Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Planned participants: 100
• From 31 Mar 2026 to the primary completion date, Sept 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with primary Sjögren's syndrome. It checks how common small fiber nerve damage is in these patients, using a quick skin test called Sudoscan.

Age

18 years or older

Sex

All sexes can join.

Disease stage

Primary Sjögren's syndrome confirmed by the ACR/EULAR 2016 criteria.

Earlier treatment

Medicines that could disturb the Sudoscan results must be stopped before joining. People who cannot stop them cannot join.

Main reasons for not taking part

• Secondary or unconfirmed Sjögren's syndrome
• Other conditions that may cause small fiber neuropathy
• Type 2 diabetes
• Excessive alcohol consumption
• Sarcoidosis or obesity

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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