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Fatica nella sindrome di Sjögren: 3 strategie terapeutiche (FESSONA)

29 settembre 2026 aggiornato da: Centre Hospitalier Universitaire de Saint Etienne

Fatica nella sindrome di Sjögren: uno studio randomizzato controllato di strategie terapeutiche non farmacologiche combinate

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

174

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Francia
      • Saint-Etienne, Francia, 42055
        • Reclutamento
        • Chu de Saint-Etienne
        • Sub-investigatore:
          • David HUPIN, MD
        • Sub-investigatore:
          • Hubert MAROTTE, MD PhD
        • Sub-investigatore:
          • Baptiste GRAMONT, MD
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Lucile GRANGE, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Apa + sham acu + tvns
Dispositivo: 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).

Altro: 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

Dispositivo: 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.
Sperimentale: APA + ACU + TVNS simulato
Altro: 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

Dispositivo: 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.

Dispositivo: 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.
Comparatore fittizio: APA + simulato tvns + sham acu
Altro: 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

Dispositivo: 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.

Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in fatigue score assessed
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proporzione (in %) delle 24 sessioni APA eseguite (almeno l'80 % degli esercizi proposti) nei diversi gruppi
Lasso di tempo: Settimana 48
Settimana 48
FACIT-F score in the different groups
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigatori

  • Investigatore principale: Martin KILLIAN, MD

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 marzo 2026

Completamento primario (Stimato)

1 aprile 2027

Completamento dello studio (Stimato)

1 aprile 2028

Date di iscrizione allo studio

Primo inviato

4 febbraio 2025

Primo inviato che soddisfa i criteri di controllo qualità

10 marzo 2025

Primo Inserito (Effettivo)

13 marzo 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 24CH125
  • ANSM (Altro identificatore: 2024-A02116-41)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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