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New treatment option for Sjogren Syndrome
Official title Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies
ClinicalTrials.gov ID: NCT06875102
What this study is testing
- What it's testing
- Unexplained fatigue is a frequent (60-70%) chronic complaint in Sjögren's syndrome (SjS) with a clear unmet therapeutic need, despite the recommendation of adapted physical activity (APA) programs, which are effective and feasible, but only to some extent. Hence, other therapeutic approaches, such as Acupuncture (ACU) or transcutaneous vagal nerve stimulation (tVNS), have been evaluated during the past years, with varying degrees of success in alleviating fatigue.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient affiliated or entitled to a social security scheme.
- Age \> 18 years.
- Patient informed and having signed the information form and consent to participate in the study.
- Patient with Sjögren's syndrome according to ACR/EULAR 2016 or AECG 2002 criteria, usually followed up every year or more frequently
- Fatigue present for ≥ 6 months, without obvious explanation and/or specific treatment to conduct (e.g., disease's flare, chronic infection), with a...
You likely can't join if
- Pre-existing atrial fibrillation or severe cardiac conduction disorders,
- Recent stroke or myocardial infarction (\<6 months),
- Left ventricular ejection fraction \<40% or severe heart failure (New York Heart Association functional class III or IV)
- Recurrent episodes of vasovagal syncope, or history of vagotomy
- People with dermatological problems in the area where the stimulation electrodes are to be placed
- Current episode of venous or arterial thrombosis
See the full eligibility criteria
- Patient affiliated or entitled to a social security scheme.
- Age \> 18 years.
- Patient informed and having signed the information form and consent to participate in the study.
- Patient with Sjögren's syndrome according to ACR/EULAR 2016 or AECG 2002 criteria, usually followed up every year or more frequently
- Fatigue present for ≥ 6 months, without obvious explanation and/or specific treatment to conduct (e.g., disease's flare, chronic infection), with a current FACIT-F score \< 34
- Pre-existing atrial fibrillation or severe cardiac conduction disorders,
- Recent stroke or myocardial infarction (\<6 months),
- Left ventricular ejection fraction \<40% or severe heart failure (New York Heart Association functional class III or IV)
- Recurrent episodes of vasovagal syncope, or history of vagotomy
- People with dermatological problems in the area where the stimulation electrodes are to be placed
- Current episode of venous or arterial thrombosis
- Pregnancy or breastfeeding
- Patient under protective measures (legal protection, curatorship, guardianship)
- Inability or refusal to understand and/or sign informed consent to participate in the study, or to perform follow-up examinations required under the study
The study team makes the final eligibility decision.
Where it's taking place
- Saint-Etienne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint-Etienne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.