RecruitingNAINTERVENTIONAL

Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies

This study is for people with Sjögren's syndrome who often feel very tired, a common symptom that can be hard to treat. It aims to find better ways to reduce this tiredness. Researchers are comparing three different approaches: a special exercise programme on its own, the exercise programme combined with acupuncture, or the exercise programme combined with 'transcutaneous vagus nerve stimulation' (tVNS), which gently stimulates a nerve in the neck. There will also be control groups using 'sham' (dummy) treatments to ensure fair comparisons. The study will track how participants' tiredness changes over time and check if the treatments are safe and easy to do.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrolment target

174

Start

24 Mar 2026

Estimated completion

01 Apr 2028

Sjogren Syndrome

What is this study about?

Many people with Sjögren's syndrome experience something called 'fatigue', which means feeling very tired all the time, even without obvious reasons. This tiredness can be really hard to live with, and current treatments don't always help enough. That's why researchers are looking for better ways to support people dealing with it.

This study, called FESSONA, wants to compare three different ways of tackling fatigue in Sjögren's syndrome. The first approach is a special exercise programme, designed to be gentle and helpful. The second combines this exercise with acupuncture, a traditional therapy involving very fine needles. The third approach combines the exercise programme with something called 'transcutaneous vagus nerve stimulation' (tVNS), which uses a small device placed on the skin to gently stimulate a specific nerve. The study will also include control groups who receive 'sham' (dummy) versions of acupuncture or tVNS, which look and feel similar but don't deliver the active treatment. This helps researchers work out if the real treatments are making a difference, or if other things like the attention from the study staff are having an effect.

The main goal is to see if any of these methods can significantly reduce fatigue. Researchers will check participants' fatigue levels and other symptoms at the beginning, then after 12 weeks of treatment, and again at 24 and 48 weeks to see if the effects last over time. They will also be looking at how well people tolerate the treatments and if they are practical to use in everyday life.

Key takeaways

This study explores new ways to help with fatigue in Sjögren's syndrome.
It compares exercise with exercise plus acupuncture or nerve stimulation.
The study includes control groups using dummy treatments.
It lasts for 48 weeks, with 12 weeks of active treatment.
Participation involves regular check-ups to measure fatigue levels.

Who may be eligible?

To join this study, you need to be at least 18 years old and have Sjögren's syndrome, diagnosed by specific medical guidelines. A key requirement is that you've been experiencing significant tiredness for at least six months that doesn't have another clear explanation or treatment.

However, there are reasons you might not be able to take part. This includes having certain heart conditions like a recent heart attack or a very weak heart, or if you've had a stroke recently. Also, if you have a history of fainting spells due to nerve issues, or if you are pregnant or breastfeeding, you wouldn't be able to join. Your doctor will carefully check all these points to make sure the study is safe for you.

Finally, you need to be able to understand what's involved and give your permission to take part, as well as attend all the scheduled follow-up appointments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Sjögren's syndrome?
Have you had unexplained, significant tiredness for at least 6 months?
Do you have any serious heart conditions or a history of recent stroke?
Are you pregnant or breastfeeding?
Are you able to attend follow-up appointments and give your consent?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would be assigned to one of several groups: either exercise alone, exercise plus acupuncture, exercise plus tVNS, or one of the sham (dummy) treatment groups. The interventions would typically last for 12 weeks.

During this time, you would have appointments at the study centre. Researchers would measure your fatigue levels and other symptoms at the beginning of the study, after 12 weeks of treatment, and then again at 24 weeks and 48 weeks to see how you're doing in the short and longer term. The total duration of the study would be about 48 weeks, including the treatment and follow-up periods. You won't be given any new medications by the study, only the specific interventions being tested.

Potential risks and benefits

Participating in this study might offer you the potential benefit of trying new approaches that could help reduce your fatigue. However, there's no guarantee that any specific treatment will work for you. There might be some minor risks or discomforts associated with the treatments, such as slight skin irritation from the tVNS device or mild bruising from acupuncture, but these are generally well-tolerated. The research team will carefully explain any known risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Chu de Saint-Etienne
Verified postcode
Saint-Etienne, France· Recruiting

Common questions

What is Sjögren's syndrome?

Sjögren's syndrome is a long-term condition that mainly affects the glands that produce tears and saliva, leading to dry eyes and mouth. It can also cause fatigue and pain.

What is tVNS?

tVNS stands for 'transcutaneous vagus nerve stimulation.' It's a method where a small device gently stimulates a nerve in your neck through the skin to help with certain health conditions.

What does 'sham' treatment mean?

'Sham' treatment means you receive something that looks or feels like the real treatment but doesn't have the active effect. It helps researchers compare results fairly.

How long will the treatments last?

The active treatment period for this study will last for 12 weeks.

Will I know which treatment group I'm in?

This is a 'blinded' study, meaning neither you nor the study team will know which specific treatment group you are in until the study is over, to ensure fair results.

How to find out more

Martin KILLIAN, MD

martin.killian@chu-st-etienne.fr (33)477 82 91 79 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.