stroke or myocardial infarction (\<6 months),
• • Left ventricular ejection fraction \<40% or severe heart failure (New York Heart Association functional class III or IV)
• • Recurrent episodes of vasovagal syncope, or history of vagotomy
• • People with dermatological problems in the area where the stimulation electrodes are to be placed
• • Current episode of venous or arterial thrombosis
• • Pregnancy or breastfeeding
• • Patient under protective measures (legal protection, curatorship, guardianship)
• • Inability or refusal to understand and/or sign informed consent to participate in the study, or to perform follow-up examinations required under the study