Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies
France174 participantsStarted 2026-03-24
Plain-language 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, which are effective and feasible, but only to some extent. Hence, other therapeutic approaches, such as Acupuncture (ACU) or transcutaneous vagal nerve stimulation (tVNS), have been evaluated during the past years, with varying degrees of success in alleviating fatigue.
FESSONA has been designed as a randomized controlled monocentric trial, aiming at comparing the effects of 3 different programs on fatigue in SjS: APA alone, APA+ACU and APA+tVNS. Relevant controls will be included as well (sham ACU and simulated tVNS).
Multiple fatigue and SjS-related features will be measured before (at inclusion) and after (week 12) the intervention, as well as at week 24 and 48, to evaluate the short- and long-term impact of each program. Tolerance and feasibility will also be evaluated.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing three different strategies for managing fatigue in Sjögren's syndrome — can you explain what those three approaches are and whether any of them overlap with treatments I might already be trying or considering?
2Since this trial is listed as Phase NA, which often means it's not testing a new drug but rather comparing care approaches, what would my experience in this study actually look like day-to-day, and how much time or effort would it require from me?
3The main thing being measured here is a change in my fatigue score — can you help me understand how fatigue is being defined and tracked in this study, and whether that aligns with the kind of fatigue I'm actually experiencing with my Sjögren's?
4Are there any standard-of-care options for Sjögren's-related fatigue that I should try first before considering joining a study like this, or is my fatigue severe enough that a trial might be a reasonable next step to discuss?
5Given that this trial is actively recruiting right now, what is the process for finding out if I might be a good candidate to discuss with the research team, and what questions should I be prepared to answer at that screening conversation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in fatigue score assessed
Timeframe: Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)
Trial details
NCT IDNCT06875102
SponsorCentre Hospitalier Universitaire de Saint Etienne