Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies (FESSONA)

Centre Hospitalier Universitaire de Saint Etienne

Status: Not yet enrolling

Conditions: Sjogren Syndrome

Treatments: Device: Acupuncture (sham_ACU); Device: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS); Device: Transcutaneous Vagus Nerve Stimulation (tVNS); Other: APA (adapted physical activity ); Device: Acupuncture (ACU)

Study type: Interventional

Funder types: Other

Identifiers

NCT06875102

ANSM (Other Identifier)

24CH125

Details and patient eligibility

About

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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 3 patient groups

APA + sham ACU + tVNS

Experimental group

Treatment:

Other: APA (adapted physical activity )

Device: Transcutaneous Vagus Nerve Stimulation (tVNS)

Device: Acupuncture (sham_ACU)

APA + ACU + simulated tVNS

Experimental group

Treatment:

Device: Acupuncture (ACU)

Other: APA (adapted physical activity )

Device: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)

APA + Simulated tVNS + sham ACU

Sham Comparator group

Treatment:

Other: APA (adapted physical activity )

Device: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)

Device: Acupuncture (sham_ACU)