Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies

Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Study ID
NCT06875102
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acupuncture (ACU) — DEVICE
    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.
  • Transcutaneous Vagus Nerve Stimulation (tVNS) — DEVICE
    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).
  • APA (adapted physical activity ) — OTHER
    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
  • Acupuncture (sham_ACU) — DEVICE
    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.
  • Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 24, 2026
Status verified
Jul 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: APA + sham ACU + tVNS
  • Experimental: APA + ACU + simulated tVNS
  • Sham Comparator: APA + Simulated tVNS + sham ACU

Primary Outcome Measure

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

Central Contacts

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