FatiguE in Sjögren's Syndrome: a randomised controlled trial of cOmbined Non-phArmacological therapeutic strategies (FESSONA).
Xinyao Zhou, Jinzhou Chen, Claire Colas...
https://pubmed.ncbi.nlm.nih.gov/40546749Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06875102
Fatigue in Sj f6gren's Syndrome: a Randomized Controlled Trial of Combined Non-pharmacological Therapeutic Strategies
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-03-27
174
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating three different non-drug treatment programs to address unexplained fatigue in adults with Sj f6gren's syndrome, a condition where fatigue affects 60-70% of patients and current physical activity programs only help to some extent. This randomized controlled trial compares adapted physical activity (APA) alone, APA combined with acupuncture (ACU), and APA combined with transcutaneous vagal nerve stimulation (tVNS). The trial also includes control groups receiving sham acupuncture and simulated tVNS to better understand the effects of these approaches. The study involves 12 weeks of intervention with APA sessions twice a week, each lasting 90 minutes including aerobic and resistance exercises. Participants in the ACU groups will receive acupuncture twice weekly at specific acupoints, while those in the tVNS groups will have nerve stimulation via an ear clip device. Sham treatments mimic acupuncture and tVNS without active stimulation. The aim is to compare how these programs impact fatigue and other related features in Sj f6gren's syndrome. Participants will be assessed for fatigue and Sj f6gren's symptoms before starting the program, immediately after 12 weeks, and again at 24 and 48 weeks to track short- and long-term effects. Measures include fatigue scores, heart rate variability, exercise adherence, disease activity, anxiety and depression scales, quality of life surveys, eye dryness tests, physical fitness tests, and daily activity tracking. The study also evaluates how well participants tolerate and can follow the programs, with total participation lasting up to 48 weeks.
CONDITIONS
Brief Title
Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient affiliated or entitled to a social security scheme
- Age greater than 18 years
- Patient informed and having signed the information form and consent to participate in the study
- Patient with Sj�f6gren's syndrome according to ACR/EULAR 2016 or AECG 2002 criteria
- Fatigue present for 6 months or more without obvious explanation and current FACIT-F score less than 34
You will not qualify if you...
- Pre-existing atrial fibrillation or severe cardiac conduction disorders
- Recent stroke or myocardial infarction within 6 months
- Left ventricular ejection fraction less than 40% or severe heart failure (New York Heart Association class III or IV)
- Recurrent episodes of vasovagal syncope or history of vagotomy
- Dermatological problems in the area where stimulation electrodes would be placed
- Current episode of venous or arterial thrombosis
- Pregnancy or breastfeeding
- Patient under protective measures such as legal protection, curatorship, or guardianship
- Inability or refusal to understand or sign informed consent or perform required follow-up examinations
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive a 12-week intervention consisting of adapted physical activity sessions twice a week combined with either acupuncture or sham acupuncture and transcutaneous vagus nerve stimulation or simulated stimulation.
Twice-weekly sessions for 12 weeks
Follow-up
Duration - Up to 36 weeks after treatment
Participants are assessed for fatigue and other health outcomes up to 48 weeks after starting the study interventions.
Visits at 12, 24, and 48 weeks
Trial Site Locations
Total: 1 location
1
Chu de Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
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Research Team
M
Martin KILLIAN, MD
F
Florence RANCON, Chef de projet
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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