Three approaches to reduce fatigue in Sjögren's syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

FESSONA is a randomized, single-center trial comparing adapted physical activity (APA) alone, APA plus acupuncture (ACU), and APA plus transcutaneous vagal nerve stimulation (tVNS), each with sham controls. Adults meeting ACR/EULAR or AECG criteria for Sjögren's syndrome with unexplained fatigue for at least six months and a FACIT-F score under 34 are eligible. Fatigue and other SjS-related outcomes, together with safety, feasibility, and tolerance, are measured at baseline, week 12 (end of intervention), and at weeks 24 and 48 to capture short- and long-term effects. Standardized APA programs and device protocols are used to compare clinical benefit across groups.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu de Saint-Etienne
  Saint-Etienne, France Recruiting

Study contacts

• Principal investigator: Martin KILLIAN, MD
• Study coordinator: Martin KILLIAN, MD
• Email: martin.killian@chu-st-etienne.fr
• Phone: (33)477 82 91 79

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.