An interventional study of Sudoscan testing in Sjögren's Syndrome, Small Fiber Neuropathy and Autonomic Dysfunction, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Diagnostic
The investigators propose to conduct a prospective study evaluating the prevalence of SNN in pSS patients and to find clinical characteristics and specific immunological profiles in pSS patients with SFN. Peripheral nervous system involvement account for 15% of pSS cases. Among peripheral nervous system complication, SFN appears to be prevalent. However the association between pSS and SFN has been scarcely evaluated. There are not many relevant studies using similar methodology to evaluate pSS patients for small fiber dysfunction. Furthermore, autoimmune mechanisms are thought to play a key role in SFN pathogenesis in pSS and the association between SFN and specific immunological profiles has been poorly studied. So the aim of this study is to evaluate the prevalence of SFN in pSS patients by using the Sudoscan which is a fast and non- invasive tool. The Sudoscan could offer an accessible alternative for early SFN detection, improving patient management. The secondary purpose is to analyze systemic and immunological profiles, as well as disease's activity and quality of life of patients with pSS-related SFN.
330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 218 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sudoscan testing with autoimmune serology for immune-mediated neuropathy evaluation.
prevalence of SFN in patients with pSS
To assess the prevalence of SFN in patients with pSS
Time frame: 18 months
time of onset of peripheral neuropathies
Time frame: 1 day
correlation of clinical features correlation with neuropathy severity
correlation of clinical features correlation with neuropathy severity
Time frame: 18 months
correlation of immunological profile with neuropathy severity
correlation of immunological profile with neuropathy severity
Time frame: 18 months
correlation of disease's activity with the quality of life
correlation of disease's activity with the quality of life
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Sep 2027, 18 months after the start.
Of 39 non-industry interventional studies with no phase under Sjogren's Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 18 months is close to that.
Counting every sponsor, half of 44 studies reached it within 18 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre Hospitalier Universitaire, Amiens →