Sjogren SyndromeFESSONANCT06875102
Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies
A study testing Acupuncture (ACU), Transcutaneous Vagus Nerve Stimulation (tVNS) and APA (adapted physical activity ) in people with Sjogren Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren Syndrome
- What is being tested?
- Acupuncture (ACU), Transcutaneous Vagus Nerve Stimulation (tVNS) and APA (adapted physical activity )
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2026to Apr 2028
- 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
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
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 de Saint-Etienne
Saint-Etienne, 42055
Martin KILLIAN, MD, (33) 4 77 82 91 79 ext. +33, martin.killian@chu-st-etienne.fr
Florence RANCON, Chef de projet, (33) 4 77 82 94 58 ext. +33, florence.rancon@chu-st-etienne.fr
About this study
Official title: Fatigue in Sjögren's Syndrome: a Randomized Controlled Trial of Combined Non-pharmacological Therapeutic Strategies
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.
FESSONA has been designed as a randomized controlled monocentric trial, aiming at comparing the effects of 3 different programs on fatigue in SjS: APA alone, APA+ACU and APA+tVNS. Relevant controls will be included as well (sham ACU and simulated tVNS).
Multiple fatigue and SjS-related features will be measured before (at inclusion) and after (week 12) the intervention, as well as at week 24 and 48, to evaluate the short- and long-term impact of each program. Tolerance and feasibility will also be evaluated.
- Conditions
- Sjogren Syndrome
- Being tested
- Acupuncture (ACU), Transcutaneous Vagus Nerve Stimulation (tVNS), APA (adapted physical activity ), Acupuncture (sham_ACU), Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)
- Keywords
- Sjögren's Syndrome, fatigue, acupuncture, adapted physical activity (APA), transcutaneous vagal nerve stimulation (tVNS)
- Medical subject headings
- Sjogren's Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture (ACU)Device
acupoints will be Baihui (GV20); Zhongwan (CV12), Guanyuan (CV4), bilateral Zusanli (ST36) bilateral Taichong (LV3). The needles will remain for 30 min. Subjects will receive acupuncture twice a week during the 12-week intervention.
Transcutaneous Vagus Nerve Stimulation (tVNS)Device
Transcutaneous Vagus Nerve Stimulation (tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. In the groups receiving simulated tVNS, stimulation will be delivered to the ear lobe, which is devoid of vagal innervation.
Stimulation will be delivered at a frequency of 20 Hz and a pulse width of 200 ms, while the stimulation amplitude will be individually titrated to 1 mA below the level that will lead to a mild unpleasant feeling, according to the parameters defined by Stavrakis et al (2017, 2020).
APA (adapted physical activity )Other
The APA (adapted physical activity ) program : 2 sessions of 90 min (with 60 min of aerobic exercise and 30 min of resistance exercises per session) per week, for 12 consecutive weeks
Acupuncture (sham_ACU)Device
Needles well be used in the non-acupoint area 2 centimeters away from the real acupoints. The needles will remain for 30 min. Subjects will receive sham acupuncture twice a week during the 12-week intervention.
Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)Device
Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. NSVt devices will be used in "simulated" mode.
