Sjögren's SyndromeNEUROSSNCT07917442
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
A study testing Sudoscan testing in people with Sjögren's Syndrome and Small Fiber Neuropathy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjögren's Syndrome, Small Fiber Neuropathy, Autonomic Dysfunction
- What is being tested?
- Sudoscan testing
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Primary Sjögren's syndrome confirmed according to ACR/EULAR criteria 2016
- Body Mass Index between 18 and 35 kg/m²
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Valéry SALLE, PhD, 03 22 66 88 22, Salle.Valery@chu-amiens.fr
About this study
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.
- Conditions
- Sjögren's Syndrome, Small Fiber Neuropathy, Autonomic Dysfunction, Autoantibodies, Non-invasive Diagnosis
- Being tested
- Sudoscan testing
- Keywords
- Sjögren's syndrome, small fiber neuropathy, Sudoscan, autonomic dysfunction, autoantibodies, non-invasive diagnosis
- Medical subject headings
- Sjogren's Syndrome, Small Fiber Neuropathy, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudoscan testingDiagnostic test
Sudoscan testing with autoimmune serology for immune-mediated neuropathy evaluation.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of SFN in patients with pSS
To assess the prevalence of SFN in patients with pSS
Measured: 18 months
Secondary outcomes (4)
time of onset of peripheral neuropathies
Measured: 1 day
correlation of clinical features correlation with neuropathy severity
correlation of clinical features correlation with neuropathy severity
Measured: 18 months
correlation of immunological profile with neuropathy severity
correlation of immunological profile with neuropathy severity
Measured: 18 months
correlation of disease's activity with the quality of life
correlation of disease's activity with the quality of life
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start31 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917442
- Sponsor's protocol ID
- PI2025_843_0185
- Acronym
- NEUROSS
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT07917442
- Acronym / sponsor ID
- NEUROSS / PI2025_843_0185
- Conditions
- Sjögren's Syndrome, Small Fiber Neuropathy, Autonomic Dysfunction, Autoantibodies, Non-invasive Diagnosis
- Keywords
- Sjögren's syndrome, small fiber neuropathy, Sudoscan, autonomic dysfunction, autoantibodies, non-invasive diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Primary Sjögren's syndrome confirmed according to ACR/EULAR criteria 2016
- Body Mass Index between 18 and 35 kg/m²
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sudoscan testingSudoscan testing with autoimmune serology for immune-mediated neuropathy evaluation. | Diagnostic test | – |
Primary outcome
prevalence of SFN in patients with pSS
Time frame: 18 months
To assess the prevalence of SFN in patients with pSS
4 secondary outcomes
time of onset of peripheral neuropathies
Time frame: 1 day
correlation of clinical features correlation with neuropathy severity
Time frame: 18 months
correlation of immunological profile with neuropathy severity
Time frame: 18 months
correlation of disease's activity with the quality of life
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sudoscan testing in people with Sjögren's Syndrome and Small Fiber Neuropathy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valéry SALLE, MD (33+3 22 66 82 30, salle.valery@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of SFN in patients with pSS (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.