Three approaches to reduce fatigue in Sjögren's syndrome

Fatigue in Sjögren's Syndrome: a Randomized Controlled Trial of Combined Non-pharmacological Therapeutic Strategies

This trial will try adapted physical activity alone, adapted physical activity plus acupuncture, and adapted physical activity plus transcutaneous vagal nerve stimulation to see if they reduce chronic fatigue in adults with Sjögren's syndrome.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (other)
• Locations: 1 site (Saint-Etienne)
• Trial ID: NCT06875102 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with ACR/EULAR or AECG–defined Sjögren's syndrome who have had unexplained fatigue for six months or more with a FACIT-F score below 34 and who can attend in-person visits at the study center.

Not a fit: Patients whose fatigue is due to an identifiable cause (for example active disease flare, recent cardiac events, severe cardiac conduction disorders), or who have contraindications such as problematic skin at electrode sites, recurrent vasovagal syncope, or prior vagotomy, may not benefit or may be excluded.

Why it matters

Potential benefit: If successful, these programs could provide safe, non-drug options to reduce fatigue and improve daily functioning and quality of life for people with Sjögren's syndrome.

How similar studies have performed: Adapted physical activity has supportive evidence for improving fatigue in various conditions, while acupuncture and tVNS have produced mixed or preliminary results in smaller studies.

Eligibility criteria

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 this trial is running

Saint-Etienne

• Chu de Saint-Etienne — Saint-Etienne, France (RECRUITING)

Study contacts

• Principal investigator: Martin KILLIAN, MD
• Study coordinator: Martin KILLIAN, MD

Conditions: Sjogren Syndrome, Sjögren's Syndrome, fatigue, acupuncture, adapted physical activity, transcutaneous vagal nerve stimulation