| Study group | Role | What they receive |
|---|---|---|
| APA + sham ACU + tVNS | Experimental | Not described Receives: Device: Transcutaneous Vagus Nerve Stimulation (tVNS); Other: APA (adapted physical activity ); Device: Acupuncture (sham_ACU) |
| APA + ACU + simulated tVNS | Experimental | Not described Receives: Device: Acupuncture (ACU); Other: APA (adapted physical activity ); Device: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) |
| APA + Simulated tVNS + sham ACU | Sham comparator | Not described Receives: Other: APA (adapted physical activity ); Device: Acupuncture (sham_ACU); Device: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue score assessed
Change in fatigue score assessed using the FACIT-F questionnaire (Functional Assessment of Chronic Illness Therapy - Fatigue; ranging from 0 to 52, 0 meaning extreme fatigue and 52 the total absence of fatigue)
Measured: Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)
Secondary outcomes (12)
FACIT-F score in the different groups
FACIT-F score at 48 weeks, in the different groups
Measured: between inclusion (Week 0) and week 48
Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds)
Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds), measured from a nocturnal ECG recording by Holter ECG, in the different groups
Measured: at 12, 24 and 48 weeks,
Proportion (in %) of the 24 APA sessions carried out (at least 80% of the exercises proposed) in the different groups
Measured: week 48
ClinESSDAI score
ClinESSDAI score (clinical part of the EULAR Sjögren's Syndrome Disease Activity Index; assessed on 11 "domains" corresponding to the main clinical manifestations of the disease; ranging from 0 to 135, a score of 0 meaning the existence of a disease and a score of 135 a disease whose activity would be maximal) in the different groups
Measured: at 12, 24 and 48 weeks,
ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index)
ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index); calculated as the mean of 3 self-measurement scales assessing fatigue, dryness and pain, each ranging from 0 to 10; 0 meaning the total absence of the symptom considered and 10 a symptom whose intensity would be at the maximum imaginable) in the different groups
Measured: at 12, 24 and 48 weeks
HADS questionnaire (Hospital Anxiety and Depression Scale)
HADS questionnaire (Hospital Anxiety and Depression Scale) composed of an anxiety score and a depression score both ranging from 0 to 21, 0 meaning the absence of symptoms of this type, and 21 the presence of an anxiety and/or major depressive state) in the different groups
Measured: at 12, 24 and 48 weeks
Self-measurement questionnaire SF-36 (Short Form Health Survey 36)
Self-measurement questionnaire SF-36 (Short Form Health Survey 36); comprising 36 questions assessing 8 dimensions, namely physical functioning, role limitation due to physical problems, role limitation resulting from emotional problems, vitality (energy/fatigue), emotional well-being, social functioning, bodily pain, and perception of general and mental health; each dimension is represented by a score ranging from 0 to 100, with a low score signifying poor health perception in the dimension considered, and a high score signifying the opposite)
Measured: between inclusion (Week 0) and week 48
EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health
EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health (mobility, autonomy, daily activities, pain/discomfort and anxiety/depression) with 1 question per domain, with the possibility of choosing 5 degrees of severity each time (1 corresponding to no difficulty for the domain and 5 corresponding to the maximum degree of difficulty in the domain), the total of the 5 notes of the 5 domains giving a score ranging from 5 to 25, and this questionnaire is associated with a visual analogue scale (VAS) allowing the patient to rate his state of health of the day from 0 (the worst state of health imaginable) to 100 (the best state of health imaginable), in the different groups
Measured: at 12, 24, and 48 weeks,
Schirmer test
the area of the graduated blotter that became wet after 5 min of placement on the lower eyelid of each eye, expressed in millimeters and as the average of the two eyes) at 12, 24 and 48 weeks, in the different groups
Measured: at 12, 24 and 48 weeks
VO2max
VO2max (in ml/min/kg; after metabolic test) in the different groups
Measured: at 12, 24 and 48 weeks
Handgrip test
Handgrip test (in kg; via a grip test on the dominant upper limb) in the different groups
Measured: at 12, 24 and 48 weeks
Number of daily steps
Number of daily steps measured via a connected watch on average over the week preceding the assessments at 12, 24 and 48 weeks, in the different groups
Measured: at 12, 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start24 Mar 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sjogren SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin KILLIAN, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875102
- Sponsor's protocol ID
- 24CH125
- Other IDs
- ANSM
- Acronym
- FESSONA
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou X, Chen J, Colas C, Hupin D, Killian M. FatiguE in Sjogren's Syndrome: a randomised controlled trial of cOmbined Non-phArmacological therapeutic strategies (FESSONA). BMJ Open Sport Exerc Med. 2025 Jun 16;11(2):e002677. doi: 10.1136/bmjsem-2025-002677. eCollection 2025.
PubMed 40546749
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Sjögren's Syndrome: a Randomized Controlled Trial of Combined Non-pharmacological Therapeutic Strategies
- ClinicalTrials.gov ID
- NCT06875102
- Acronym / sponsor ID
- FESSONA / 24CH125
- Conditions
- Sjogren Syndrome
- Keywords
- Sjögren's Syndrome, fatigue, acupuncture, adapted physical activity (APA), transcutaneous vagal nerve stimulation (tVNS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 13 Mar 2025 (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.
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.
FESSONA has been designed as a randomized controlled monocentric trial, aiming at comparing the effects of 3 different programs on fatigue in SjS: APA alone, APA+ACU and APA+tVNS. Relevant controls will be included as well (sham ACU and simulated tVNS).
