Status:
NOT_YET_RECRUITING
Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Sjogren Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Unexplained fatigue is a frequent (60-70%) chronic complaint in Sjögren's syndrome (SjS) with a clear unmet therapeutic need, despite the recommendation of adapted physical activity (APA) programs, wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT06875102
Start Date
July 1 2025
End Date
April 1 2028
Last Update
July 8 2025
Active Locations (1)
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1
Chu de Saint-Etienne
Saint-Etienne, France, 42055