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New hope for Sjögren's fatigue: acupuncture and nerve zaps join exercise in clinical trial

NCT ID NCT06875102

Symptom relief Sponsor: Centre Hospitalier Universitaire de Saint Etienne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding acupuncture or a mild nerve stimulation device to an exercise program can reduce fatigue in people with Sjögren's syndrome. About 174 adults with long-term fatigue will be randomly assigned to one of three groups: exercise alone, exercise plus acupuncture, or exercise plus nerve stimulation. Researchers will measure fatigue levels at 12, 24, and 48 weeks to see which approach works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acupuncture and transcutaneous vagus nerve stimulation
What this could lead to
If successful, this could offer new, drug-free ways to manage chronic fatigue in Sjögren's syndrome, improving daily life for many patients.
What could go wrong
This is a single-center trial with 174 people, so results may not apply to everyone. The treatments are non-invasive but may not work better than placebo or exercise alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 174 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Fatigue Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sjogren syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chu de Saint-Etienne

    RECRUITING

    Saint-Etienne, 42055, France

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