Multiple fatigue and SjS-related features will be measured before (at inclusion) and after (week 12) the intervention, as well as at week 24 and 48, to evaluate the short- and long-term impact of each program. Tolerance and feasibility will also be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| APA + sham ACU + tVNS | Experimental | Device: Transcutaneous Vagus Nerve Stimulation (tVNS), Other: APA (adapted physical activity ), Device: Acupuncture (sham_ACU) |
| APA + ACU + simulated tVNS | Experimental | Device: Acupuncture (ACU), Other: APA (adapted physical activity ), Device: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) |
| APA + Simulated tVNS + sham ACU | Sham comparator | Other: APA (adapted physical activity ), Device: Acupuncture (sham_ACU), Device: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Acupuncture (ACU)acupoints will be Baihui (GV20); Zhongwan (CV12), Guanyuan (CV4), bilateral Zusanli (ST36) bilateral Taichong (LV3). The needles will remain for 30 min. Subjects will receive acupuncture twice a week during the 12-week intervention. | Device | APA + ACU + simulated tVNS |
| Transcutaneous Vagus Nerve Stimulation (tVNS)Transcutaneous Vagus Nerve Stimulation (tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. In the groups receiving simulated tVNS, stimulation will be delivered to the ear lobe, which is devoid of vagal innervation. Stimulation will be delivered at a frequency of 20 Hz and a pulse width of 200 ms, while the stimulation amplitude will be individually titrated to 1 mA below the level that will lead to a mild unpleasant feeling, according to the parameters defined by Stavrakis et al (2017, 2020). | Device | APA + sham ACU + tVNS |
| APA (adapted physical activity )The APA (adapted physical activity ) program : 2 sessions of 90 min (with 60 min of aerobic exercise and 30 min of resistance exercises per session) per week, for 12 consecutive weeks | Other | APA + ACU + simulated tVNS, APA + Simulated tVNS + sham ACU, APA + sham ACU + tVNS |
| Acupuncture (sham_ACU)Needles well be used in the non-acupoint area 2 centimeters away from the real acupoints. The needles will remain for 30 min. Subjects will receive sham acupuncture twice a week during the 12-week intervention. | Device | APA + Simulated tVNS + sham ACU, APA + sham ACU + tVNS |
| Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. NSVt devices will be used in "simulated" mode. | Device | APA + ACU + simulated tVNS, APA + Simulated tVNS + sham ACU |
Primary outcome
Change in fatigue score assessed
Time frame: Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)
Change in fatigue score assessed using the FACIT-F questionnaire (Functional Assessment of Chronic Illness Therapy - Fatigue; ranging from 0 to 52, 0 meaning extreme fatigue and 52 the total absence of fatigue)
12 secondary outcomes
FACIT-F score in the different groups
Time frame: between inclusion (Week 0) and week 48
Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds)
Time frame: at 12, 24 and 48 weeks,
Proportion (in %) of the 24 APA sessions carried out (at least 80% of the exercises proposed) in the different groups
Time frame: week 48
ClinESSDAI score
Time frame: at 12, 24 and 48 weeks,
ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index)
Time frame: at 12, 24 and 48 weeks
HADS questionnaire (Hospital Anxiety and Depression Scale)
Time frame: at 12, 24 and 48 weeks
Self-measurement questionnaire SF-36 (Short Form Health Survey 36)
Time frame: between inclusion (Week 0) and week 48
EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health
Time frame: at 12, 24, and 48 weeks,
Schirmer test
Time frame: at 12, 24 and 48 weeks
VO2max
Time frame: at 12, 24 and 48 weeks
Handgrip test
Time frame: at 12, 24 and 48 weeks
Number of daily steps
Time frame: at 12, 24 and 48 weeks
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 30 Sep 2026.
- Derived from this study: PubMed 40546749Zhou X, Chen J, Colas C, Hupin D, Killian M. FatiguE in Sjogren's Syndrome: a randomised controlled trial of cOmbined Non-phArmacological therapeutic strategies (FESSONA). BMJ Open Sport Exerc Med. 2025 Jun 16;11(2):e002677. doi: 10.1136/bmjsem-2025-002677. eCollection 2025.
- 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.
Martin KILLIAN, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture (ACU), Transcutaneous Vagus Nerve Stimulation (tVNS) and APA (adapted physical activity ) in people with Sjogren Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 9 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 30 Sep 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. Some participants in this study may receive a placebo. 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 Martin KILLIAN, MD ((33)477 82 91 79 ext. +33, martin.killian@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue score assessed (time frame: Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06875102, which also lists 1 linked publication.
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 30 Sep 2026.