Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies
FESSONA
2 other identifiers
interventional
174
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
March 13, 2025
CompletedStudy Start
First participant enrolled
March 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
March 27, 2026
July 1, 2025
1 year
February 4, 2025
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in fatigue score assessed
Change in fatigue score assessed using the FACIT-F questionnaire (Functional Assessment of Chronic Illness Therapy - Fatigue; ranging from 0 to 52, 0 meaning extreme fatigue and 52 the total absence of fatigue)
Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)
Secondary Outcomes (12)
FACIT-F score in the different groups
between inclusion (Week 0) and week 48
Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds)
at 12, 24 and 48 weeks,
Proportion (in %) of the 24 APA sessions carried out (at least 80% of the exercises proposed) in the different groups
week 48
ClinESSDAI score
at 12, 24 and 48 weeks,
ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index)
at 12, 24 and 48 weeks
- +7 more secondary outcomes
Study Arms (3)
APA + sham ACU + tVNS
EXPERIMENTALAPA + ACU + simulated tVNS
EXPERIMENTALAPA + Simulated tVNS + sham ACU
SHAM COMPARATORInterventions
acupoints will be Baihui (GV20); Zhongwan (CV12), Guanyuan (CV4), bilateral Zusanli (ST36) bilateral Taichong (LV3). The needles will remain for 30 min. Subjects will receive acupuncture twice a week during the 12-week intervention.
Simulated Transcutaneous Vagus Nerve Stimulation (sim\_tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. NSVt devices will be used in "simulated" mode.
Transcutaneous Vagus Nerve Stimulation (tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. In the groups receiving simulated tVNS, stimulation will be delivered to the ear lobe, which is devoid of vagal innervation. Stimulation will be delivered at a frequency of 20 Hz and a pulse width of 200 ms, while the stimulation amplitude will be individually titrated to 1 mA below the level that will lead to a mild unpleasant feeling, according to the parameters defined by Stavrakis et al (2017, 2020).
The APA (adapted physical activity ) program : 2 sessions of 90 min (with 60 min of aerobic exercise and 30 min of resistance exercises per session) per week, for 12 consecutive weeks
Needles well be used in the non-acupoint area 2 centimeters away from the real acupoints. The needles will remain for 30 min. Subjects will receive sham acupuncture twice a week during the 12-week intervention.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu de Saint-Etienne
Saint-Etienne, 42055, France
Related Publications (1)
Zhou X, Chen J, Colas C, Hupin D, Killian M. FatiguE in Sjogren's Syndrome: a randomised controlled trial of cOmbined Non-phArmacological therapeutic strategies (FESSONA). BMJ Open Sport Exerc Med. 2025 Jun 16;11(2):e002677. doi: 10.1136/bmjsem-2025-002677. eCollection 2025.
PMID: 40546749DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin KILLIAN, MD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2025
First Posted
March 13, 2025
Study Start
March 24, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
March 27, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share