NCT06875102Recruiting
Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies
Fatigue in Sjögren's Syndrome: a Randomized Controlled Trial of Combined Non-pharmacological Therapeutic Strategies
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 174 (estimated)
- First submitted
- 4 Feb 2025
- Start date
- 24 Mar 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Diseases
- Sjögren's disease
- NCT number
- NCT06875102
What you commit to
- Study type: Interventional
- Planned participants: 174
- From 24 Mar 2026 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pre-existing atrial fibrillation or severe cardiac conduction disorders,
- Recent stroke or myocardial infarction (\<6 months),
- Recurrent episodes of vasovagal syncope, or history of vagotomy
- Current episode of venous or arterial thrombosis
Lab values
- Left ventricular ejection fraction \<40% or severe heart failure (New York Heart Association functional class III or IV)
Other
- People with dermatological problems in the area where the stimulation electrodes are to be placed
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu de Saint Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.