Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies

Not Applicable

Not yet recruiting

• Conditions: Sjogren Syndrome

• Registration Number: NCT06875102
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-13
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2027-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in fatigue score assessed	Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)	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)

Secondary Outcome Measures

Name	Time	Method
FACIT-F score in the different groups	between inclusion (Week 0) and week 48	FACIT-F score at 48 weeks, in the different groups
Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds)	at 12, 24 and 48 weeks,	Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds), measured from a nocturnal ECG recording by Holter ECG, in the different groups
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,	ClinESSDAI score (clinical part of the EULAR Sjögren's Syndrome Disease Activity Index; assessed on 11 "domains" corresponding to the main clinical manifestations of the disease; ranging from 0 to 135, a score of 0 meaning the existence of a disease and a score of 135 a disease whose activity would be maximal) in the different groups
ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index)	at 12, 24 and 48 weeks	ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index); calculated as the mean of 3 self-measurement scales assessing fatigue, dryness and pain, each ranging from 0 to 10; 0 meaning the total absence of the symptom considered and 10 a symptom whose intensity would be at the maximum imaginable) in the different groups
HADS questionnaire (Hospital Anxiety and Depression Scale)	at 12, 24 and 48 weeks	HADS questionnaire (Hospital Anxiety and Depression Scale) composed of an anxiety score and a depression score both ranging from 0 to 21, 0 meaning the absence of symptoms of this type, and 21 the presence of an anxiety and/or major depressive state) in the different groups
Self-measurement questionnaire SF-36 (Short Form Health Survey 36)	between inclusion (Week 0) and week 48	Self-measurement questionnaire SF-36 (Short Form Health Survey 36); comprising 36 questions assessing 8 dimensions, namely physical functioning, role limitation due to physical problems, role limitation resulting from emotional problems, vitality (energy/fatigue), emotional well-being, social functioning, bodily pain, and perception of general and mental health; each dimension is represented by a score ranging from 0 to 100, with a low score signifying poor health perception in the dimension considered, and a high score signifying the opposite)
EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health	at 12, 24, and 48 weeks,	EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health (mobility, autonomy, daily activities, pain/discomfort and anxiety/depression) with 1 question per domain, with the possibility of choosing 5 degrees of severity each time (1 corresponding to no difficulty for the domain and 5 corresponding to the maximum degree of difficulty in the domain), the total of the 5 notes of the 5 domains giving a score ranging from 5 to 25, and this questionnaire is associated with a visual analogue scale (VAS) allowing the patient to rate his state of health of the day from 0 (the worst state of health imaginable) to 100 (the best state of health imaginable), in the different groups
Schirmer test	at 12, 24 and 48 weeks	the area of the graduated blotter that became wet after 5 min of placement on the lower eyelid of each eye, expressed in millimeters and as the average of the two eyes) at 12, 24 and 48 weeks, in the different groups
VO2max	at 12, 24 and 48 weeks	VO2max (in ml/min/kg; after metabolic test) in the different groups
Handgrip test	at 12, 24 and 48 weeks	Handgrip test (in kg; via a grip test on the dominant upper limb) in the different groups
Number of daily steps	at 12, 24 and 48 weeks	Number of daily steps measured via a connected watch on average over the week preceding the assessments at 12, 24 and 48 weeks, in the different groups

Trial Locations

Locations (1)

Chu de Saint-Etienne; 🇫🇷 Saint-etienne, France