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Træthed i Sjögrens syndrom: 3 terapeutiske strategier (FESSONA)

29. september 2026 opdateret af: Centre Hospitalier Universitaire de Saint Etienne

Træthed i Sjögrens syndrom: et randomiseret kontrolleret forsøg med kombinerede ikke-farmakologiske terapeutiske strategier

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

174

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Saint-Etienne, Frankrig, 42055
        • Rekruttering
        • Chu de Saint-Etienne
        • Underforsker:
          • David HUPIN, MD
        • Underforsker:
          • Hubert MAROTTE, MD PhD
        • Underforsker:
          • Baptiste GRAMONT, MD
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Lucile GRANGE, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: APA + SHAM ACU + TVNS
Enhed: Transcutaneous Vagus Nerve Stimulation (tVNS)

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).

Andet: APA (adapted physical activity )

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

Enhed: Acupuncture (sham_ACU)

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.
Eksperimentel: APA + ACU + simulerede TVN'er
Andet: APA (adapted physical activity )

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

Enhed: Acupuncture (ACU)

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.

Enhed: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)

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.
Sham-komparator: APA + simulerede TVNS + Sham ACU
Andet: APA (adapted physical activity )

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

Enhed: Acupuncture (sham_ACU)

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.

Enhed: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in fatigue score assessed
Tidsramme: 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)
Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Andel (i %) af de 24 APA -sessioner udført (mindst 80 % af de foreslåede øvelser) i de forskellige grupper
Tidsramme: Uge 48
Uge 48
FACIT-F score in the different groups
Tidsramme: between inclusion (Week 0) and week 48

FACIT-F score at 48 weeks, 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)
Tidsramme: 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
at 12, 24 and 48 weeks,
ClinESSDAI score
Tidsramme: 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
at 12, 24 and 48 weeks,
ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index)
Tidsramme: 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
at 12, 24 and 48 weeks
HADS questionnaire (Hospital Anxiety and Depression Scale)
Tidsramme: 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
at 12, 24 and 48 weeks
Self-measurement questionnaire SF-36 (Short Form Health Survey 36)
Tidsramme: 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)
between inclusion (Week 0) and week 48
EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health
Tidsramme: 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
at 12, 24, and 48 weeks,
Schirmer test
Tidsramme: 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
at 12, 24 and 48 weeks
VO2max
Tidsramme: at 12, 24 and 48 weeks

VO2max (in ml/min/kg; after metabolic test) in the different groups
at 12, 24 and 48 weeks
Handgrip test
Tidsramme: at 12, 24 and 48 weeks

Handgrip test (in kg; via a grip test on the dominant upper limb) in the different groups
at 12, 24 and 48 weeks
Number of daily steps
Tidsramme: 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
at 12, 24 and 48 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Efterforskere

  • Ledende efterforsker: Martin KILLIAN, MD

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. marts 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

4. februar 2025

Først indsendt, der opfyldte QC-kriterier

10. marts 2025

Først opslået (Faktiske)

13. marts 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 24CH125
  • ANSM (Anden identifikator: 2024-A02116-41)

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