Clinical trial NCT06875102: Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies
Official title: Fatigue in Sjögren's Syndrome: a Randomized Controlled Trial of Combined Non-pharmacological Therapeutic Strategies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sjogren Syndrome
Keywords: Sjögren's Syndrome
fatigue
acupuncture
adapted physical activity (APA)
transcutaneous vagal nerve stimulation (tVNS)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


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

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: FACIT-F score in the different groups
timeFrame: between inclusion (Week 0) and week 48
measure: Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds)
timeFrame: at 12, 24 and 48 weeks,
measure: Proportion (in %) of the 24 APA sessions carried out (at least 80% of the exercises proposed) in the different groups
timeFrame: week 48
measure: ClinESSDAI score
timeFrame: at 12, 24 and 48 weeks,
measure: ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index)
timeFrame: at 12, 24 and 48 weeks
measure: HADS questionnaire (Hospital Anxiety and Depression Scale)
timeFrame: at 12, 24 and 48 weeks
measure: Self-measurement questionnaire SF-36 (Short Form Health Survey 36)
timeFrame: between inclusion (Week 0) and week 48
measure: EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health
timeFrame: at 12, 24, and 48 weeks,
measure: Schirmer test
timeFrame: at 12, 24 and 48 weeks
measure: VO2max
timeFrame: at 12, 24 and 48 weeks
measure: Handgrip test
timeFrame: at 12, 24 and 48 weeks
measure: Number of daily steps
timeFrame: at 12, 24 and 48 weeks
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Chu de Saint-Etienne
Study officials:
name: Martin KILLIAN, MD
role: PRINCIPAL_INVESTIGATOR
References: