See if small fiber neuropathy is common in people with primary Sjögren’s syndrome
Official title: Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Run by Centre Hospitalier Universitaire, Amiens · NCT07917442 · Data updated 2026-11-12
This study tests whether small fiber neuropathy is common in adults with primary Sjögren’s syndrome using a quick, non-invasive Sudoscan test.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | March 31, 2026 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07917442 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with primary Sjögren’s syndrome confirmed by ACR/EULAR criteria 2016, and BMI between 18 and 35 kg/m².
✕Probably not a fit
Patients with secondary Sjögren’s, other causes of SFN, or conditions excluding Sudoscan participation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective study will measure how often small fiber neuropathy occurs in patients with primary Sjögren’s syndrome and describe the associated clinical features and immune profiles. The researchers will use Sudoscan, a non-invasive skin conductance test, to screen for SFN and explore correlations with autoimmune markers. Participants will be adults with confirmed pSS, and several exclusion criteria are in place to minimize confounding conditions that cause SFN. The study aims to improve early detection and inform how SFN relates to pSS pathology. Results could help guide patient management and future research directions.
Why it matters
Potential benefit: If successful, the study could support earlier SFN detection in pSS patients and inform monitoring and treatment decisions.
How similar studies have gone: Previous work suggests a link between pSS and SFN, but standardized, non-invasive screening in this population is limited and this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Primary Sjögren's syndrome confirmed according to ACR/EULAR criteria 2016 * Body Mass Index between 18 and 35 kg/m² Exclusion Criteria: * Secondary or unconfirmed Sjögren's syndrome, * Age \< 18 years, Use of medications that could interfere with Sudoscan results and which could not be discontinued before inclusion, * Other conditions that may cause small fiber neuropathy, * type 2 diabetes, * excessive alcohol consumption, * sarcoidosis * obesity
Where it's running
-
CHU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Valéry SALLE, MD
- Email: salle.valery@chu-amiens.fr
- Phone: 33+3 22 66 82 30
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.