Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06875102 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
MinorEligibility criteria expanded, about 14 wordsSecondary endpoints: details revised at 6 of 12 entries · Publications: details revised at 1 of 1 entryShow 2 more changesShow less
Secondary endpoints: details revised at 6 of 12 entries
Publications: details revised at 1 of 1 entry
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of Jul 2025 to Mar 24, 2026 · Site details revisedv6Show 2 more changesShow less
Start date changed from estimate of Jul 2025 to Mar 24, 2026
Site details revised
MinorStart date: Jun 2025 to Jul 2025v5
MinorStart date: May 2025 to Jun 2025v4
MinorPrimary completion date: Dec 2026 to Apr 2027Completion date: Dec 2027 to Apr 2028 · Start date: Apr 2025 to May 2025v3Show 2 more changesShow less
Completion date: Dec 2027 to Apr 2028
Start date: Apr 2025 to May 2025
MinorStart date: Mar 2025 to Apr 2025Site contact updatedv2Show 1 more changeShow less
Site contact updated
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.