Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorCentre Hospitalier Universitaire, Amiens
Academic / other
Locations1 site (Amiens)
StatusRecruiting
StartedMarch 31, 2026
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedNovember 4, 2026
Trial IDNCT07917442 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.